A COMPARISON OF INTRAVENOUS VERSUS INTRAPERITONEAL CHEMOTHERAPY FOR THE INITIAL TREATMENT OF OVARIAN-CANCER

A phase III study was conducted comparing intraperitoneal tip) versus intravenous (iv) cisplatin-based therapy for patients with newly diagn osed ovarian cancer to determine if the pharmacologic advantage of ip delivery could be translated into an improved response and survival ra te. Twenty-nine patients were randomized to receive six cycles of ip c isplatin 200 mg/m(2) plus ip etoposide 350 mg/m(2) with iv thiosulfate protection given every 4 weeks; thirty-three patients were randomized to receive six cycles of iv cisplatin 100 mg/m(2) plus iv cyclophosph amide 600 mg/m(2) administered every 3 weeks. Patients were stratified by stage (IIC-IV) and size of residual disease (> or less than or equ al to 1 cm). The study was conducted in a community-wide setting. The complete response in evaluable patients was 48% in the ip group and 52 % in the iv group. The surgical complete response rate for all patient s on study, underestimated because not all patients in complete clinic al remission had a second-look laparotomy, was 31% in the ip group and 33% in the iv group. There was no difference in the response rates be tween the treatment arms as a function of residual disease less than o r equal to or >1 cm. With a median follow-up of 46 months (range 21-70 months) there is no difference in response duration or survival. Both regimens were well tolerated with comparable hematologic and nonhemat ologic toxicity. (C) 1994 Academic Press, Inc.