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1 Meeting: Breast Expert Advisory Group Date: 9 November 2017 Time: 1.00 4.00pm Venue: Evolve Business Centre Present: Mike Carr, Chair, Consultant Surgeon, Northumbria MC Pam Lee, LWBC Clinical Lead, Cancer Alliance PL Val Cross, BCN, North Tees VC Jan Harley, Lead Cancer Nurse, North Tees & Hartlepool JH Beak Kim, Registrar Breast Surgery, RVI BK Henry Cain, Consultant, RVI HC Jonathan Slade, Deputy Medical Director, NHSE JS Caroline Buchanan, BCN, Gateshead CB Anne Richardson, Service Improvement Lead AR Linda Wingersgill, Information Manager LW Wendy Taylor, Consultant Oncologist, Newcastle WT Louise Hunter, Macmillan Brest CNS, County Durham and Darlington LH Sophie Harvey, Oncologist, James Cook University Hospital SH Janine Graham, Consultant, James Cook University Hospital JG Penny Williams, Research Delivery Manager, CRN NENC PW Alice Townend, Consultant Breast Surgeon, Northumbria AT Wendy Carr, Breast Physician, Northumbria WC Amir Bhatti, Consultant Surgeon, County Durham and Darlington AB Dionne Lennox, Consultant Radiographer, Newcastle DL Jane Potterton, Consultant Radiologist Gateshead JP Kath Wall, Patient & Carer Representative, NECN KWa Claire McNeill, Quality Assurance Co-ordinator, Cancer Alliance CM Karen Dunn, Business Support Assistant KD Apologies: Adam Critchley, Newcastle AC Colm Hennessy, North Tees and Hartlepool CH Angela Tait, Northumbria AT Ludger Barthelmes, North Cumbria LB Eve Dixon, Newcastle Hospitals ED Julie Cox, Sunderland JC Kath Jones, Cancer Alliance KJ Katherine Kay, RVI KK Joanne Wilson, RVI JW Alison Wright, RVI AW Eileen Tague, RVI ET Louise Saddler, Friarage Hospital, South Tees LS
Transcript
Page 1: Meeting: Breast Expert Advisory Group

1

Meeting: Breast Expert Advisory Group

Date: 9 November 2017

Time: 1.00 – 4.00pm

Venue: Evolve Business Centre

Present:

Mike Carr, Chair, Consultant Surgeon, Northumbria MC

Pam Lee, LWBC Clinical Lead, Cancer Alliance PL

Val Cross, BCN, North Tees VC

Jan Harley, Lead Cancer Nurse, North Tees & Hartlepool JH

Beak Kim, Registrar Breast Surgery, RVI BK

Henry Cain, Consultant, RVI HC

Jonathan Slade, Deputy Medical Director, NHSE JS

Caroline Buchanan, BCN, Gateshead CB

Anne Richardson, Service Improvement Lead AR

Linda Wingersgill, Information Manager LW

Wendy Taylor, Consultant Oncologist, Newcastle WT

Louise Hunter, Macmillan Brest CNS, County Durham and Darlington

LH

Sophie Harvey, Oncologist, James Cook University Hospital

SH

Janine Graham, Consultant, James Cook University Hospital

JG

Penny Williams, Research Delivery Manager, CRN NENC PW

Alice Townend, Consultant Breast Surgeon, Northumbria AT

Wendy Carr, Breast Physician, Northumbria WC

Amir Bhatti, Consultant Surgeon, County Durham and Darlington

AB

Dionne Lennox, Consultant Radiographer, Newcastle DL

Jane Potterton, Consultant Radiologist Gateshead JP

Kath Wall, Patient & Carer Representative, NECN KWa

Claire McNeill, Quality Assurance Co-ordinator, Cancer Alliance

CM

Karen Dunn, Business Support Assistant KD

Apologies:

Adam Critchley, Newcastle AC

Colm Hennessy, North Tees and Hartlepool CH

Angela Tait, Northumbria AT

Ludger Barthelmes, North Cumbria LB

Eve Dixon, Newcastle Hospitals ED

Julie Cox, Sunderland JC

Kath Jones, Cancer Alliance KJ

Katherine Kay, RVI KK

Joanne Wilson, RVI JW

Alison Wright, RVI AW

Eileen Tague, RVI ET

Louise Saddler, Friarage Hospital, South Tees LS

Page 2: Meeting: Breast Expert Advisory Group

2

Matei Dordea, NTH MD

Sheron Robson, Cancer Alliance SR

Nicola Johnson, NHCT NJ

MINUTES

1. INTRODUCTION Lead Enc

1.1 Welcome and Apologies

MC welcomed all to the meeting, apologies as listed above.

1.2 Declaration of Interest

No declaration of conflict of Interest was made.

1.3 Minutes of the previous meeting 16.03.17

Minutes agreed as a true and accurate record.

Enc 1

1.4 Matters arising

Chemo –prevention with tamoxifen No updates were noted.

Adjuvant bisphosphonates – Business case

HC confirmed there was a degree of variation across the patch. The Group noted Sunderland had commissioned an Adjuvant bisphosphonates service and Newcastle had produced a Business Case. Durham was providing a service but not a commissioned service. This topic would be discussed further at the Cancer Alliance Meeting, following which an update would be shared with the Group. This would be discussed at the next meeting.

KD

2. AGENDA ITEMS

2.1 Breast Cancer in Pregnancy

LW stated TB was currently on leave, an update would be sought from him on his return and sent out to the Group with the minutes. JS referred to a draft Breast Cancer document sent out with last minutes. LW would verify the status of the document with TB on his return; an update would be sent to the group with the minutes.

2.2 Breast Service Task Group update

The Alliance was conducting a configuration of breast cancer services across the patch. All areas had conducted preliminary meetings. The following was noted:

Page 3: Meeting: Breast Expert Advisory Group

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South of the patch a hub and spoke model was currently being put forward.

Mid patch resources were not available to take on North Durham patients.

North of patch had held their first meeting the previous week; Providers were to look at their capacity. Commissioner tasked with looking at their model.

It was noted the Screening Service had carried out a review the previous year which had looked at configuration of future services. The lack of radiology cover in most areas was highlighted as an issue by the group. The Trusts expressed the importance of commissioning services and set an agreed date for Hub and Spoke services. Trusts in the north of the patch have agreed to explore the possibility of a mutual support network to help each other out in the event of a surgeon, radiologist or pathologist becoming indisposed without notice.

2.3 Regional Update on services from each Trust

Gateshead

Screening service for South of Tyne

2 new consultant breast surgeons now in post

2 new breast nurse specialists appointed

Exploring alternative imaging resources and have appointed a trainee consultant radiographer

Consultant radiologist vacancies plan to re-advertise

Run Symptomatic services on two sites, 5 days per week at QE site, currently 2 one stop clinics at Grindon Lane , looking to start a third

trying to work towards increasing clinics for patients in Sunderland

Low risk pathway up and running

Taking on Sunderland follow up patients

Newcastle

Appointed two new breast Cancer Nurse specialists.

Page 4: Meeting: Breast Expert Advisory Group

4

From March 2018 will be 2.5 whole time equivalent radiologists short. Next year will be losing two surgeons who run one stop clinics, specialist nurse will be going too, no replacement training expected. Made 2 band 6 specialist nurse appointments, lost band 7 lead nurse. Trying to keep up with Symptomatics In order to meet breast screening targets, the group noted facilities were needed to accommodate their imaging equipment. It was acknowledged there was a lack of radiologists, however, the trust has a seven year plan to address this. This included in house training, looking at efficiency to best utilise resources and commitment to the one stop clinic which currently had 105 – 120 patients per week using evening capacity. Real estate was also highlighted as an issue, discussion followed on the possible use of Hubs across the area.

Tees Service

North Tees and Hartlepool

Symptomatic work screening KPIs has put a lot of stress on radiologist within the Teesside service

Recruited trainee breast care nurse

Unit refurbished, additional funds required to extend services

CDDFT

2 associate specialists would like another surgeon

Got a good locum based in Darlington

1 Radiologist

Retired consultant who wants to carry on 2/3 years more

2 breast nurse vacancies

Medical and clinical oncologists covering patch JS gave an update on STPs and workforce issues.

Page 5: Meeting: Breast Expert Advisory Group

5

Group discussed the issues holding back service development. JS suggested all to continue to feed back issues to NHS England. Group also discussed the issues around European employees and the unclear position regarding Brexit.

2.4 Cancer Alliance Update

Transformation Bids With regards to early diagnosis the Alliance had been successful in securing monies in phase 1; Julie Owens, Programme Manager had been appointed. Pathway improvement work has been prioritised on upper, lower GI and Lung pathways. The delivery plan had been condensed into a plan on a page, this was now accessible via website. http://www.necn.nhs.uk/wp-content/uploads/2014/04/Cancer-plan-on-a-page-FINAL.pdf LW confirmed the Alliance had been successful in bidding for living with and beyond cancer transformation funding and is currently preparing milestone documents with regards to stratified pathways and recovery package.

2.5 Activity Reporting

LW presented the yearly Breast Cancer Activity Report which will be emailed with the minutes. Any feedback on the data presented to be forwarded to [email protected]. This presentation will not be uploaded onto the website due to unpublished data.

KD

Enc 2

2.6 Terms of Reference

Currently the Alliance was updating the Terms of Reference for all Expert Advisory Groups; these have been circulated for comments to the Leadership Group, following which they would be forwarded to the specific groups. The Group considered the draft ToR and discussed the quoracy requirements. It was agreed the draft document

Page 6: Meeting: Breast Expert Advisory Group

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would be circulated with the minutes to the group for further consideration. Following confirmation from MC that he was standing down as chair of the group, it was agreed KD would send out the job specification with the minutes. Any expressions of interest were to be forwarded to TB.

KD KD

Enc 3 Enc 4

2.7 Clinical Advice to Cancer Alliance for the Provision of Breast Cancer Service

National recommendation for the provision of breast services is attached for information.

KD

Enc 5

3. STANDING ITEMS

3.1 Audit Newcastle Breast and Genetic Joint Clinic -

presentation

Baek Kim, TIG Oncoplastic Fellow, RVI gave a presentation on Oncoplastic MDT meeting and Joint Genetics Clinic, this would be sent out with the minutes The Group discussed the joint genetics clinic in great detail and noted this clinic is run in addition to the Cancer MDT. It was acknowledged that patients may be asked to stop smoking in order to receive treatment.

KD

Enc 6

3.2 Living with and beyond cancer presentation

PL gave a presentation on Living with and Beyond Cancer; this would be sent out with the minutes. PL informed the group of the successful bid for living with and beyond cancer transformation monies specifically stratified pathways and recovery package. The group noted the alliance were currently planning spend against projects and meeting with the hosting CCGs to discuss finance. PL asked if any trusts had current living with and beyond cancer projects which may benefit from Alliance support. A letter will be issued next week asking for people to contact PL with further details. Expressions of interest to be received by 4 December 2017. HC discussed a randomised trial and asked if that was appropriate. PL advised it would not be able to support the trial but could support health and wellbeing patient events.

KD

Enc 7

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The process for the allocation of funding for projects was discussed in detail. PL to raise this at the Transformation Board the following day and feedback to MC. HC to forward PL details of the project for consideration.

HC

3.3 Presentation – Oncotype Data – Breast TSG

This would be discussed at next meeting. KD to Invite Daniella Lee to present the item.

KD

3.4 Research Presentation

PW gave a presentation on Breast Cancer Research. PW to send out for information to the group. The Group discussed current trials available and how to improve recruitment numbers. PW asked for suggestions on how to improve recruitment to Mammo 50 trials. Cumbria South Tees and Tyneside had been approached for additional sites PW to send out for information to the group. PW asked HC to contact her once in a position to add the Northumbria University trial and she would assist him to add this to the portfolio. PW asked all to consider recruiting TYA patients into trials, however, the group advised her that TYA for breast were very low.

PW PW

3.5 Clinical Governance Issues

No clinical governance issues noted.

3.6 Any Other Business

2 WW proforma

The group agreed the form was an improvement. The following amendments were noted:

Removal of tick box agreed

Reason box, state “if no info in box referral will be returned”

Page 8: Meeting: Breast Expert Advisory Group

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The group agreed to give further consider to the form and feedback any comments to Katie Elliott. [email protected] Clinical Guidelines With regards to reviewing the Clinical Guidelines it was agreed a group approach would be necessary to share the workload. A table outlining allocated actions to individuals would be circulated with the minutes.

KD

Enc 8

3.7 Meeting Dates

Provisional dates to be confirmed Thursday 10 May 2018 2.00 – 5.00, Evolve Thursday 8 November 2018 2.00 – 5.00, Evolve

4. MEETING CLOSE

Contact [email protected] tel 011382521608

Page 9: Meeting: Breast Expert Advisory Group

1

Meeting: Breast NSSG

Date: 16 March 2017

Time: 2.00 – 4.00pm

Venue: Evolve Business Centre

Present: Amanda Allan CDDFT AA

Tony Branson. Network Medical Director, NESCN TB

Mike Carr, Chair, Consultant Surgeon, Northumbria MC

Val Cross, BCN, North Tees VC

Kath Jones, Network Delivery Lead, Cancer Alliance KJ

Mel Jones CDDFT MJ

Dionne Lennox, Consultant Radiographer, Newcastle DL

Jo Macintosh, Macmillan engagement and Co-design , Cancer Alliance JM

Jane Potterton, Consultant Radiologist Gateshead JP

Mel Robinson, Cancer Lead Sunderland MR

Kath Wall, Patient & Carer Representative, NECN KWa

Claire McNeill, Quality Assurance Co-ordinator, Cancer Alliance CM

Apologies: Helen Turnbull, Newcastle HT

Nicola Storey, South Tees NS

Ludger Barthelmes North Cumbria LB

Kevin Clark, Gateshead KC

Mark Verrill, Newcastle MV

Adam Critchley, Consultant Surgeon, Newcastle AC

Colm Hennessy, Consultant Surgeon, North Tees and Hartlepool CH

Nicola Johnson, CNS, Northumbria NJ

Amanda Walshe, Lead Cancer Nurse , Northumbria AW

Sarah Lawless South Tees SL

Wendy Taylor, Newcastle WT

Wendy Carr, Breast Physician, Northumbria WC

MINUTES

1. INTRODUCTION Lead Enc

1.1 Welcome and Apologies

MC welcomed all to the meeting, apologies as listed above.

1.2 Declaration of Interest

No Declaration of conflict of Interest made.

1.3 Minutes of the previous meeting 08.12.16 Enc 1

Minutes agreed as a true and accurate record.

1.4 Matters arising

Chemo –prevention with tamoxifen MC to chase and update at next meeting.

MC

Adjuvant bisphosphonates – Business case

Page 10: Meeting: Breast Expert Advisory Group

2

Application has been submitted to Steve Williamson. TB advised application is making progress. MC will contact Steve Williamson.

MC

2. AGENDA ITEMS

2.1 Breast Cancer in Pregnancy

No additional comments received document endorsed and added to clinical guidelines. TB informed the contact / support group to be available to staff treating these patients still needs to be established. TB to update at the next meeting.

TB

Enc 2

2.2 Breast Service Task Group update

The Regional Breast Review continues to progress, however it has been acknowledged that further inclusive and collaborative discussions are required, therefore the Alliance will facilitate these meetings incorporating service providers and commissioners using the STP footprints within the Alliance geography. It is anticipate the first meeting will take place at the beginning of June with other meetings planned through June/July. The Alliance will be in touch with individuals to participate in these discussions in due course. KJ advised of discussions considering aligning Hub and spoke services to screening units. Group discussed the impact on radiologists, capacity, productivity and unused diagnostic equipment in great detail. Group also discussed the possibility of providing alternative clinics within the same trust if they had capacity elsewhere, to avoid delays. Group discussed the necessity of ensuring Nurses are involved in future discussions. KJ to ensure the nurses voice is represented.

KJ

2.3 Regional Update on services from each Trust

Gateshead

JP advised Gateshead have appointed a consultant radiologist but still have resource issues. Grindon is now running two clinics a week and open on choose and book

Page 11: Meeting: Breast Expert Advisory Group

3

and looking to increase patient numbers. 62 day target has been challenging. The Screening Unit had a reasonably successful QA visit and awaiting full report. JP discussed surveillance mammograms particularly the safety netting of Sunderland patients. MR advised Sunderland patients are having their review mammograms carried out at a private Hospital in Washington, however, this is unsustainable. It is the intention for reviews to be carried out at Grindon or the QE in the future.

Newcastle

New replacement radiologists starting in June replacing two retired consultants. Waiting list initiatives being undertaken to meet demand. Spike in referrals in young people but now appears to have levelled out. Extra screening being undertaken.

Northumbria

MC discussed the two tier service run at Northumbria with some patients needing to attend twice. Overall managing to see everyone in 2 weeks but running weekend clinics to meet demand. Recently lost clinical oncologist with Newcastle providing cover. New radiologist consultant appointed.

Tees Service

2 Nurses retiring soon and need to recruit. Looking at succession planning.

CDDFT

Situation remains the same currently running on locums and holding evening clinics and at maximum capacity.

All Trusts updated working extra sessions over evenings and weekends to meet demand. KJ asked all to send list of new staffs emails to be added to the distribution list to CM.

All

2.4 Cancer Alliance Update

Transformation Bids Early diagnosis TB discussed the cancer alliance’s successful bid in phase 1 contained the following;

Pathology network- digital system

Page 12: Meeting: Breast Expert Advisory Group

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Radiology – digital workflow system and workforce

Pathway redesign for -, lung, upper and lower GI, Urology and vague symptoms.

Workforce and training.

Prevention and Awareness Recovery package and stratified pathways Phase 2 was also successful- timescales are expected to be September /October.

Cancer Alliance Launch Event

Launch event is being held on the 30th March 2017 at Newcastle Race Course. If anyone is having difficulties registering please email [email protected]

MDT Review

TB informed the group on work being undertaken looking at making MDTs more efficient. Meeting held on the 10 March 2017, with representation from all Trusts. The focus of the group was to establish if all discussions taken place at MDT added value. Gap analysis being undertaking and looking to reduce attendance levels to 25% but more focus on quoracy. Work is ongoing. Update to be provided at the next meeting.

3. STANDING ITEMS

3.1 Audit Presentation – Newcastle Breast and Genetic

Joint Clinic AC sent his apologies as he was unable to attend but agree to present this at the next meeting in October.

3.2 Living with and beyond cancer

Karen Robert or Anne Richardson to be invited to present at the next meeting.

3.3 NICE Guidelines

None

3.4 Clinical Governance Issues

None

3.5 Any Other Business

Page 13: Meeting: Breast Expert Advisory Group

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Locality Groups

KJ advised patient issues would be addressed at locality groups, if these remain unresolved these would then be escalated to the cancer alliance. Post meeting note The “patient and carer” standing agenda item has been removed from future agenda’s as it is expected patient representatives will contribute to all discussions.

Duty of Candour

JP discussed the national toolkit and template letters to address duty of candour. Group agreed to use national papers once available.

Symptomatic guidance age

National Symptomatic Guidance age is 40 however, the Alliance Guidelines state 35. Trusts to clarify local practice. All to take back to trusts and feedback at the next meeting re the age range Trusts are working to.

All

Clinical Guidelines to be reviewed. Clinical guidelines are due to be renewed. Discussions on how to manage this took place and it was agreed for the group to share this work out. All to consider which sections they can review/update. CM to send out index and members to confirm which sections they will review.

ALL CM

3.6 Meeting Dates;

Thursday 12th October 2017, 1.00- 4.00, Evolve Business Centre- Outcomes Data Presentation

4. MEETING CLOSE

Contact [email protected] tel 01138252976

Page 14: Meeting: Breast Expert Advisory Group

Version Control: Version: 1 Date: 27/09/17 Review: September 2020

U

Northern Cancer Alliance Expert Advisory Group

For insert name

TERMS OF REFERENCE

Chairperson:

insert name

Purpose: The primary purpose of Northern Cancer Alliance (NCA) Expert Advisory Group insert name is to provide cross organisational representation to ensure that all patients with cancer in the North East and North Cumbria receive equitable access to safe, evidence based and effective care. We will achieve this by holding each other to account for performance in this respect.

Membership: Core membership: Chair person Representative from each service provider organisation Patient and carer representative

Locality representatives Clinical Network administration support Clinical lead Northern Cancer Alliance

Additional membership to be determined by group.

Extended membership Palliative care representative Clinical research network representative TYA representative

Specific Role: To be the insert name expert advisory group to the Northern

Cancer Alliance. To support the delivery plan of the NCA. To develop and maintain up to date clinical guidelines. These

may in part be reference to nationally developed guidelines where available.

To review local data and metrics such as the cancer dashboard, and where possible use them to inform service improvement proposals.

To provide a forum for the sharing of good practice, discussing local and national issues and initiatives.

To ensure the views of patients and carers are taken into account in the planning, operation and evaluation of services including Patient Information material.

To lead rapid change, including the development and implementation of consistent standards within available

Page 15: Meeting: Breast Expert Advisory Group

Version Control: Version: 1 Date: 27/09/17 Review: September 2020

resources. To ensure NCA clinical and strategic service development

issues are shared within member organisations. To ensure that clinical research is incorporated into the work

of the Group. To contribute to the Alliance needs assessment of education,

training and work force planning

Accountability: The tenure of the Chair will be 2 years with an option to extend for a further 2 years. (maximum tenure at discretion of group) A vice chair will deputise for the chair when necessary and normally succeed the chair when they step down To report to the NCA board through the Chair’s membership of the NCA Clinical Leadership group of which the Expert Advisory Group Chairs are members.

Frequency of Meetings:

Bi-annual meetings will be held with one inclusive of NCA site specific performance data.

Quorum: A minimum requirement for quorate to be achieved is attendance by 75% of core members who provide a service.

Admin: Action Points ☐ Minutes ☒

Ownership of Group Projects and Initiatives:

All projects, initiatives and outcomes will be owned by each member of the group that has taken part in the group project or initiative.

Ways of Working Together

All relationships must be handled in an open and transparent manner, which comply with the requirements of guidance issued by the Department of Health. Healthcare professionals have a responsibility to comply with their own codes of conduct at all times.

Communication Arrangements:

Minutes will be forwarded to members within three weeks. Agendas and minutes will be posted on the group page of the Northern England Clinical Network website. Items for the agenda should be received 7 days before the meeting. Inter meeting communication will be circulated by email from the NCA.

Declaration of Interest:

All potential or perceived conflicts of interest should be declared.

Page 16: Meeting: Breast Expert Advisory Group

Northern Cancer Alliance Expert Reference Groups

Chair Job Specification February 17

Job Title: Chair Expert Reference Group

Responsible to: Clinical Lead Cancer Alliance

Accountable to: Northern Cancer Alliance Manager

ROLES AND RESPONSIBILITIES The Expert Reference Group (ERG) Chair has overall responsibility for the development of co-ordinated, cohesive and integrated networked cancer services for a specific tumour site. This will be achieved primarily by ensuring that the ERG operates efficiently and effectively to facilitate these developments across the Alliance. Specifically, the Chair should:

Work with the Northern Cancer Alliance to ensure all Trusts in the network are involved and primary care is appropriately represented.

Aim to ensure groups are multi-professional in nature.

Take responsibility for delivering on the Cancer Alliance Work Plan for the Group.

Ensure that systems and processes are in place to:

- Review (and update) local and national outcomes - Collect minimum cancer data sets - Support accreditation/quality assurance - Facilitate user involvement in the development of services

Ensure that any Tumour specific issues of clinical governance are supported by

adequate protocols across the region.

Organise meetings at least twice a year. The Northern Cancer Alliance will provide support to book rooms and circulate agendas for these meetings. (see ERG TOR for additional local meetings)

Prepare the agenda for and chair ERG meetings ensuring that adequate time is allowed

for each item under discussion and stakeholders’ views are sought.

Ensure that minutes and action notes are circulated as appropriate.

Ensure a vice chair is nominated. This would support succession planning and help in attending various meetings.

Page 17: Meeting: Breast Expert Advisory Group

Ensure that the Cancer Alliance Manager is briefed about the progress being made by the ERG or any specific issues.

Lead discussions with other ERGs on issues of common interest.

VICE CHAIR

The ERG Chair is a challenging role. Good practice would be Chair and Vice Chair (preferably one from North and one from South) this would support succession planning. NOMINATION AND SELECTION PROCESS

Nominations for Chair and Vice Chair, to come from the ERG, followed by a selection process (undertaken by the Northern Cancer Alliance Board). TERM OF OFFICE

2 years with an option to a further 2 years (maximum 4 years Term of Office). The chair and the vice chair may agree to switch role after 1-2 years. SUPPORT

Employing Trust The chair must secure its own Trust support to undertake the role Northern Cancer Alliance staff/ team

PERSONAL QUALITIES AND EXPERIENCE Ideally, the Chair will:

Be able to influence others to develop a commonly held vision for the development of the service

Demonstrate enthusiasm for working collaboratively with other organisations, including other Trusts and primary care

Be energetic and enthusiastic and capable of enthusing others Have excellent communication skills Be a team player, able to lead and work within a multidisciplinary environment, with an

appreciation of the skills which different professions can bring to the service Have capacity in their current workload to carry out the function of Chair Be a recognised expert in the care of cancer patients for the tumour site Have widespread experience in the general care of cancer patients Show commitment to developing the Site Specific Group Have the ability to think strategically

Review Date: March 2019

Page 18: Meeting: Breast Expert Advisory Group

Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

This document was produced by Breast Cancer Clinical Expert Group August 2017

Page 19: Meeting: Breast Expert Advisory Group

OFFICIAL

Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

Breast Cancer Clinical Expert Group

Issue/approval date: August 2017 Next review date: May 2019 Page 2

Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

Date of issue: August 2017 Date of review: May 2019 Prepared by: This Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services was prepared by the Breast Cancer Clinical Expert Group (CEG), whose Chair is Professor Ian Smith and Vice-chair is Professor Chris Holcombe. The Breast Cancer CEG has a wide geographical and multi-disciplinary representation from the full range of professionals involved in delivering breast cancer services, as well as patient representatives and groups. The CEG’s secretariat is provided by Breast Cancer Now. Audience: Both the initial diagnosis and treatment of breast cancer and the treatment of breast cancer when it has spread elsewhere is changing and improving rapidly. This document gives a summary of current best practice and can be used as a ‘check list’ against which to measure a local service, to be used by:

Commissioners

Acute Trusts

Cancer Alliances

Patients Commissioners can and should commission in reference to this document. Acute trusts and others providing care should make sure all elements of the service described herein are provided. Cancer Alliances should have a role in coordinating with commissioners and providers to ensure all elements of the service described herein are provided within their geographical footprint. Patients can know whether or not their local service is up to scratch. Groups consulted: The Chemotherapy and Radiotherapy Clinical Reference Groups, the Association of Breast Surgeons and the UK Breast Cancer Group have reviewed this clinical advice. Purpose:

- This clinical advice covers essential services for patients with early, and recurrent (local/regional and metastatic) breast cancer.

- It is provided to support the commissioning of clinical breast cancer services at national and local level.

- This document gives a summary of current best practice and can be used as a ‘check list’ against which to measure a local service.

Page 20: Meeting: Breast Expert Advisory Group

OFFICIAL

Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

Breast Cancer Clinical Expert Group

Issue/approval date: August 2017 Next review date: May 2019 Page 3

Contents

1 Executive summary ............................................................................................. 4

2 Key breast statistics............................................................................................. 5

3 Outcomes ............................................................................................................ 5

4 Key themes ......................................................................................................... 5

5 Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services 8

5.1 Purpose .................................................................................................... 8

5.2 Essential services ..................................................................................... 8

DIAGNOSIS and STAGING ................................................................ 8

MULTI-DISCIPLINARY TEAM (MDT) ................................................. 9

GENERAL SUPPORT ......................................................................... 9

NEOADJUVANT SYSTEMIC THERAPY........................................... 10

SURGERY......................................................................................... 11

RADIOTHERAPY ............................................................................. 12

ADJUVANT ENDOCRINE THERAPY ............................................... 13

ADJUVANT CHEMOTHERAPY ........................................................ 14

ANTI-HER2 THERAPY ..................................................................... 14

ADJUVANT BISPHOSPHONATES ................................................... 15

ADJUVANT LIFESTYLE MEASURES .............................................. 15

RECURRENT/METASTATIC BREAST CANCER ............................. 15

CLINICAL TRIALS ............................................................................. 16

FOLLOW UP ..................................................................................... 16

RISK REDUCTION ............................................................................ 17

6 Appendices ........................................................................................................ 18

Appendix 1: NHS Outcomes Framework Domains ............................ 18

Appendix 2: Example breast pathways ............................................. 19

Appendix 3: Underpinning documents ............................................... 21

Appendix 4: Adjuvant bisphosphonates – guidelines for

implementation .................................................................................. 22

Appendix 5: Open Access Follow Up ................................................ 25

7 Glossary ............................................................................................................ 26

8 Abbreviations ..................................................................................................... 29

9 References ........................................................................................................ 30

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OFFICIAL

Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

Breast Cancer Clinical Expert Group

Issue/approval date: August 2017 Next review date: May 2019 Page 4

1 Executive summary This Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services gives a summary of current best practice, and highlights areas where there have been recent advances and changes in patient management. Commissioners should be asking the following key questions of their local service: Are relevant data collected shared and acted upon? Good data are needed for service provision and improvement. Collection of the cancer outcomes and services dataset (COSD) is mandatory at diagnosis and on recurrence. 5.2.7

Do all patients have optimal treatment planning? Patients with invasive breast cancer should have tumour ER and HER2 status available as soon as possible and certainly within two weeks to allow treatment planning. 5.2.4 Are breast cancer patients offered the best treatment regardless of their age? Breast cancer treatment should be based on clinical need and fitness for treatment and not age. 5.2.15 Are appropriate patients offered breast cancer treatment as a day case? Offering appropriate patients to have their breast cancer treated as a day case or on a 23 hour stay pathway, can significantly improve their experience of care. 5.2.24 Are patients with recurrent breast cancer being discussed at a MDT meeting? MDT working has led to improved decision-making and it is advised that all patients at first relapse (local or metastatic) are added to MDM so this event is recorded 5.2.51 Do patients with recurrent breast cancer have a named clinical nurse specialist? The single most important factor associated with high patient satisfaction is access to a named clinical nurse specialist in charge of their care. 5.2.52

Following treatment for breast cancer, are patients given lifestyle advice? Patients who maintain a healthy weight and take regular exercise can reduce the risk of breast cancer recurrence by approximately 30%. 5.2.50 Are patients considered for referral to genetics services? Women who meet current guidelines for genetic testing should be given appropriate information and have the opportunity to access such testing. 5.2.19

Are appropriate patients offered adjuvant bisphosphonate therapy? Adjuvant bisphosphonate therapy should be offered to most postmenopausal women with early breast cancer to reduce the risk of bone recurrence and fractures, and to improve breast cancer survival. 5.2.49 Are appropriate patients offered Open Access Follow Up? Stratified Open Access Follow Up including supported self-management should be strongly considered for patients with early breast cancer. 5.2.60

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OFFICIAL

Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

Breast Cancer Clinical Expert Group

Issue/approval date: August 2017 Next review date: May 2019 Page 5

2 Key breast statistics

Breast cancer is the most common cancer in England with around 46,000 women diagnosed each year1.

Around 300 men are diagnosed with breast cancer every year in England1.

In 2015, the incidence rate for female breast cancer in the UK was 170.2 per 100,000 population1.

It is estimated that there are almost 600,000 people living with and beyond breast cancer in the UK2.

An estimated five out of six women diagnosed with breast cancer in England and Wales survive for at least five years1.

Over 9,500 women die of breast cancer every year in England1.

3 Outcomes Breast cancer is the most common cancer in England affecting mainly women and a very small proportion of men. Although survival has improved greatly over the last 20 years, breast cancer outcomes in England remain inferior to the best in Europe. Breast cancer is the second biggest cause of cancer death for women after lung cancer. This may be because more patients are diagnosed when their cancer is already in the advanced stage, and has spread significantly within the breast or to other organs of the body (stage 3 or 4 disease). It may also be because there are variations in the quality and appropriateness of care that breast cancer patients receive. It is estimated that almost 600,000 people are alive in England after a diagnosis of breast cancer, but it is unknown how many of them have recurrent or metastatic disease. Dealing with recurrent and metastatic breast cancer remains a significant and challenging medical problem, exacerbated by the lack of information about this specific group of patients. Despite significant improvements in survival, there are variations in the quality of care that breast cancer patients receive. This Clinical Advice focuses specifically on areas where significant improvements are needed to improve breast cancer outcomes as well as to ensure patients have the best possible experience throughout their care.

4 Key themes Relevant sections mapped against the NHS Outcomes Framework Domains are included in appendix 1. Are relevant data collected and shared so that appropriate action can be

taken?

At diagnosis, the provision of the cancer outcomes and services dataset (COSD) is mandatory. This should include tumour, node and metastasis (TNM) staging information for all new diagnoses of breast cancer, in order to provide the data needed to assess whether progress is being made on improving survival rates

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through earlier diagnosis. All diagnoses of recurrent and/or metastatic breast cancer should be recorded via the COSD, to enable improved service planning for these patients (section 5.2.7 – Domain 1; Cancer Strategy recommendation 90). Do all patients have optimal treatment planning?

All patients with invasive breast cancer should have tumour ER and HER2 status assessed on the diagnostic core biopsy to allow optimal multimodality treatment sequencing and planning. Results should be available as soon as possible; if these tests are performed locally the immunohistochemical results should be available within one week. If these receptor assays are submitted to a central laboratory for assessment, immunohistochemical results should be available, as a minimum, within two weeks. This will also improve patients’ experience of care as they are not left waiting for a significant length of time for a treatment plan (section 5.2.4 – Domains 1, 4 & 5). Are breast cancer patients offered the best possible treatment regardless of

their age?

A third of breast cancers in the UK occur in women over the age of 70 and breast cancer in older women is expected to quadruple over the next three decades. However, evidence suggests that older people do not always receive the same standard of treatment as younger patients3. Older women are less likely to be assessed for HER2 status and less likely to receive optimal treatment. Breast cancer treatment should be based on clinical need and fitness for treatment, rather than age alone (section 5.2.15 – Domains 1 & 4; Cancer Strategy recommendation 41). Are appropriate patients offered breast cancer treatment as a day case or on a

23 hour stay pathway?

Offering appropriate patients to have their breast cancer treated as a day case or on a 23 hour stay pathway, can significantly improve their experience of care and reduce their length of stay in hospital (section 5.2.24 – Domain 3, 4 & 5). Are patients with recurrent or metastatic breast cancer being discussed at a

MDT meeting?

MDT working has led to improved decision-making, more coordinated patient care and improvement in overall quality of care. A survey of 2,050 MDT members in September 2009 found that there is an overwhelming consensus that MDTs are beneficial to patient care and should remain the cornerstone of cancer treatment4. However, evidence suggests that many patients with recurrent or metastatic breast cancer do not have their treatment and care discussed in this way. It is advised that all patients at first relapse (local or metastatic) are added to MDM so this event is recorded. Cancer Research UK have also recently commissioned research into the MDT and have suggested streamlining the MDT meeting, and improving the quality of discussions, especially for complex patients who would benefit most from this5 (section 5.2.51; Cancer Strategy recommendation 46).

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Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

Breast Cancer Clinical Expert Group

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Do patients with recurrent or metastatic breast cancer have access to a clinical

nurse specialist?

Analysis of Cancer Patient Experience Survey data shows that the single most important factor associated with high patient scores is patients being given the name of a clinical nurse specialist in charge of their care. However, access to such support varies and people with metastatic breast cancer have less access to support from clinical nurse specialists than patients undergoing primary treatment, at a time when they need it most (section 5.2.52 – Domains 2 & 4; Cancer Strategy recommendation 61). Following treatment for breast cancer, are patients given lifestyle advice?

Evidence shows that patients who maintain a healthy weight and take regular exercise can reduce the risk of breast cancer recurrence, sometimes to the same degree as with adjuvant medical treatment – a reduction in risk of recurrence of approximately 30%. Currently, however, there is uncertainty about how many patients are being given this crucial lifestyle advice (section 5.2.50 - Domains 1, 2 & 3; Cancer Strategy recommendation 8). Following treatment for breast cancer, are patients considered for referral to

genetics services?

A small proportion of women diagnosed with breast cancer (<3% overall) have a mutation to one of the high risk breast cancer genes, BRCA1 or BRCA2. This gives a much greater risk of developing a new primary cancer (breast and ovary). Women who meet current guidelines for genetic testing should be given appropriate information and have the opportunity to access such genetic testing.6 Furthermore, this should be offered as soon as possible after diagnosis since it may alter both surgical and medical treatment options (section 5.2.19; Cancer Strategy recommendation 36). Are appropriate patients offered adjuvant bisphosphonate therapy?

Adjuvant bisphosphonate therapy with zoledronate or ibandronate should be offered to most postmenopausal women with early breast cancer to reduce the risk of bone recurrence and fractures, and improve breast cancer survival (section 5.2.49 - Domain 1; Cancer Strategy recommendation 47). Are appropriate patients offered Open Access Follow Up?

There is no evidence of benefit for routine clinical follow up. Stratified Open Access Follow Up including self-management and supported self-management should be strongly considered for patients with early breast cancer, on the basis of established patient satisfaction and resource savings (sections 5.2.60 - Domains 2, 3 & 4; Cancer Strategy recommendation 67).

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5 Clinical Advice to Cancer Alliances for the Provision of Breast Cancer Services

5.1 Purpose

5.1.1 This Clinical Advice for the Provision of Breast Cancer Services covers essential services for patients with early, and recurrent (local/regional and metastatic) breast cancer. It is provided to support the commissioning of clinical breast cancer services at national and local level (see appendix 2 for example breast pathways). There is already a detailed range of documentation on the provision of breast cancer services (appendix 3), which have been cross-referenced in this document.

5.1.2 Breast screening services are not included in the Clinical Advice but are commissioned by Public Health England via a mandate to NHS England7. However, the NHS Breast Screening Programme excludes services for women with a significant risk of familial breast cancer, except for the minority categorised at very high risk. Commissioning policies developed by the Medical Genetics Clinical Reference Group (which covers family history services)8, Chemotherapy Clinical Reference Group9 and Radiotherapy Clinical Reference Group10 will also be relevant when commissioning breast cancer services. Statements from the Breast Cancer Quality Standard11 have been incorporated into this Clinical Advice where appropriate. A number of the essential services detailed in this document are also directly related to improvement areas in the CCG Outcomes Indicator Set 2015/1612. When these essential services are delivered collectively they will contribute to improving the effectiveness, safety and experience of care for patients with breast cancer across the NHS Outcomes Framework Domains (appendix 1)13.

5.1.3 This Clinical Advice supports a more integrated approach to commissioning as recommended by the Independent Cancer Taskforce in their report “Achieving world-class cancer outcomes: a Strategy for England 2015-2020”14.

5.2 Essential services

DIAGNOSIS and STAGING

5.2.1 Standard triple assessment should be undertaken at a single visit to enable

accurate and timely diagnosis or exclusion of BC. This is convenient, cost efficient, and gives the patient a positive experience of their care15. MRI should not be used as routine imaging but reserved for specific indications16 and reasons documented in the notes (Domain 4 & 5).

5.2.2 Pre-operative radiology staging for early breast cancer should follow standard

guidelines. This should include assessment of the axilla by ultrasound and guided fine needle aspirate or core biopsy of nodes which are suspicious on imaging. Radiology staging investigations for metastatic disease (e.g. CT scan, isotopic bone scan) should not be used in all patients but only those at high risk (e.g. 4 or more nodes involved, T3 >5cm cancers)17. PET-CT should

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Breast Cancer Clinical Expert Group

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likewise not be used as a routine investigation but reserved for specific indications18 (Domain 1, 4 & 5).

5.2.3 Patients should be informed of the histological result of the diagnostic core biopsy within 7 days19 (Domain 4).

5.2.4 ER and HER2 status of invasive breast cancer should also be assessed on the core biopsy sample of every patient. Results should be available as soon as possible; if these tests are performed locally the immunohistochemical results should be available within one week. If these receptor assays are submitted to a central laboratory for assessment, immunohistochemical results should be available, as a minimum, within two weeks. This will allow optimal multimodality treatment planning and sequencing by the MDT20. Routine repeat receptor status assessment on the excised tumour is not required21. Assessment of progesterone receptor status and Ki67 levels is regarded as optional (Domain 1, 4 & 5).

5.2.5 All breast cancer specimens should be handled and reported as per UK NHS Breast Screening Programme and Royal College of Pathologists guidelines, including provision of the pathology minimum datasets.

MULTI-DISCIPLINARY TEAM (MDT)

5.2.6 Patients with newly diagnosed breast cancer should be discussed at a full

MDT meeting before any treatment and a record of this discussion kept in the notes22 (Domain 5).

5.2.7 The provision of the cancer outcomes and services dataset (COSD) is mandatory. This includes TNM staging information for all new diagnoses of breast cancer, including recurrence and metastases, in order to provide data needed to assess whether progress is being made on improving survival rates through earlier diagnosis. This should be captured electronically at MDT meetings (Domain 1).

5.2.8 All units are encouraged to recruit to clinical trials; many are now open in the window of opportunity before surgery and should be offered at this point.

GENERAL SUPPORT

5.2.9 All patients must have access to a clinical nurse specialist at all stages in their

treatment pathway. This specifically includes patients with recurrent/metastatic disease. This should be recorded in the notes and the name and contact details given to the patient. Analysis of Cancer Patient Experience Survey data shows that the single most important factor associated with high patient scores is the patient being given the name of a clinical nurse specialist in charge of their care23 (Domain 2 & 4).

5.2.10 Every patient should be offered a Holistic Needs Assessment (HNA) at key pathway points, including at diagnosis, the start of treatment and at the end of

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Breast Cancer Clinical Expert Group

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primary treatment. A formal care plan should be developed. It should be ensured that the results of patients' HNAs are taken into account in MDT decision making and that patients are referred to other services as appropriate24 (Domain 2 & 4).

5.2.11 All patients having treatment for newly diagnosed, or recurrent breast cancer should be offered psychological support. This may be formal psychology or psychiatry appointments or may include face-to-face or online peer support from other patients, local support groups, online support groups and helplines (Domain 2, 3 & 4).

5.2.12 All patients should be offered quality mark accredited written information

tailored to their individual circumstances (Domain 2 & 4). This should include (but not limited to):

Before starting treatment: Information on all appropriate treatment options available to them and the potential benefits and risks of these treatments.

During and after any treatment: Specific information on managing any side effects of treatment including fatigue, menopausal symptoms, and joint pain and details of how to contact a named healthcare professional25.

5.2.13 All patients should be offered information on lymphoedema and

physiotherapy, and referral to these specialised services if required (Domain 3).

5.2.14 There should be appropriate assessment of patients’ rehabilitative and re-enablement needs across the pathway including signposting as appropriate to fertility specialists, wig and prosthesis providers and physiotherapists for post-operative exercises (Domain 2, 3 & 4).

5.2.15 Patients with newly diagnosed early breast cancer, irrespective of age, should be offered standard surgery, radiotherapy and appropriate systemic therapy, unless clinically inappropriate or significant comorbidity precludes standard of care treatment26. Breast cancer treatment should be based on clinical need and fitness for treatment rather than age alone. Formal assessment of fitness for surgery and other neoadjuvant therapy should be considered by the anaesthetist, care of elderly physician or cardiologist as appropriate. This is an area of focus for Quality, Improvement, Productivity and Prevention (QIPP) and Commissioning for Quality and Innovation (CQUIN) (Domain 1 & 4)27.

5.2.16 Patients with a personal or family history of breast or ovarian cancer, or with triple negative breast cancer under the age of 50 years, should be offered genetic risk assessment and consideration of genetic testing according to local agreements for access to genetic testing28,29. Furthermore, this should be offered as soon as possible after diagnosis since it may alter both surgical and medical treatment options.

NEOADJUVANT SYSTEMIC THERAPY

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Breast Cancer Clinical Expert Group

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5.2.17 Neoadjuvant chemotherapy or endocrine therapy is being used in increasingly

large numbers of patients who have a biologically aggressive tumour, for those who are HER 2 positive and can therefore access pertuzumab or for downsizing to allow for breast conservation, or more limited axillary surgery. Neoadjuvant therapy will also be used within trial protocols where an in vivo assessment of sensitivity to treatment is required30.

5.2.18 The rationale for primary surgical and medical treatment decisions should always be recorded in the notes (Domain 1).

5.2.19 The option of neoadjuvant chemotherapy (if appropriate) can also be considered in patients who are eligible for genetic testing (based on tumour type, young onset and/or strong family history) when this will allow adequate time to appropriately inform patients about future new primary cancer risk based on family history assessment and genetic test outcome. Information about genetic status may impact on the patient’s subsequent choice about breast surgery and reconstruction (Domain 1).

SURGERY

5.2.20 All patients should have all appropriate surgical options discussed in

conjunction with their clinical nurse specialist. Oncoplastic conservation procedures should be available, offered and used where appropriate. Most will not require any further adjustment procedures. Neoadjuvant chemotherapy or endocrine therapy should be considered to allow downsizing of the tumour and breast conservation.

5.2.21 Patients requiring mastectomy should have the option of immediate or delayed breast reconstruction31. Breast reconstruction is a process rather than a single event, most will require more than one operation. All patients who have breast conservation or reconstruction should have the option of contra-lateral symmetrisation surgery, either simultaneously or as a second procedure, as well as any other secondary procedures to optimise outcomes where appropriate. Patients make decisions at very different speeds so delayed reconstruction or further operative procedures to optimise symmetry should be available without time restrictions. (Domain 4 & 5).

5.2.22 The reasons for surgical treatment choices should be clearly recorded for every patient e.g. why surgery was not carried out in those on primary endocrine therapy, the reasons for mastectomy if this is recommended, and in those having mastectomy without reconstruction, why reconstruction was not performed.

5.2.23 Sentinel node biopsy should be offered to all appropriate (clinically/radiologically node negative) patients32. The current standard methodology for localisation is blue dye and radioisotope (Domain 1 & 5).

5.2.24 Since 2007, following the NHS Improvement Transforming Inpatient Care Programme, the length of stay for non-reconstructive breast surgery has

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Breast Cancer Clinical Expert Group

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progressively decreased. Day case or one night stay should be regarded as best practice for the majority of women undergoing this type of breast surgery. This is an area of focus for Quality, Improvement, productivity and Prevention (QIPP) and Commissioning for Quality and Innovation (CQUIN) (Domain 3, 4 & 5).

5.2.25 All patients undergoing surgery on their axilla must be given information on risk reduction strategies for lymphoedema. Pathways should be in place for the referral of patients with the condition to specialised lymphoedema services33 (Domain 2 & 3).

5.2.26 Positive SLNB: micrometastases or isolated tumour cells on sentinel node biopsy do not require further axillary treatment. Patients with one or two sentinel node macrometastases who are postmenopausal, receiving breast conservation and whole breast radiotherapy, are having systemic endocrine or chemotherapy, and who are also T1, G1/2, ER positive and HER2 negative do not require mandatory further axillary treatment (Domain 5). The total number of involved axillary nodes is not usually required for decision-making on adjuvant systemic therapies (Domain 5).

5.2.27 There is no evidence of a survival benefit for those undergoing contra-lateral risk reducing mastectomy34, 35 – this should not be offered as routine, except for women with BRCA mutations, and when performed should only be done so based on a full discussion of the risks and benefits and with appropriate psychological support36 (Domain 5).

5.2.28 After primary surgery the absolute benefit of systemic therapies should be discussed at the MDT meeting (see also 5.2.37).

RADIOTHERAPY 37

5.2.29 Adjuvant radiotherapy based on standard guidelines should be available within

31 days of decision to treat in patients with early breast cancer38, or within 31 days of completing adjuvant chemotherapy, which should be given before radiotherapy if indicated. If radiotherapy needs to be delayed e.g. because of post-operative seroma or wound infection, the reason should be recorded and the earliest clinically acceptable date (ECAD) should be set when radiotherapy planning commences.

5.2.30 Specifically, adjuvant radiotherapy is indicated for the great majority of patients treated with breast-conserving surgery. If the MDT decision is not to give this, then the reasons (e.g. co-morbidities, low risk, clinical trial) must be specifically recorded.

5.2.31 All patients should have access to intensity modulated radiotherapy and/or heart sparing techniques such as deep inspiration breath hold if required (Domain 5).

5.2.32 Micrometastases or isolated tumour cells on sentinel node biopsy do not require further axillary treatment. One or two sentinel node macrometastases

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in patients who are postmenopausal, receiving breast conservation and whole breast radiotherapy, are having systemic endocrine or chemotherapy, and who are also T1, G1/2 and ER positive do not require mandatory further axillary treatment (Domain 5).

5.2.33 Axillary radiotherapy is a reasonable alternative to axillary node clearance following sentinel node biopsy for non-bulky axillary nodal metastases (i.e. negative on axillary imaging) in patients with early breast cancer and may have less morbidity than axillary surgery39. The total number of involved axillary nodes is not usually required for decision-making as regards systemic therapies in early breast cancer (Domain 5) but can influence the need for locoregional nodal RT.

ADJUVANT ENDOCRINE THERAPY

5.2.34 Adjuvant endocrine therapy should be offered to all patients with invasive ER

positive disease, except for those with a very low risk where there is a no more than 1% 10 year survival gain based on standard risk prediction tools (e.g. NHS PREDICT). In these circumstances this should be documented in the notes (Domain 1).

5.2.35 Adjuvant tamoxifen should be offered to pre-and peri-menopausal patients with invasive ER positive disease (Domain 1 & 5).

5.2.36 Recent data report that the addition of ovarian suppression to tamoxifen further decreases the risk of recurrence in higher risk pre-menopausal women who have had adjuvant chemotherapy, and that substituting an aromatase inhibitor (AI) for tamoxifen further enhances this effect40. However this has to be balanced against the risk of a significantly worse quality of life for 2 years or more. The pros and cons of these results need to be discussed with appropriate patients.

5.2.37 An AI should be offered to post-menopausal women with invasive ER positive disease in whom endocrine therapy is appropriate. Tamoxifen can be substituted if persisting significant side effects occur with an AI41 (Domain 1 & 5).

5.2.38 Patients who have undergone premature ovarian suppression or are on an AI should have a bone density scan and bone health management as per national guidelines42 (Domain 5).

5.2.39 The standard duration of endocrine therapy after 5 years of tamoxifen has extended from 5 to 10 years for patients with moderate to high risk disease (including the option of switching to an AI for patients who are post-menopausal). Where treatment is stopped after 5 years (e.g. because of low risk or treatment-related morbidity) the reasons should be recorded in the notes43, 44 (Domain 1).

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5.2.40 Recent evidence suggests that more than 5 years of an AI without preceding tamoxifen has only very minor further outcome improvement and is not recommended except in patients with initial high risk disease. In contrast, an AI after around 5 years of tamoxifen does have significant further clinical benefit except for patients at low initial risk45.

ADJUVANT CHEMOTHERAPY

5.2.41 Adjuvant chemotherapy reduces the risk of metastatic disease, but the actual

benefit to any individual patient is dependent on their baseline risk of developing metastatic disease as predicted by standard prognostic factors at diagnosis. All patients with early breast cancer should have their risk of recurrence assessed and benefits of systemic therapies discussed in the MDT meeting following primary surgery as per section 5.2.28. The final plan of systemic therapy should be made in the oncology clinic using this and other patient information and taking into account their views (Domain 5).

5.2.42 A number of online tools are available to assist e.g. NHS PREDICT, and for those with ER positive disease a number of molecular tests can give further refinement of the likely benefit from chemotherapy e.g. Oncotype DX, IHC4 and EndoPredict. NICE now recommends the use of Oncotype DX in in ER positive, HER2-ve, node negative patients where the benefit of adjuvant chemotherapy is uncertain. A proportion of patients who might otherwise have had adjuvant chemotherapy can avoid this on the basis of these further tests46 (Domain 5).

5.2.43 Anthracyclines should be avoided if there is a significant history of cardiac disease and used with caution in those over 60 or with significant hypertension, with a pre-treatment left ventricular ejection fraction carried out (Domain 1 & 5).

5.2.44 Treatment should be with a standard schedule of which there are several (as covered by Chemotherapy CRG: https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-b/b15/).

ANTI-HER2 THERAPY

5.2.45 All patients with invasive HER2 positive disease 1cm or greater should be

offered adjuvant trastuzumab for 1 year along with adjuvant chemotherapy. The benefit of such treatment for HER2 positive cancers <1cm is less certain and the decision should be left to the oncologist in charge (Domain 1 & 5).

5.2.46 Single agent paclitaxel with trastuzumab appears as effective as standard chemotherapy for small node-negative cancers (2cm or less) and is a lot less toxic and expensive47. It should also be encouraged where there is a contra-indication to standard chemotherapy e.g. because of age or co-morbidity (Domain 1 & 4).

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5.2.47 Cardiac monitoring should be carried out based on standard guidelines48.

5.2.48 Recently, the addition of 4-6 courses of neoadjuvant pertuzumab to trastuzumab and chemotherapy has been shown to improve significantly both pathological complete remission rates and 5 year survival outcome, and this is recommended for patients with higher risk cancers. In contrast, the evidence from the APHINITY trial does not suggest a clinically worthwhile benefit for yearlong adjuvant pertuzumab, despite the trial statistically meeting its primary endpoint49.

ADJUVANT BISPHOSPHONATES

5.2.49 Based on strong evidence, adjuvant bisphosphonate therapy with zoledronate

4mg by IV infusion 6 monthly or oral ibandronate 50mg daily, for a minimum of 3 years, should be offered to postmenopausal women with early breast cancer to reduce the risk of bone recurrence and fractures, and improve breast cancer survival50. For lower risk patients, however, the absolute benefit is likely to be very small and may be outweighed by the potential side effects (in particular a 1% risk of osteonecrosis of the jaw). This is being reviewed by NICE. Note that switching between zoledronate and ibandronate is an option

(appendix 4; Domain 1; Cancer Strategy Recommendation 47).

ADJUVANT LIFESTYLE MEASURES

5.2.50 Evidence shows that patients who maintain a healthy weight and take regular

exercise can reduce the risk of recurrence in breast cancer, sometimes to the same degree as with adjuvant medical treatment51. It is therefore mandatory that all patients are given advice on weight control and regular moderate exercise, and this must be recorded in the notes (Domain 1,2 & 3; Cancer Strategy recommendation 8).

RECURRENT/METASTATIC BREAST CANCER

5.2.51 Patients with recurrent/metastatic disease should be re-discussed at a

dedicated metastatic MDT slot if they develop local and/or metastatic disease. A record of this discussion must be filed in the notes and relevant fields in the COSD completed (Cancer Strategy recommendation 46).

5.2.52 It is particularly important that all patients with recurrent or metastatic breast cancer have access to a clinical nurse specialist with specialist knowledge of secondary disease52. They should be available to give information and psychological support to patients and their families53 (Domain 2 & 4).

5.2.53 Re-biopsy with re-assessment of ER and HER2 markers on disease recurrence is strongly recommended. This is to confirm histology and determine whether markers (ER, HER2) have changed, altering treatment options (Domain 1).

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5.2.54 There is no single ‘best treatment’ for patients with recurrent/metastatic breast cancer. All appropriate options should be discussed with the patient who should be involved in choice of therapy54. The availability and importance of clinical trials should also be discussed.

5.2.55 Treatment should be selected based on the following principles (Domain 1 & 4):

Endocrine therapy should be used prior to chemotherapy for invasive

ER positive disease except for immediately life-threatening disease

Single agent palliative chemotherapy is as effective as combination

treatment and generally less toxic

No one type of chemotherapy has been shown superior to others, and

selection should be based on previous treatments, toxicity, co-

morbidities and patient choice (e.g. preference for oral therapy or wish

to avoid alopecia).

5.2.56 All patients should be offered a Holistic Needs Assessment (HNA) at diagnosis of recurrent and/or metastatic disease. A formal care plan should be developed. It should be ensured that the results of patients’ HNAs are taken into account at MDT decision making and that patients are offered referral to other services as appropriate (Domain 2, 3 & 4).

5.2.57 Patients with metastatic breast cancer should be referred to a palliative care team at any point where symptoms require this, and when the patient or medical team decide that further active treatment is inappropriate.

CLINICAL TRIALS

5.2.58 The availability and importance of clinical trials should be discussed with all

patients for both early and advanced disease at appropriate time points.

FOLLOW UP

5.2.59 All patients should have an end of primary treatment consultation, a summary

of treatment given, advice on signs and symptoms of which to be aware, access to a health and wellbeing event or programme and a plan for follow-up. These interventions, when delivered together with a HNA, form The Recovery Package55 (Domain 2 & 3; Cancer Strategy Recommendation 65).

5.2.60 There is no evidence of benefit for routine clinical follow up, despite this being widespread current practice. Stratified Open Access Follow Up including self-management and supported self-management should be strongly considered for patients with early breast cancer, on the basis of established patient satisfaction and resource savings. This should not, however, jeopardise appropriate follow up of patients in clinical trials (appendix 5; Domain 2, 3 & 4; Cancer Strategy Recommendation 67).

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5.2.61 There is evidence that regular surveillance with mammography conveys a survival benefit and is most likely to be considered cost-effective if performed on an annual basis. The optimum frequency and duration has yet to be determined, whilst randomised and other trial data (such as Mammo-50) are awaited56, 57.

RISK REDUCTION

5.2.62 Chemoprevention with (tamoxifen or raloxifene for 5 years) should be

discussed with women at an estimated moderate or high risk of developing breast cancer, based on NICE guidelines58 59 (Domain 1; Cancer Strategy Recommendation 6).

Professor Ian Smith Chair of the Breast Cancer Clinical Expert Group Professor Chris Holcombe Vice Chair of the Breast Cancer Clinical Expert Group

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6 Appendices

Appendix 1: NHS Outcomes Framework Domains

Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/513157/NHSOF_at_a_glance.pdf

NHS Outcomes Framework Domains Relevant sections

Domain 1

Preventing people from dying prematurely

5.2.2; 5.2.4; 5.2.7; 5.2.15; 5.2.18; 5.2.23; 5.2.34; 5.2.35; 5.2.37; 5.2.39; 5.2.43; 5.2.45; 5.2.46; 5.2.49; 5.2.50; 5.2.53; 5.2.55; 5.2.58; 5.2.62

Domain 2

Enhancing quality of life for people with long term conditions

5.2.9; 5.2.10; 5.2.11; 5.2.12; 5.2.14; 5.2.25; 5.2.46; 5.2.48; 5.2.50; 5.2.52; 5.2.55; 5.2.56; 5.5.59; 5.2.60

Domain 3

Helping people to recover from episodes of ill health or following injury

5.2.10; 5.2.11; 5.2.12; 5.2.13; 5.2.14; 5.2.24; 5.2.25; 5.2.46; 5.2.50; 5.2.52; 5.2.55; 5.2.56; 5.5.59; 5.2.60

Domain 4

Ensuring people have a positive experience of care

5.2.1; 5.2.2; 5.2.4; 5.2.9; 5.2.10; 5.2.11; 5.2.12; 5.2.14; 5.2.15; 5.2.21; 5.2.24; 5.2.46; 5.2.52; 5.2.55; 5.2.56; 5.2.60

Domain 5

Treating and caring for people in a safe environment and protecting them from avoidable harm

5.2.1; 5.2.2; 5.2.4; 5.2.6; 5.2.21; 5.2.23; 5.2.24; 5.2.26; 5.2.27; 5.2.31; 5.2.32; 5.2.33; 5.2.35; 5.2.37; 5.2.38; 5.2.39; 5.2.41; 5.2.42; 5.2.43; 5.2.45;

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Written information: • Each point of the pathway

should be supported by quality mark accredited written information tailored to the patients’ individual circumstances (5.2.11)

Recovery Package: • Holistic needs assessment (HNA). • A treatment summary (including surveillance programme) sent to

the patient and their GP. • Information on likely side-effects of treatment and how best to

manage these. • Information on potential symptoms of recurrence/secondary

cancers and what to do in these occurrences. • Key contact point for rapid re-entry if symptoms of recurrence are

experienced or if serious side effects become apparent. • Access to a patient education and support event, such as a Health

and Wellbeing Clinic, to prepare the person of the transition to supported self-management, including advice on healthy lifestyle and physical activity. Referral to a health trainer is often helpful.

• Signposting to rehabilitation, work and financial support services.

Appendix 2: Example breast pathways

Early and locally advanced breast cancer NB numbers in brackets denote relevant paragraphs in the Clinical Advice for the Provision of Breast Cancer Services.

Key: = Primary care

= Secondary care

Abbreviations: A&E – Accident and Emergency CNS – Clinical Nurse Specialist ER – Oestrogen Receptor GP – General Practitioner HER2 – Human Epithelial Growth Factor receptor OPA = Outpatient Appointment MDT – Multidisciplinary team Breast Cancer Clinical Expert Group, August 2017

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Key:

= Secondary care

Abbreviations: OPA = Outpatient Appointment MDT – Multidisciplinary team

Breast Cancer Clinical Expert Group, August 2017

Metastatic breast cancer NB numbers in brackets denote relevant paragraphs in the Clinical Advice for the Provision of Breast Cancer Services.

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Appendix 3: Underpinning documents

Advanced Breast Cancer (update): Diagnosis and Treatment (CG81), NICE

(2014)

Best Practice Diagnostic Guidelines for Patients Presenting with Breast

Symptoms (2010)

Breast Cancer Quality Standard (QS12), NICE (2011, last updated June 2016)

Early and Locally Advanced Breast Cancer (CG80), NICE (2009, last updated

March 2017)

Familial Breast Cancer (CG164), NICE (2013, last updated March 2017)

Living With and Beyond Cancer: Taking Action to Improve Outcomes,

Department of Health, NHS Improvement and Macmillan Cancer Support

(2013)

Oncoplastic Breast Reconstruction – Guidelines for Best Practice, Association

of Breast Surgery and British Association of Plastic Reconstructive and

Aesthetic Surgeons (2012)

Royal College of Radiologists, Postoperative radiotherapy for breast cancer:

UK consensus statements (2016).

Report of the Independent Cancer Taskforce, Achieving world-class cancer

outcomes: A strategy for England 2015-2020

NHS England, Delivering World-Class Cancer Outcomes: Guidance for

Cancer Alliances and the National Cancer Vanguard (2016).

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Appendix 4: Adjuvant bisphosphonates – guidelines for

implementation

Evidence for use

Until recently the results of adjuvant bisphosphonate breast cancer trials had not provided evidence of consistent benefit across all patient groups and study-level meta-analyses of these studies had also provided conflicting results. There is now, however, a patient-level meta-analysis of data from all unconfounded trials in early breast cancer that randomized between bisphosphonate and control. Data was received on 18766 women of which 97% were of studies of between 2 and 5 years of bisphosphonate therapy. Median follow up was 5.6 woman-years. This meta-analysis has been published in the Lancet by the Early Breast Cancer Trialists Collaborative Group (EBCTCG) (on-line open access July 23rd 2015; http://press.thelancet.com/EBCTCG2.pdf) following presentation by Rob Coleman at the 2013 San Antonio Breast Cancer Symposium (SABCS: abstract S4-07, 2013) and has provided important results, which are considered to be practice changing.

The primary outcomes of the study were time to recurrence, distant recurrence, and breast cancer mortality. Primary planned subgroup analyses were site of first distant recurrence (bone or other) menopausal status, and bisphosphonate class.

There was definite benefit only in postmenopausal women (11767), with highly significant reductions in:

1] recurrence (RR 0.86, 95% CI 0.78-0.94; 2p=0.002)

2] distant recurrence (bone or otherwise, RR 0.82, 95% CI 0.74-0.92; 2p=0.003)

3] bone recurrence (RR 0.72, 0.60-0.86; 2p=0.002)

4] breast cancer mortality (RR 0.82, 95% CI 0.73-0.93; 2p=0.02)

The absolute gain from treatment at 10 years was 3.3% for breast cancer mortality (95% CI 0.8-5.7) and 2.2% for bone recurrence (95% CI 0.6-3.8)

With regards to reductions in bone recurrence and breast cancer mortality, these did not depend significantly on patient or clinicopathological primary tumour characteristics, including oestrogen receptor status, nodal status, tumour grade or concomitant chemotherapy. Analysing bone recurrence, the most reliable end-point for the sub-group analyses, there was no significant effect from the class or duration of bisphosphonate but pamidronate showed no benefit. Early data presented at ASCO 2015 indicated no obvious benefit of one bisphosphonate over another in the adjuvant setting (Gralow et al, Study S0307 J Clin Oncol 33, 2015 suppl; abstr 503).

Another important effect was the significant reduction in bone fractures (RR 0.85,95%CI 0.75-0.97; 2p=0.02).

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These data are compelling and the benefits of adjuvant bisphosphonates in postmenopausal women are as large if not larger than a number of adjuvant interventions used routinely in early breast cancer.

Implementation guidelines

The following have been constructed using input from clinicians involved in UKBCM group (UK Breast Cancer Meeting) and members of the Breast and Chemotherapy CRGs. They are intended as guidance and local protocols should be developed with CCGs and providers. Registered indication

Bisphosphonates are not licensed in this indication and since all of them are off-patent they are unlikely to be licensed in this setting. Patient selection

The evidence clearly indicates benefit in postmenopausal women (both natural and induced). The evidence does not support starting bisphosphonate therapy in patients who are beyond the stage of initial diagnosis and no specific risk group is identified. A risk/benefit discussion should be undertaken with each patient on an individual basis as per standard practice with adjuvant treatments. Choice, dose and duration of bisphosphonate.

From the data above and recent presentation at ASCO (Gralow et al Study S0307, J Clin Oncol 33, 2015 suppl; abstr 503) oral bisphosphonates and/or IV bisphosphonate could be considered depending on factors eg ability to comply with oral medication, GI tract disturbance. Recommendations are given below.

IV Zoledronate (4mgs every 6 months for 3 years)

Oral Ibandronate (50mg daily for 3 years)

Note that switching between the IV Zoledronate and Oral Ibandronate is also an option. Where?

For IV Zoledronate, patients should be treated in the Oncology Units with monitoring and input by Oncology teams. Tariffs need to reflect this as an additional adjuvant oncology treatment and not just ‘within baseline’ as currently exists for this IV drug.

For oral Ibandronate, this should be initiated in secondary care but continued in primary care.

Monitoring of renal function & Calcium

Baseline renal function and calcium, vitamin D3 level

Repeat prior each infusion ie 6/12 but may need earlier depending on baseline

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Calcium and Vitamin D supplementation

Patients should be replete in both calcium and vitamin D before commencing treatment and replacement schedules should be followed as per local protocols

Once replete daily supplementation should be followed as per local guidance eg Adcal D3

Oral/Dental Health

Incidence on osteonecrosis of the jaw (ONJ) was not possible to assess in the above meta-analysis but ONJ appears to be predominantly associated with ‘intensive’ dosing of zoledronate (as in the AZURE trial, Coleman et al N Engl J Med2011; 31: 1396-405 ) and is likely to be less of a problem with 6 monthly zoledronate or oral bisphosphonates with the estimated rate of 1% (Paterson et al, Lancet Oncol 2012;13:734-42, von Minckwitz et al, J Clin Oncol 2013; 31: 3531-39, Gnant et al, Ann Oncol 2014; 26: 313-20.) A cautious approach at this stage would be appropriate and thus the following guidance is suggested;

Baseline assessment of dental health. If seen dentist in last 6/12 with no concerns can commence infusion.

If no dental review in last 6/12 to attend dentist and complete any required treatment before commencing first infusion.

General guidance on dental hygiene as per individual local guidelines as per treatment in advanced disease and should follow general principles of company information sheets.

Potential cost savings over time

Many patients will be on aromatase inhibitors which may induce bone loss. This regimen will improve bone loss related to these drugs and should reduce the need for DEXA scans. The regimen is also sufficient to treat osteopenia and some levels of osteoporosis (after discussion with bone expert) thus simplifying the management of these patients.

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Appendix 5: Open Access Follow Up

Open Access Follow Up is appropriate for most breast cancer survivors with

supportive self-management and open access back to the specialist service as

required.

Several studies have shown most cases of recurrence are detected by the patient or

mammographically and the resources released by the conventional model of routine

clinical follow up would be better directed towards general support.

The supportive elements are through implementation of the 'recovery package'

including holistic needs assessment and care planning, treatment summary and GP

cancer care review, together with a health and well-being programme to better inform

and educate survivors about healthy life style interventions (especially diet and

physical exercise) and what to look out for in terms of early warning of further

problems relating to recurrence or metastatic disease or due to the late effects of

treatments - and who to contact.

The supportive and educational components of survivorship, together with some

specialist services for the management of consequences of treatment do have

resource implications, which will need commissioning support - with funding partly

from resources released from changes in follow up (with no routine medical follow

ups).

There will need to be robust 'remote' surveillance systems to ensure five years of annual mammographic surveillance (NICE guidance) with results shared with patients and their GPs or recall for further assessment by the symptomatic service managed in a similar way to the NHS Breast Screening Programme.

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7 Glossary

Adjuvant treatment – treatment given in addition to other treatment e.g. chemotherapy given after surgery

Advanced breast cancer – breast cancer that has involved the whole breast or has spread (see metastasis)

Anthracyclines – type of chemotherapy drugs, includes doxorubicin and epirubicin

Anti-HER2 therapy – treatment with drugs that target the HER2 receptor e.g. trastuzumab

Aromatase inhibitors – type of hormone treatment used to treat breast cancer by blocking the production of oestrogen in the body

Axilla – the medical term for the armpit

Axillary node sampling – removal of a few lymph nodes from the armpit

Bilateral – both sides of the body e.g. a bilateral mastectomy is the removal of both breasts

Biopsy – removal of tissue for examination under a microscope

Bisphosphonate - a class of drugs used to strengthen bone e.g. zoledronate. Bisphosphonates are used to treat osteoporosis and the bone pain from diseases such as metastatic breast cancer

Breast conserving surgery – surgery that removes a tumour and surrounding tissue but not the whole breast. Also known as lumpectomy or wide local excision

Breast reconstruction – surgery to rebuild a breast after a tumour is removed

Chemoprevention - the use of drugs or other agents to try to reduce the risk of, or delay the development or recurrence of, cancer

Chemotherapy – drug treatment that aims to destroy cancer cells, usually injected into the bloodstream, but can also be injected into muscle or given as a tablet

Core biopsy - removal of tissue using a needle to check for cancer cells

DCIS (Ductal Carcinoma in Situ) – a pre-cancerous breast condition where the cancerous cells remain in the duct and have not spread to the surrounding area in the breast. DCIS may or may not become cancerous in time

Deep inspiration breath hold – an effective method of limiting radiation exposure to the heart and lungs used in radiotherapy treatment

Early breast cancer – cancer in the breast that has not spread beyond the breast and axillary lymph nodes

Endocrine therapy – see hormone therapy

Fine needle aspiration (FNA) – biopsy using a thin needle to extract cells to see if they are cancerous

Holistic Needs Assessment (HNA) – a process of gathering and discussing information with the patient and/or carer in order to develop an understanding of what the person living with and beyond cancer knows, understands and needs. This holistic assessment is focused on the whole person and their entire well-being is discussed – physical, emotional, spiritual, mental, social, and environmental. The process culminates when the assessment results are used to inform a care plan

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Hormone/hormonal/endocrine therapy – drug treatment used to stop the hormones oestrogen and progesterone from helping breast cancer cells to grow e.g. tamoxifen

Intensity modulated radiotherapy – an advanced form of radiation therapy using advanced technology to manipulate beams of radiation to conform to the shape of a tumor

Invasive breast cancer - cancer that has spread from where it began in the breast to surrounding normal tissue. The most common type of invasive breast cancer is invasive ductal carcinoma

Isotopic bone scan - a way of imaging bones, organs and other parts of the body by using a small dose of a radioactive chemical

Locally advanced breast cancer – cancer cells have extensively spread to lymph nodes and/or other tissue in the area of the breast, but not to distant sites in the body

Lumpectomy – see breast conserving surgery

Lymph node – a gland which is part of the immune system; it filters lymph fluid, fights infection and forms white blood cells

Lymphoedema – long-term swelling in the tissues, which can occur in the arm or upper body after breast cancer surgery or radiotherapy. It is caused by a build-up of excess fluid in the tissues

Mammography – an x-ray of the breast using very low doses of radiation

Mastectomy – surgery to remove the breast

Metastasis/metastases/metastatic – cancer cells that have spread to another part of the body, also called secondary or advanced cancer

MRI (magnetic resonance imaging) – a type of scan using radio waves and a magnetic field to create images of the body

MDT (multidisciplinary team) – a team of health professionals with a variety of roles and specialisms, who work together to provide treatment and care

Neoadjuvant therapy – treatment given before surgery e.g. the use of chemotherapy before surgery to shrink a large tumour so surgery can be performed

Nodes – glands that are part of the lymphatic system. When breast cancer spreads, lymph nodes in and around the armpit are some of the first places it travels, and surgeons often remove some of these nodes to determine whether the cancer has spread

Oestrogen receptor (ER) test – test to discover if a tumour is sensitive to the hormone oestrogen

Oncologist – a doctor specialising in the treatment of cancer, known as a clinical or medical oncologist

Oncoplastic conservation – surgery involving lumpectomy and cosmetic surgery, sometimes to both breasts to even their appearance (known as contra-lateral symmetrisation surgery)

Ovarian suppression – completely blocking the release of hormones by the ovaries either by surgery, radiotherapy to the ovaries, or treatments with drugs

Paclitaxel – a chemotherapy drug (see taxanes)

Primary breast cancer - see early breast cancer

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Raloxifene – a drug that blocks the effects of the hormone oestrogen in the breast and increases the amount of calcium in bone. It is a type of selective oestrogen receptor modulator (SERM)

Receptor status - a test that tells you whether or not the breast cancer cells have certain receptors e.g. for the hormones oestrogen and progesterone

Recovery Package - a combination of different interventions, which when delivered together, will greatly improve the outcomes and coordination of care for people living with and beyond cancer.

Recurrence - when breast cancer returns in the chest/breast area, or in the skin near the original site or scar, this is called a local recurrence. Regional recurrence is breast cancer which has come back following treatment and has spread to lymph nodes (glands) around the breast.

Radiotherapy – the use of high energy x-rays to destroy cancer

Secondary cancer – see metastasis

Sentinel node biopsy – a way of checking to see whether cancer has spread to the lymph nodes in the armpit; sentinel nodes are the first nodes in the armpit that cancer could spread to

Seroma – swollen area of tissue filled with blood serum

Staging – the process to determine the extent to which a cancer has grown and spread

Stratified Open Access Follow Up – see appendix 5

Systemic treatment – treatment that affects the whole body, such as chemotherapy and hormone therapy

Tamoxifen – a drug used in the treatment of breast cancer that blocks the effects of oestrogen

Taxanes – group of chemotherapy drugs e.g. Taxotere

Trastuzumab (Herceptin) – a targeted treatment for breast cancer used to treat approximately 1 in 5 breast cancers known as HER2 positive

Triple negative breast cancer – triple negative breast cancer ie tumours which are oestrogen receptor negative, progesterone receptor negative and HER2 receptor negative

TNM (tumour, nodes, metastases) – a way of describing the cancer and whether it has spread

Triple assessment – initial testing for breast cancer, carried out in a breast clinic, which includes physical examination, imaging of the breast and biopsy

Ultrasound imaging – technique for taking pictures inside the body using sound waves

Wide local excision – see breast conserving surgery

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8 Abbreviations AI – Aromatase inhibitor

BRCA 1 or 2 – two genes that, if inherited in a mutated form, may predispose some

carriers to develop breast or ovarian cancer

COSD – Cancer Outcomes Services Dataset

CT – Computed tomography

DCIS – Ductal Carcinoma in Situ

ECAD – Earliest clinically acceptable date

ER – Oestrogen receptor

FNA – Fine needle aspiration

HER2 – Human epidermal growth factor receptor 2

HNA – Holistic Needs Assessment

IMRT – Intensity Modulated Radiotherapy

MDT – Multidisciplinary team

MRI – Magnetic resonance imaging

NHSBSP – NHS Breast Screening Programme

PET-CT – Positron emission tomography – computed tomography

TNM – Tumour, nodes, metastases

T3 – Part of staging. Indicates the size/extent of the primary tumour

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9 References 1 Office of National Statistics, Cancer Registration Statistics, England (2015). Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/datasets/cancerregistrationstatisticscancerregistrationstatisticsengland 2 National Cancer Registration and Analysis Service and Macmillan Cancer Support in collaboration with the national cancer registries of Northern Ireland, Scotland and Wales, UK Complete Cancer Prevalence for 2013 Technical report. (2015) Available from: http://www.ncin.org.uk/about_ncin/segmentation 3 National Audit of Breast Cancer in Patients, First Annual Report (2017). Available from: https://www.nabcop.org.uk/content/uploads/2017/07/NABCOP-2017-Annual-Report.pdf 4 National Cancer Action Team, Multidisciplinary team members’ views about MDT working: Results from a survey commissioned by the National Cancer Action Team (2009). 5 Cancer Research UK, Meeting patients’ needs: improving the effectiveness of multidisciplinary team meetings in cancer services CRUK commissioned research into MDT’s. 2017 Executive summary available from: http://www.cancerresearchuk.org/sites/default/files/executive_summary_meeting_patients_needs_improving_the_effectiveness_of_multidisciplinary_team_meetings.pdf 6 NICE, Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer [CG164], section 1.7(2013, updated 2017). Available from: https://www.nice.org.uk/guidance/cg164 7 Department of Health and NHS England. NHS public health functions agreement 2015-16 – Service specification no.24, Breast Screening Programme (2014). Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/383198/1516_No24_Breast_Screening_Programme_FINAL.pdf 8 NHS England, EO1. Medical Genetics. Available from: https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-e/e01/ 9 NHS England, B02. Chemotherapy. Available from: https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-b/b02/ 10 NHS England, BO1. Radiotherapy. Available from: https://www.england.nhs.uk/commissioning/spec-services/npc-crg/group-b/b01/ 11 NICE, Breast Cancer Quality Standard [QS12] (2011, last updated 2016). Available from: https://www.nice.org.uk/guidance/qs12/resources/breast-cancer-pdf-2098481951941 12 NHS England, CCG outcomes indicator set. Available from: https://www.england.nhs.uk/resources/resources-for-ccgs/ccg-out-tool/ccg-ois/http://www.england.nhs.uk/ccg-ois/http://www.england.nhs.uk/ccg-ois/ 13 NHS England, NHS Outcomes Framework – 5 domains resources. Available from: http://content.digital.nhs.uk/nhsof 14 Independent Cancer Taskforce, Achieving world-class cancer outcomes in England, 2015-2020 (2015). Available from: http://www.cancerresearchuk.org/sites/default/files/achieving_world-class_cancer_outcomes_-_a_strategy_for_england_2015-2020.pdf 15 Association of Breast Surgery. Best practice diagnostic guidelines for patients presenting with breast symptoms, section 2.1 (2010). Available from:

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http://www.associationofbreastsurgery.org.uk/media/4585/best_practice_diagnostic_guidelines_for_patients_presenting_with_breast_symptoms.pdf 16 NICE, Early and locally advanced breast cancer: diagnosis and treatment [CG80], recommendation 1.1.1 and 1.1.2 (2009). Available from: https://www.nice.org.uk/guidance/cg80 17 NICE, Breast Cancer Quality Standard [QS12], (2011). Available from: https://www.nice.org.uk/guidance/qs12/resources/breast-cancer-pdf-2098481951941 18 Royal College of Radiologists and Royal College of Physicians. Evidence-based indications for the use of PET-CT in the UK 2013 (2013). Available from: https://www.rcr.ac.uk/sites/default/files/publication/2013_PETCT_RCP_RCR.pdf 19 Royal College of Pathologists. Key Performance Indicators – Proposals for Implementation (2013). Available from: https://www.rcpath.org/profession/clinical-effectiveness/key-performance-indicators-kpi.html 20 NICE. Advanced breast cancer [CG81], recommendation 1.1.8, (2014) and Early and locally advanced breast cancer: diagnosis and treatment [CG80], recommendations 1.6.1, 1.6.3 and 1.6.4(2009). Available from: https://www.nice.org.uk/guidance/cg81 and https://www.nice.org.uk/guidance/cg80 21 Rakha EA et al. Updated UK Recommendations for HER2 assessment in breast cancer. J Clin Pathol. 2015; 68(2): 93-9. Available from: doi: 10.1136/jclinpath-2014-20257 22 The Association of Breast Surgery @BASO, Royal College of Surgeons of England. Guidelines for the management of symptomatic breast disease. EJSO. 2005; 31:S1-S21. Available from: doi: http://dx.doi.org/10.1016/j.ejso.2005.02.006 23 Quality Health, 2015 National Cancer Patient Experience Survey (2016). Available from: http://www.ncpes.co.uk/index.php/reports/national-reports/2489-cpes-2015-national-report-pdf/file 24 London Cancer Alliance. LCA Breast Cancer Clinical Guidelines, section 7.1 (2013). Available from: http://www.londoncanceralliance.nhs.uk/media/59178/FINAL%20LCA_BreastGuidelines_231013%20revised%20(3).pdf 25 NICE, Early and locally advanced breast cancer: diagnosis and treatment [CG80], recommendation 1.14.6 (2009). Available from: https://www.nice.org.uk/guidance/cg80 26 NICE, Early and locally advanced breast cancer: diagnosis and treatment [CG80], recommendation 1.12.1 (2009). Available from: https://www.nice.org.uk/guidance/cg80 27 National Audit of Breast Cancer in Patients, First Annual Report (2017). 28 NICE, Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer [CG164], section 1.5 (2013, updated 2017). Available from: https://www.nice.org.uk/guidance/cg164 29 NHS UK Genetic Testing Network, UKGTN Testing Criteria – breast cancer http://ukgtn.nhs.uk/upoads/tx_ukgtn/UKGTN_breast_cancer_testing_criteria_Final_161014.pdf 30 London Cancer Alliance. LCA Breast Cancer Clinical Guidelines, section 6.1.9 (2013). Available from: http://www.londoncanceralliance.nhs.uk/news,-events-publications/news/2013/10/new-breast-cancer-clinical-guidelines-published/?restricted=1&?returnurl=%2fmedia%2f59178%2fFINAL+LCA_BreastGuidelines_231013+revised+(3).pdf

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31 Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons. Oncoplastic Breast Reconstruction – Guidelines for Best Practice(2012). Available from: http://www.associationofbreastsurgery.org.uk/media/23851/final_oncoplastic_guidelines_for_use.pdf 32 NICE, Early and locally advanced breast cancer [CG80], section 1.4 (2009). Available from: https://www.nice.org.uk/guidance/cg80 33 NICE, Early and locally advanced breast cancer [CG80], section 1.13(2009). Available from: https://www.nice.org.uk/guidance/cg80 34 Boughey J et al. Contralateral Prophylactic Mastectomy (CPM) Consensus Statement from the American Society of Breast Surgeons: Data on CPM Outcomes and Risks (2016). Available from: http://associationofbreastsurgery.org.uk/media/1421/contralateral-prophylactic-mastctomy-consensus-stamte-from-the-american-society-of-breast-surgeons-data-on-cpm-outcomes-and-risks.pdf 35 Association of Breast Surgeons, ABS Summary Statement: Contralateral Mastectomy for Unilateral Breast Cancer (2016). Available from http://associationofbreastsurgery.org.uk/media/63462/contralateral-mastectomy-abs-summary-document.pdf 36 Boughey et al, Contralateral Prophylactic Mastectomy Consensus Statement from the American Society of Breast Surgeons: Additional Considerations and a Framework for Shared Decision Making (2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4999472/ 37 Royal College of Radiologists, Postoperative radiotherapy for breast cancer: UK consensus statements (2016). Available from: https://www.rcr.ac.uk/system/files/publication/field_publication_files/bfco2016_breast-consensus-guidelines.pdf 38 NICE, Early and locally advanced breast cancer [CG80], section 1.4 (2009). Available from: https://www.nice.org.uk/guidance/cg80 39 Donker M et al., Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial (2014). Available from: Lancet Oncol. 2014 Nov;15(12):1303-10. https://www.ncbi.nlm.nih.gov/pubmed/25439688 40 Francis PA et al. Adjuvant Ovarian Suppression in Premenopausal Breast Cancer.N Engl J Med. 2015;372:436-46. Available from: doi: 10.1056/NEJMoa1412379. 41 NICE, Early and locally advanced breast cancer [CG80], recommendation 1.7.3 (2009). Available from: https://www.nice.org.uk/guidance/cg80 42 Reid DM et al.Guidance for the management of breast cancer treatment induced bone loss: a consensus position statement from a UK Expert Group. Cancer Treatment Reviews. 2008;34(1): S3-S18. Available from: https://www.nos.org.uk/NetCommunity/Document.Doc?id=124 43 Jin H et al, Longer term outcomes of letrozole versus placebo after 5 years tamoxifen in the NCIC CTG MA.17 trial: analysis adjusting for treatment crossover. J Clin Oncol. 2012; 30(7): 718-721. Available from: doi: 10.1200/JCO.2010.34.4010 44 Davies C et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013; 381(9869): 805-16. Available from: doi: 10.1016/S0140-6736(12)61963-1

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Breast Cancer Clinical Expert Group

Issue/approval date: August 2017 Next review date: May 2019 Page 33

45 Goss P et al. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years (2016). Available from http://www.nejm.org/doi/full/10.1056/NEJMoa1604700#t=article 46 NICE, Gene Expression Profiling and Expanded Immunohistochemistry Tests for Guiding Adjuvant Chemotherapy in Early Breast Cancer Management: Mammaprint, Oncotype Dx, IHC4 and Mammostrat [DG10](2013). Available from: https://www.nice.org.uk/guidance/dg10 47 Tolaney SM et al. A phase II study of adjuvant paclitaxel and trastuzumab (APT trial) for node-negative, HER2-positive breast cancer. San Antonio Breast Cancer Symposium, December 10-14, 2013. Abstract S1-04. 48 Jones et al. Management of cardiac health in trastuzumab-treated patients with breast cancer: updated United Kingdom National Cancer Research Institute recommendations for monitoring. British Journal of Cancer (2009). 49 von Minckwitz et al. (2017). Adjuvant pertuzumab andtrastuzumab in early HER2 Positive Breast Cancer, NEJM, Volume 377 50 Early Breast Cancer Trialists’ Collaborative Group (EBCTCG),Adjuvant bisphosphonate treatment in early breast cancer: meta-analyses of individual patient data from randomised trials. Lancet. 2015;386(10001): 1353-1361 Available from: doi: http://dx.doi.org/10/1016/S0140-6736(15)609084 51 Scmid D & Leitzmann MF Association between physical activity and mortality among breast cancer and colorectal survivors: a systematic review and meta-analysis. Annals of Oncology 2014; 25(7): 1293-1311. Available from: doi: 10.1093/annonc/mdy012 52 London Cancer Alliance, Metastatic Breast Model Service Specification (2016). Appendix 3: CNS knowledge and skills framework. Available from: http://www.londoncanceralliance.nhs.uk/media/121058/lca-metastatic-breast-service-specification-feb-2016-revised-march-2016-.pdf 53 NICE, Advanced breast cancer [CG81]: diagnosis and treatment, recommendation 1.4.1(2014). Available from: https://www.nice.org.uk/guidance/cg81 54 Partridge AH et al. Chemotherapy and Targeted Therapy for Women with HER2 negative (or unknown) Advanced Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline, recommendation 4. JCO. 2014; 32(29): 3307-3329. Available from: doi: 10.1200/JCO.2014.56.7479 55 National Cancer Survivorship Initiative. The Recovery Package. Available from: http://www.ncsi.org.uk/what-we-are-doing/the-recovery-package/ 56 UK Clinical Research Network: Portfolio Database. MAMMO-50. Available from: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=16250 57 Robertson C et al. The clinical effectiveness and cost-effectiveness of different surveillance mammography regimens after the treatment for primary breast cancer: systematic reviews, registry database analyses and economic evaluation. Health Technology Assessment. 2011; 15(34): 1366-5278. Available from: doi: http://dx.doi.org/10/3310/hta15340 58 NICE, Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer [CG164], section 1.7(2013, updated 2017). Available from: https://www.nice.org.uk/guidance/cg164 59 Cancer Research UK, 2017 Chemoprevention commissioned research: http://www.cancerresearchuk.org/sites/default/files/gp_attitudes_to_cancer_preventing_drugs_exec_summary.pdf

Page 51: Meeting: Breast Expert Advisory Group

Baek Kim

TIG Oncoplastic Fellow, RVI, Newcastle

Oncoplastic MDT meeting and Joint genetics clinic

Page 52: Meeting: Breast Expert Advisory Group

Introduction

• Started 4 years ago

• Identified need to run joint reconstructive clinic given the increasing number of immediate reconstruction

• MDT with clinic to discuss reconstructive cases with regards to decision making

• MDT cases identified and presented by TIG oncoplastic fellow

Page 53: Meeting: Breast Expert Advisory Group

Oncoplastic MDT and clinic

• Every Thursday morning

• Oncoplastic breast and plastic surgeons

• Specialist reconstructive nurses

• Genetics consultant (Dr Alex Henderson) joint clinic every 8 weeks to discuss challenging cases

• Standardised proforma

• Patient photography

Page 54: Meeting: Breast Expert Advisory Group

Number and type of cases

• 13 cases October 2017

• 22 cases September 2017

• 17 cases August 2017

• Generally immediate reconstructive cases (autologous and implant-based)/ therapeutic mammoplasties +/- contralateral symmetrising surgery/ chest wall perforator flaps

Page 55: Meeting: Breast Expert Advisory Group

Patient JD (AC/HC patient)

2/11/17

High risk surveillance

Cervical Ewing’s sarcoma- CxRx/ Type II DM

Metformin Gliclazide Thyroxine

Retail

Non-smoker Nil

Yes

---- (L) 3

+ve

-ve Normal USS

Unlikely benefit

Already had radiotherapy

Page 56: Meeting: Breast Expert Advisory Group

Patient JD

13mm UIQ + 10mm 6 o’clock

N/A Completed

Nil

Nil significant

A

Grade 1

Potential discussion at later date

Page 57: Meeting: Breast Expert Advisory Group

Patient JD

Left SSM + SNB + LD/CWP flap recon 14/11/17 AC list

Awaited

N/A

Page 58: Meeting: Breast Expert Advisory Group

Patient JD (imaging)

Page 59: Meeting: Breast Expert Advisory Group

Joint genetics clinic

• Cases identified by oncoplastic breast and plastic surgeons and geneticist

• Patients seen jointly every 8 weeks

• Complex cases discussed with regards to decision making regards to contralateral mastectomy/ family history/ patient with previous cancer diagnosed with potential genetic risk

• Those with BRCA gene mutation requesting risk reducing mastectomy not discussed

Page 60: Meeting: Breast Expert Advisory Group

Benefits of the service

• Joined up message between surgeons and geneticist

• Unique opportunity to discuss oncological risk with genetic risk in a single setting

• Educational benefit

Page 61: Meeting: Breast Expert Advisory Group

Living With and Beyond Cancer

Pam Lee

Consultant in Public Health

Page 62: Meeting: Breast Expert Advisory Group

LWBC

• Vision

• Aims

• Priorities

• Governance

• Delivery

Page 63: Meeting: Breast Expert Advisory Group

LWBC Vision

Improve quality of life for people

living with and beyond cancer

Page 64: Meeting: Breast Expert Advisory Group

LWBC Aims

• increased support to live well after

cancer

• better experience of cancer care

• developing consistent care across

the NCA

Page 65: Meeting: Breast Expert Advisory Group

LWBC Priorities

1. Commissioning - develop toolkit to

• drive improvement

• support re-design of pathways after treatment:

– recovery package embedded in the patient

pathway

– stratified follow up pathways

Page 66: Meeting: Breast Expert Advisory Group

LWBC Priorities (cont)

2. Workforce

• Education

• Increase staff capacity

• Enhance skills

Page 67: Meeting: Breast Expert Advisory Group

LWBC Priorities (cont)

3. Patients

- Ensure all patients have named key worker

- Involved in redesigning pathways

Page 68: Meeting: Breast Expert Advisory Group

LWBC Governance

• NCA Board

• LWBC Transformation Board

• LWBC Expert Ref Group

Page 69: Meeting: Breast Expert Advisory Group

LWBC Delivery

• Locality groups

• Commissioning Forum

• Providers – trusts/practices/third

sector

Page 70: Meeting: Breast Expert Advisory Group

LWBC

• Questions and discussion

Page 71: Meeting: Breast Expert Advisory Group

Allocated Actions

INTRODUCTION one page (page 5) Cancer Alliance

Terms of Reference Cancer Alliance

Facts and Figures Cancer Alliance

Public Health and Prevention Cancer Alliance

SCREENING Page 6 -10 [email protected]

General Population Screening [email protected]

Management of Patients with a Family History indicating increased risk of Breast Cancer

[email protected]

Chemoprophylaxis for Women at High Risk of Breast Cancer [email protected]

Pathway(s) for High Risk Women – in the North East and North Cumbria

[email protected]

Protocols for the surveillance of women at higher risk of developing breast cancer

[email protected]

Pathway for patients with suspected Breast Cancer Cancer Alliance

Referral Pathways Cancer Alliance

NSSG Guidelines for Teenage and Young Adults Cancer Alliance

HOSPITAL INVESTIGATION AND ASSESSMENT OF BREAST CANCER (5,6) page 19

[email protected]

COMMUNICATING THE DIAGNOSIS – page 20

Informing the Patient

Informing the Primary Care Team

CANCER WAITING TIMES TARGETS 2009/10 page 21 Cancer Alliance

GUIDELINES FOR SYMPTOMATIC BREAST IMAGING page 22 to 25 [email protected]

General Principles [email protected]

Symptom-Specific Imaging [email protected]

Lumpiness or "Asymmetric Nodularity" [email protected]

Nipple Discharge – No Lump [email protected]

Breast pain [email protected]

Suspected Breast Sepsis [email protected]

Presumed Fat Necrosis [email protected]

Intracystic Papillary Lesions [email protected]

Skin Lesions, eg Sebaceous Cysts and Non-Suspicious Nipple Eczema

[email protected]

Gynaecomastia [email protected]

Imaging of the Axilla [email protected]

Needle Biopsy

Indications for MRI Scanning

NECN GUIDELINES FOR PATHOLOGY REPORTING page 27 [email protected]

REFERRAL GUIDELINES BETWEEN MDTS WITHIN AND OUTSIDE THE NECN page 28

SURGICAL TREATMENT OF BREAST CANCER page 29-31

Management of In situ breast cancer

Lobular carcinoma in situ (LCIS)

SURGICAL TREATMENT OF INVASIVE BREAST CANCER page 32-37 [email protected]

Small unifocal invasive cancers with no palpable nodes. [email protected]

Axillary Sentinel Lymph Node Biopsy [email protected]

Page 72: Meeting: Breast Expert Advisory Group

Management of the Patient with Tumour-Positive SLNB [email protected]

Larger tumours or with palpable nodes [email protected]

Cosmetic Breast Reconstruction: [email protected]

Pre and Peri-operative Staging [email protected]

RADIOTHERAPY FOR BREAST CANCER 38 -43 Daniela Lee

Introduction Daniela Lee

Post Breast Conserving Surgery Daniela Lee

Post Mastectomy Daniela Lee

Patients unsuitable for surgery: Daniela Lee

Adjuvant Radiotherapy for DCIS Daniela Lee

ENDOCRINE THERAPY FOR INVASIVE BREAST CANCER Daniela Lee

Hormone Treatment Recommendations Daniela Lee

Endocrine Therapy For Metastatic Disease Daniela Lee

CHEMOTHERAPY FOR INVASIVE BREAST CANCER 49 -53

Adjuvant Chemotherapy

Management of cardiac events in trastuzumab-treated patients

Neo-Adjuvant Chemotherapy

Chemotherapy In Metastatic Disease

BISPHOSPHONATES FOR BONY SECONDARIES 55

BREAST CANCER FOLLOW UP-56 and 57

THE BREAST CARE CLINICAL NURSE SPECIALIST (CNS)-58 Nurses

PALLIATIVE CARE59-61

CLINICAL TRIALS- 62 Penny Williams

AUDIT -63

PATIENT SUPPORT GROUPS- 64

Nurses

BIBLIOGRAPHY- 65-70

Appendix 1 – TNM Staging of Breast Cancer-70-71

Appendix 2 – Algorithms for Management of Breast Cancer Treatment-Induced Bone Loss-72-73

Appendix 3 - Follow-Up Care After Treatment For Breast Cancer- 74-75

Appendix 4 – NECN Chemotherapy Algorithm- 76 -84

Appendix 5, Association of Breast Surgery Consensus Statement 85


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