Cetuximab and First-Line Taxane/Carboplatin Chemotherapy in Advanced Non-Small-Cell Lung Cancer: Results of the Randomized Multicenter Phase III Trial BMS099.
Lynch TJ, Patel T, Dreisbach L, McCleod M, Heim WJ, Hermann RC, Paschold E, Iannotti NO, Dakhil S, Gorton S, Pautret V, Weber MR, Woytowitz D.Yale School of Medicine, New Haven; Bristol-Myers Squibb, Wallingford, CT; Mid Ohio Oncology/Hematology, Columbus, OH; Desert Hematology Oncology Medical Group, Rancho Mirage, CA; Florida Cancer Specialists, Fort Myers; Hematology-Oncology Associates of The Treasure Coast, Port Saint-Lucie, FL; Hematology & Oncology Associates of Northeastern Pennsylvania, Dunmore, PA; Northwest Georgia Oncology Centers, Marietta, GA; Piedmont Hematology Oncology Associates, Winston-Salem, NC; Cancer Center of Kansas, Wichita, KS; Western Washington Oncology, Lacey, WA; and Bristol-Myers Squibb, Braine l'Alleud, Belgium.
PURPOSE: To evaluate the efficacy of cetuximab plus taxane/carboplatin (TC) as first-line treatment of advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: This multicenter, open-label, phase III study enrolled 676 chemotherapy-naïve patients with stage IIIB (pleural effusion) or IV NSCLC, without restrictions by histology or epidermal growth factor receptor expression. Patients were randomly assigned to cetuximab/TC or TC. TC consisted of paclitaxel (225 mg/m(2)) or docetaxel (75 mg/m(2)), at the investigator's discretion, and carboplatin (area under the curve = 6) on day 1 every 3 weeks for