Abstract
16062 Background: Patients with epithelial ovarian cancer are often diagnosed with advanced-stage disease. Although clinical complete remissions are obtained in the majority of patients through a combination of cytoreductive surgery and chemotherapy, relapse is common. Relapsed patients with a short treatment-free interval (TFI) after prior chemotherapy have a poor prognosis. We conducted a pilot study of irinotecan (CPT-11) and docetaxel (DTX) in patients with platinum-resistant relapsed epithelial ovarian cancer. Methods: Eligible patients must have at least one platinum and paclitaxel-containing regimen, and recur with a TFI of less than 6 months. CPT-11 60 mg/m2 and DTX 30 mg/m2 were administrated on days 1, 8, 15 of a 28-day cycle. Eligibility included preserved organ function, aged 20–75, and ECOG performance status 0 or 1. The primary endpoint was response rate, and secondary objectives were duration of response, time to progression (TTP) and safety. Toxicity was assessed using NCI-CTCAE ver.2.0. Results: Between 12/2000 and 4/2005, 26 patients were enrolled, 24 of whom were eligible. The median age was 57.5 years (range 35–75). A total of 99 cycles were analyzed, median number of cycles was 3 (range 1–12). Grade 3/4 hematologic toxicities occurred in 33.3% for anemia, 4.2% for thrombocytopenia, 50.0% for leucopenia, and 62.5% for neutropenia. Non-hematologic grade 3/4 toxicities were not observed. Efficacy based on RECIST criteria was available for 20 patients, and the overall response rate was 10% (2 PR) with SD in 40%. In addition, of 4 patients with no measurable diseases, 2 patients had a confirmed PR by CA125 criteria (GCIG). Over all, clinical benefit (PR, SD) was seen in 63.6% of patients. The median duration of response was 17 weeks (range 2–49). The median TTP was 31 weeks (range 7–86). Conclusions: These results suggest that weekly treatment with CPT-11 and DTX is feasible and effective chemotherapy regimen for platinum-resistant relapsed ovarian cancer. No significant financial relationships to disclose.
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