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J Clin Oncol. 2011 Jun 1;29(16):2171-7. doi: 10.1200/JCO.2010.32.3139. Epub 2011 Apr 18.

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

Collaborators (198)

Macbeth FR, Steward W, Russell JM, Harnett AN, Symonds RP, Canney PA, Reed NS, Jones R, Crawford M, Graham JD, Newman HF, Sibley GN, Chetiyawardana AD, Read G, Cole DJ, Harris AL, Clark PI, Littler J, Myint S, Cottier B, Errington RD, Brock JE, Gildersleve J, Snee M, Benghiat A, Guthrie D, Glaholm F, Spooner D, Arkell DG, Hall RR, Neal DE, Roberts JT, Ferro A, Wiltshire R, Coltart S, Madden F, Heal R, Chetiyawardana D, Harland SJ, Duchesne G, Hoskin PJ, Maher EJ, Roberts JT, Bozzino JM, Branson AN, Lucraft HH, Quilty-Windsor M, Sethia KK, Gaches CG, Ashken MR, Beacock C, Wallace DM, Chetiyawardana AD, Glaholm J, Spooner D, Goodman AG, James ND, Kaisary AV, Horwich A, Beacock C, Hay A, Mead GM, Glaholm J, Dunlop PR, Rathmell AJ, Robinson A, Selby P, Cornbleet MA, McDougall P, Nicol D, Walpole E, Sandeman T, Tai KH, Tong M, Lewis C, Friedlander M, Olver I, Walker Q, Raghavan D, Ganju V, McLennan R, Jeffery GM, Perez D, Allan SG, Coppin C, Murray N, Venner P, Findlay B, Dhaliwal HS, Chritchley JH, Armitage G, Gospodarowicz M, Moore M, Jewett MA, Tannock I, Wells WA, Ernst S, Stewart DA, Choo R, Wajsman Z, Flodgren P, Abratt RP, Rzepecki J, Madej G, Fossa SD, Aass N, Wahre H, Alfthan O, Fourcade RO, Bittard, Botto, Vallencien G, Callet B, Boccon-Gibod L, Marechal M, Theodore C, Denis L, Van Cangh PJ, Lantsoght KE, Carpentier P, Casselman J, Verbaeys A, Van Poppel H, Van Groeningen CJ, Keizer HJ, Veenhof CH, Van de Beek C, Kirkels W, Splinter TA, Van der Meijden AP, Karthaus PP, Dijkman GA, Debruyne F, Jansen H, Boeken Kruger CG, Bono AV, Tizzani A, Sternberg C, Pansadoro V, Pavone-Macaluso M, Flores N, Bastus R, Martinez-Pineiro JA, Martin B, Portillo J, Rioja LA, Isorna S, Santos Garcia Vaquero A, Tallada M, Hetherington J, Whelan P, Studler G, Pont J, Kirkali Z, Akdas A, Borkowski A, Recker F, Kliment J, Cutajar CL, Hall RR, Mead GM, Roberts JT, Hall RR, Mead GM, Roberts JT, Wallace DM, Splinter TA, Calais da Silva F, Sternberg CN, Vallencien G, Raghavan D, Gospodarowicz M, Fossa S, Alfhan O, Martinez-Pineiro JA, Heaton J, Schaafsma J, Berner A, Philips J, Richmond H, Nordling S, Griffiths GO, Parmar MK, Sylvester RJ, Uscinska BM, de Pauw M, de Balincourt C, Gospodarowicz M, Hall RR, Mead GM, Parmar MK, Raghavan D, Roberts JT, Splinter TA, Sylvester RJ, Barrett A, Scher H, Dalesio O.



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.


This was a randomized phase III trial of either no neoadjuvant chemotherapy or three cycles of CMV.


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.


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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