Docetaxel in second-line treatment of non-small-cell lung cancer.

The survival and quality-of-life benefits of docetaxel in the second-line treatment of non-small-cell lung cancer (NSCLC) are supported by two phase III trials: TAX 317 and TAX 320. In TAX 317, 204 patients were randomized to receive either docetaxel 100 mg/m2 (D100) or 75 mg/m2 (D75) intravenously every 3 weeks, or best supportive care (BSC). Median survival was 9.0 months with D75 versus 4.6 months for BSC (P = 0.016); 1-year survival was 40% for D75 versus 16% for BSC (P = 0.016). Quality-of-life analysis showed significant improvement in several disease-related symptoms in patients who received docetaxel. TAX 320 was a supportive trial, in which 373 patients were randomized to receive D100, D75, or the control treatment of vinorelbine or ifosfamide (V/I). The partial response rate was 12% with D100 and 8% with D75 versus 1% with V/I (D100, P = 0.001 and D75, P = 0.036). Median response duration was 7+ months. One-year survival was 32% with D75 and 19% with V/I (P = 0.025). In TAX 320, prior paclitaxel exposure had no bearing on the response rate and survival advantage of second-line treatment with docetaxel. Response rates to docetaxel were equivalent in the cohort of patients who had received prior paclitaxel (10.5%) and the group of patients who had not received prior paclitaxel (8.5%). Furthermore, 1-year survival rates for patients with no prior paclitaxel therapy were 33% (D75) and 20% (V/I); 1-year survival rates for patients who had received prior paclitaxel were 30% (D75) and 17% (V/I). Docetaxel at a dose of 75 mg/m2 every 3 weeks offers a clinically meaningful improvement in response rate, time to progression, survival, and quality of life in the second-line treatment of advanced NSCLC. Furthermore, prior paclitaxel did not decrease the likelihood of response to docetaxel, nor did it lessen the survival advantage seen with docetaxel.

RCT Entities:   Population Interventions Outcomes