The objective of this study was to determine the effects of docetaxel(Drug information on docetaxel) (Taxotere) on survival, clinical benefits, quality of life, and safety parameters for chemonaive patients with advanced nonsmall-cell lung cancer (NSCLC), when compared to best supportive care (BSC) (no chemotherapy or systemic anticancer therapy permitted).
From October 1995 to December 1997, 207 patients were randomized to two arms (docetaxel vs BSC, 2:1 allocation) with stratification by Eastern Cooperative Oncology Group (ECOG) performance status (01 vs 2) and stage (advanced vs metastatic). Eight countries (18 centers) participated, with 137 patients receiving docetaxel 100 mg/m2 day 1, 1-hour intravenous infusion, every 3 weeks, and 70 receiving BSC. Baseline characteristics were well balanced between the two arms.
Docetaxel superiority is clearly shown for survival, particularly in later follow-up times (6 months: 49% vs 46%; 12 months: 25% vs 16%; 20 months: 12% vs 0% [stratified log rank P = .04]); for time to progression (median 12.6 vs 8.9 weeks [P < .001]); and for clinical benefit (improvement in pain and dyspnea symptoms and less use of morphinics [P < .001], of nonmorphine analgesics [P < .001], of other tumor-related medication [P < .01], and of radiotherapy [P = .01]). Response rate in the docetaxel arm was 20% (95% CI: 12%29%).
CONCLUSION: Single-agent docetaxel (100 mg/m² day 1, every 3 weeks) does improve survival and clinical benefit for patients with unresectable NSCLC.