Topotecan given as a 21-day infusion in the treatment of advanced ovarian cancer

A phase II programme was carried out in both Europe and North America to ev aluate the activity of topotecan administered as a 21-day continuous intrav enous infusion to patients with recurrent ovarian cancer. The European resu lts are reported here. Patients who had failed first line therapy with a pl atinum-based regimen received topotecan 0.4 mg/m(2)/day, as a 21-day infusi on every 28 days. Patients were only permitted one prior regimen. 35 patien ts were enrolled and evaluable for response. 3 patients (8.6%) had a partia l response to treatment (95% CI 1.8%, 23.1%) with a median time to response of 8.1 weeks and a median duration of response of 17.6 weeks, Response was also evaluated by CA125 and was also found to be 8%. For all 35 patients, median time to progression was 16.1 weeks and median survival was 43.6 week s. The principal toxicity was myelosuppression although grade 4 neutropenia occurred in only 8.8% of patients (2.1% of courses) and infectious complic ations were relatively infrequent. Non-haematological toxicity was generall y mild and mainly consisted of gastrointestinal events, alopecia and fatigu e. A prolonged infusion of topotecan was well tolerated with a low incidenc e of severe neutropenia. Responses were seen in both North American and Eur opean patients. Response rates varied between the 2 studies possibly due to differences in patient demographics. (C) 2001 Cancer Research Campaign.