Salvage treatment with paclitaxel and gemcitabine for patients with non-small-cell lung cancer after cisplatin- or docetaxel-based chemotherapy: A multicenter phase II study

Background. To evaluate the tolerance and efficacy of the combination of paclitaxel and gemcitabine as salvage treatment in patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods. Forty-nine patients with measurable NSCLC (PS 0-1: 80%; stage IV: 84%) who progressed or failed first-line chemotherapy were enrolled. Prior chemotherapy was cisplatin-based with (n = 20) or without (n = 22) docetaxel and docetaxel-vinorelbine (n = 7). Patients received gemcitabine (900 mg/m(2) i.v.; days 1 and 8) and paclitaxel (175 mg/m(2); day 8) every three weeks; G-CSF (150 mu g/m(2)/day s.c.; days 9-15) was given prophylactically to all patients. Results: One (2%) complete and eight (16%) partial responses were achieved (overall response 18%; 95% CI: 4%-24%); 14 patients (29%) had stable disease and 26 (53%) progressive disease. Six responses were observed in 17 patients who responded to first-line chemotherapy. The median duration of response was seven months, the median TTP eight months and the median survival 11 months. The one-year survival rate was 37%. Grade 3-4 neutropenia occured in six (12%) patients, grade 2-3 neurotoxicity in 16 (32%) and grade 2-3 asthenia in 25 (51%). Other toxicities were mild. Conclusions. The paclitaxel-gemcitabine combination is a well-tolerated and relatively active salvage regimen in patients with NSCLC and it merits further investigation.