Ps. Braly et al., INTRAPERITONEAL ADMINISTRATION OF CISPLATIN AND 5-FLUOROURACIL IN RESIDUAL OVARIAN-CANCER - A PHASE-II GYNECOLOGIC-ONCOLOGY-GROUP TRIAL, Gynecologic oncology, 56(2), 1995, pp. 164-168
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.