• Ann-Lii Cheng, Gerardo Cornelio, Lin Shen, Timothy Price, Tsai-Sheng Yang, Ik Joo Chung, Guang-Hai Dai, Jen-Kou Lin, Atul Sharma, Kun-Huei Yeh, Brigette Ma, Adel Zaatar, Zhongzhen Guan, Nehal Masood, Vichien Srimuninnimit, Thomas Yau, Peter Gibbs, Xiuwen Wang, Dinesh Chandra Doval, Seung-Taek Oh, Byoung Yong Shim, Charity Gorospe, Hwei-Ming Wang, Ekaphop Sirachainan, Andrew Hill, Kwang Wook Suh, Frank Beier, Sudipto Chatterjee, and Robert Lim.
• National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan. Electronic address: alcheng@ntu.edu.tw.
• Clin Colorectal Cancer. 2017 Jun 1; 16 (2): e73-e88.

BackgroundIn patients with KRAS wild-type (wt) metastatic colorectal cancer (mCRC), outcomes with first-line chemotherapies are improved by adding weekly cetuximab. The APEC study investigated first-line once-every-2-weeks cetuximab plus chemotherapy for patients with KRAS wt mCRC; additional biomarker subgroups were also analyzed.Patients And MethodsAPEC was a nonrandomized phase 2 trial conducted in the Asia-Pacific region. Patients (n = 289) received once-every-2-weeks cetuximab with investigator's choice of chemotherapy (FOLFOX or FOLFIRI). The primary end point was best confirmed overall response rate (BORR); progression-free survival (PFS) and overall survival (OS) were secondary end points. Early tumor shrinkage (ETS) and depth of response (DpR) were also evaluated.ResultsIn the KRAS wt population, BORR was 58.8%, median PFS 11.1 months, and median OS 26.8 months. Expanded RAS mutational analysis revealed that patients with RAS wt mCRC had better outcomes (BORR = 64.7%; median PFS = 13.0 months; median OS = 28.4 months). The data suggest that ETS and DpR may be associated with survival outcomes in the RAS wt population. Although this study was not designed to formally assess differences in outcome between treatment subgroups, efficacy results appeared similar for patients treated with FOLFOX and FOLFIRI. There were no new safety findings; in particular, grade 3/4 skin reactions were within clinical expectations.ConclusionThe observed activity and safety profile is similar to that reported in prior first-line pivotal studies involving weekly cetuximab, suggesting once-every-2-weeks cetuximab is effective and tolerable as first-line therapy and may represent an alternative to weekly administration.Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

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