International phase III trial assessing neoadjuvant cisplatin, methotrexate, and vinblastine chemotherapy for muscle-invasive bladder cancer: long-term results of the BA06 30894 trial.

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.

• Authors: International Collaboration of Trialists, Medical Research Council Advanced Bladder Cancer Working Party (now the National Cancer Research Institute Bladder Cancer Clinical Studies Group), European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group, Australian Bladder Cancer Study Group, National Cancer Institute of Canada Clinical Trials Group, Finnbladder, Norwegian Bladder Cancer Study Group, Club Urologico Espanol de Tratamiento Oncologico Group, Gareth Griffiths, Reginald Hall, Richard Sylvester, Derek Raghavan, Mahesh K B Parmar
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 29 Issue 16 Pg. 2171-7 (Jun 01 2011) ISSN: 1527-7755 [Electronic] United States
• PMID: 21502557 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Vinblastine
• Cisplatin
• Methotrexate

Topics

• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Transitional Cell (drug therapy, mortality, pathology)
• Cisplatin (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Kaplan-Meier Estimate
• Male
• Methotrexate (administration & dosage, therapeutic use)
• Middle Aged
• Muscle Neoplasms (drug therapy, secondary)
• Neoadjuvant Therapy (methods)
• Neoplasm Invasiveness
• Neoplasm Staging
• Urinary Bladder Neoplasms (drug therapy, mortality, pathology)
• Vinblastine (administration & dosage, therapeutic use)