HIGH FAILURE RATE OF CARBOPLATIN ETOPOSIDE COMBINATION IN GOOD RISK NONSEMINOMATOUS GERM-CELL TUMORS

24 patients with good risk non-seminomatous germ cell tumours (GR-NSGC T) were enrolled in a phase II trial combining carboplatin (C) and eto poside (E). Carboplatin was given at a fixed dose of 450 mg/m2 at d2, and E 120 mg/m2, d1-3, every 4 weeks x 4 cycles (cy). Myelosuppression was the major toxicity with neutropenia grade 4 in 18 cy (19%) and gr ade 3 in 26 cy (27%). Thrombocytopenia grade 3 and 4 occurred in 7 and 1 cy, respectively. Responses included: 20 complete responses (CR) (8 3%) with 16 clinical CR and 4 pathological CR; 3 additional patients h ad complete surgical removal of residual disease (SRRD) with viable tu mour (surgical CR); 1 patient progressed during C + E therapy. 5 of th e 16 clinical CR relapsed, and all the 3 surgical CR progressed despit e post-operative salvage chemotherapy. Adverse events occurred in 9 pa tients (37.5%; 95% C.I., 19-59%). After a median follow-up of 24 m (ra nge 14 to 38) 4 patients had died [3 progressive disease (PD), 1 suici de while in CR], 3 were alive with PD, and 17 had no evidence of disea se. No significant correlation between area under the curve values of carboplatin, overall treatment failure and the platelet nadirs was obs erved. We conclude that the efficacy of the C + E regimen as given in our protocol is inferior to the standard cisplatin-containing regimens . The low dose-density (D/I) of carboplatin could be responsible for t he high failure rate.