Phase II study on weekly bolus topotecan in advanced or recurrent cervical cancer.

ABSTRACT

OBJECTIVE: It was the aim of our study to evaluate the efficacy and safety of weekly topotecan in patients with advanced or recurrent cervical disease. METHODS: Topotecan was administered intravenously as a weekly infusion at a dose of 3.5 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. After the second cycle, the dose was increased to 4 mg/m(2) if no grade >2 toxicity occurred. Treatment was continued until disease progression or unacceptable toxicity. RESULTS: Twenty-one patients were enrolled, but only 18 were evaluable for response and toxicity. Ten patients (56%) had received primary surgery + chemoradiation, 6 patients (33%) had previously received surgery + chemotherapy and 2 patients (11%) exclusive chemoradiation. Patients received a mean of 3.5 courses (range 1-6). No complete or partial responses were reported. Two patients (11%) presented disease stabilization as maximum response. Median progression-free survival was 11 weeks (95% CI 15-25), and median overall survival was 28 weeks (95% CI 24-72). The treatment was generally well tolerated. CONCLUSIONS: This trial did not report any activity of weekly bolus topotecan in the treatment of advanced or recurrent cervical cancer. Actually, there is no evidence to recommend this therapy in this patient population.