A MULTICENTER PHASE-II STUDY OF CARBOPLATIN IN ADVANCED OVARIAN-CARCINOMA - FINAL REPORT

A phase II trial of single-agent carboplatin in advanced ovarian cance r was performed by 19 institutions from 10 European countries. A total of 260 patients were treated, with a median age of 55 (range: 20-79) years. Karnofsky peformance status was 80-100 in about two-thirds of t he patients. Prior therapy consisted of surgery only in 31 patients, i rradiation in 9, chemotherapy without cisplatin in 45, and with cispla tin in 175. Carboplatin was administered as second-line therapy in abo ut one-half and as third-line or more in one additional third of the s tudy population. Initial dose was 400 mg/m2 in 90, 360 mg/m2 in 152, a nd 320 mg/m2 or less in 18 patients. A total of 971 courses (mean 3.7, median 2, range: 1-13) of therapy were administered. A total of 16 co mplete and 46 partial responses were observed in 226 evaluable patient s, for an objective response rate of 27%. Efficacy was greater in chem otherapy-untreated patients (51% vs. 23%, p = 0.002). In cisplatin-pre treated patients activity was significantly higher in non-refractory p atients (26% vs. 4%, p = 0.015). Myelosuppression was the most signifi cant side effect. However, low hemotologic counts seldom translated in to clinically significant complications. Patients with impaired baseli ne creatinine clearance and poor performance status were at higher ris k of developing severe myelosuppression during the initial course of t reatment. Non hematologic side effects were rare and mild, except for emesis. Carboplatin has a definite role in the treatment of ovarian ca ncer, but almost complete cross-resistance with the parent compound wa s observed clinically.