PHASE-II STUDY OF PIRARUBICIN COMBINED WITH CISPLATIN IN RECURRENT OVARIAN-CANCER

Although 50%-80% of patients with advanced ovarian cancer demonstrate an objective response after platinum-based chemotherapy, a majority of these patients will ultimately experience a relapse of their disease. Effective second-line treatment for these patients is of the utmost i mportance. We performed a phase II study with cisplatin and pirarubici n (each drug 50 mg/m2 i.v. every 28 days) in 17 patients with relapsed or persistent ovarian carcinoma. All patients had received platinum-c ontaining primary chemotherapy. Overall survival from the time of diag nosis was 38.3 months (45.3 months in relapsed ovarian carcinoma and 2 8.3 months in ovarian carcinoma persisting after primary chemotherapy) . Survival from entrance into the study was 13.0 months (14.2 months i n relapsed disease and 11.2 months in refractory disease). Time to pro gression was 10.3 months. An objective response was observed in 4 pati ents and another 3 patients had stable disease. Major toxicity consist ed of emesis (grade III/IV in 60/64 courses) and myelosuppression WHO grade III/IV in 15 courses. Neurotoxicity occurred in 3 patients and n ephrotoxicity in 1 patient. Alopecia occurred in 12 patients. Tachycar dia and other low-grade heart toxicities were observed after 5 courses . Dose reduction was necessary because of severe myelosuppression in 4 courses and because of nephrotoxicity in 1 course. Delay of subsequen t chemotherapy courses for more than 7 days was necessary after 13 cou rses and was always due to myelosuppression. The dose-limiting toxicit y of combination chemotherapy with cisplatin and pirarubicin is myelos uppression. Response and survival rates are superior in patients with relapsed disease compared to patients with resistent ovarian carcinoma .