Adjuvant carboplatin, docetaxel, bevacizumab, and erlotinib versus chemotherapy alone in patients with resected non-small cell lung cancer: A randomized phase II study of the Sarah Cannon Research Institute (SCRI).

7035 Background: Adjuvant chemotherapy improves overall survival (OS) in patients (pts) with resected non small cell lung cancer (NSCLC). Bevacizumab and erlotinib improve survival in pts with advanced unresectable NSCLC. This randomized phase II multicenter pilot study examined the safety and efficacy of chemotherapy and bevacizumab followed by bevacizumab and erlotinib vs. chemotherapy alone in pts with resected NSCLC. Methods: Eligible pts had completely resected (R0) stage IB, II, or IIIA NSCLC (TNM 6th Ed.), any NSCLC histology, and an ECOG PS 0-1. Pts were excluded for preoperatively confirmed N2 disease; N2 disease found at surgery was allowed. Pts were randomized 1:1 to carboplatin AUC=5, docetaxel 60 mg/m2, and bevacizumab 15 mg/kg IV d1 q 21 days x 4, followed by maintenance bevacizumab 15 mg/kg d1 and erlotinib 150 mg PO daily x 8 cycles (Arm A) or carboplatin AUC=6 and docetaxel 75 mg/m2 IV d1 q 21 days x 4 (Arm B). The primary endpoint was 1-year disease-free survival (DFS); safety, 2-year DF...