ANAHEIM, California—A phase III Intergroup trial has provided strong evidence that neoadjuvant MVAC—methotrexate, vinblastine(Drug information on vinblastine), doxorubicin(Drug information on doxorubicin) (Adriamycin), cisplatin(Drug information on cisplatin) (Platinol)—provides a survival benefit in patients with locally advanced bladder cancer, David Crawford, MD, said at the American Urological Association (AUA) annual meeting (abstract 1069).
Dr. Crawford is professor of urologic oncology, University of Colorado Cancer Center, Denver. [The study, not previously reported in ONI, was also presented at the 2001 ASCO annual meeting plenary session (abstract 3).]
Although cystectomy and removal of surrounding lymph nodes provides the best survival benefit for patients with advanced bladder cancer, about 60% of these patients harbor micrometastases and die of their disease. The only therapy that has proved superior to cisplatin alone in patients with grossly advanced metastatic disease is MVAC.
Neoadjuvant MVAC
This study, by SWOG, ECOG, and CALGB, aimed to determine if three cycles of MVAC followed by cystectomy would improve survival in patients treated at an earlier stage. SWOG 8710 (Intergroup 0080) was a randomized phase III trial of neoadjuvant MVAC followed by cystectomy vs cystectomy alone in 307 patients evaluated over a 14-year period. Patients had T2-4a, N0, M0 transitional cell carcinomas and were stratified according to age and stage.
Dr. Crawford reported that survival was 2.4 years longer for patients receiving neoadjuvant MVAC, compared with those who underwent surgery alone. With median follow-up of 7.1 years, 128 patients remain alive, with 85 and 94 deaths, respectively, in the MVAC and no MVAC arms. Estimated median survivals are 6.2 years and 3.8 years, respectively, and the hazard ratio is 0.74 for patients receiving MVAC (P = .027).
Additionally, pathologic examination of the bladder after cystectomy revealed that 38% of patients receiving MVAC had no evidence of remaining disease. Among these patients, 85% were still alive 5 years after surgery.
