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A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: results of medical research council trial BA09

A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: results of medical research council trial BA09
A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: results of medical research council trial BA09

PURPOSE: To compare the efficacy and toxicity of two hypofractionated radiotherapy schedules for the improvement of local symptoms from muscle-invasive bladder cancer.

METHODS AND MATERIALS: A multicenter randomized trial was conducted comparing the efficacy and toxicity of two radiotherapy schedules (35 Gy in 10 fractions and 21 Gy in 3 fractions) for symptomatic improvement in patients considered unsuitable for curative treatment through disease stage or comorbidity. The primary outcome measures were overall symptomatic improvement of bladder-related symptoms at 3 months and changes in bladder- and bowel-related symptoms from pretreatment to end-of-treatment and 3-month assessments. Overall symptomatic improvement was defined prospectively as the improvement in one bladder-related symptom of at least one grade at 3 months, with no deterioration in any other bladder-related symptom.

RESULTS: Five hundred patients were recruited, but data on symptomatic improvement at 3 months was only available on 272 patients. Of these, 68% achieved symptomatic improvement (71% for 35 Gy, 64% for 21 Gy), with no evidence of a difference in efficacy or toxicity between the two arms. There was no evidence of a difference in survival between the two schedules (hazard ratio [HR] = 0.99, 95% CI 0.82-1.21, p = 0. 933).

CONCLUSION: This is the largest prospective trial to date in the palliative treatment of bladder cancer, and provides baseline data against which other results may be compared. The use of 21 Gy in 3 fractions appears as effective as 35 Gy in 10 fractions, although modest differences in survival, symptomatic improvement rates, and toxicity can not be reliably excluded.

Aged, Aged, 80 and over, Cystoscopy, Dose Fractionation, Female, Humans, Male, Middle Aged, Palliative Care, Prospective Studies, Quality of Life, Severity of Illness Index, Survival Analysis, Urinary Bladder Neoplasms, Urination Disorders, Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial
0360-3016
379-88
Duchesne, G M
29098cf4-c090-4063-852e-7e6a72c1422a
Bolger, J J
011c6711-7b1f-40cb-8f72-70bd2d3b4dc1
Griffiths, G O
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Trevor Roberts, J
d8e6944f-bc8a-42ed-bb06-47590c998ca7
Graham, J D
79dca0cf-cc75-4b61-af6e-b6bf38b84e94
Hoskin, P J
93234810-cf18-4663-8b13-bc0025823f21
Fossâ, S D
03120de1-4ac9-4adc-ab0d-2d0a186b5bb9
Uscinska, B M
6bcb4367-19f0-47c9-95f5-fec657623fe1
Parmar, M K
41d04a75-3bd9-441f-8455-7164445c3ecd
Duchesne, G M
29098cf4-c090-4063-852e-7e6a72c1422a
Bolger, J J
011c6711-7b1f-40cb-8f72-70bd2d3b4dc1
Griffiths, G O
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Trevor Roberts, J
d8e6944f-bc8a-42ed-bb06-47590c998ca7
Graham, J D
79dca0cf-cc75-4b61-af6e-b6bf38b84e94
Hoskin, P J
93234810-cf18-4663-8b13-bc0025823f21
Fossâ, S D
03120de1-4ac9-4adc-ab0d-2d0a186b5bb9
Uscinska, B M
6bcb4367-19f0-47c9-95f5-fec657623fe1
Parmar, M K
41d04a75-3bd9-441f-8455-7164445c3ecd

Duchesne, G M, Bolger, J J, Griffiths, G O, Trevor Roberts, J, Graham, J D, Hoskin, P J, Fossâ, S D, Uscinska, B M and Parmar, M K (2000) A randomized trial of hypofractionated schedules of palliative radiotherapy in the management of bladder carcinoma: results of medical research council trial BA09. International Journal of Radiation: Oncology, Biology, Physics, 47 (2), 379-88.

Record type: Article

Abstract

PURPOSE: To compare the efficacy and toxicity of two hypofractionated radiotherapy schedules for the improvement of local symptoms from muscle-invasive bladder cancer.

METHODS AND MATERIALS: A multicenter randomized trial was conducted comparing the efficacy and toxicity of two radiotherapy schedules (35 Gy in 10 fractions and 21 Gy in 3 fractions) for symptomatic improvement in patients considered unsuitable for curative treatment through disease stage or comorbidity. The primary outcome measures were overall symptomatic improvement of bladder-related symptoms at 3 months and changes in bladder- and bowel-related symptoms from pretreatment to end-of-treatment and 3-month assessments. Overall symptomatic improvement was defined prospectively as the improvement in one bladder-related symptom of at least one grade at 3 months, with no deterioration in any other bladder-related symptom.

RESULTS: Five hundred patients were recruited, but data on symptomatic improvement at 3 months was only available on 272 patients. Of these, 68% achieved symptomatic improvement (71% for 35 Gy, 64% for 21 Gy), with no evidence of a difference in efficacy or toxicity between the two arms. There was no evidence of a difference in survival between the two schedules (hazard ratio [HR] = 0.99, 95% CI 0.82-1.21, p = 0. 933).

CONCLUSION: This is the largest prospective trial to date in the palliative treatment of bladder cancer, and provides baseline data against which other results may be compared. The use of 21 Gy in 3 fractions appears as effective as 35 Gy in 10 fractions, although modest differences in survival, symptomatic improvement rates, and toxicity can not be reliably excluded.

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More information

Published date: 1 May 2000
Keywords: Aged, Aged, 80 and over, Cystoscopy, Dose Fractionation, Female, Humans, Male, Middle Aged, Palliative Care, Prospective Studies, Quality of Life, Severity of Illness Index, Survival Analysis, Urinary Bladder Neoplasms, Urination Disorders, Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial
Organisations: SAA Fac of Engineering & the Environment, Clinical Trials Unit

Identifiers

Local EPrints ID: 408906
URI: http://eprints.soton.ac.uk/id/eprint/408906
ISSN: 0360-3016
PURE UUID: 860bd616-412c-4b25-9ba0-9edd3edd6eeb
ORCID for G O Griffiths: ORCID iD orcid.org/0000-0002-9579-8021

Catalogue record

Date deposited: 28 May 2017 04:04
Last modified: 19 Nov 2019 01:34

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Contributors

Author: G M Duchesne
Author: J J Bolger
Author: G O Griffiths ORCID iD
Author: J Trevor Roberts
Author: J D Graham
Author: P J Hoskin
Author: S D Fossâ
Author: B M Uscinska
Author: M K Parmar

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