The role of gemcitabine and paclitaxel as second-line chemotherapy for the treatment of advanced non small-cell lung cancer (NSCLC).

Second-line chemotherapy with the newer active anticancer drugs like docetaxel may confer some benefit in patients with non small-cell lung cancer (NSCLC) who failed front-line treatment with cisplatin-contain-ing chemotherapy regimens. However, young patients with good performance status need further efforts for palliation and, probably, survival prolongation. Phase II trials have shown that gemcitabine, a new nucleoside analogue, is effective as second-line treatment with a 7%-25% objective response and a 22- to 33-week median survival in patients with NSCLC. Paclitaxel also seems to be active as second-line treatment with a 3%-38% objective response and 17- to 40-week median survival. The antitumor activity of second-line paclitaxel seems to be dose related. The combination of gemcitabine (900 mg/m2 on days 1 and 8) and paclitaxel (175 mg/m2 on day 8) every 3 weeks was administered in 49 patients pretreated with cisplatin- and/or docetaxel-based chemotherapy. Objective responses were observed in 18% (95% confidence interval: 4%-24%) of the patients (one complete response and eight partial responses); three of the responses were observed in patients who failed to respond to front-line chemotherapy. The median survival was 44 weeks. The toxicity profile of the regimen was mild with grade 3/4 neutropenia and thrombocytopenia occurring in 12% and 2% of the patients, respectively. There was only one episode of neutropenic fever. Grade 2 and 3 neurotoxicity occurred in 24% and 8% of the patients, respectively, and 51% of the patients reported grade 2 and 3 asthenia. In conclusion, the combination of gemcitabine/paclitaxel is an effective and well-tolerated second-line chemotherapy regimen which can be given on an outpatient basis.