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4022 Background: Resection of initially unresectable metastatic lesions in pts with mCRC who have responded to systemic therapy offers a potential for cure in selected pts. Here we describe the frequency, outcome and safety of pts undergoing resection of metastatic lesions with curative intent in two large clinical trials (First BEAT: phase IV uncontrolled; NO16966: phase III, placebo P controlled) using standard CT plus BEV as first-line treatment for pts with initially unresectable mCRC. Methods: BEAT enrolled 1,965 pts and 1,400 pts were enrolled in the P controlled part of NO16966. In both trials pts received first-line CT plus BEV 5mg/kg q2w (5-FU-based CT) or 7.5mg/kg q3w (capecitabine-based CT). CT was physician’s choice in BEAT. Pts were randomised 1:1 between XELOX or FOLFOX and then BEV or P in NO16966. Data were collected prospectively. Surgery was recommended 6 to 8 weeks after BEV discontinuation. Surgery with curative intent was a predefined secondary endpoint in BEAT. Criteria for initial unresectability of metastatic lesions was not defined in either trial and was based on investigators’ evaluations. Results: 215/1,914 (11.2%) eligible pts underwent surgery with curative intent in BEAT; 170 pts (8.8%) had no residual disease following surgery (79% R0 resection). Overall survival (OS) is not mature, but preliminary 2-year OS is 44% for the overall ITT population and 82% for R0 resected pts (p<0.0001). In NO16966, 44/699 (6.3%) pts receiving BEV underwent R0 resection compared with 34/701 (4.9%) pts receiving P (p=NS). R0 resection rates in pts with no extrahepatic metastatic disease were 11.5% in BEAT and 12.3% vs 11.5% (p=NS) in NO16966. No clinically meaningful increase in wound-healing complications or bleeding events was observed compared with either historical data or control. Conclusions: Safety and feasibility of secondary resection of metastatic lesions with curative intent does not appear to be compromised in pts receiving BEV plus CT. Updated efficacy data, including relapse-free survival, will be presented at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen, Roche, sanofi-aventis Roche, sanofi-aventis Amgen, Bayer, Bristol-Myers Squibb, Genentech, ImClone, Merck, Pfizer Oncology, Roche, sanofi-aventis, Taiho Roche Roche
Cassidy et al. (Tue,) studied this question.