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Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study

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资源类型：
作者：
Cheng, Ann-Lii[3,4] ; Cornelio, Gerardo[5] ; Shen, Lin[6] ; Price, Timothy[7] ; Yang, Tsai-Sheng[8] ; Chung, Ik Joo[9] ; Dai, Guang-Hai[10] ; Lin, Jen-Kou[11] ; Sharma, Atul[12] ; Yeh, Kun-Huei[3,4] ; Ma, Brigette[13] ; Zaatar, Adel[1,14] ; Guan, Zhongzhen[15] ; Masood, Nehal[16] ; Srimuninnimit, Vichien[17] ; Yau, Thomas[18] ; Gibbs, Peter[19] ; Wang, Xiuwen[20] ; Doval, Dinesh Chandra[21] ; Oh, Seung-Taek[22] ; Shim, Byoung Yong[23] ; Gorospe, Charity[24] ; Wang, Hwei-Ming[25] ; Sirachainan, Ekaphop[17] ; Hill, Andrew[26] ; Suh, Kwang Wook[27] ; Beier, Frank[28] ; Chatterjee, Sudipto[29] ; Lim, Robert[2,30] ;
机构： [1]Gleneagles Penang, George Town, Penang, Malaysia; [2]Singapore Oncol Consultants, Singapore, Singapore; [3]Nat Taiwan Univ Hosp, 7 Zhongshan S Rd, Taipei 100, Taiwan; [4]Natl Taiwan Univ Canc Ctr, 7 Zhongshan S Rd, Taipei 100, Taiwan; [5]San Juan de Dios Hosp, 7 Zhongshan S Rd, Pasay City, Philippines; [6]Peking Univ, Canc Hosp & Inst, Beijing, Peoples R China; [7]Queen Elizabeth Hosp, Woodville, SA, Australia; [8]Chang Gung Mem Hosp LinKou, Taoyuan, Taiwan; [9]Chonnam Natl Univ, Hwasun Hosp, Hwasun Eup, South Korea; [10]Gen Hosp Peoples Liberat Army, Beijing, Peoples R China; [11]Taipei Vet Gen Hosp, Taipei, Taiwan; [12]All India Inst Med Sci, New Delhi, India; [13]Chinese Univ Hong Kong, Prince Wales Hosp, Sha Tin, Hong Kong, Peoples R China; [14]Mt Miriam Canc Hosp, Tanjung Bungah, Penang, Malaysia; [15]Sun Yat Sen Univ, Canc Ctr, Guangzhou, Guangdong, Peoples R China; [16]Aga Khan Univ & Hosp, Karachi, Pakistan; [17]Ramathibodi Hosp, Siriraj Hosp, Bangkok, Thailand; [18]Queen Mary Hosp, Pok Fu Lam, Hong Kong, Peoples R China; [19]Western Hosp, Footscray, Vic, Australia; [20]Shandong Univ, Qilu Hosp, Shandong, Peoples R China; [21]Rajiv Gandhi Canc Inst & Res Ctr, New Delhi, India; [22]Catholic Univ Korea, Seoul St Marys Hosp, Seoul, South Korea; [23]Catholic Univ Korea, St Vincents Hosp, Suwon, South Korea; [24]St Lukes Med Ctr, Quezon City, Philippines; [25]Taichung Vet Gen Hosp, Taichung, Taiwan; [26]Gold Coast Hosp, Southport, Qld, Australia; [27]Ajou Univ Hosp, Suwon, South Korea; [28]Merck KGaA, Darmstadt, Germany; [29]Merck Ltd, Bombay, Maharashtra, India; [30]Natl Univ Singapore, Inst Canc, Singapore, Singapore
出处：
DOI： 10.1016/j.clcc.2016.08.005
ISSN：

关键词： Depth of response Dosing schedule Early tumor shrinkage Erbitux mCRC

摘要：
The nonrandomized phase 2 APEC trial investigated first-line once-every-2-weeks cetuximab plus chemotherapy (investigator's choice of FOLFOX or FOLFIRI) studied patients with KRAS/RAS wild-type metastatic colorectal cancer. We observed an activity and safety profile similar to that reported in prior first-line pivotal studies involving weekly cetuximab, suggesting that once-every-2-weeks cetuximab is effective and tolerable as first-line therapy. Background: In 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-2weeks cetuximab plus chemotherapy for patients with KRAS wt mCRC; additional biomarker subgroups were also analyzed. Patients and Methods: APEC 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. Results: In 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. Conclusion: The 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. (C) 2016 The Author(s). Published by Elsevier Inc.

基金：
Merck KGaA, Darmstadt, GermanyMerck & Company
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2017]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学
最新[2023]版：
大类 | 3 区 医学
小类 | 4 区 肿瘤学
第一作者：
第一作者机构： [3]Nat Taiwan Univ Hosp, 7 Zhongshan S Rd, Taipei 100, Taiwan; [4]Natl Taiwan Univ Canc Ctr, 7 Zhongshan S Rd, Taipei 100, Taiwan;
通讯作者：
通讯机构： [3]Nat Taiwan Univ Hosp, 7 Zhongshan S Rd, Taipei 100, Taiwan; [4]Natl Taiwan Univ Canc Ctr, 7 Zhongshan S Rd, Taipei 100, Taiwan;
推荐引用方式(GB/T 7714)：
Cheng Ann-Lii,Cornelio Gerardo,Shen Lin,et al.Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study[J].CLINICAL COLORECTAL CANCER.2017,16(2):E73-E88.doi:10.1016/j.clcc.2016.08.005.
APA：
Cheng, Ann-Lii,Cornelio, Gerardo,Shen, Lin,Price, Timothy,Yang, Tsai-Sheng...&Lim, Robert.(2017).Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study.CLINICAL COLORECTAL CANCER,16,(2)
MLA：
Cheng, Ann-Lii,et al."Efficacy, Tolerability, and Biomarker Analyses of Once-Every-2-Weeks Cetuximab Plus First-Line FOLFOX or FOLFIRI in Patients With KRAS or All RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 APEC Study".CLINICAL COLORECTAL CANCER 16..2(2017):E73-E88

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