Interventions for the treatment of metastatic extradural spinal cord compression in adults

Reena George; Jenifer Jeba; Govindaraj Ramkumar; Ari G Chacko; Mhoira Leng; Prathap Tharyan

doi:10.1002/14651858.CD006716.pub2

Intervenciones para el tratamiento de la compresión medular extradural metastásica en adultos

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Referencias

Referencias de los estudios incluidos en esta revisión

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Graham PH, Capp A, Delaney G, Goozee G, Hickey B, Turner S, et al. A pilot randomised comparison of dexamethasone 96 mg vs 16 mg per day for malignant spinal‐cord compression treated by radiotherapy: TROG 01.05 Superdex study. Clinical Oncology (R Coll Radiol) 2006;18(1):70‐6.

Kwok Y, Patchell RA, Regine WF. Journal of Clinical Oncology2005; Vol. 23, issue 32:8272‐4.

Kwok Y, Regine WF, Patchell RA. Radiation therapy alone for spinal cord compression: time to improve upon a relatively ineffective status quo [comment on: Journal of Clinical Oncology 2005;23(15),3358‐65]. Journal of Clinical Oncology 2005;23(15):3308‐10.

Macbeth F, Stephens R, Hoskin P. Journal of Clinical Oncology2005; Vol. 23, issue 32:8270.

Maranzano E, Bellavita R, Rossi R. Radiotherapy alone or surgery in spinal cord compression? The choice depends on accurate patient selection. Journal of Clinical Oncology2005; Vol. 23, issue 32:8270‐2.

Google Scholar

Maranzano E, Bellavita R, Rossi R, De Angelis V, Frattegiani A, Bagnoli R, et al. Short‐course versus split‐course radiotherapy in metastatic spinal cord compression: results of a phase III, randomized, multicenter trial. Journal of Clinical Oncology 2005;23(15):3358‐65.

Koch M, De Keyser J. Surgical resection in metastatic spinal cord compression. Lancet2006; Vol. 367, issue 9505:109.

Google Scholar

Kunkler I. Surgical resection in metastatic spinal cord compression. Lancet2006; Vol. 367, issue 9505:109.

Google Scholar

Patchell R, Tibbs PA, Regine F, Payne R, Saris S, Kryscio RJ, et al. A randomized trial of direct decompressive surgical resection in the treatment of spinal cord compression caused by metastasis. Journal of Clinical Oncology 2003;21:237S.

Google Scholar

Patchell RA, Tibbs PA, Regine WF, Payne R, Saris S, Kryscio RJ, et al. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Lancet 2005;366(9486):643‐8.

van den Bent MJ. Surgical resection improves outcome in metastatic epidural spinal cord compression [comment on: Lancet 2005;366(9486):643‐8]. Lancet 2005;366(9486):609‐10.

Sorensen S, Helweg‐Larsen S, Mouridsen H, Hansen HH. Effect of high‐dose dexamethasone in carcinomatous metastatic spinal cord compression treated with radiotherapy: a randomised trial. European Journal of Cancer 1994;30A(1):22‐7.

Vecht CJ, Haaxma‐Reiche H, van Putten WL, de Visser M, Vries EP, Twijnstra A. Initial bolus of conventional versus high‐dose dexamethasone in metastatic spinal cord compression. Neurology 1989;39(9):1255‐7.

Young RF, Post EM, King GA. Treatment of spinal epidural metastases: randomized prospective comparison of laminectomy and radiotherapy. Journal of Neurosurgery 1980;53:741‐8.

Referencias de los estudios excluidos de esta revisión

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Aviles A, Fernandez R, Gonzalez JL, Garcia EL, Neri N, Talavera A, et al. Spinal cord compression as a primary manifestation of aggressive malignant lymphomas: long‐term analysis of treatments with radiotherapy, chemotherapy or combined therapy. Leukemia & Lymphoma 2002;43(2):355‐9.

Referencias de los estudios en curso

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A randomised phase III trial of two Ffactionation schemes in the treatment of malignant spinal cord compression . Ongoing studyFebruary 2007.

A randomised feasibility study of single fraction radiotherapy compared to multi‐fraction radiotherapy in patients with metastatic spinal cord compression. http://controlled‐trials.com, UK Clinical Trials Gateway.

Referencias adicionales

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Bauer HC, Wedin R. Survival after surgery for spinal and extremity metastases. Prognostication in 241 patients. Acta Orthopedica Scandinavia 1995;66(2):143‐6.

CONSORT statement. www.consort‐statement.org accessed 5th October 2007.

Deeks JJ, Higgins, JPT, Altman DG, editors. Analysing and presenting results. In: Higgins JPT, Green S, editors. Cochrane Handbook of Systematic Reviews. 4.2.5 [updated September 2006]; Section 8. Cochrane Database of Systematic Reviews. Chichester, UK: Wiley‐Blackwell, 2008.

Google Scholar

Delattre JY, Arbit E, Rosenblum MK, Thaler HT, Lau N, Galicich JH, et al. High dose versus low dose dexamethasone in experimental epidural spinal cord compression. Neurosurgery 1988;22(6):1005‐7.

Delattre JY, Arbit E, Thaler HT, Rosenblum MK, Posner JB. A dose‐response study of dexamethasone in a model of spinal cord compression caused by epidural tumor. Journal of Neurosurgery 1989;70(6):920‐5.

Falkmer U, Jarhult J, Wersall P, Cavallin‐Stahl E. A systematic overview of radiation therapy effects in skeletal metastases. Acta Oncologica 2003;42(5/6):620‐33.

Heimdal K, Hirschberg H, Slettebo H, Watne K, Nome O. High incidence of serious side effects of high‐dose dexamethasone treatment in patients with epidural spinal cord compression. Journal of Neuroncology 1992;12(2):141‐4.

Helweg‐Larsen S, Sorensen PS, Kreiner S. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables including survival and gait function in 153 patients. International Journal of Radiation Oncology, Biology and Physics 2000;46(5):1163‐9.

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327:557‐60.

Higgins JPT, Green S, Editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated September 2006]. Cochrane Database of Systematic Reviews. Vol. 1, Chichester, UK: Wiley‐Blackwell, 2008.

Google Scholar

Klimo P, Schmidt MH. Surgical management of spinal metastases. Oncologist 2004;9(2):188‐96.

Klimo P, Thompson CJ, Kestle JRW, Schmidt MHS. A meta‐analysis of surgery versus conventional radiotherapy for the treatment of metastatic spinal epidural disease. Neuro‐oncology 2005;7(1):64‐76.

Lapierriere NJ. The management of spinal cord compression. Toronto, Ontario, Canada, Princess Margaret Hospital1996.

Google Scholar

Loblaw DA, Laperriere NJ. Emergency treatment of malignant spinal cord compression: an evidence based guideline. Journal of Clinical Oncology 1998;16(4):1613‐24.

Loblaw DA, Laperriere NJ, Mackillop WJ. A population‐based study of malignant spinal cord compression in Ontario. Clinical Oncology (R Coll Radiol) 2003;15(4):211‐7.

Loblaw A, Perry J, Chambers A, Laperriere NJ. Systematic review of the diagnosis and management of malignant extradural spinal cord compression: The Cancer Care Ontario Practice Guidelines Initiative's Neuro‐oncology Disease Site Group. Journal of Clinical Oncology 2005;23:2028‐37.

Maranzano E, Latini P, Checcaglini F, Ricci S, Panizza BM, Aristei C, et al. Radiation therapy in metastatic spinal cord compression. A prospective analysis of 105 consecutive patients. Cancer 1991;67(5):1311‐7.

Rades D, Blach M, Bremer M, Wildfang I, Karstens JH, Heidenreich F. Prognostic significance of the time of developing motor deficits before radiation therapy in metastatic spinal cord compression: one‐year results of a prospective trial. Internation Journal of Radiation Oncology Biology Physics 2000;48(5):1403‐8.

Rades D, Fehlauer F, Stalpers LJ, Wildfang I, Zschenker O, Schild SE. A prospective evaluation of two radiotherapy schedules with 10 versus 20 fractions for the treatment of metastatic spinal cord compression: final results of a multicenter study. Cancer 2004;101(11):2687‐92.

Rades D, Fehlauer F, Schulte R, Veninga T, Stalpers LJ, Basic H, et al. Prognostic factors for local control and survival after radiotherapy of metastatic spinal cord compression. Journal of Clinical Oncology 2006;20(24):3388‐93.

Schaberg J, Gainor BJ. A profile of metastatic carcinoma of the spine. Spine 1985;10:19‐20.

Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine 2001;26(3):298‐306.

Ushio Y, Posner R, Posner JB, Shapiro WR. Experimental spinal cord compression by epidural neoplasms. Neurology1977; Vol. 27, issue 5:422‐9.

Google Scholar

Van der Linden YM, Dijkstra SP, Vonk EJ, Marijnen CA, Leer JW, Dutch Bone Metastasis Study Group. Prediction of survival in patients with metastases in the spinal column: results based on a randomized trial of radiotherapy. Cancer 2005;103(2):320‐8.

Wang JC, Boland P, Mitra N, Yamada Y, Lis E, Stubblefield M, et al. Single‐stage posterolateral transpedicular approach for resection of epidural metastatic spine tumors involving the vertebral body with circumferential reconstruction: results in 140 patients. Journal of Neurosurgery. Spine 2004;1(3):287‐98.

Wise JJ, Fischgrund JS, Herkowitz HN, Montgomery D, Kurz LT. Complication, survival rates, and risk factors of surgery for metastatic disease of the spine. Spine 1999;24(18):1943‐51.

Wong DA, Fornasier VL, MacNab I. Spinal metastases: the obvious, the occult, and the impostors. Spine 1990;15:1‐4.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Graham 2006

Methods	"Pilot randomized comparison" Study closed due to low recruitment Concealment of Allocation: yes, website randomization Generation of allocation sequence: computerized Blinding: no Attrition: 20% Intention‐to‐treat analysis: no
Participants	Australia, September 2001 to November 2003, multi‐institutional Inclusion: MRI evidence, ECOG less than four, minimum survival two months, and minimum power 1/5. Exclusion: prior treatment for MESCC, lymphoma and myeloma, people undergoing surgery, central nervous system disease, multi‐level MESCC, ongoing steroid medication, pregnancy, peptic ulcer or cardiac failure Age: 41 to 81 years Gender: males ‐ 14, females ‐ 6 Ambulant pretreatment: High dose dexamethasone versus low dose dexamethasone: 6 versus 9 Performance status: not stated Type of primary tumours: Breast , prostate ‐ 11 Others ‐ 9 Visceral metastasis: not stated Duration and rapidity of cord compression: not stated Spinal level: Cervical ‐ 1 Thoracic ‐ 15 Lumbar ‐ 4 Spinal instability: not stated
Interventions	High dose dexamethasone 96 intravenous on days 0 to 2; n = 9 Low dose dexamethasone 16 intravenous on days 0 to 2; n = 11 then weaned over 15 days in both arms Radiotherapy 30 Gray in 10 fractions in both arms Timing of intervention in relation to development of cord compression not stated Concomitant medications: omeprazole, trimethoprim if on urinary catheter, oral nystatin drops and laxatives
Outcomes	Outcomes of interest reported and used: Overall ambulation rate (at one month) Adverse events Outcomes reported but not used : Mean Functional Improvement score (FIS) Changes in Barthel score, Functional Independence Measure (FIM) Pain relief: Mean Visual analogue pain score (no SD provided) Median survival
Notes	No provision for rehabilitation was reported Outcomes of interest not reported: Survival rates, reduction in analgesic use, urinary continence, quality of life, participant and caregiver satisfaction, characteristics of participants who benefit from treatment
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Maranzano 2005

Methods	Randomized controlled trial. Generation of allocation sequence: one to one randomization, central. Concealment of allocation: yes, by centralized registration. Blinding : no Attrition: seven loss to follow up. Intention‐to‐treat analysis : no
Participants	Italy, February 1998 to November 2002, multicenter trial Inclusion: MRI or CT diagnosis, short life expectancy (less than or equals six months, as defined by unfavourable histologies or favourable histologies with poor performance status, motor or sphincter dysfunction). Exclusion: Diagnostic doubt, spinal instability, bony impingement, previous irradiation, favourable histology with life expectancy greater than or equals 6 months (15% of observed patients). Age: 30 to 89 years Gender: male ‐ 191, female ‐ 85 Pretreatment ambulant: Two fractions versus eight fractions: 93 versus 91 Performance status: Karnovsky performance status: </=40 ‐ 86, 50 to 70 ‐ 143, 80 to 100 ‐ 47 Type of primary tumours: Favourable histology (lymphoma, seminoma, myeloma, breast and prostate cancer) ‐ 99 Unfavourable histology (lung, renal, gastrointestinal, head and neck carcinoma, melanoma, sarcoma) ‐ 177 Visceral metastasis: unclear Duration and rapidity of cord compression: not stated Spinal level: Cervical ‐ 8%, Thoracic ‐ 50%, lumbar ‐ 23%, sacral ‐ 7%, cervicothoracic ‐ 1%, thoracolumbar ‐ 6%, lumbosacral ‐ 2%
Interventions	Two fractions: "Short course regimen"( 8 Gray, 6‐days rest, and then 8 Gray, to a total of 16 Gray in 1 week ), n = 153 Eight fractions: "Split course regimen" (5 Gray x 3, 4 days rest, then 3 Gray x 5, to a total of 30 Gray in 2 weeks), n = 147 Timing of intervention in relation to development of cord compression not stated Concomitant medications: Dexamethasone: 8 mg twice daily tapered after completion of radiotherapy. Parenteral 5 hydroxytriptamine‐3 receptor antagonist if radiation included upper abdomen.
Outcomes	Outcomes of interest reported and used : Ambulation (able to walk with or without support at one month after radiotherapy): overall ambulatory rate, proportion maintaining and regaining ambulation Reduction in analgesic use Urinary continence: overall, proportion maintaining and regaining continence Adverse effects: gastrointestinal and late spinal cord morbidity. Outcomes reported but not used: Percent probability of survival and median survival In‐field recurrences
Notes	The author's analysis excluded 8% of participants (seven lost to follow up and seventeen deaths that occurred within the first ten days. Characteristics of participants who benefit from treatment: favourable histology Outcomes not reported: patient rated pain relief, survival rates, quality of life, participant and caregiver satisfaction Provision for rehabilitation not reported Intention‐to‐treat analysis was used for survival outcome
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Patchell 2005

Methods	Randomized trial Concealment of allocation: yes, computerized technique Generation of allocation sequence: yes, computerized permutation blocks Blinding:no Attrition:nil Intention‐to‐treat analysis: yes
Participants	United States of America, September 1992 to December 2002, multi‐institutional Inclusion: MRI diagnosis, life expectancy greater than or equals three months, less than 48 hours total paraplegia, cervical or thoracic lesions Exclusion: total paraplegia more than 48 hours, multiple discrete compression, radiosensitive tumours (haematologic and germ cell tumours), previous irradiation, compression of only cauda equina or spinal roots, preexisting neurological problems Age: median 60 years Gender: males ‐ 70, females ‐ 31 Pretreatment ambulant: Surgery plus radiotherapy versus radiotherapy alone: 34 versus 35 Performance status: not stated Type of primary tumours: all except radiosensitive tumours (haematologic and germ cell tumours) Visceral metastasis: not stated Duration of cord compression: Not less than 48 hours Rapidity of cord compression: not stated Spinal level: cervical ‐ 13, upper thoracic ‐ 38, lower thoracic ‐ 50 Spinal instability: Surgery plus radiotherapy versus radiotherapy alone: 20 versus 18
Interventions	Surgery with radiotherapy: n = 50 Surgery‐ direct circumferential decompression with or without stabilization within 24 hours of randomization Radiotherapy‐ 3 Gray x 10, starting within 14 days of surgery Radiotherapy alone: n = 51 Radiotherapy ‐ 3 Gray x 10 fractions Timing of intervention in relation to development of cord compression ‐ Surgery plus radiotherapy versus radiotherapy alone: median time 10 versus 12 days Concomitant medications: Dexamethasone, both arms 100 mg immediate, 24 mg four times daily till start of radiotherapy or surgery then tapered.
Outcomes	Outcomes of interest reported and used : Ambulation (able to take at least two steps with each foot unassisted (four steps total), even if a cane or walker was needed, immediately after radiotherapy) Overall ambulatory rates, proportion maintaining and regaining ambulation. Survival (30 day mortality) Outcomes reported but not used: Median duration of ambulation Changes in Frankel functional scale scores, American Spinal Injury Association (ASIA) motor scores Median survival Median duration of maintenance of urinary continence Pain relief: mean daily morphine equivalent dose (without SD)
Notes	Eighteen participants with unstable spine were randomized to radiotherapy alone Ten participants crossed over from radiotherapy to surgery arm (due to decline in motor strength, and three regained ambulation) Stratification ‐ treating institution, tumour type, ambulatory status, relative stability of the spine No provision for rehabilitation was reported. Characteristics of participants who benefit from treatment: stable spine, cervical spinal level, baseline neurology status, breast primary tumours Outcomes not reported: urinary continence and analgesic reduction as dichotomous data, quality of life, participant and caregiver satisfaction.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Sorensen 1994

Methods	Randomized trial Generation of allocation sequence: method not stated Allocation concealment: unclear Blinding: single, observer blinded, method not stated Intention‐to‐treat analysis: yes
Participants	Denmark, May 1987 to April 1989 Single institution. Inclusion: confirmation by myelogram, carcinoma Exclusion: lymphoma, surgery for cord compression, unstable vertebral lesions, previous treatment for epidural metastasis, carcinomatous meningitis, peptic ulcer, infection Age: 41 to 81 years Gender: males ‐ 18, females 39 Pretreatment ambulant: High dose corticosteroids versus no corticosteroids: 17 versus 19 Performance status: not stated Type of primary tumours: all types except lymphoma Visceral metastasis: not stated Duration and rapidity of cord compression: not stated Spinal level: Cervical ‐ 3 Thoracic ‐ 33 Lumbar ‐ 21
Interventions	Dexamethasone 96 mg intravenous stat and per oral for 3 days and taper over 15 days ‐ n = 27 No dexamethasone ‐ n = 30 Radiotherapy in both arms ‐ 28 Gray in 7 fractions Timing of intervention in relation to development of cord compression ‐ not stated Concomitant medications: prophylactic medication in peptic ulcer and dyspepsia.
Outcomes	Outcomes of interest reported and used: Ambulation (able to walk at three months) Overall, proportion maintaining and regaining. Survival Adverse effects Outcomes reported but not used: median survival
Notes	No provision for rehabilitation was reported. Stratification by primary tumour and gait function. Outcomes of interest not reported: pain relief, urinary continence, quality of life, participant and caregiver satisfaction and characteristics of participants who benefit from treatment
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Vecht 1989

Methods	Randomized trial Allocation concealment: yes Generation of allocation sequence: unclear Blinding: yes, by identical coded ampules, code broken by statistician Attrition: data for three participants not available Intention‐to‐treat analysis: no
Participants	Netherlands, multi‐institutional Inclusion: complete obstruction on myelogram, carcinoma or lymphoreticular malignancy Exclusion: not mentioned Age: 22 to 87 years Gender: males ‐ 26, females ‐ 11 Pretreatment ambulant: High dose versus moderate dose corticosteroids: 14 versus 7 Performance status: not stated Type of primary tumours: Carcinoma ‐ 26 Lymphoreticular malignancy ‐ 11 Visceral metastasis: not stated Duration and rapidity of cord compression: not stated Spinal level: not stated Spinal instability: not stated
Interventions	Dexamethasone 100 mg (n = 22) versus 10 mg (n = 15) intravenous followed by 16 mg orally Radiotherapy in both arms: 3 Gray x 7 or 10 fractions Timing of intervention in relation to development of cord compression ‐ not stated Concomitant medications: not stated
Outcomes	Outcomes of interest reported and used: Ambulation (walking independently or with aid at one week): overall Urinary continence Patient rated pain relief Outcomes reported and not used: mean pain score
Notes	No provision for rehabilitation was reported Stratification for carcinoma versus lymphoreticular malignancy. Outcomes of interest not reported: survival, quality of life, participant and caregiver satisfaction and characteristics of participants who benefit from treatment
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate

Young 1980

Methods	Randomized prospective comparison Concealment of allocation: unclear Generation of allocation sequence: table of random numbers Blinding: no Attrition: nil Intention‐to‐treat analysis: yes
Participants	United States of America. Inclusion: myelogram showing extradural lesion or block that correlated with clinical presentation Exclusion: prior radiotherapy, unfit for surgery, more than one lesion, presence of only spinal or radicular pain. Age: 19 to 83 years Gender: not stated Pretreatment ambulant: Laminectomy plus radiotherapy versus radiotherapy alone: 6 versus 5 Performance status: not stated Type of primary tumours: all types Visceral metastasis: not stated Duration and rapidity of cord compression: not stated Spinal level: not stated Spinal instability: not stated
Interventions	Laminectomy with radiotherapy: 30 Gray in ten fractions over 14 days, n = 16 Radiotherapy alone: 30 Gray in ten fractions (4 Gray/day first 3 days, then 18 Gray in 7 fractions over 14 days), n = 13 Timing of intervention in relation to development of cord compression ‐ not stated Concomitant medications: Dexamethasone 12 mg stat followed by 4 mg four times daily till radiotherapy completion
Outcomes	Outcomes of interest reported and used: Ambulation (ability to take steps alone with or without a cane or walker at four months): Overall ambulatory rates, proportion maintaining ambulation and proportion regaining ambulation Survival Pain relief: Reduction in analgesic use Urinary continence : Overall, proportion maintaining and regaining continence Adverse effects Outcomes reported but not used: Mean survival
Notes	Radiotherapy alone: Mortality ‐ 24% (due to underlying disease) No provision for rehabilitation was reported Outcomes of interest not reported: quality of life, participant and caregiver satisfaction and characteristics of patients who benefit the treatment
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

MRI‐ magnetic resonance imaging
CT‐ computed tomography
ECOG‐ Eastern Co‐operative Oncology Group
SD ‐ Standard Deviation

Characteristics of excluded studies [ordered by study ID]

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Study	Reason for exclusion
Aviles 2002	Abstract described it as randomized, but on reviewing the full paper we found it to be a retrospective rather than a prospective randomized comparison

Characteristics of ongoing studies [ordered by study ID]

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ICORG 05‐03

Trial name or title	A randomised phase III trial of two Ffactionation schemes in the treatment of malignant spinal cord compression
Methods
Participants	Inclusion: Diagnosis of spinal cord compression, confirmed on MRI Histologically proven malignancy other than leukaemia, myeloma, germ cell tumours, or primary tumours of the spine or vertebral column MRI of the entire spine performed Karnofsky performance score greater or equal to 30 Age greater or equal to 18 years Written informed consent Exclusion: Previous treatment with radiotherapy to the involved area of the spinal cord such that further treatment exceeds spinal cord tolerance Single bone metastasis with controlled primary site Patients deemed suitable for neurosurgical intervention at the time of initial assessment (patients deemed medically inoperable are eligible) Patients who have a medical or psychiatric condition, which in the opinion of the investigator/research team, contraindicates the patient's participation in this study
Interventions	Radiotherapy (single or multiple fractions): Arm 1: 20 Gy/5 fractions daily for five consecutive days Arm 2: 10 Gy/1 fraction
Outcomes	Primary outcome measure(s): Change in motor functioning as measured by the change in physical functioning dimension of the EORTC QLQ‐C30 version 3 quality of life questionnaire, over a four week period Secondary outcome measure(s): Quality of life: assessed according to the EORTC QLQ‐C30 version 3 quality of life questionnaire Toxicity ? assessed at first follow‐up, evaluated as per standard RTOG criteria Mobility Pain control Median survival ‐ calculated on the basis of time from date of randomisation to death.
Starting date	February 2007
Contact information	Dr Joe O'Sullivan Senior Lecturer and Consultant in Clinical Oncology The Northern Ireland Cancer Centre Belfast City Hospital Belfast BT9 7AB Northern Ireland Tel: +44 (0)28 90699204 joe.osullivan@Queens‐Belfast.ac.uk
Notes

ISRCTN97555949

Trial name or title	A randomised feasibility study of single fraction radiotherapy compared to multi‐fraction radiotherapy in patients with metastatic spinal cord compression
Methods
Participants	Inclusion: 1. Proven diagnosis of spinal cord compression on Magnetic Resonance Imaging (MRI) 2. Histologically or cytologically confirmed malignant disease 3. Life expectancy > 1 month 4. Age 18 years or older 5. Able to give informed consent 6. Willing and able to complete assessment forms Exclusion : 1. Patients for whom surgery or chemotherapy treatment is more appropriate 2. Patient who are known to be pregnant
Interventions	Radiotherapy (single or multiple fractions): Arm 1: 20 Gy/5 fractions daily for five consecutive days Arm 2: 8 Gy/1 fraction
Outcomes	Primary outcome measure(s) Patient accrual per centre over a 12 month period Secondary outcome measure(s) 1. Ambulatory status at 1, 4, 8 and 12 weeks from Day 1 of treatment compared to baseline 2. Bladder and bowel function at baseline compared to week 1, 4, 8 and 12 3. Acute side effects at week 1 and 4. assessed using Radiation Therapy Oncology Group (RTOG) scales 4. Quality of life at week 1, 4, 8 and 12, measured by the EORTC QLQ‐C30 questionnaire 5. Further treatment 6. Overall survival at 3, 6 and 12 months 7. Total number of days spent in hospital 8. Preferred place of care 9. Number of patients who were eligible but not randomised and reasons for non‐randomisation
Starting date	November 2007
Contact information	Prof Peter J Hoskin Marie Curie Research Wing Mount Vernon Hospital Rickmansworth Road Northwood Middlesex Northwood United Kingdom HA6 2RN
Notes

Data and analyses

Open in table viewer

Comparison 1. Radiotherapy 8 fractions versus 2 fractions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ambulation (short term) Show forest plot	1	276	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.90, 1.15]
Open in figure viewer Analysis 1.1 $Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 1 Ambulation (short term).$ Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 1 Ambulation (short term).
1.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	184	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.93, 1.12]
1.2 Pretreatment non‐ambulant subgroup ‐ regaining ambulation	1	92	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.51, 1.88]
2 Reduction in analgesic use Show forest plot	1	262	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.96, 1.67]
Open in figure viewer Analysis 1.2 $Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 2 Reduction in analgesic use.$ Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 2 Reduction in analgesic use.
3 Urinary continence (short term) Show forest plot	1	275	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.93, 1.02]
Open in figure viewer Analysis 1.3 $Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 3 Urinary continence (short term).$ Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 3 Urinary continence (short term).
3.1 Proportion maintaining urinary continence	1	246	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.93, 1.00]
3.2 Proportion regaining urinary continence	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.20, 7.58]
4 Gastrointestinal adverse effects Show forest plot	1	276	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [0.43, 7.25]
Open in figure viewer Analysis 1.4 $Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 4 Gastrointestinal adverse effects.$ Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 4 Gastrointestinal adverse effects.

Open in table viewer

Comparison 2. Laminectomy plus radiotherapy versus radiotherapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ambulation (short term) Show forest plot	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.59, 2.43]
Open in figure viewer Analysis 2.1 Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 1 Ambulation (short term).
1.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	11	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [0.84, 4.00]
1.2 Pretreatment non‐ambulant subgroup ‐ regaining ambulation	1	18	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.15, 2.59]
2 Ambulation (intermediate term) Show forest plot	1	15	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.70, 2.24]
Open in figure viewer Analysis 2.2 Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 2 Ambulation (intermediate term).
3 Survival Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.3 Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 3 Survival.
3.1 Short term survival	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.56, 1.06]
3.2 Intermediate term survival	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.40, 1.70]
4 Reduction in analgesic use Show forest plot	1	26	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.42, 1.81]
Open in figure viewer Analysis 2.4 Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 4 Reduction in analgesic use.
5 Urinary continence (short term) Show forest plot	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.50, 1.77]
Open in figure viewer Analysis 2.5 Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 5 Urinary continence (short term).
5.1 Proportion maintaining urinary continence	1	18	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.42, 1.52]
5.2 Proportion regaining urinary continence	1	11	Risk Ratio (M‐H, Fixed, 95% CI)	2.67 [0.23, 30.40]
6 Urinary continence (intermediate term) Show forest plot	1	15	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.87, 2.35]
Open in figure viewer Analysis 2.6 Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 6 Urinary continence (intermediate term).

Open in table viewer

Comparison 3. Decompressive surgery plus radiotherapy versus radiotherapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ambulation (short term) Show forest plot	1	101	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.53, 0.86]
Open in figure viewer Analysis 3.1 Comparison 3 Decompressive surgery plus radiotherapy versus radiotherapy alone, Outcome 1 Ambulation (short term).
1.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.64, 0.98]
1.2 Pretreatment non‐ambulant subgroup regaining ambulation	1	32	Risk Ratio (M‐H, Fixed, 95% CI)	0.3 [0.10, 0.89]
2 Survival (short term) Show forest plot	1	101	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.81, 1.05]
Open in figure viewer Analysis 3.2 Comparison 3 Decompressive surgery plus radiotherapy versus radiotherapy alone, Outcome 2 Survival (short term).

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Comparison 4. High dose versus no or moderate dose corticosteroids

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall ambulation (short term) Show forest plot	3	105	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.68, 1.23]
Open in figure viewer Analysis 4.1 Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 1 Overall ambulation (short term).
1.1 High dose versus no corticosteroids	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.56, 1.08]
1.2 High versus moderate corticosteroids	2	48	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.68, 2.12]
2 Participants maintaining or regaining ambulation (short term) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 4.2 Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 2 Participants maintaining or regaining ambulation (short term).
2.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.9 [0.75, 1.08]
2.2 Pretreatment non‐ambulant subgroup regaining ambulation	1	21	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.09, 1.47]
3 Survival (long term) Show forest plot	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	0.9 [0.20, 4.09]
Open in figure viewer Analysis 4.3 Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 3 Survival (long term).
4 Pain reduction Show forest plot	1	25	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.83, 1.61]
Open in figure viewer Analysis 4.4 Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 4 Pain reduction.
5 Urinary continence (short term) Show forest plot	1	34	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.47, 1.52]
Open in figure viewer Analysis 4.5 Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 5 Urinary continence (short term).
6 Serious drug related adverse effects Show forest plot	2	77	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.02, 0.97]
Open in figure viewer Analysis 4.6 Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 6 Serious drug related adverse effects.
6.1 High dose versus no corticosteroids	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 1.78]
6.2 High dose versus moderate dose corticosteroids	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.01, 3.08]

$Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 1 Ambulation (short term).$

Analysis 1.1

Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 1 Ambulation (short term).

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$Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 2 Reduction in analgesic use.$

Analysis 1.2

Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 2 Reduction in analgesic use.

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$Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 3 Urinary continence (short term).$

Analysis 1.3

Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 3 Urinary continence (short term).

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$Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 4 Gastrointestinal adverse effects.$

Analysis 1.4

Comparison 1 Radiotherapy 8 fractions versus 2 fractions, Outcome 4 Gastrointestinal adverse effects.

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Analysis 2.1

Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 1 Ambulation (short term).

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Analysis 2.2

Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 2 Ambulation (intermediate term).

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Analysis 2.3

Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 3 Survival.

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Analysis 2.4

Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 4 Reduction in analgesic use.

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Analysis 2.5

Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 5 Urinary continence (short term).

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Analysis 2.6

Comparison 2 Laminectomy plus radiotherapy versus radiotherapy alone, Outcome 6 Urinary continence (intermediate term).

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Analysis 3.1

Comparison 3 Decompressive surgery plus radiotherapy versus radiotherapy alone, Outcome 1 Ambulation (short term).

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Analysis 3.2

Comparison 3 Decompressive surgery plus radiotherapy versus radiotherapy alone, Outcome 2 Survival (short term).

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Analysis 4.1

Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 1 Overall ambulation (short term).

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Analysis 4.2

Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 2 Participants maintaining or regaining ambulation (short term).

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Analysis 4.3

Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 3 Survival (long term).

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Analysis 4.4

Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 4 Pain reduction.

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Analysis 4.5

Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 5 Urinary continence (short term).

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Analysis 4.6

Comparison 4 High dose versus no or moderate dose corticosteroids, Outcome 6 Serious drug related adverse effects.

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Table 1. Detailed results

Parameters	Results
Different radiotherapy schedules (Eight versus two fractions)
Overall ambulatory rates (short term)	95/134 (71%) versus 97/142 (68%) RR 1.02; (95% CI 0.90 to 1.15) (n = 276).
Pretreatment ambulant participants maintaining ambulation (short term)	83/91 (91%) versus 83/93 (89%) RR 1.02; (95% CI 0.93 to 1.12) (n = 184).
Pretreatment non‐ambulant participants regaining ambulation (short term)	12/43 (28%) versus 14/49 (29%) RR 0.98; (95% CI 0.51 to 1.88) (n = 92)
Median duration of ambulation	3.5 months in both arms (excluding 17 early deaths)
Survival	Four months in both arms (excluding 17 early deaths), five months in pretreatment ambulant participants and three months in pretreatment non‐ambulant participants.
Pain relief (short term)	61/126 (48%) versus 52/136 (38%) RR 1.24; (95% CI 0.94 to 1.64) (n = 262)
Urinary continence (short term)	118/134 (89%) versus 128/142 (90%) RR 0.97; (95% CI 0.93 to 1.02) (n = 275)
Participants maintaining urinary continence (short term)	116/120 (97%) versus 126/126 (100%) RR 0.97; (95% CI 0.93 to 1.00) (n = 246)
Participants regaining urinary continence (short term)	2/13 (15%) versus 2/16 (13%) RR 1.23; (95% CI 0.20 to 7.58) (n = 29)
Adverse effects (early)	Grade three acute gastrointestinal mucositis attributable to radiation ‐ 5/134 (4%) versus 3/142 (2%) RR 1.77; (95% CI 0.43 to 7.25) 6/276 participants had Grade three vomiting; the incidence was similar in both the arms. Grade three nausea was present in 5/276 participants (n = 276).
Adverse effects (late)	No documented late radiation myelopathy or serious adverse effects
Outcomes not reported	Survival rates, quality of life, participant and caregiver satisfaction.
Laminectomy plus radiotherapy versus radiotherapy alone
Overall ambulatory rates (short term)	7 /16 (44%) versus 7/13 (54%) RR 1.20; (95% CI 0.59 to 2.43) (n = 29)
Pretreatment ambulant participants maintaining ambulation (short term)	3/6 (50%) versus 5/5 (100%) RR 1.83; (95% CI 0.84 to 4.00) (n = 11)
Pretreatment non‐ambulant participants regaining ambulation (short term)	4/10 (40%) versus 2/8 (25%) RR 0.63; (95% CI 0.15 to 2.59) (n = 18)
Overall ambulatory rates (intermediate term)	6/9 (67%) versus 5/6 (83%) RR 1.25; (95% CI 0.70 to 2.24) (n = 15)
Survival (short term)	16/16 (100%) versus 10/13 (76%) RR 0.77; (95% CI 0.56 to 1.06) (n = 29)
Survival (Intermediate term)	9/16 (56%) versus 6/13 (46%) RR 0.82; (95% CI 0.40 to 1.70) (n = 29)
Pain relief	8/14 (57%) versus 6/12 (50%) RR 0.88; (95% CI 0.42 to 1.81) (n = 26)
Overall urinary continence (short term)	7/16 (44%) versus 7/13 (54%) 95% CI RR 0.94; (95% CI 0.50 to 1.77) (n = 29)
Proportion of participants maintaining urinary continence (short term)	6/8 (75%) versus 6/10 (60%) RR 0.80; (95% CI 0.42 to 1.52) (n = 18)
Proportion of participants regaining urinary continence (short term)	1/8 (13%) versus 1/3 (33%) RR 2.67; (95% CI 0.23 to 30.40) (n = 11)
Overall urinary continence (intermediate term)	6/9 (67%) versus 6/6 (100%) RR 1.43; (95% CI 0.87 to 2.35) (n = 15)
Adverse effects	There were no surgery or radiotherapy related complications
Outcomes not reported	Quality of life, participant and caregiver satisfaction.
Direct decompressive surgery with radiotherapy versus radiotherapy
Overall ambulatory rates (short term)	29/51 (57%) versus 42/50 (84%), RR 0.67; (95% CI 0.53 to 0.86) (n = 101), NNTB 3.70 (95% CI 2.38 to 7.69)
Proportion of pretreatment ambulant participants maintaining ambulation (short term)	26/35 (74%) versus 32/34 (94%) RR 0.79; (95% CI 0.64 to 0.98) (n = 69), NNTB 5.00 (95% CI 2.78 to 33.33)
Proportion of pretreatment non‐ambulant participants regaining ambulation (short term)	3/16 (19%) versus 10/16 (63%) RR 0.30; (95% CI 0.10 to 0.89) (n = 32), NNTB 2.27 (95% CI 1.35 to 7.69)
Median duration of ambulation	The median duration of ambulation was 13 days versus 122 days, (those maintaining ambulation 54 days versus 153 days and regaining ambulation was 0 versus 59 days)
Survival (short term)	44/51 (86%) versus 47/50 (94%) RR 0.92; (95% CI 0.81 to 1.05) (n = 101)
Median survival	100 days versus 126 days
Outcomes not reported	Quality of life, participant and care giver satisfaction were not assessed. Participant rated pain relief , adverse effects and dichotomous data for analgesic reduction and urinary continence
High dose corticosteroids versus no or moderate dose corticosteroids
Overall ambulatory rates (short term)	RR 0.91; (95% CI 0.68 to 1.23) (n = 105, three trials)
Proportion of pretreatment ambulant participants maintaining ambulation (short term)	17/17 (100%) versus 17/19 (90%) RR 0.90; (95% CI 0.75 to 1.08) (n = 36, one trial)
Proportion of pretreatment non‐ambulant participants regaining ambulation (short term)	5/10 (50%) versus 2/11 (18%) RR 0.36; (95% CI 0.09 to 1.47) (n = 21, one trial)
Survival (long term)	5/10 (50%) versus 2/11 (18%) RR 0.36; (95% CI 0.09 to 1.47) (n = 21, one trial)
Pain relief	11/14 (79%) versus 10/11(91%) RR 1.16; (95% CI 0.83 to 1.61) (n = 25, one trial)
Urinary continence	12/19 (63%) versus 8/15 (53%) RR 0.84; (95% CI 0.47 to 1.52) (n = 34, one trial)
Adverse effects	High dose corticosteroids versus no or moderate dose corticosteroids RR 0.12; (95% CI 0.02 to 0.97) (n = 77, two trials) High dose versus no corticosteroids RR 0.10; (95% CI 0.01 to 1.78) (n = 57, one trial) High dose versus moderate dose corticosteroids RR 0.17; (95% CI 0.01 to 3.08) (n = 20, one trial)
Outcomes not reported	Quality of life, participant rated and care giver satisfaction. Intermediate term outcomes from Sorensen 1994 could not be calculated as survival rates were not available.

Table 1. Detailed results

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Comparison 1. Radiotherapy 8 fractions versus 2 fractions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ambulation (short term) Show forest plot	1	276	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.90, 1.15]

1.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	184	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.93, 1.12]
1.2 Pretreatment non‐ambulant subgroup ‐ regaining ambulation	1	92	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.51, 1.88]
2 Reduction in analgesic use Show forest plot	1	262	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.96, 1.67]

3 Urinary continence (short term) Show forest plot	1	275	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.93, 1.02]

3.1 Proportion maintaining urinary continence	1	246	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.93, 1.00]
3.2 Proportion regaining urinary continence	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.20, 7.58]
4 Gastrointestinal adverse effects Show forest plot	1	276	Risk Ratio (M‐H, Fixed, 95% CI)	1.77 [0.43, 7.25]

Comparison 1. Radiotherapy 8 fractions versus 2 fractions

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Comparison 2. Laminectomy plus radiotherapy versus radiotherapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ambulation (short term) Show forest plot	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.59, 2.43]

1.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	11	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [0.84, 4.00]
1.2 Pretreatment non‐ambulant subgroup ‐ regaining ambulation	1	18	Risk Ratio (M‐H, Fixed, 95% CI)	0.63 [0.15, 2.59]
2 Ambulation (intermediate term) Show forest plot	1	15	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [0.70, 2.24]

3 Survival Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 Short term survival	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.77 [0.56, 1.06]
3.2 Intermediate term survival	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.82 [0.40, 1.70]
4 Reduction in analgesic use Show forest plot	1	26	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.42, 1.81]

5 Urinary continence (short term) Show forest plot	1	29	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.50, 1.77]

5.1 Proportion maintaining urinary continence	1	18	Risk Ratio (M‐H, Fixed, 95% CI)	0.8 [0.42, 1.52]
5.2 Proportion regaining urinary continence	1	11	Risk Ratio (M‐H, Fixed, 95% CI)	2.67 [0.23, 30.40]
6 Urinary continence (intermediate term) Show forest plot	1	15	Risk Ratio (M‐H, Fixed, 95% CI)	1.43 [0.87, 2.35]

Comparison 2. Laminectomy plus radiotherapy versus radiotherapy alone

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Comparison 3. Decompressive surgery plus radiotherapy versus radiotherapy alone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ambulation (short term) Show forest plot	1	101	Risk Ratio (M‐H, Fixed, 95% CI)	0.67 [0.53, 0.86]

1.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	69	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.64, 0.98]
1.2 Pretreatment non‐ambulant subgroup regaining ambulation	1	32	Risk Ratio (M‐H, Fixed, 95% CI)	0.3 [0.10, 0.89]
2 Survival (short term) Show forest plot	1	101	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.81, 1.05]

Comparison 3. Decompressive surgery plus radiotherapy versus radiotherapy alone

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Comparison 4. High dose versus no or moderate dose corticosteroids

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Overall ambulation (short term) Show forest plot	3	105	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.68, 1.23]

1.1 High dose versus no corticosteroids	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	0.78 [0.56, 1.08]
1.2 High versus moderate corticosteroids	2	48	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [0.68, 2.12]
2 Participants maintaining or regaining ambulation (short term) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Pretreatment ambulant subgroup ‐ maintaining ambulation	1	36	Risk Ratio (M‐H, Fixed, 95% CI)	0.9 [0.75, 1.08]
2.2 Pretreatment non‐ambulant subgroup regaining ambulation	1	21	Risk Ratio (M‐H, Fixed, 95% CI)	0.36 [0.09, 1.47]
3 Survival (long term) Show forest plot	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	0.9 [0.20, 4.09]

4 Pain reduction Show forest plot	1	25	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.83, 1.61]

5 Urinary continence (short term) Show forest plot	1	34	Risk Ratio (M‐H, Fixed, 95% CI)	0.84 [0.47, 1.52]

6 Serious drug related adverse effects Show forest plot	2	77	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.02, 0.97]

6.1 High dose versus no corticosteroids	1	57	Risk Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 1.78]
6.2 High dose versus moderate dose corticosteroids	1	20	Risk Ratio (M‐H, Fixed, 95% CI)	0.17 [0.01, 3.08]

Comparison 4. High dose versus no or moderate dose corticosteroids

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Referencias

Referencias de los estudios incluidos en esta revisión

Graham 2006 {published data only}

Maranzano 2005 {published data only}

Patchell 2005 {published data only}

Sorensen 1994 {published data only}

Vecht 1989 {published data only}

Young 1980 {published data only}

Referencias de los estudios excluidos de esta revisión

Aviles 2002 {published data only}

Referencias de los estudios en curso

ICORG 05‐03 {unpublished data only}

ISRCTN97555949 {published data only}

Referencias adicionales

Bauer 1995

CONSORT 2001

Deeks 2005

Delattre 1988

Delattre 1989

Falkmer 2003

Heimdal 1992

Helweg‐Larsen 2000

Higgins 2003

Higgins 2006

Klimo 2004

Klimo 2005

Laperriere 1996

Loblaw 1998

Loblaw 2003

Loblaw 2005

Maranzano 1991

Rades 2000

Rades 2004

Rades 2006

Schaberg 1985

Tomita 2001

Ushio 1977

Van der Linden 2005

Wang 2004

Wise 1999

Wong 1990

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Characteristics of ongoing studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

Usuarios institucionales

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