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/m2/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.