International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial
International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial
PURPOSE: This article presents the long-term results of the international multicenter randomized trial that investigated the use of neoadjuvant cisplatin, methotrexate, and vinblastine (CMV) chemotherapy in patients with muscle-invasive urothelial cancer of the bladder treated by cystectomy and/or radiotherapy. Nine hundred seventy-six patients were recruited between 1989 and 1995, and median follow-up is now 8.0 years.
PATIENTS AND METHODS: This was a randomized phase III trial of either no neoadjuvant chemotherapy or three cycles of CMV.
RESULTS: The previously reported possible survival advantage of CMV is now statistically significant at the 5% level. Results show a statistically significant 16% reduction in the risk of death (hazard ratio, 0.84; 95% CI, 0.72 to 0.99; P = .037, corresponding to an increase in 10-year survival from 30% to 36%) after CMV.
CONCLUSION: We conclude that CMV chemotherapy improves outcome as first-line adjunctive treatment for invasive bladder cancer. Two large randomized trials (by the Medical Research Council/European Organisation for Research and Treatment of Cancer and Southwest Oncology Group) have confirmed a statistically significant and clinically relevant survival benefit, and neoadjuvant chemotherapy followed by definitive local therapy should be viewed as state of the art, as compared with cystectomy or radiotherapy alone, for deeply invasive bladder cancer.
Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Cisplatin, Female, Humans, Kaplan-Meier Estimate, Male, Methotrexate, Middle Aged, Muscle Neoplasms, Neoadjuvant Therapy, Neoplasm Invasiveness, Neoplasm Staging, Urinary Bladder Neoplasms, Vinblastine, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
2171-2177
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Hall, Reginald
7d1b123b-5088-44ae-8dd5-66ce59c9e3d5
Sylvester, Richard
6c66badb-835e-4fea-8ac2-ec0b7bf14de0
Raghavan, Derek
c31d87dd-3270-4bfa-95b3-b909b63cd05a
Parmar, Mahesh K B
5574463d-506e-499e-9381-6130f1ef7dbe
International Collaboration of Trialists
1 June 2011
Griffiths, Gareth
7fd300c0-d279-4ff6-842d-aa1f2b9b864d
Hall, Reginald
7d1b123b-5088-44ae-8dd5-66ce59c9e3d5
Sylvester, Richard
6c66badb-835e-4fea-8ac2-ec0b7bf14de0
Raghavan, Derek
c31d87dd-3270-4bfa-95b3-b909b63cd05a
Parmar, Mahesh K B
5574463d-506e-499e-9381-6130f1ef7dbe
Griffiths, Gareth, Hall, Reginald, Sylvester, Richard, Raghavan, Derek and Parmar, Mahesh K B
,
International Collaboration of Trialists
(2011)
International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial.
Journal of Clinical Oncology, 29 (16), .
(doi:10.1200/JCO.2010.32.3139).
Abstract
PURPOSE: This article presents the long-term results of the international multicenter randomized trial that investigated the use of neoadjuvant cisplatin, methotrexate, and vinblastine (CMV) chemotherapy in patients with muscle-invasive urothelial cancer of the bladder treated by cystectomy and/or radiotherapy. Nine hundred seventy-six patients were recruited between 1989 and 1995, and median follow-up is now 8.0 years.
PATIENTS AND METHODS: This was a randomized phase III trial of either no neoadjuvant chemotherapy or three cycles of CMV.
RESULTS: The previously reported possible survival advantage of CMV is now statistically significant at the 5% level. Results show a statistically significant 16% reduction in the risk of death (hazard ratio, 0.84; 95% CI, 0.72 to 0.99; P = .037, corresponding to an increase in 10-year survival from 30% to 36%) after CMV.
CONCLUSION: We conclude that CMV chemotherapy improves outcome as first-line adjunctive treatment for invasive bladder cancer. Two large randomized trials (by the Medical Research Council/European Organisation for Research and Treatment of Cancer and Southwest Oncology Group) have confirmed a statistically significant and clinically relevant survival benefit, and neoadjuvant chemotherapy followed by definitive local therapy should be viewed as state of the art, as compared with cystectomy or radiotherapy alone, for deeply invasive bladder cancer.
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Accepted/In Press date: 21 December 2010
Published date: 1 June 2011
Keywords:
Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Cisplatin, Female, Humans, Kaplan-Meier Estimate, Male, Methotrexate, Middle Aged, Muscle Neoplasms, Neoadjuvant Therapy, Neoplasm Invasiveness, Neoplasm Staging, Urinary Bladder Neoplasms, Vinblastine, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
Organisations:
Clinical Trials Unit
Identifiers
Local EPrints ID: 406320
URI: http://eprints.soton.ac.uk/id/eprint/406320
ISSN: 1527-7755
PURE UUID: 9398d9ee-28a8-4676-aaf5-32f2866607a7
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Date deposited: 10 Mar 2017 10:44
Last modified: 16 Mar 2024 04:19
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Contributors
Author:
Reginald Hall
Author:
Richard Sylvester
Author:
Derek Raghavan
Author:
Mahesh K B Parmar
Corporate Author: International Collaboration of Trialists
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