Randomized phase II study comparing topotecan/cisplatin administration for 5 days versus 3 days in the treatment of extensive stage small cell lung cancer (SCLC)

Background: Topotecan (T) is an active drug in SCLC. A combination of topotecan with cisplatin (DDP) was suggested to be highly synergistic. This phase II trial was initiated to assess the activity of T/DDP in chemotherapy-naive patients suffering from extensive disease small cell Lung cancer (SCLC) and to compare the conventional 5-day regime with an experimental 3-day schedule. Patients and methods: A total of 86 patients were included. Patients were randomized to receive either T 1.0 mg/m(2) d 1-5 and DDP 75 mg/m(2) d 5 (arm A) or T 1.5 mg/m(2) d 1-3 and DDP 75 mg/m(2) d 3 (arm B). Six cycles were given at a 3-week interval. Results: Data of 84 evatuable patients (67 mates and 17 females) were analysed. All patients had metastatic disease. The best response rate was 61.9% in arm A and 59.5% in arm B. Median overall survival was 8.7 months in arm A and 7.6 months in arm B (p = 0.6809). Conclusions: Combination of T and DDP is active in ED SCLC, Toxicity and median survival were comparable in both arms. Three days treatment seems to be similar to the 5 days regime (c) 2005 Elsevier Ireland Ltd. All rights reserved.