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Phase II APEC trial: The impact of primary tumor side on outcomes of first-line cetuximab plus FOLFOX or FOLFIRI in patients with RAS wild-type metastatic colorectal cancer.

Abstract：

AIM:The open-label, nonrandomized, phase II APEC study enrolled 167 patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) to investigate the safety and efficacy of first-line, every-2-weeks cetuximab plus investigator's choice of FOLFIRI or FOLFOX in this patient population. METHODS:A subgroup analysis of the APEC study population by primary tumor location was performed. RESULTS:A total of 130 patients (81.8%) had left-sided and 29 (18.2%) had right-sided mCRC. Median progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) were 14.0 months, 30.6 months and 68.5% for patients with left-sided tumors and 8.9 months, 24.6 months and 51.7% for patients with right-sided mCRC, concurring with pivotal phase III trial results. In patients with right-sided tumors, median PFS was 15.4 months vs 8.3 months with cetuximab plus FOLFIRI vs cetuximab plus FOLFOX, respectively; median OS was 32.1 months vs 21.8 months with cetuximab plus FOLFIRI vs cetuximab plus FOLFOX, respectively. CONCLUSION:The APEC tumor-location subgroup analysis results were largely consistent with available literature regarding the equivalent efficacy of cetuximab plus FOLFIRI/FOLFOX in patients with left-sided RAS wt mCRC. A trend toward improved efficacy with cetuximab plus FOLFIRI compared with cetuximab plus FOLFOX was observed in patients with right-sided tumors; however, a direct comparison between groups cannot be made due to the nonrandomized study design. Nevertheless, the similar ORR observed with either chemotherapy backbone in patients with right-sided RAS wt mCRC suggests a potential role for both regimens in this patient population when cytoreduction is a treatment goal.

journal_name

Asia Pac J Clin Oncol

journal_title

Asia-Pacific journal of clinical oncology

authors

Price T,Shen L,Ma B,Esser R,Chen W,Gibbs P,Lim R,Cheng AL

doi

10.1111/ajco.13154

subject

Has Abstract

pub_date

2019-08-01 00:00:00

pages

225-230

issue

eissn

1743-7555

issn

1743-7563

journal_volume

pub_type

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Phase II APEC trial: The impact of primary tumor side on outcomes of first-line cetuximab plus FOLFOX or FOLFIRI in patients with RAS wild-type metastatic colorectal cancer.