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 c ancer who had persistent or recurrent disease following intravenous (i v) 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 max imum tumor diameter) at the completion of surgery and were without cli nical, radiographic, or histologic evidence of extraperitoneal disease . Of the 45 patients evaluable for response, 13 had a documented parti al response (PR) or complete response (CR) to previously administered iv cisplatin (cisplatin-sensitive) while the remaining 32 patients wer e noted to have stable or progressive disease on the previous iv cispl atin regimen (cisplatin-refractory). The median number of treatment cy cles was six. At the completion of eight cycles of chemotherapy, 22 pa tients had no clinical or radiographic evidence of persistent disease and were thus eligible for a third-look laparotomy. Seven patients ref used surgical evaluation. Three of the 15 patients who underwent a thi rd-look laparotomy had a pathologic complete response (PCR) while 3 ot her patients had surgically documented partial response. All the surgi cally 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 al l previously cisplatin-refractory, had stable or progressive disease d ocumented at third-look laparotomy. Thirty-four patients experienced l eukopenia with a median WBC nadir of 2800/mu l while 12 patients exper ienced thrombocytopenia with the median platelet nadir of 122,000/mu l . There was one treatment-related death secondary to sepsis. Four pati ents experienced catheter-related complications. ip cisplatin and 5-FU as salvage therapy is feasible in a multi-institutional cooperative g roup trial and, in cisplatin-sensitive patients, is an effective treat ment option. (C) 1995 Academic Press, Inc.