Information and support for patients on MKI treatment - guidance for physicians and patient organizations

Fabián Pitoia, MD Hospital de Clínicas

University of Buenos AiresArgentina

Conflicts of interest

Consultancy & Speaker Bureau Genzyme/SanofiConsultancy / Ad Board / Speaker Bureau/ Steering Comittee Bayer

2

33

International patient-led workshop on “TKIs and what it means for patients” organized by the Thyroid Cancer Alliance (TCA), Paris, October 2014

Perea, Soledad R. Thyroid Cancer Alliance, Diss, Norfolk, United Kingdom and ACTIRA, Buenos Aires, Argentina; Armstrong, Nicola, Freeman Hospital, Newcastle Upon Tyne, United Kingdom; Bartès, Beate, Vivre sans Thyroide , Paris, France; Brose, Marcia S., University of Pennsylvania, Philadelphia, PA, United States; Elisai, Rossella, University of Pisa, Pisa, Italy ; Farnell, Kate, Butterfly Thyroid Cancer Trust, Newcastle, United Kingdom; Grey, Joanna, Association for Multiple Endocrine Neoplasm Disorders, Tunbridge Wells, United Kingdom ; Harmer, Clive, Clinical Oncologist, London, United Kingdom ; Hobrough, Helen, Thyroid Cancer Support Group Wales, Cardiff, United Kingdom; Luster, Markus, University of Marburg, Marburg, Germany ; Mallick, Ujjal, Freeman Hospital, Newcastle Upon Tyne, United Kingdom ; McGarry, Mary, Thyroid Cancer Support Group Ireland, Dublin, Ireland; Moss, Laura, Velindre Cancer Centre, Cardiff, United Kingdom ; Palazzo, Fausto, Hammersmith Hospital & Imperial College, London, United Kingdom ; Porrey, Marika, Schildklier Organisaties Nederland (SON), Amersfoort, Netherlands; Pitoia, Fabian A., Hospital de Clínicas – University of Buenos Aires, Buenos Aires, Argentina ; Schlumberger, Martin, Centre de Lutte Contre le Cancer (CLCC) de Villejuif , Institut Gustave Roussy , Villejuif, France ; Taylor, Judith, Thyroid Cancer Alliance, Diss, Norfolk, United Kingdom; Villar, Carmen, AECAT, Madrid, Spain and Thyroid Cancer Alliance, Diss, Norfolk., United Kingdom

Parafollicular cells

Thyroid Cancer: Clinical Pathology

Follicular cells Differentiated

Anaplastic

Medullary

Papillary

Follicular

Hürthle cell

Sporadic

Familial

4

1. American Cancer Society. What is thyroid cancer? http://www.cancer.org/cancer/thyroidcancer/detailedguide/thyroid-cancer-what-is-thyroid-cancer. Accessed April 24, 2014.2. Carling T, Udelsman R. Thyroid tumors. In: DeVita VT Jr, et al, eds. Cancer: Principles & Practice of Oncology. 9th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:1457-1472.

DTC: Surgery (TT +/- LND; HT; +/- Remnant Ablation)MTC: Surgery (TT + generally LND)

Differentiated Thyroid CancerPatients With Locally Recurrent or Metastatic

Disease May Become RAI-Refractory

• It was estimated1 that worldwide there will be – Approximately 300,000 new cases of thyroid cancer– Approximately 40,000 deaths due to thyroid cancer

• Approximately 7% to 23% of patients with thyroid cancer develop distant metastases2,3

– Two-thirds of these patients become RAI-refractory2

– The most common sites of distant metastases are4

• Lung• Bone

5

RAI, radioactive iodine.1. GLOBOCAN 2012: Estimated cancer incidence, mortality and incidence worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed March 12, 2014. 2. Brose MS, et al. Lancet. 2014;384(9940):319-328. 3. Anderson RT, et al. Thyroid. 2013;23(4):392-407. 4. Durante C, et al. J Clin Endocrinol Metab. 2006;91(8):2892-2899.

• WHEN should information be provided?

– Clear and understandable explanation of the • expected clinical course of their thyroid cancer, • available treatment options,

- Active surveillance might also be a valid option

Considerations when a MKI is prescribed

6

• WHAT information should be provided when a DTC become RAI-refractory or a MTC becomes metastatic and proggresses?

– What does radioiodine resistance in DTC mean?

– What treatments, including targeted therapies, may be available and appropriate

– Is the treatment curative?

– If palliative: benefits (PFS, QOL, etc)

Considerations when a MKI is prescribed

7

• WHAT information should be provided when a DTC become RAI-refractory or a MTC becomes metastatic and proggresses?

Intended duration of treatment

– How the patient will be monitored, how often, and what tests will be done?

– Availability of clinical trials

– How to access supportive care (patient organizations, community support)

– What costs are involved (co-funding in some countries)

Considerations when a MKI is prescribed

8

• WHAT information should be provided when a DTC become RAI-refractory or a MTC becomes metastatic and proggresses?

– It should be made clear that:• the course of the disease varies greatly in individuals, • the disease may not progress for many years, • there may be other options (surgery, radiotherapy, radioactive isotope

therapy) before considering an MKI

– The information may need to be communicated over several consultations at different stages of the disease

Considerations when a MKI is prescribed

9

• WHAT information should be provided when a DTC become RAI-refractory or a MTC becomes metastatic and proggresses?

– Decision to start a MKI therapy should not be “paternalistic”, it should be taken together with patients/relatives

Considerations when a MKI is prescribed

10

• Before starting treatment

– What to expect and when

– How to take the medication and when

– What are the possible side effects and how can these be managed

– Who is the patient’s primary medical team contact

– How to access supportive care (patient organizations, community support)

Considerations when a MKI is prescribed

11

• HOW should the information be provided?

– Oral information

– Patient should be encouraged to bring a relative or friend to consultation

– QOL should be discussed

– Doctors should adapt to patient´s needs and learning level

– Preferable written info (or multimedia) should be given to patients to allow the incorporation of the information

– Contact information nurse or doctor (telephone or e-mails)

Considerations when a MKI is prescribed

12

• Management of side-effects of MKIs

– What side effects may occur

– What to do to prevent them

– What the medical team can do to lessen them

– How to report them, and to whom

– The importance of reporting side effects promptly (easy contact with nurse, resident, doctor)

Considerations when a MKI is prescribed

13

• WHO should be the patient’s primary contact person?

– Endocrinologist

– Oncologist

– Clinical nurse specialist/ nurse practitioner

Support

14

Regional differences

Brose, Schlumberger, Pitoia et al. Expert Reviews Anticancer Therapy 2012Pacini, Pitoia et al. Expert Reviews Endocr Metab 2012Schlumberger & Sherman. Eur. J. Endocrinol 2011

Interdisciplinary approach

Brose, Pitoia et al. Expert Review of Endocrinol Metab. Sept 2012

• What role can patient organizations play in supporting patients on MKI treatment?

– Patient information materials, jointly with clinicians, and give feedback to the medical community on the patient perspective

– Publish patient stories and testimonials

– Help with the access to drugs, social work, welfare rights, legal advice

– They can provide support through holding support meetings and by one to one contact (telephone or face to face)

Support

16

• When treatment ends

– Treatment with an MKI is not curative

– When treatment ends, the clinical team and the patient should review together the path ahead, with an emphasis on being realistic

– If there are other options to be explored, such as a second MKI, or participation in a clinical trial, these should be reviewed carefully together

– The clinical team should assess the patient’s psychological well-being at each stage (psycological and physical impact)

Support

17

Together, doctors and patient´s organizations have an important task for making MKI treatment properly prescribed

Doctors need to be following these patients very closely

Patients should participate actively in the decision of the treatment with MKI

Conclusions

18