Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy

Purpose: To evaluate whether treatment with single-agent docetaxel would re sult in longer survival than would best supportive care in patients with no nsmall-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (doceta xel arm only), toxicity, and quality of life. Patients and Methods: Patients with performance statuses of 0 to 2 and stag e IIIB/IV non-small-cell lung cancer with either measurable or evaluable le sions were eligible for entry onto the study if they had undergone one or m ore platinum-based chemotherapy regimens and if they had adequate hematolog y and biochemistry parameters. They were excluded if they had symptomatic b rain metastases or if they had previously been heated with paclitaxel. Pati ents were stratified by performance status and best response to cisplatin c hemotherapy and were then randomized to treatment with docetaxel 100 mg/m(2 ) (49 patients) or 75 mg/m(2) (55 patients) or best supportive care. Patien ts in both arms were assessed every 3 weeks. Results: One hundred four patients (103 of whom were eligible for entry ont o the study) were well balanced for prognostic factors, Of 84 patients with measurable lesions, six (7.1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P < .001), as was median survival (7.0 v 4.6 months; log-rank test, P =.047). T he difference was more significant for docetaxel 75 mg/m(2) patients, compa red with corresponding best supportive care patients (7.5 v 4.6 months; log -rank test, P =.010; 1-year survival, 37% v 11%; chi(2) test, P =.003). Feb rile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m(2) , three of whom died, and in one patient treated with docetaxel 75 mg/m(2). Grade 3 or 4 nonhematologic toxicity, with the exception of diarrhea, occu rred at a similar rate in both the docetaxel and best supportive care group s. Conclusion: Treatment with docetaxel is associated with significant prolong ation of survival, and at a dose of 75 mg/m(2), the benefits of docetaxel t herapy outweigh the risks. J Clin Oncol 18:2095-2103. (C) 2000 by American Society of Clinical Oncology.