A Multicenter Phase 2 Trial to Evaluate the Efficacy of mFOLFOX6 + Cetuximab as Induction Chemotherapy to Achieve R0 Surgical ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2020-06-08

AUTHORS

Yoshihiro Mise, Kiyoshi Hasegawa, Akio Saiura, Masaru Oba, Junji Yamamoto, Yukihiro Nomura, Tadatoshi Takayama, Yojiro Hashiguchi, Masayuki Shibasaki, Hirohiko Sakamoto, Seiichi Yamagata, Nobuyoshi Aoyanagi, Hironori Kaneko, Hiroto Koyama, Shinichi Miyagawa, Eiji Shinozaki, Shuntaro Yoshida, Hiroaki Nozawa, Norihiro Kokudo

ABSTRACT

BackgroundThe effect of cetuximab plus mFOLFOX on downsizing of the tumors for curative resection has yet to be assessed for patients with advanced colorectal liver metastases (CRLMs). This study aimed to assess the oncologic benefit of cetuximab plus mFOLFOX for wild-type KRAS patients with advanced CRLMs.MethodsIn this multicenter phase 2 trial, patients with technically unresectable tumor and/or five or more CRLMs harboring wild-type KRAS were treated with mFOLFOX plus cetuximab. The patients were assessed for resectability after 4 treatments, and then every 2 months up to 12 treatments. Patients with resectable disease were offered surgery after a waiting period of 1 month. The primary end point of the study was the R0 resection rate. The secondary end points were safety, progression-free survival (PFS), and overall survival (OS). The study is registered with the University Hospital Medical Information Network-Clinical Trials Registry Clinical Trials Registry (no. C000007923).ResultsBetween 2012 and 2015, 50 patients from 13 centers were enrolled in this trial. Two patients were excluded because they had not received induction therapy. The 48 patients had a complete response rate of 0% and a partial response rate of 64.6%. For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred. During a median follow-up period of 31 months, the median OS for all the patients was calculated to be 41 months (95% confidence interval, 28–not reached). The 3-year OS rate was 59%.ConclusionFor patients with advanced CRLMs harboring wild-type KRAS, cetuximab administered in combination with mFOLFOX yields high response rates, leading to significantly high R0 resection rates and favorable prognoses. More... »

PAGES

4188-4195

Journal

TITLE

Annals of Surgical Oncology

ISSUE

11

VOLUME

27

Identifiers

URI

http://scigraph.springernature.com/pub.10.1245/s10434-020-08627-y

DOI

http://dx.doi.org/10.1245/s10434-020-08627-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1128303303

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32514802


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This table displays all metadata directly associated to this object as RDF triples.

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21 schema:description BackgroundThe effect of cetuximab plus mFOLFOX on downsizing of the tumors for curative resection has yet to be assessed for patients with advanced colorectal liver metastases (CRLMs). This study aimed to assess the oncologic benefit of cetuximab plus mFOLFOX for wild-type KRAS patients with advanced CRLMs.MethodsIn this multicenter phase 2 trial, patients with technically unresectable tumor and/or five or more CRLMs harboring wild-type KRAS were treated with mFOLFOX plus cetuximab. The patients were assessed for resectability after 4 treatments, and then every 2 months up to 12 treatments. Patients with resectable disease were offered surgery after a waiting period of 1 month. The primary end point of the study was the R0 resection rate. The secondary end points were safety, progression-free survival (PFS), and overall survival (OS). The study is registered with the University Hospital Medical Information Network-Clinical Trials Registry Clinical Trials Registry (no. C000007923).ResultsBetween 2012 and 2015, 50 patients from 13 centers were enrolled in this trial. Two patients were excluded because they had not received induction therapy. The 48 patients had a complete response rate of 0% and a partial response rate of 64.6%. For 26 R0 resections (54.2%) and 5 R1 resections (10.4%), no mortality occurred. During a median follow-up period of 31 months, the median OS for all the patients was calculated to be 41 months (95% confidence interval, 28–not reached). The 3-year OS rate was 59%.ConclusionFor patients with advanced CRLMs harboring wild-type KRAS, cetuximab administered in combination with mFOLFOX yields high response rates, leading to significantly high R0 resection rates and favorable prognoses.
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