Abstract

Objective To evaluate safety and outcome of weekly carboplatin and paclitaxel as the initial postoperative adjuvant chemotherapy for epithelial ovarian carcinoma (EOC) patients. Methods Patients with stage IC-IV epithelial ovarian cancer (EOC) primary peritoneal or tubal carcinoma were enrolled in this phase II study. Intravenous carboplatin (area under the curve 2) and paclitaxel (80 mg/m 2) were administered on days 1, 8, and 15 of a 28-day cycle for 6–8 cycles. Cytoreductive surgery was performed as primary treatment or after 3 cycles of weekly neoadjuvant chemotherapy, followed postoperatively by an additional 3 cycles of chemotherapy. Results Sixty-four women (median age 65 years, range 39.9–82.8) were enrolled. Fifty-six of them (87.6%) were diagnosed with stage III–IV disease. Neutropenia was the most common hematological toxicity: 25% of the subjects had grade 3–4 neutropenia, 34.4% were supported by GCSF and 15.6% received epoetin. The majority (89%) of the patients had grade 1 and only 7.8% had grade 2 alopecia. 7.8% had grade 3 fatigue and 14.1% had grade 2 and 3.1% grade 3 neuropathy, none developed grade 4 neuropathy and only 6.3% had some residual neuropathy at > 6 months after treatment. With a median follow-up of 31.5 months (range 5.9–57.3), estimated median survival was 52.0 months and median progression-free survival 25.74 (8.4–57.3) months (95% CI, 21.2–30.3). Overall and complete response rates were 92.1% and 64.1% respectively. Conclusion Weekly carboplatin and paclitaxel as the initial chemotherapy for EOC is a feasible and well tolerated regimen and should be further evaluated in a larger phase III study.

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