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 Morère, 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

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39 Citations (Scopus)

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/m2 d 1, 8 q 21d) (n=42) or docetaxel (75mg/m2 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.

Original languageEnglish
Pages (from-to)301-307
Number of pages7
JournalLung Cancer
Volume70
Issue number3
DOIs
Publication statusPublished - 1 Dec 2010
Externally publishedYes

Keywords

  • Chemotherapy
  • Gefitinib
  • Lung cancer
  • Performance status 3

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