Randomized Trial of Paclitaxel Plus Supportive Care Versus Supportive Care for Patients With Advanced Non-Small-Cell Lung Cancer

Background: In phase II trials, paclitaxel has been shown to have antitumor activity in patients with advanced non-small-cell lung cancer (NSCLC). However, the survival and qual-ity-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 pa-tients with stage IIIB or IV NSCLC who had received no prior chemotherapy were randomly assigned to receive ei-ther best supportive care alone (78 patients) or paclitaxel plus supportive care (79 patients). Paclitaxel was adminis-tered as a 3-hour intravenous infusion every 3 weeks. Sup-portive care included palliative radiotherapy and supportive therapy with corticosteroids, antibiotics, analgesics, anti-emetics, transfusions, and other symptomatic therapy as re-quired. The primary end point of the study was survival. Time to disease progression, response rate, adverse events, and QOL were secondary end points. Results: Pretreatment characteristics were evenly distributed between the two arms. Survival was statistically significantly better in the paclitaxel plus supportive care arm than in the supportive care alone arm (two-sided P =.037) (median survival = 6.8 months versus 4.8 months). Cox multivariate analysis showed paclitaxel plus supportive care to be statistically sig-nificantly associated with improved survival (two-sided P =.048). QOL was similar for both treatment arms, except for the functional activity score of the Rotterdam Symptom Checklist, where QOL data statistically significantly favored the paclitaxel plus supportive care arm (two-sided P =.043). Conclusion: The addition of paclitaxel to best supportive care significantly improved survival and time to disease pro-gression compared with best supportive care in patients with advanced NSCLC and may improve some aspects of QOL. [