Phase II randomized, open-label study of cetuximab (Cet) and bevacizumab (Bev) in combination with paclitaxel (P) and carboplatin (C) in patients with stageIII/IV non-small cell lung cancer (NSCLC)
Authors: Bonomi P. D. , Mace J. , Mandanas R. D. , Min M. , Zhang Y. , Rowinsky E. , Youssoufian H. 
Published: August 2020

8046^

Background: Cet, a monoclonal antibody (mAb) that specifically targets epidermal growth factor receptor (EGFR) and Bev (anti-VEGF mAb) combined with chemotherapy has resulted in superior survival compared to chemotherapy alone in some stage IV NSCLC trials. Combining both mAb's with chemotherapy might increase survival in stage IV NSCLC pts. Methods: Chemotherapy naïve advanced NSCLC patients with ECOG status <1, adequate hematologic, hepatic, and renal function received Cet (400 mg/m2 on Day 1 as initial dose and weekly thereafter at 250 mg/m2) plus Bev (15 mg/kg on Day 8 of each 3-week cycle) for 6 cycles in combination with either 6 cycles (Arm A) or 3 cycles (Arm B) of P (200 m/kg) and C (AUC=6) on Day 1 of each 3-week cycle. Patients without progressive disease (PD) after 6 cycles continued Cet until PD or other withdrawal criteria were met. Comparison of progression-free survival (PFS) for arm A vs B is the primary objective. Results: Accrual is completed. Data are available for 85 pts: 47% women, median age 65 yrs, and 88% Caucasian. Median PFS for arm A was 6.0 vs 4.2 months for arm B, hazard ratio of 0.57 for arm A relative to arm B. Objective response was Arm A=31% and B=30%. Most frequent AEs ≥Grade 3 in pts were neutropenia [9 (10.6%), A=8, B=1], fatigue [8 (9.4%), A=4, B=4], dermatitis acneiform [6 (7.1%), A=3, B=3].13 pts withdrew due to AEs (A=4, B=9), 4 were related to Cet (2 per arm). Two pts discontinued due to death (A=2, B=0) unrelated to Cet. Conclusions: Adding both mAb's to PC resulted in acceptable toxicity. The trend for superior PFS with 6 courses of PC suggests that 3 courses of PC are not optimal.

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