A phase II study of a 3-day schedule with topotecan and cisplatin every three weeks in patients with previously in treated small cell lung cancer and extensive disease: Final results

Abstract

7207 Background: The role of campthotecins in small cell lung cancer (SCLC) is emerging, and 5-day regimens with topetecan alone or with cisplatin have been shown to be active and tolerable. In order to provide a more feasible regimen for patients with extensive disease we developed a three-day regimen of topetecan and cisplatin. Preliminary data has previously been presented and we now present the final, updated results with a median follow-up time of 18 months. This investigators initiated study was supported by a grant from GlaxoSmithKline. Methods: This phase II study was planned to include 43 patients with histologically confirmed SCLC, extensive stage of disease, age 18–75 and WHO performance status 0–2. Patients received topetecan 2.0 mg/m2 on day 1–3 and cisplatin 50 mg/m2 on day 3, repeated every 3 weeks, for a maximum of 6 cycles. Patients with progressive disease (PD) or no-change (NC) after 3 cycles go off-study. Results: From May 2001 to September 2003, a total of 43 patients were included. An objective response has been observed in 74% (CR 16% and PR 58%). The regimen seems tolerable with no significant non-haematological toxicity. Until now there were no toxic deaths. Grade III and IV neutropenia was seen in 16% and 9%, respectively, and grade III and IV thrombocytopenia was observed in 3% and 3%, respectively. Non-hematological toxicity was mild. The median time to progression was 7.3 months (5.9–8.7), and the median survival time was 10.3 months (8.4–11.9). Conclusions: These updated results from this phase II study indicate this regimen is very active with limited toxicity. The data suggest that the efficacy and toxicity is similar to the 5-day schedule of topotecan and cisplatin. The schedule is attractive to patients with extensive stage SCLC and will now be evaluated in a phase III study. No significant financial relationships to disclose.