CARBOPLATIN-BASED VERSUS CISPLATIN-BASED CHEMOTHERAPY IN THE TREATMENT OF SURGICALLY INCURABLE ADVANCED BLADDER-CARCINOMA

BACKGROUND. The carboplatin-based chemotherapeutic regimen M-CAVI (met hotrexate, carboplatin, and vinblastine) is active against bladder car cinoma and can be administered to patients who are ineligible to recei ve cisplatin or doxorubicin. The authors designed a randomized study t o evaluate whether M-CAVI offers a therapeutic advantage over the cisp latin-based regimen M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin) in the treatment of patients with surgically incurable adv anced bladder carcinoma, METHODS. Patients with surgically incurable a dvanced bladder carcinoma were enrolled on a randomized trial comparin g M-CAVI, which consists of carboplatin (300 mg/m(2) on Day 2, adjuste d using Calvert's formula for an area under the curve of 5), methotrex ate (30 mg/m(2) on Days 1, 15, and 22), and vinblastine (3 mg/m(2) on Days 2, 15, and 22) administered every 28 days, versus standard M-VAC. The eligibility criteria included histologically proven bladder carci noma, surgically incurable disease, and no prior chemotherapy. Patient s were treated until disease progression or unacceptable toxicity occu rred. RESULTS. From January 1989 to January 1994, 47 assessable patien ts were included. Seventeen patients had lymph node disease and 30 had distant metastatic disease. Twenty-three patients were randomized to receive M-CAVI and 24 to receive M-VAC. Patient characteristics in the two groups were similar. Overall response rates were 39% (95% confide nce interval [CI], 20-62%) for M-CAVI and 52% (95% CI, 30-73%) for M-V AC (P = 0.3), with 3 complete responses observed among patients treate d with M-VAC and none among those in the M-CAVI group, M-VAC was assoc iated with more gastrointestinal toxicity, stomatitis, alopecia, and G rade 4 neutropenia than M-CAVI. One toxicity-related death occurred in the M-VAC group. There was a statistically significant difference in median disease-related survival time favoring M-VAC (16 months; range, 6 to 22+) versus M-CAVI (9 months; range, 6 to 14+) (P = 0.03). CONCL USIONS. M-CAVI is less toxic but less active than M-VAC in the treatme nt of patients with advanced bladder carcinoma. Carboplatin-based regi mens in which carboplatin is administered at the dose range used in th e current study should be reserved for patients who cannot tolerate ci splatin treatment. Further research is required to assess the impact o f high dose carboplatin in the treatment of this disease. (C) 1997 Ame rican Cancer Society.