Combination of vinorelbine plus gemcitabine in previously treated patients with small cell lung cancer: A multicentre phase II study

Purpose: To evaluate the efficacy and toxicity of the gemcitabine plus vinorelbine combination in pretreated patients with small cell lung cancer (SCLC). Patients and methods: Thirty-five pretreated patients (median age 59 years, PS: 0-1 in 97% and 2 in 3%) were treated with gemcitabine (1100 mg/m(2)) and vinorelbine (25 mg/m(2)) on d1 and d8 every 3 weeks. Seven (20%) patients were treated with two prior regimens and 20 (57%) were refractory to front-line chemotherapy. Results: In an intention-to-treat analysis two (6%) partial responses (PR) were observed with a duration of 5.6 and 11.1 months. Stable disease (SD) was documented in 8 (23%) patients and progressive disease (PD) in 25 (71%). The overall median survival was 4.5 and the 6 months survival rate was 42.6%. Grades 3-4 neutropenia and thrombocytopenia were observed in 25 and 14% of the patients, respectively. Non-hematological toxicity consisted of grade 2 neurotoxicity occurring in 14% of the patients and grades 2-3 fatigue in 17%. Febrile neutropenia was observed in three (8.6%) patients and one of them died from sepsis. Conclusion: The combination of gemcitabine plus vinorelbine cannot be considered as an effective salvage treatment in pretreated patients with SCLC. (C) 2005 Elsevier Ireland Ltd. All rights reserved.