PREVENTION OF PATHOLOGICAL FRACTURE · PRESENTATIONof impending pathological fractures is likely to...
Transcript of PREVENTION OF PATHOLOGICAL FRACTURE · PRESENTATIONof impending pathological fractures is likely to...
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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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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2.1 Investigation of bone pain (2)
• 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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2.1 Investigation of bone pain (3)
• 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
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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.
•