Randomized trial of paclitaxel plus supportive care versus supportive carefor patients with advanced non-small-cell lung cancer

Background: In phase II trials, paclitaxel has been shown to have antitumor activity in patients,vith advanced non-small-cell lung cancer (NSCLC), How ever, the survival and quality-of-life (QOL) benefits of paclitaxel used as a single agent compared with supportive care alone have not been assessed in a randomized clinical trial. Methods: A total of 157 patients with stage IIIB or IV NSCLC who had received no prior chemotherapy were randomly assi gned to receive either best supportive care alone (78 patients) or paclitax el plus supportive care (79 patients). Paclitaxel was administered as a 3-h our intravenous infusion every 3 weeks, Supportive care included palliative radiotherapy and supportive therapy with corticosteroids, antibiotics, ana lgesics, antiemetics, transfusions, and other symptomatic therapy as requir ed, The primary end point of the study was survival, Time to disease progre ssion, response rate, adverse events, and QOL were secondary end points. Re sults: Pretreatment characteristics were evenly distributed between the two arms. Survival was statistically significantly better in the paclitaxel pl us supportive care arm than in the supportive care alone arm (two-sided P = .037) (median survival = 6.8 months versus 4.8 months). Cos multivariate a nalysis showed paclitaxel plus supportive care to be statistically signific antly associated with improved survival (two-sided P = .048). QOL was simil ar for both treatment arms, except for the functional activity score of the Rotterdam Symptom Checklist, where QOL data statistically significantly fa vored the paclitaxel plus supportive care arm (two-sided P = .043), Conclus ion: The addition of paclitaxel to best supportive care significantly impro ved survival and time to disease progression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL.