Prospective Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
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Published:2000-05-10
Issue:10
Volume:18
Page:2095-2103
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ISSN:0732-183X
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Container-title:Journal of Clinical Oncology
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language:en
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Short-container-title:JCO
Author:
Shepherd Frances A.1, Dancey Janet1, Ramlau Rodryg1, Mattson Karin1, Gralla Richard1, O’Rourke Mark1, Levitan Nathan1, Gressot Laurent1, Vincent Mark1, Burkes Ronald1, Coughlin Susan1, Kim Yong1, Berille Jocelyne1
Affiliation:
1. From the University of TorontoToronto, and London Regional Cancer Centre, London, Ontario, Canada; Regional Hospital of Lung Disease and Tuberculosis, Poznan, Poland; Helsinki University, Helsinki, Finland; Alton Ochsner Medical Foundation, New Orleans, LA; Greenville Memorial Medical Center, Greenville, SC; University Hospitals of Cleveland, Cleveland, OH; Veterans Affairs Medical Center, Houston, TX; and Rhône-Poulenc Rorer, Collegeville, PA, and Paris, France.
Abstract
PURPOSE: To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non–small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life. PATIENTS AND METHODS: Patients with performance statuses of 0 to 2 and stage IIIB/IV non–small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m2 (49 patients) or 75 mg/m2 (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks. RESULTS: One hundred four patients (103 of whom were eligible for entry onto 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). The difference was more significant for docetaxel 75 mg/m2 patients, compared with corresponding best supportive care patients (7.5 v 4.6 months; log-rank test, P = .010; 1-year survival, 37% v 11%; χ2 test, P = .003). Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m2, 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, occurred at a similar rate in both the docetaxel and best supportive care groups. CONCLUSION: Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m2, the benefits of docetaxel therapy outweigh the risks.
Publisher
American Society of Clinical Oncology (ASCO)
Subject
Cancer Research,Oncology
Reference22 articles.
1. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials 2. Shepherd FA: Chemotherapy for non-small cell lung cancer: Have we reached a new plateau? Semin Oncol 26:3,1999-11, 3. Fossella FV, Lee JS, Hong WK: Management strategies for recurrent non-small cell lung cancer. Semin Oncol 24:455,1997-462, 4. Burris HA, Eckardt J, Fields S, et al: Phase II trials of Taxotere in patients with non–small-cell lung cancer. Proc Am Soc Clin Oncol 12:335a,1993 (abstr 1116) 5. Phase II study of docetaxel for advanced or metastatic platinum-refractory non-small-cell lung cancer.
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