Alternating weekly administration of paclitaxel and gemcitabine: a phase II study in patients with advanced non-small-cell lung cancer

Background: We sought to evaluate toxicity and efficacy of an alternating week schedule of paclitaxel and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Patients (n = 27, mean age 56 years, range 27 - 73 years) received paclitaxel (100 mg/m(2) i.v. infusion over 1 h) on days 1 and 15 alternating with gemcitabine ( 1000 mg/m(2)) on days 8 and 22 of a 36-day cycle. Responses were evaluated after three cycles, and after the proposed six cycles. Results: In total, 116 cycles were administered ( mean 4.25 cycles per patient). Haematological toxicity was slight: febrile neutropenia (n = 1) and neutropenia grade III - IV (n = 5). Non-haematological toxicities included arthromyalgia grade II (n = 6) and neurotoxicity grade III (n = 1). Objective response was 29%, stable disease 25% and disease progression 46%. Median duration of response was 8 months (95% CI 5 - 11 months), median progression-free survival was 7 months ( 95% CI 4-11 months), median overall survival was 13 months ( 95% CI 7 - 17 months) and survival at 1 year was 52%. Conclusions: A regimen of alternating weekly paclitaxel and gemcitabine is feasible in patients with advanced NSCLC, showing a lower toxicity pro. le compared with other platinum-based combinations, which makes this novel scheme attractive for these patients.