COMBINATION CHEMOTHERAPY WITH CARBOPLATIN AND METHOTREXATE IN THE TREATMENT OF ADVANCED UROTHELIAL CARCINOMA - A PHASE-II STUDY

The activity and toxicity of a carboplatin (300 mg/m2, day 1) and meth otrexate (50 mg/m2, days 8 and 15) combination chemotherapy in the tre atment of advanced urothelial cancer (UC) was evaluated in the present study. A total of 49 patients entered the study: 44 patients were eva luable for response, and 48 for toxicity. A complete response (CR) was found in 4/44 patients (9.1%) and a partial remission (PR) in 12/44 p atients (27.2%) for an overall response rate of 16/44 (36.3%). Stable disease was found in 21/44 patients (47.7%), and progressive disease i n 7/44 patients (15.9%). Survival was significantly longer in respondi ng patients than nonresponders (median: 62 weeks vs 50 weeks, P < .05) . Hematologic and renal toxicities were mild, thrombocytopenia and leu kopenia being the most relevant side effects. The first consecutive 7 patients received methotrexate also on day 22; 5 of them underwent gra de III-IV hematologic toxicity, so methotrexate on day 22 was omitted in the subsequent patients. No toxic deaths were reported. CBDCA and M TX combination chemotherapy is well tolerated and moderately active in the treatment of advanced urothelial cancer and may represent a valid alternative to cisplatin-containing regimens in patients with poor pe rformance status and/or impaired renal function.