Response and toxicity to topotecan in sensitive ovarian cancer cases with small residual disease after first-line treatment with carboplatinum and paclitaxel

Objective. The objective of this open uncontrolled study was to evaluate the toxicity and efficacy of topotecan in ovarian cancer cases with microscopic small residual disease to a first-line treatment, given as sequential treatment, including carboplatinum and paclitaxel. Methods. Inclusion criteria were laparotomically or laparoscopically documented microscopic or macroscopic (<2 cm) residual disease after first-line chemotherapy including carboplatinum plus paclitaxel in patients with histologically documented epithelial ovarian cancer FIGO stage III or IV at first diagnosis. All patients had a response >50% after first-line treatment. Eligible patients received 1.25 mg/m(2)/day of topotecan intravenously as a 30-min infusion for 5 consecutive days every 21 days for four cycles. A total of 38 women entered the study. Surgical "third-look" laparotomy or laparoscopy was performed in patients without clinical/instrumental evidence of progressive disease within 1 month from the last topotecan administration, Results. A complete response was observed in 10 cases (28.6%, 95% confidence interval, based on the Poisson's approximation, 15.6-59.5), a partial response in 1 (2.5%), progressive disease in 11 (31.4%) and no change/stable disease in 13, The median duration of response was 8 months (range 5-20). The overall 1-year survival after treatment was 82.8% (SE 6.4), Conclusion. This study indicates that sequential therapy with carboplatin plus paclitaxel followed by topotecan, all given at standard doses, is feasible and provides favorable response rates. (C) 2001 Academic Press.