Weekly topotecan-gemcitabine for pretreated small cell lung cancer (SCLC) patients (pts): A phase II study.

Abstract

e18070 Background: Topotecan IV at dose of 1.5 mg/m2 days 1 –5 every 3 weeks is the standard treatment for pretreated SCLC pts. Weekly topotecan at dose of 4 mg/m2 has shown an excellent toxicity profile. Based in previous studies of our group using gemcitabine doublets in pretreated SCLC pts, we conducted a prospective phase II study to determine the activity of this combination in this population. Methods: Pts were eligible if they had measurable or evaluable disease, previous treatment with platins, adequate hepatic, renal and bone marrow function. Topotecan dose was 4 mg/m2 IV days 1 and 8, and gemcitabine 1,250 mg/m2 (30-minute IV infusion) days 1 and 8 every 3 weeks. Results: 58 pts were enrolled, 54 male and 4 female. Median age was 61 years (range 39- 83); 92% had PS 0 or 1; 38 pts had sensitive disease and 20 pts had refractory disease. The median of cycles per patient was 3 (range 1-3). All the pts were evaluable for efficacy and toxicity. In an intent to treat analysis the response rate was 12% (95% CI: 5%-23%), 1 patient with sensitive disease achieved a complete response (1.7%). 21% of pts showed stable disease and 67% progression. Median time to progression was3 months (95% CI: 2-4 m) and median survival 5 months (95% C.I: 3-7 m). Toxicity was very mild with grade 3-4 hematological toxicity in 17% of patients, without non-hematological grade 3-4 toxicity. 2 patients developed skin toxicity grade 1-2. Conclusions: Weekly topotecan- gemcitabine does not seem to improve the efficacy of the standard schedule of IV topotecan in monotherapy. The tolerability is acceptable. In our opinion further development of this combination is not warranted. No significant financial relationships to disclose.