An open label evaluation of topotecan in patients with relapsed or refractory epithelial ovarian cancer - single institution experience in a developing country.

Abstract

Investigators in developing countries rarely get an opportunity to participate in clinical drug trials in oncology. We recently participated in two clinical trials involving the use of topotecan in patients with advanced epithelial ovarian cancer who had failed initial platinum based chemotherapy. It provided us an opportunity to gain experience with the use of a rather highly myelosuppressive drug and also enabled us to compare our data with those reported from the western countries. Thirty-nine patients with good performance status and adequate bone marrow, liver, and renal functions were accrued. All patients had previously received at least one platin containing regimen of chemotherapy. The most common histologic sub type was serous adenocarcinoma. Almost half of the patients had platinum refractory disease. Mean number of cycles delivered was 7.5. Eleven patients (28%) achieved complete or partial remission. Time to progression was 4.6 months. Mean overall survival was 11.3 months. Toxicity was primarily hematologic and manageable. Performance status was the only variable predictive of response. Ability to obtain informed consent, data management, and availability of adequate radiologic and laboratory facilities were important limitations. Our results confirm the applicability of results obtained in the western countries to other patient groups and ability to conduct clinical trials in oncology in the developing countries.