PREVENTION OF PATHOLOGICAL FRACTURE · PRESENTATIONof impending pathological fractures is likely to...

$Page 1: PREVENTION OF PATHOLOGICAL FRACTURE · PRESENTATIONof impending pathological fractures is likely to result JULY 2012 V1.0 1.GENERAL PRINCIPLES (2) • Survival rates for people with$
PREVENTION OF PATHOLOGICAL

FRACTURE

14TH NOVEMBER 2013

PREVENTION OF PATHOLOGICAL FRACTURE (PPF) GUIDELINE DEVELOPMENT GROUP

DR MARIA DEBATTISTA

PAULA HORTON

SUSAN HOWARTH

BARBARA HUMPHRIES

DR ANDREW KHODABUKUS

JOANNE REYNOLDS

DR JENNY SMITH

MR PAUL COOL

DR AZMAN IBRAHIM

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PRESENTATION JULY 2012

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SESSION OUTLINE

• Overview

• Existing Standards

• Updated Standards &

Guidelines

• Mr Paul Cool - External

Review

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PROVENANCE

• April 2005 – initial guidelines produced

• 3rd May 2012 – Review meeting of MCPCNAG, majority quorate vote to review guidelines

• Meetings of membership of Prevention of Pathological Fracture (PPF) guideline development group

– 17th July 2012

– 25th September 2012

– 13th November 2012

– 11th June 2013

– 12th September 2013

– 16th October 2013

– 4th November 2013

• Presentation of Literature Review on 4th July 2013

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LITERATURE REVIEW

• Main changes to evidence base:

– Mirels Score • upgraded to Level 2+ evidence

– Denosumab licensed for PPF • Breast cancer and solid tumours if

bisphosphonates would otherwise be prescribed

• Not used in prostate cancer

• Level 1+ Evidence

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EXISTING STANDARDS & AUDIT

RESULTS

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REVISED GUIDELINES FOR

THE PREVENTION OF

PATHOLOGICAL FRACTURES

IN PALLIATIVE

CARE

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1.GENERAL PRINCIPLES (1)

• Bone is one of the commonest sites of metastatic

disease. The most likely primary tumours to spread

to bone are breast, bronchus, kidney, thyroid and

prostate. The axial skeleton (skull, ribs, spine and

pelvis) is more likely to develop metastatic disease

than the appendicular skeleton. l

• The major associated morbidities of bone metastases

include pain (the most common symptom occurring

in 70% of patients), pathological fractures (occurring

in 8-30% of patients) and hypercalcaemia.2, 3

• Advances in hormonal treatments, use of

bisphosphonates and chemotherapy treatments have

meant that the prognosis of patients with bone

metastases, without visceral metastatic disease, has

greatly improved. 4

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1.GENERAL PRINCIPLES (2)

• Survival rates for people with bone metastases vary

depending on the primary tumour type. In breast

cancer, median survival is 24 months with a 5-year

survival rate of 20% and in prostate cancer there is a

5-year survival rate of 25% and a median survival of

40 months5.

• Prediction of pathological fractures before the event

is a relevant clinical problem. Prophylactic fixation of

long bone metastases is generally easier for the

surgeon and less traumatic for the patient.

Therefore, prophylactic fixation of long bones prior

to radiotherapy should be considered. Stabilisation

of impending pathological fractures is likely to result

in shorter hospital stays, with patients more likely to

be discharged to their own homes.9

• The prevention and management of pathological

fractures should be within the context of a multi-

disciplinary team. 5,10

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2. GUIDELINES

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2.1 Investigation of bone pain (1)

• Pain may be described as a dull ache to a deep

intense pain; pain at rest; pain exacerbated by weight

bearing and importantly, pain which is worse at night. 2 Patients should be encouraged to report skeletal

symptoms promptly.4

• Bone pain may be due to structural damage,

periosteal irritation, nerve entrapment or secretion of

chemical mediators causing osteolysis e.g.

prostaglandins and cytokines. These mediators

activate both osteoclasts and nociceptors.2

• The clinical conundrum is to determine which pains

are due to new or existing metastatic disease and

which of these lesions may progress to a pathological

fracture. As such, reports of bone pain should be

investigated following the British Association of

Surgical Oncology (BASO) Guidelines (see Table 2.1). 10 [Level 4]

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BASO GUIDELINES FOR THE INVESTIGATION OF

BONE PAIN10 [LEVEL 4]

Level of clinical suspicion of

metastatic disease Clinical features Action

Minimal

Known cause for pain.

Resolves well usually 2-3

weeks from onset.

Normal outpatient review.

Return to GP if resolution not

complete.

Low Probable cause known. Good

resolution over 4-6 weeks.

Plain radiograph. If negative:

no action.

If positive: follow advice

regarding the need for

orthopaedic assessment.

Moderate

No clear cause for pain which

is persistent but not

progressive.

Plain radiographs, serum

calcium and bone scan within

10 working days. Review one

week later.

If all negative, review in 8

weeks if symptomatic.

If one or more tests positive,

follow advice regarding the

need for orthopaedic

assessment.

High

No identified cause for pain.

Night pain, severe and / or

progressive pain.

Neurological symptoms and

signs.

Plain radiographs, serum

calcium and bone scan within

10 working days. Review one

week later.

If all negative but suspicion

high, review in 1 week

(appendicular skeleton). If

pain in spine, then arrange

MRI.

If one or more tests positive,

then follow advice regarding

need for orthopaedic

assessment.

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• Plain radiographs should be of the entire bone,

including the joint above and below the site of pain.

Specific radiographs should be centralised over the

painful area in an AP and lateral view.

• Bone metastases may be described as osteolytic (bone

appears less dense on imaging), osteoblastic (where

bone looks denser or whiter on imaging) or mixed in

nature.4 [Level 4]

• Any plain radiograph report that details the presence of

a lytic lesion in a long bone should be discussed with a

radiologist regarding its size and degree of cortical

involvement, if not already stated. 7, 8, 10[Level 4]

• Plain radiographs are relatively insensitive at detecting

bone metastases.19 Thus if clinical suspicion is high

and radiographs are normal, further imaging is

warranted. This should be an isotope scan if the

appendicular skeleton is suspected, and an MRI if the

spine is potentially involved.19

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• Areas of increased uptake in any long bones on an

isotope bone scan should be followed up by plain

radiographs of the whole bone in two planes at 90° to

each other, to assess for size and cortical

involvement.10 [Level 4]

• Patients with symptomatic bone metastases should

be referred urgently to an orthopaedic clinic or be

discussed at a site-specific multidisciplinary team

meeting if they have any of the following:

Structurally significant bone destruction.

Uncertainty whether the destruction is

significant.

Pain of sudden onset (or change in character)

that is exacerbated by movement.10 [Level 4]

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PREDICTION OF PATHOLOGICAL

FRACTURE

• Clinical features of impending pathological fracture

include pain on movement, persistent pain and

increasing pain. Pain in an area which has already

been treated with radiotherapy, but has not

responded, may also be considered as a clinical

indicator of possible impending fracture.7,8

• The risk of a pathological fracture occurring, and

therefore the need to consider prophylactic

fixation, may be assessed using either Mirels

scoring system (for use in long weight bearing

bones) or Harrington's classic definitions (use

restricted to the proximal femur).7

• In Mirels scoring system (Table 32.2) [Level 2+], the

maximum possible score is 12. If a lesion scores 8

or above, then prophylactic fixation is

recommended prior to radiotherapy.

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Table 32.2 Mirels scoring system for the prediction of

pathological fractures 6 [Level 2+]

Score Clinical features

1 2 3

Site Upper limb Lower limb Peritrochanter

ic

Pain severity Mild Moderate Functional

Type of lesion Blastic Mixed Lytic Size (Maximum destruction of cortex in any view as seen on plain x-ray)

<l/3

1/3-2/3

>2/3

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ANY ONE OF HARRINGTON'S CLASSIC DEFINITIONS

INDICATES A HIGH RISK OF PATHOLOGICAL

FRACTURE IN THE PROXIMAL FEMUR (SEE TABLE

2.3).8 [LEVEL 3].

Table 2.3 Harrington's classic definitions. Risk of a pathological fracture 8 [Level 3]

1. 50% of circumferential cortical bone has been destroyed.

2. Where pain with weight bearing stresses persists, increases or recurs, despite adequate local irradiation.

3. Lesions in the proximal femur in excess of 2.5cm in any dimension.

4. Lesions in the proximal femur associated with avulsion of the lesser trochanter.

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2.3 ROLE OF ORTHOPAEDIC SURGEON

• A lead orthopaedic surgeon for appendicular

metastatic bone disease should be identified in

each local NHS trust. 4 [Level 4]

• Referral to an orthopaedic surgeon is appropriate in

the following situations:

Prophylactic fixation of metastatic deposits

when there is a high risk of fracture i.e.Mirels

score equal or greater than 8 (see Table 32.2) or

the presence of any one of Harrington's classic

definitions (see Table 32.3).

Stabilisation or reconstruction after

pathological fracture.

Decompression of the spinal cord and nerve

roots and / or stabilisation for spinal

instability. 4 [Level 4] (see Guidelines on the

Management of Metastatic Spinal Cord

Compression).

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2.4 RADIOTHERAPY

• Radiotherapy has a major role in the treatment of

bone metastases. 70% of patients will achieve pain

relief with palliative external beam radiotherapy. It

may also prevent additional bone destruction, help

to maintain function, prevent neurological

compromise and maintain quality of life.6

• Following nailing of a bone, radiotherapy should be

considered by appropriate specialists

within the context of the multidisciplinary team. 5, 11,

12 [Level 2-]

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2.5 OTHER TREATMENT MODALITIES (1)

• Bisphosphonates should be considered, where

clinically appropriate, for the prevention of

skeletal related events and treatment of malignant

bone pain in patients with bone metastases

from breast cancer or hormone refractory prostate

cancer, and also patients with multiple

myeloma.13 [Level 1+] Decisions to treat should be

based on an assessment of their general

medical condition and expected survival time (see

Guidelines on the Use of Bisphosphonates in

the Management of Malignant Bone Disease).

[Level 4].

• Radiofrequency ablation of bone metastases is an

emerging alternative therapy for the

management of bony metastatic disease. Referral to

an appropriate specialist may be beneficial

for effective pain palliation and local control of

disease. 15 [Level 3]

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2.5 OTHER TREATMENT MODALITIES (2)

• Percutaneous cementoplasty is indicated for

patients with painful vertebral metastases. It is a

minimally invasive technique involving injection of

polymethylmethacrylate to strengthen a

vertebra. It may provide fast pain relief for patients

when traditional surgical options are considered to

be too invasive. 16,17 [Level 3]

• Denosumab is recommended as an option for

preventing skeletal-related events from breast

cancer and from solid tumours, if bisphosphonates

would otherwise be prescribed. It can be used in

poor renal function. It is however not

recommended by NICE for use in prostate cancer,

and carries the risk of potential osteonecrosis of

the jaw5. [Level 1+]

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2.3 STANDARDS 1. Reports of bone pain should be promptly and

appropriately investigated following British

Association of Surgical Oncology (BASO) Guidelines.10

[Grade D].

2. If there is evidence of significant risk of a pathological

fracture, urgent orthopaedic review should be

considered.4, 10 [Grade D]

3. Following any orthopaedic intervention (prophylactic

stabilisation or fracture management) a patient should

be discussed with an oncologist regarding the

possibility of further therapy.10

[Grade D]

4. Patients presenting with a NEW OR SYMPTOMATIC

lesion due to metastatic bone disease must be

discussed with an oncologist for consideration of

further therapy (e.g. hormonal manipulation,

bisphosphonates, chemotherapy, radiotherapy)

regardless of orthopaedic intervention.10 [Grade C]

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2.4 REFERENCES (1)

• Tubiana-Hulin M. Incidence, prevalence and distribution of bone

metastases. Bone 1991; 12(Suppll):S9-S10.

• Mercadante S. Malignant bone pain. Pathophysiology and treatment. Pain

1997; 69: 1-18.

• Orthoteers Orthopaedic resource. Bone metastases. Available from

www.orthoteers.org Updated 29 May 2009. [Last accessed 1 June 2009]

• British Orthopaedic Association Working Party on Metastatic Bone Disease.

Metastatic Bone Disease: A Guide to Good Practice. London. 2001.

• NICE (2012) ‘Denosumab for prevention of skeletal related events in adults

with bone metastases from solid tumours’ Accessed electronically at

http://www.nice.org.uk/nicemedia/live/13939/61129/61129.pdf

• Frassica DA. General principles of external beam radiation therapy for

skeletal metastases. Clin Orthop Rel Res 2003; 415 (Suppl): S158-164.

• Mirels H. Metastatic disease in long bones. A proposed scoring system for

diagnosing impending pathological fracture. Clin Orthop Rel Res 1989; 249:

256-264.

• Harrington KD. Impending pathological fractures from metastatic malignancy:

evaluation and management. Instr Course Lect 1986; 35: 357-381.

• Ward WG, Spang J, Howe D, Gordan S. Femoral recon nails for metastatic

disease:

Indications, technique and results. AmJOrthop 2000; 29(9 Suppl): 34-42.

• Breast Specialty Group of the British Association of Surgical Oncology. The

management of metastatic bone disease in the United Kingdom. Eur JSurg

Oncol 1999; 25: 3-23

http://www.orthoteers.org/



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2.4 REFERENCES (2)

• Saarto T, James R, Tenhunen M, Kouri M. Palliative radiotherapy in the treatment of

skeletal metastases. Eur J Pain 2002; 6(5): 323-330.

• Townsend PW, Smalley SR, Cozad SC, Rosenthal HG, Hassanein RES. Role of

postoperative radiation therapy after stabilisation of fractures caused by metastatic

disease. Int J Radiat Oncol Biol Phys 1995; 31: 43-49.

• Wong R, Wiffen PJ. Bisphosphonates for the relief of pain secondary to bone

metastases. Cochrane Database of Systematic Reviews 2002. Issue 2. Art

No.:CD002068. DOI:10.1002/14651858. CD002068.

• Rosen LS, Gordon D, Tchekmedyian S, Yanaghihara R, Hirsh V, Krzakowski M et al.

Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with

lung cancer and other solid tumours: a phase III double blind randomised trial - the

Zolendronic Acid Lung Cancer and Other Solid Tumour Groups Study Group. J Clin

Oncol 2003; 21(16): 3150-3157.

• Thannos L, Mylona S, Galani P, Tzavoulis D, Kalioras V, Tanteles S et al.

Radiofrequency ablation of osseous metastases for the palliation of pain. Skeletal

Radio! 2008; 37: 189-194.

• National Institute for Health and Clinical Excellence. Percutaneous cementoplasty

forpalliative treatment of bony malignancies (interventional procedures overview)

January 2006. Available from: www.nice.org.uk/ip304overview. [Last accessed 1 June

2009]

• Lieberman I, Reinhardt MK. Vertebroplasty and kyphoplasty for osteolytic vertebral

collapse.

Clin Orthop Relat Res 2003; 415 (Suppl): S176-186.

• Edelyston GA, Gillipsie PJ, Grebbell FS. The radiological demonstration of osseous

metastases: Experimental Observations. CLin Radiol 1967;18:158-62.

• Eastley N, Newey M, Ashford. Skeletal metastases - The role of the orthopaedic and

spinal surgeon. Surg Oncol. 2012 Sep;21(3):216-22.

•

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