Results of all-intraperitoneal carboplatin and paclitaxel regimen shows good tolerability and efficacy for advanced ovarian cancer

Abstract

5521 Background: A phase III trial (GOG 172) demonstrated improved survival for patients (pts) with optimally-debulked ovarian cancer treated with intraperitoneal (IP) cisplatin and paclitaxel, as compared with standard IV dosing. Studies to further enhance efficacy and minimize toxicity of IP platinum/taxane regimens are needed. We present the clinical results of a novel IP regimen in follow-up to the pharmacokinetics (pk) results presented last year. Methods: Carboplatin at an AUC 6 on day 1 and paclitaxel 60 mg/m 2 on days 1, 8, 15 was given, IV in cycle 1 and IP in the 5 subsequent 21-day cycles. The initial IV cycle was designed to allow for intra-patient IV vs. IP pk comparison. Pts completing 6 cycles with clinical complete response (CCR) underwent second-look operation (SLO). Results: Accrual is complete with 40 evaluable pts, 8 pts remain on trial. Pts came off study for: port-related complications (7), allergy (2), heme tox (2), vaginal leak (2), and infection (4). Toxicity was mild, with grade 3 or 4 toxicity consisting of neutropenia: 10 (25%), plts: 2 (5%), vomiting: 2 (5%), fatigue: 2 (5%) and anemia: 1 (2.5%). There was no grade 3 or 4 peripheral neuropathy or alopecia. Completion rate was good with 82% of pts completing = 4 cycles, as compared with 52% in GOG 172. All pts completing chemotherapy were judged to be in CCR; there was no progressive disease on trial. Of the pts undergoing SLO, 14 pts were negative, 4 pts were positive, for complete pathological response rate of 78%. Conclusions: Pts were able to complete more cycles of therapy on this regimen as compared with GOG 172. The incidence of gastrointestinal, metabolic, and neurotoxicity is very low. Preliminary SLO rate compares favorably to the 57% seen in GOG 172. Previously reported pk results as well as tolerability and efficacy are encouraging and suggest this regimen should be studied in a larger population. Final toxicity and response data will be available. No significant financial relationships to disclose.