Meeting
2014 Gastrointestinal Cancers Symposium
A phase II study of cetuximab (cet) and mFOLFOX6 in metastatic colorectal cancer (mCRC) (JACCRO CC-05).
Authors
Tatsuro Yamaguchi
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan
Tatsuro Yamaguchi , Akihito Tsuji , Yu Sunakawa , Masato Nakamura , Mitsugu Kochi , Tadamichi Denda , Ken Shimada , Satoshi Tani , Akinori Takagane , Masahito Kotaka , Hidekazu Kuramochi , Junichi Koike , Kaoru Furushima , Yutaka Yonemura , Yuji Negoro , Yasutaka Takinishi , Masahiro Takeuchi , Wataru Ichikawa , Masashi Fujii , Toshifusa Nakajima
Organizations
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan, Kobe City Medical Center General Hospital, Kobe, Japan, Showa University Northern Yokohama Hospital, Yokohama, Japan, Aizawa Hospital, Matsumoto, Japan, Nihon University School of Medicine, Tokyo, Japan, Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan, Kohnan Hospital, Kobe, Japan, Hakodate Goryokaku Hospital, Hakodate, Japan, Sano Hospital, Kobe, Japan, Department of Chemotherapy and Palliative Care, Tokyo Women's Medical University, Tokyo, Japan, Toho University School of Medicine, Tokyo, Japan, NTT Medical Center Tokyo, Tokyo, Japan, Kishiwada Tokushukai Hospital, Kishiwada, Japan, Kochi Health Sciences Center, Kochi, Japan, Kitasato University School of Pharmacy, Tokyo, Japan, National Defense Medical College Hospital, Tokorozawa, Japan, Japan Clinical Cancer Research Organization, Tokyo, Japan
Research Funding
Other
Background: FOLFOX4 combined with cet for mCRC patients (pts) with KRAS wild tumor demonstrated the prolonged progression-free survival (PFS) with higher response rate (RR) in the OPUS study. To evaluate the clinical efficacy and safety of the cet plus mFOLFOX6, we conducted a multi-center phase II study of Japanese pts. Methods: In this trial, pts with KRAS wild type tumor and receiving no prior chemotherapy for mCRC were treated with cet (initial dose 400, and 250 mg/m2 weekly) followed by mFOLFOX6 (oxaliplatin 85mg/m2, l-leucovorin 200 mg/m2, fluorouracil, as 400mg/m2 intravenous bolus then 2,400mg/m246-hour continuous infusion). The treatment was repeated every 2 weeks. The primary endpoint was RR evaluated by the external review board according to RECIST v1.1. Secondary endpoints included PFS, OS, % chronological change at the base line and safety. Results: A total of 57 pts were enrolled from August 2010 to September 2011. The median age was 60 years, 65% of pts were male, and ECOG PS 0 was observed in 91% of pts. All pts had EGFR-expressing disease. The median treatment courses were 21 (cet) and 10 (FOLFOX). The RR was 66.7% (95%CI, 53.4 to 77.7). Complete remission was observed in 5 cases (9.3%). The median PFS was 11.1 months (95%CI, 8.0 to 14.7). The early tumor shrinkage (ETS; over 20% regression at 8 weeks) was observed in 80% of pts, and the PFS for pts with ETS was statistically significantly prolonged as compared with pts without ETS (median PFS, 11.5 vs. 3.7 months, respectively; p = 0.0002). The OS was not reached at the time of median follow-up (19.2 months). Grade 3 or worse adverse events were neutropenia (48.2%), leucopenia (22.2%), rash acneform (20.4%), and peripheral neuropathy (18.5%). Conclusions: The first-line cet+mFOLFOX6 has an acceptable safety profile and demonstrates advantages in response rate for pts with KRAS wild tumor. The first-line cet+mFOLFOX6 should be considered as one of the recommended treatment regimens for pts with KRAS wild tumor. Update survival data will be presented. Clinical trial information: UMIN000004197.
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Abstract Details
Session Type
Poster Session
Session Title
General Poster Session C: Cancers of the Colon and Rectum
Track
Cancers of the Colon, Rectum, and Anus
Sub Track
Multidisciplinary Treatment
Clinical Trial Registration Number
UMIN000004197
Citation
J Clin Oncol 32, 2014 (suppl 3; abstr 611)
DOI
10.1200/jco.2014.32.3_suppl.611
Abstract #
611
Poster Bd #
E2
Abstract Disclosures
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