119 524

Cited 9 times in

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

Authors
Cheng, AL | Cornelio, G | Shen, L | Price, T | Yang, TS | Chung, IJ | Dai, GH | Lin, JK | Sharma, A | Yeh, KH | Ma, B | Zaatar, A | Guan, Z | Masood, N | Srimuninnimit, V | Yau, T | Gibbs, P | Wang, X | Doval, DC | Oh, ST | Shim, BY | Gorospe, C | Wang, HM | Sirachainan, E | Hill, A | Suh, KW  | Beier, F | Chatterjee, S | Lim, R
Citation
Clinical colorectal cancer, 16(2). : e73-e88, 2017
Journal Title
Clinical colorectal cancer
ISSN
1533-00281938-0674
Abstract
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-2-weeks 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.
MeSH

DOI
10.1016/j.clcc.2016.08.005
PMID
27780749
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Surgery
Ajou Authors
서, 광욱
Files in This Item:
27780749.pdfDownload
Export

qrcode

해당 아이템을 이메일로 공유하기 원하시면 인증을 거치시기 바랍니다.

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

Browse