Three-day topotecan schedule in heavily pretreated recurrent ovarian cancer patients

Objective: To evaluate the clinical benefit of a 3-day topotecan schedule in heavily pretreated recurrent ovarian cancer patients scheduled for palliative treatment. Methods: Eligibility criteria were 2 or more prior chemotherapy regimens, Eastern Cooperative Oncology Group performance status of 2 or less; adequate organ function, assessable disease by serum CA-125 measurement before each cycle; and 1 or more cycle of topotecan (1.5 mg/m(2) per day) on 3 consecutive days of a 28-day treatment cycle. Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria version 3. Tumor response, stable disease, and progression were evaluated on the basis of CA-125 levels. Results: A total of 68 patients were considered eligible for the Study. Median age was 58 years (range, 40-77 years), and the median number of prior chemotherapy regimens was 2 (range, 2-6). A total of 272 cycles of topotecan were administered, with a median of 4 cycles per patient (range, 1-8). No treatment delays or dose reduction was recorded. Major toxicities were grade 3/4 (18%) neutropenia, neutropenic fever (6%), grade 4 thrombocytopenia (3%), requirements for blood (5%), and platelet transfusions (3%). Thirty-five (54%) of the 64 evaluable patients showed a clinical benefit. Of these, 11 patients (17%) had a partial response, and 24 (37%) had stable disease with a median time to progression of 7.5 months (range, 6-10 months) and 4 months (range, 2-6 months), respectively. Conclusion: More than half of heavily pretreated ovarian cancer patients may benefit from 3-day topotecan.