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)

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2010-12, Vol.70 (3), p.301-307
• Main Authors: Morère, Jean-François, Bréchot, Jeanne-Marie, Westeel, Virginie, Gounant, Valerie, Lebeau, Bernard, Vaylet, Fabien, Barlési, Fabrice, Urban, Thierry, Souquet, Pierre-Jean, Debieuvre, Didier, Baudrin, Laurence, Zalcman, Gérard, Morin, Franck, Milleron, Bernard, Moro-Sibilot, Denis
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Biological and medical sciences; Cancer; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Non-Small-Cell Lung - physiopathology; Chemotherapy; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Disease-Free Survival; Female; Gefitinib; Hematology, Oncology and Palliative Medicine; Humans; Karnofsky Performance Status; Life Sciences; Lung cancer; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Lung Neoplasms - physiopathology; Male; Medical sciences; Middle Aged; Neoplasm Staging; Performance status 3; Pneumology; Pulmonary/Respiratory; Quinazolines - administration & dosage; Quinazolines - adverse effects; Survival Analysis; Taxoids - administration & dosage; Taxoids - adverse effects; Tumors; Tumors of the respiratory system and mediastinum
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2010.03.003

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 250 mg daily ( n = 43) or to gemcitabine (1250 mg/m2 d 1, 8 q 21d) ( n = 42) or docetaxel (75 mg/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.