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 th e toxicity and efficacy of topotecan in ovarian cancer cases with microscop ic small residual disease to a first-line treatment, given as sequential tr eatment, including carboplatinum and paclitaxel. Methods. Inclusion criteria were laparotomically or laparoscopically docume nted microscopic or macroscopic (<2 cm) residual disease after first-line c hemotherapy including carboplatinum plus paclitaxel in patients with histol ogically documented epithelial ovarian cancer FIGO stage III or IV at first diagnosis. All patients had a response >50% after first-line treatment. El igible patients received 1.25 mg/m(2)/day of topotecan intravenously as a 3 0-min infusion for 5 consecutive days every 21 days for four cycles. A tota l of 38 women entered the study. Surgical "third-look" laparotomy or laparo scopy was performed in patients without clinical/instrumental evidence of p rogressive disease within 1 month from the last topotecan administration, Results. A complete response was observed in 10 cases (28.6%, 95% confidenc e interval, based on the Poisson's approximation, 15.6-59.5), a partial res ponse in 1 (2.5%), progressive disease in 11 (31.4%) and no change/stable d isease in 13, The median duration of response was 8 months (range 5-20). Th e overall 1-year survival after treatment was 82.8% (SE 6.4), Conclusion. This study indicates that sequential therapy with carboplatin p lus paclitaxel followed by topotecan, all given at standard doses, is feasi ble and provides favorable response rates. (C) 2001 Academic Press.