Phase II study of weekly topotecan in patients with recurrent or persistent epithelial ovarian cancer

To assess the toxicity and effectiveness of once-weekly administration of topotecan (Hycamtin; GlaxoSmithKline) for relapsed ovarian and primary peritoneal cancer.

Twenty-three patients with recurrent or persistent epithelial ovarian cancer (EOC) and primary peritoneal carcinoma (PPC) previously exposed to at least one line of platinum-based chemotherapy were treated with IV weekly topotecan as a 30-min bolus at a starting dose of 4 mg/m(2) administered weekly for 3 weeks in a 28-day cycle.

The patients' median age was 62 years (42-83). Thirteen women (56.5%) were defined as having platinum-sensitive and 10 (43.5%) as having platinum-resistant disease. Altogether, 88 cycles were administered for a total of 264 weekly treatments, with a median of four courses (range 2-6). There were no treatment delays. The main bone marrow toxicity was grade II and III thrombocytopenia, necessitating dose reduction in four patients (17.4%) and treatment cessation in one patient. The most frequent nonhematologic toxicity was fatigue (nine patients, 39.1%). There were four complete responses (17.4%, three in the platinum-sensitive and one in the platinum-resistant patients) and seven (30.4%) partial responses, for an overall response rate of 47.8%. The ORR was similar in platinum-sensitive and platinum-resistant patients (47.8% and 52.2%, respectively). The median progression-free survival was 4.9 months with a mean survival time of 11.59 months. Two women sustained complete response lasting >6 months.

Topotecan given as a weekly bolus is a highly active and well-tolerated treatment regimen for relapsed ovarian and primary peritoneal cancer and thus deserves further evaluation.