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

BMC Cancer

Research Article

Hideyuki Mishima¹  Hiromichi Maeda²  Koji Oba³  Shoichi Hazama⁴  Hitoshi Soda⁵  Takao Takahashi⁶  Emiko Kono⁷  Naoki Nagata⁸  Junichi Hasegawa⁹  Mutsumi Fukunaga^1,10  Masahito Kotaka^1,11  Junichi Sakamoto^1,12 

[1] Aichi Medical University, Nagakute, Japan;Cancer Treatment Center, Kochi Medical School Hospital, Kochi University, Kohasu, Oko-cho, 783-8505, Nankoku, Kochi, Japan;Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;Department of Digestive Surgery and Surgical Oncology, Yamaguchi University, Graduate School of Medicine, Ube, Japan;Department of Surgery, Showa University Fujigaoka Hospital, Yokohama, Japan;Department of Surgical Oncology, Gifu University Hospital, Gifu, Japan;Japan Community Health care Organization Osaka Hospital, Osaka, Japan;Kitakyushu General Hospital, Kitakyushu, Japan;Osaka Rosai Hospital, Sakai, Japan;Sakai City Hospital, Sakai, Japan;Sano Hospital, Kobe, Japan;Tokai Central Hospital, Kakamigahara, Japan;

关键词: Oxaliplatin;    Capecitabine;    Cetuximab;    Metastatic Colorectal Cancer;    BRAF Mutation;   

DOI  :  10.1186/s12885-015-1685-z

 received in 2015-03-19, accepted in 2015-10-06,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsSixty-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.ResultsThe 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.ConclusionsThe 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.Trial registrationThis study is registered with University Hospital Medical Information Network (UMIN 000003253). Registration date is 02/24/2010.

【 授权许可】

CC BY   
© Soda et al. 2015