Literature DB >> 20400201

Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study).

Jean-François Morère1, Jeanne-Marie Bréchot, Virginie Westeel, Valerie Gounant, Bernard Lebeau, Fabien Vaylet, Fabrice Barlési, Thierry Urban, Pierre-Jean Souquet, Didier Debieuvre, Laurence Baudrin, Gérard Zalcman, Franck Morin, Bernard Milleron, Denis Moro-Sibilot.   

Abstract

BACKGROUND: To compare 3 treatment strategies in chemotherapy naive patients with advanced NSCLC and a PS 2-3. PATIENTS AND METHODS: Patients were assigned to gefitinib 250mg daily (n=43) or to gemcitabine (1250mg/m(2) d 1, 8 q 21d) (n=42) or docetaxel (75mg/m(2) d 1 q 21d) (n=42). Treatments were taken until progression or toxicity. The primary endpoint was progression-free survival. Secondary end points were response and overall survival.
RESULTS: Disease control rates were 20.9%, 33.4% and 38.1%, respectively. Median PFS was 1.9 months in the gefitinib arm, 2.0 months in the gemcitabine arm and 2.0 months in the docetaxel arm (HR gemcitabine versus gefitinib: 0.74, 95%CI: [0.48; 1.16], HR docetaxel versus gefitinib: 0.67, 95%CI: [0.43; 1.05]). Median survival times were 2.2, 2.4 and 3.5 months, respectively (HR gemcitabine versus gefitinib: 0.76, 95%CI: [0.48; 1.20], HR docetaxel versus gefitinib: 0.69, 95%CI: [0.44; 1.09]). There were more grade 3-4 adverse events in the docetaxel arm when compared with either the gefitinib arm or the gemcitabine arm.
CONCLUSION: In unselected NSCLC patients with PS 2-3, gefitinib, gemcitabine and docetaxel achieved similar results. Docetaxel was associated with higher rates of adverse events.
Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

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Year:  2010        PMID: 20400201     DOI: 10.1016/j.lungcan.2010.03.003

Source DB:  PubMed          Journal:  Lung Cancer        ISSN: 0169-5002            Impact factor:   5.705


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