SALVAGE TREATMENT WITH PACLITAXEL AND GEMCITABINE FOR PATIENTS WITH NON-SMALL-CELL LUNG-CANCER AFTER CISPLATIN-BASED 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 ad vanced 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 chem otherapy was cisplatin-based with (n = 20) or without (n = 22) docetax el and docetaxel-vinorelbine (n = 7). Patients received gemcitabine (9 00 mg/m(2) i.v.; days 1 and 8) and paclitaxel (175 mg/m(2); day 8) eve ry three weeks; G-CSF (150 mu g/m(2)/day s.c.; days 9-15) was given pr ophylactically 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 d isease. Six responses were observed in 17 patients who responded to fi rst-line chemotherapy. The median duration of response was seven month s, 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 asthe nia in 25 (51%). Other toxicities were mild. Conclusions. The paclitax el-gemcitabine combination is a well-tolerated and relatively active s alvage regimen in patients with NSCLC and it merits further investigat ion.