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.
Copyright 2001 Academic Press.