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Multicenter Phase II study of FOLFOX or biweekly XELOX and Erbitux (cetuximab) as first-line therapy in patients with wild-type KRAS/BRAF metastatic colorectal cancer: The FLEET study

Overview of attention for article published in BMC Cancer, October 2015
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Title
Multicenter Phase II study of FOLFOX or biweekly XELOX and Erbitux (cetuximab) as first-line therapy in patients with wild-type KRAS/BRAF metastatic colorectal cancer: The FLEET study
Published in
BMC Cancer, October 2015
DOI 10.1186/s12885-015-1685-z
Pubmed ID
Authors

Hitoshi Soda, Hiromichi Maeda, Junichi Hasegawa, Takao Takahashi, Shoichi Hazama, Mutsumi Fukunaga, Emiko Kono, Masahito Kotaka, Junichi Sakamoto, Naoki Nagata, Koji Oba, Hideyuki Mishima

Abstract

The clinical benefit of cetuximab combined with oxaliplatin-based chemotherapy remains under debate. The aim of the present multicenter open-label Phase II study was to explore the efficacy and safety of biweekly administration of cetuximab and mFOLFOX-6 or XELOX as first-line chemotherapy in patients with metastatic colorectal cancer. Sixty-two patients with previously untreated KRAS/BRAF wild-type metastatic colorectal cancer were recruited to the study between April 2010 and May 2011. Patients received one of two treatment regimens, either cetuximab plus mFOLFOX-6 (FOLFOX + Cmab) or cetuximab plus biweekly XELOX (XELOX + Cmab), according to their own preference. Treatment was continued until disease progression or the appearance of intolerable toxicities. The primary endpoint was response rate; secondary endpoints were progression-free survival, overall survival, disease control rate, dose intensity, conversion rate to surgical resection, and safety. The response rates in the FOLFOX + Cmab (n = 37) and XELOX + Cmab (n = 25) groups were 64.9 % (24/37) and 72.0 % (18/25), respectively. The median PFS in the FOLFOX + Cmab and XELOX + Cmab groups was 13.1 months (95 % confidence interval [CI] 12.1-17.5) and 13.4 months (95 % CI 10.1-17.9), respectively. Neutropenia was the most frequent grade 3/4 adverse event in both groups (33.9 %), followed by anorexia, acneiform eruption, skin fissure and paronychia. A waterfall plot of tumor diameter showed prominent shrinkage of the tumors in 88.7 % of patients. The results of the present study indicate that biweekly cetuximab plus mFOLFOX-6/XELOX is an effective and tolerable treatment regimen. Biweekly administration of cetuximab requires only one hospital visit every 2 weeks, and may become a convenient treatment option for patients with KRAS/BRAF wild-type metastatic colorectal cancer. This study is registered with University Hospital Medical Information Network (UMIN 000003253 ). Registration date is 02/24/2010.

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Mendeley readers

The data shown below were compiled from readership statistics for 41 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Switzerland 1 2%
Brazil 1 2%
Unknown 39 95%

Demographic breakdown

Readers by professional status Count As %
Student > Ph. D. Student 4 10%
Researcher 4 10%
Lecturer 3 7%
Student > Doctoral Student 3 7%
Professor 3 7%
Other 12 29%
Unknown 12 29%
Readers by discipline Count As %
Medicine and Dentistry 16 39%
Pharmacology, Toxicology and Pharmaceutical Science 3 7%
Nursing and Health Professions 3 7%
Business, Management and Accounting 1 2%
Arts and Humanities 1 2%
Other 4 10%
Unknown 13 32%