International Phase III Trial Assessing Neoadjuvant Cisplatin, Methotrexate, and Vinblastine Chemotherapy for Muscle-Invasive Bladder Cancer: Long-Term Results of the BA06 30894 Trial

Griffiths, Gareth O. 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) , pp. 2171-2177. 10.1200/JCO.2010.32.3139

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) R Medicine > RM Therapeutics. Pharmacology
Additional Information:	Author Contributions: Conception and design: Reginald Hall, Richard Sylvester, Derek Raghavan, Mahesh K.B. Parmar Provision of study materials or patients: Reginald Hall Collection and assembly of data: Richard Sylvester, Derek Raghavan, Mahesh K.B. Parmar Data analysis and interpretation: Gareth Griffiths, Richard Sylvester, Derek Raghavan, Mahesh K.B. Parmar Manuscript writing: All authors Final approval of manuscript: All authors
Publisher:	Grune and Stratton
ISSN:	0732-183X
Last Modified:	19 Mar 2016 22:51
URI:	https://orca.cardiff.ac.uk/id/eprint/29424

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