CYCLOPHOSPHAMIDE, EPIDOXORUBICIN AND CARBOPLATIN AS TREATMENT FOR ADVANCED-CARCINOMA OF THE BLADDER - A PHASE-II STUDY

In advanced carcinoma of the bladder, the M-VAC chemotherapy schedule can yield positive results, but at the cost of very high toxicity. Rec ent studies have shown epidoxorubicin and to a lesser degree, carbopla tin to be active against urothelial tumors, with cardiac, haematologic al and renal toxicity lower than that observed with CISCA or M-VAC che motherapy regimens. In this study, we determined the toxicity and effi cacy of cyclophosphamide 400 mg/m(2), epidoxorubicin 75 mg/m(2) and ca rboplatin 300 mg/m(2) in a 28-day course. From February 1990 to Decemb er 1991, we enrolled 33 advanced bladder cancer patients (25 males, 8 females), mean age 63 years. 31 patients were evaluable for toxicity a nd response. The major disease localizations were: locoregional 15 (48 %), lymph nodes 6 (20%), liver 5 (16%), lung 3 (10%) and bone 2 (6%). A total of 186 cycles of therapy were administered, with a mean of 5.4 per patient. Six patients (19%) had a complete response (CR): 2 locor egional, 3 lymph node and 1 lung. Eleven patients (36%) had a partial response (PR), for an overall response rate of 55%. The median duratio n of response was 53 weeks and median survival for the entire group of patients was 40 weeks. No delays or interruptions due to sepsis occur red during therapy; haematological, cardiac and renal toxicity were be low WHO grade 3. The efficacy of this chemotherapy regimen proved to b e comparable to that of more aggressive schedules, while its toxicity was markedly lower.