COMPARISON BETWEEN A CISPLATIN-CONTAINING REGIMEN AND A CARBOPLATIN-CONTAINING REGIMEN FOR RECURRENT OR METASTATIC BLADDER-CANCER PATIENTS - A RANDOMIZED PHASE-II STUDY

BACKGROUND, The aim of this randomized Phase II study was to compare t he efficacy and toxicity of a cisplatin-containing regimen with a carb oplatin-containing regimen for patients with recurrent or metastatic b ladder cancer. METHODS, Fifty-seven patients with recurrent or metasta tic bladder cancer were randomized to receive M-VEC treatment (methotr exate, vinblastine, epirubicin, and cisplatin) (n = 29) or M-VECa trea tment (methotrexate, vinblastine, epirubicin, and carboplatin) (n = 28 ). The chemotherapy was scheduled at 28-day intervals. Recombinant gra nulocyte-colony stimulating factors were administered daily when the a bsolute neutrophil count fell below 1000/mm(3). The development of oto toxicity was evaluated by measuring auditory brain stem response. RESU LTS, Of the 57 entered patients, 55 were evaluable for response and to xicity. The overall clinical response rate was 71% (with 25% complete responses) in the M-VEC group and 41% (with 11% complete responses) in the M-VECa group (P = 0.04). M-VEC chemotherapy was associated with m ore pronounced side effects. There was a statistically significant dif ference between M-VEC and M-VECa in terms of gastrointestinal toxicity (P = 0.04), nephrotoxicity (P = 0.03), and neurotoxicity (P = 0.02) d uring Cycle 3 of chemotherapy. Leukopenia and neutropenia were worse i n the M-VECa arm, but not significantly so (P = 0.4). Ototoxicity was only detected in one of seven examined M-VEC patients after two cycles of chemotherapy. CONCLUSIONS, M-VECa has a low level of gastrointesti nal, renal, neurologic, and otologic toxicity, but is apparently less effective than M-VEC in the treatment of recurrent or metastatic bladd er cancer. However, a larger, randomized Phase III trial is needed to confirm these results. (C) 1996 American Cancer Society.