503 High dose chemotherapy in advanced ovarian carcinoma with bulky residual disease

From February 1989 to December 1991, 80 patients: stages IIIc (58)stages IV (22). Suffering from bulky ovarian adenocarcinoma with important residual diseases after first surgery were included in a study testing the feasability and the potentiality of a three drug association chemotherapy. All patients had to accept a second look laparotomy and to give an informed consent. Cisplatin (100 mg/sqm), Carboplatin (300 mg;sqm), Cyclophosphamide (300 mg/sqm), were infused every 4 weeks according to the protocols of each participating Center. Antiemetic drugs transfusions, rehydratation and hospitalizations were left to each clinician's decision. Precise guidelines were given for the delay of the chemotherapy, according to the toxicity. However only 4 G 3 infections and 7 G 2 hemorragic toxicities were observed, one patient died the day of the first course, and one stopped due to intolerable hematological toxicity. Late toxicity was observed included parasthesias tinnitus, and severe ototoxicity. Immediate results are encouraging with pathological complete responses in 27% (stage IIIc) and 23% (stage IV) patients. Survival seems also better than with current treatments: median survival 31 months stage III and 19 months for stage IV. Since June 1992, a phase III study comparing a classical regimen (Cisplatin-Cyclophosphamide) with this three-drugs association is now underway.