Addition of topotecan to standard cisplatin/etoposide combination in patients with extended stage small cell lung carcinoma

Background: Topotecan is an active agent for the management of untreated and recurrent extensive-disease small cell tung cancer, (ED-SCLC). This study was designed to evaluate the efficacy and safety of a triplet combination with topotecan added to the standard PE regimen in previously untreated patients with ED-SCLC. Materials and methods: Twenty-one patients (median age 55 years, and 18 mate) with chemotherapy-naive ED-SCLC were enrolled into the study. PET treatment consisted of etoposide 80 mg/m(2), cisplatin 20 mg/m(2) and topotecan 0.75 mg/m(2) and all were given intravenously on days 1 to 3 for every 3 weeks. Results: Leucopoenia and/or neutropenia and to a lesser extent thrombocytopenia Were the main dose-limiting toxicities. Severe leucopenia/neutropenia were observed in 14 (67%)/12 (57%) patients, and only two (10%) developed febrile neutropenia. Severe thrombocytopenia was observed in 6 (29%) patients and one patient died due to orbital and cerebra[ haemorrhage. Dose reductions were required in 13 (62%) patients, delays in 8 (38%) patients and early treatment discontinuation in 3 (14%) patients. The overall response rate was 52.6% (95% Cl: 28, 9-75.6) with 2 (10.5%) complete and 8 (42.1%) partial responses. The overall median survival time was 6.6 months (range 0.5-16.5 months) and the 6-month overall survival was 65.3% +/- 11.7. The overall median survival time of responders was 9.7 months compared to 5.7 months in non-responders (p = 0.026). Conclusion: Topotecan combined with PE regimen with this schedule and dosage does not seem to provide any benefit in terms of response and survival in ED-SCLC patients and does not deserve further studies. (c) 2007 Elsevier Ireland Ltd. All rights reserved.