Objectives: To determine the feasibility, toxicity and efficacy of a first-line combination of intraperitoneal (i.p.) paclitaxel and cisplatin and intravenous (i.v.) ifosfamide in untreated patients with Stage IIIc ovarian cancer after cytoreduction or biopsies only.
Methods: Twenty-six patients entered the trial from 1995 to 1999. Twenty underwent initial cytoreduction which was complete, with residual nodules < 0.5 cm or = 0.5 cm in six, five and nine patients, respectively. Six patients underwent biopsies only at initial surgery. Ten cycles of chemotherapy were planned by both routes. Second-look surgery was planned for all patients.
Results: Twenty-one (81%) of the 26 patients were in complete clinical remission (CCR) at the time of second-look surgery. Of the 15 patients who underwent second-look surgery, ten were in CCR including seven in complete remission (CR) confirmed pathologically. Median overall-survival had not been reached at 53 months (range 16-87), and median disease-free survival was 40 months (range 8-85), for a median follow-up of 53 months (range 16-87). Local toxicity consisted mainly of mild abdominal pain. Systemic toxicity was essentially haematological, with eight (31%) grade 3-4 leukopenia.
Conclusion: This study has demonstrated the feasibility, moderate toxicity and efficacy of first-line intraperitoneal paclitaxel-cisplatin chemotherapy.