Weekly topotecan as a salvage therapy in heavily pre-treated patients with recurrent platinum-resistant epithelial ovarian cancer

Abstract

16076 Background: The prognosis of patients with recurrent epithelial ovarian cancer is extremely poor after several lines of chemotherapy; this situation becomes more and more difficult to manage in the presence of a platinum-resistance condition. Topotecan 1.5mg/m2 on days 1 through 5 of a 21-day cycle is often employed as a second-line chemotherapy also for platinum-resistant epithelial ovarian cancer. In this phase II study we investigated the safety as well response rate of weekly topotecan as a salvage therapy in heavily pretreated patients with recurrent platinum-resistant epithelial ovarian cancer (RprEOC). Methods: To be elegible for the study patients had to be considered resistant to platinum and paclitaxel pretreated. Eleven patients (median age 51 yrs, range 45 - 70) with performance status 0–2 affected by RprEOC with measurable disease, were planned to receive weekly topotecan. They had received at least 3 prior lines of chemotherapy. Topotecan was administered at the dose of 2.0 mg/m2 via a 30-minute i.v. infusion once every week until disease progression or unacceptable toxicity. Results: All patients were evaluable for toxicity and clinical response. All the 11 pts enrolled had stage III-IV disease. Median number of chemotherapy cycles was 5 (range 3 - 8). A total of 62 cycles were administered. Dose reduction was necessary for 12% of the cycles. Main toxicities included anemia (12%), leucopenia (18%), thrombocytopenia (15%) and asthenia (20%). No deaths were attributable to therapy. No one showed complete response, while two partial response (18.2%) and four stable disease (36.4%) were observed. Five pts (45.4%) progressed on therapy. The median progression-free interval was 13 weeks. Conclusion: Salvage therapy for patients with ovarian cancer who failed several platinum and paclitaxel treatments remains a therapeutic challenge. Topotecan administered at low weekly dosage (2.0 mg/m2) is an active option in the subset of heavily RprEOC and it seems also to be a more tolerable regimen compared to the classical 5-day schedule. No significant financial relationships to disclose.