Cetuximab combined with either gemcitabine (G) followed by docetaxel (D) or carboplatin/gemcitabine (CP/G) in chemotherapy-naive patients (pts) with advanced non-small cell lung cancer (NSCLC): Safety profile from the ongoing phase II/III GemTax IV trial

8048 Background: The EGFR-targeting antibody cetuximab is undergoing broad clinical investigation in NSCLC. Our randomized trial assesses the safety of cetuximab combined with 2 different chemotherapy (CT) regimens in pts with advanced NSCLC. Phase II results are reported. Methods: Pts with histologically confirmed stage IIIB or IV NSCLC, WHO PS 0–2, and no prior CT received cetuximab 400 mg/m2 loading dose followed by 250 mg/m2 weekly either combined with G 1000 mg/m2 days 1 + 8 for 2 cycles (3qw) followed by D 75 mg/m2 day 1 for 2 cycles (q3w) (arm A) or CP AUC5 day 1 and G 1200 mg/m2 days 1 + 8 for 4 cycles (q3w) (arm B). Maintenance cetuximab was administered until disease progression or unacceptable toxicity. Results: 229 pts evaluable for safety received 1810 infusions of cetuximab combined with CT and 1216 infusions of maintenance cetuximab. 35 pts in arm A received 1–26 cycles (median 4) of maintenance cetuximab and 6 pts received ≥10 cycles; 50 pts in arm B received 1–22 cycles (median 3) and 7 p...