INTRAPERITONEAL ADMINISTRATION OF CISPLATIN AND 5-FLUOROURACIL IN RESIDUAL OVARIAN-CANCER - A PHASE-II GYNECOLOGIC-ONCOLOGY-GROUP TRIAL

Forty-eight patients with persistent or recurrent epithelial ovarian cancer who had persistent or recurrent disease following intravenous (iv) cisplatin-based chemotherapy were treated with intraperitoneal (ip) cisplatin and 5-fluorouracil (5-FU) as salvage therapy. All patients had surgically documented minimal residual disease (1.0 cm or less maximum tumor diameter) at the completion of surgery and were without clinical, radiographic, or histologic evidence of extraperitoneal disease. Of the 45 patients evaluable for response, 13 had a documented partial response (PR) or complete response (CR) to previously administered iv cisplatin (cisplatin-sensitive) while the remaining 32 patients were noted to have stable or progressive disease on the previous iv cisplatin regimen (cisplatin-refractory). The median number of treatment cycles was six. At the completion of eight cycles of chemotherapy, 22 patients had no clinical or radiographic evidence of persistent disease and were thus eligible for a third-look laparotomy. Seven patients refused surgical evaluation. Three of the 15 patients who underwent a third-look laparotomy had a pathologic complete response (PCR) while 3 other patients had surgically documented partial response. All the surgically documented responses were in cisplatin-sensitive patients for a surgically documented response rate in this patient population of 66.7% (3 of 9 PCR and 3 of 9 PR). The remaining nine patients, who were all previously cisplatin-refractory, had stable or progressive disease documented at third-look laparotomy. Thirty-four patients experienced leukopenia with a median WBC nadir of 2800/mu l while 12 patients experienced thrombocytopenia with the median platelet nadir of 122,000/mu l. There was one treatment-related death secondary to sepsis. Four patients experienced catheter-related complications. ip cisplatin and 5-FU as salvage therapy is feasible in a multi-institutional cooperative group trial and, in cisplatin-sensitive patients, is an effective treatment option. (C) 1995 Academic Press, Inc.