A CARBOPLATIN-BASED REGIMEN FOR THE TREATMENT OF PATIENTS WITH ADVANCED TRANSITIONAL-CELL CARCINOMA OF THE UROTHELIUM

BACKGROUND. Many patients with advanced transitional cell carcinoma ar e unable to receive cisplatin-based therapy. The efficacy and toxicity of a carboplatin-based regimen in the treatment of patients with adva nced transitional cell carcinoma was therefore evaluated. METHODS. Twe nty-three patients with advanced transitional cell carcinoma were trea ted. Metastatic disease was present in 19 of 23 patients (83%) whereas 4 patients with T4, and/or N1, disease were treated. Patients were tr eated every 28 days with methotrexate, 30 mg/m(2) intravenously (i.v.) on Days 1 and 15, along with leucovorin, 15 mg/m(2) orally every 6 ho urs, 3 times daily beginning 24 hours after each methotrexate dose; vi nblastine, 3 mg/m(2) i.v. on Days 1 and 15; mitoxantrone, 15 mg/m(2) i .v. on Day 1; and carboplatin, 300 mg/m(2) i.v. on Day 1, adjusted for creatinine clearance (MVNCa). Dosage in subsequent cycles was adjuste d according to hematologic toxicity. RESULTS. Median age was 70 years (range, 52-83 years) and median pretreatment creatinine clearance was 50 mL/min (range, 30-106 mL/min). Of 23 patients, 8 (34.8%) obtained a complete response, and 5 (21.7%) obtained a partial response. The ove rall response proportion was 56.5% (95% confidence interval, 34.5-76.8 %). Median survival was 10 months (range, 1-44+ months). Toxicity was moderate. Grade 4 neutropenia occurred in 10 of 107 (9.3%) administere d treatment cycles; Grade 4 thrombocytopenia occurred in 11 of 107 (10 .3%). There were 4 episodes of febrile neutropenia (3.7% of cycles). R enal, neurologic, or otic toxicity were not observed. Age older than 7 0 did not appear to impact on response proportion, survival, and toxic ity. CONCLUSIONS. The carboplatin-based MVNCa regimen is active in the treatment of patients with advanced transitional cell carcinoma and i s well tolerated. Therapy with this regimen may be a less toxic altern ative for patients for whom treatment with cisplatin is not an option. (C) 1996 American Cancer Society.