Neoadjuvant CMV 3 cycles prior to definitive local treatment for bladder cancer increases overall survival by 7 months corresponding to a 3 year survival increase from 50% to 56% and a 10 year increase from 30% to 36%
This study randomized 491 patients to neoadjuvant CMV – cisplatin, methotrexate, vinblastine and 485 to no neoadjuvant chemotherapy. 34% had T2 disease, 58% T3 and 8% T4, with a median age of 64, 43% patients choose radical radiotherapy, 50% choose cystectomy and 8% a combination of preoperative radiotherapy plus cystectomy. The median follow up was 8 years. The result was a 16% reduction in the risk of death, a 23% reduction in the risk of metastases, and a 13% reduction in the risk of local disease after neoadjuvant chemotherapy. Also more patients ended up needing salvage chemotherapy in the group who did not get neoadjuvant CMV. 60% of tumors were between 2.5-6 cm in size, patients were good ECOG performance status, and 2/3 were N0. Therefore 3 cycles of CMV before definitive local treatment resulted in a 16% reduction in risk of death which corresponds to a 3 year increased survival from 50% to 56%, and a 10 year survival from 30% to 36% which corresponds to a median survival increase of 7 months (37 to 44 months). Surprisingly there was no added benefit in terms of reducing locoregional control, in other words preventing relapse in the pelvis between CMV and no CMV groups. The CMV treatment related mortality was 1% (5/491 patients). Therefore for fit good ECOG patients neoadjuvant CMV prior to cystectomy of primary radical radiotherapy is considered state of the art.