Meeting
2017 Gastrointestinal Cancers Symposium
CEA response and depth of response (DpR) to predict clinical outcomes in patients (pts) with metastatic colorectal cancer (mCRC) treated with first-line cetuximab plus oxaliplatin-based chemotherapy: A sub-analysis of the JACCRO CC-05/06 trials.
Authors
Yu Sunakawa
Division of Medical Oncology, Showa University Northern Yokohama Hospital, Yokohama, Japan
Yu Sunakawa , Wataru Ichikawa , Akihito Tsuji , Tadamichi Denda , Yoshihiko Segawa , Yuji Negoro , Ken Shimada , Mitsugu Kochi , Masato Nakamura , Masahito Kotaka , Hiroaki Tanioka , Akinori Takagane , Satoshi Tani , Tatsuro Yamaguchi , Masahiro Takeuchi , Masashi Fujii , Toshifusa Nakajima
Organizations
Division of Medical Oncology, Showa University Northern Yokohama Hospital, Yokohama, Japan, Division of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama, Japan, Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kagawa, Japan, Chiba Cancer Center Hospital, Chiba, Japan, Department of Medical Oncology, Saitama Medical University International Medical Center, Hidaka, Japan, Kochi Health Sciences Center, Kochi, Japan, Division of Medical Oncology, Showa University Koto Toyosu Hospital, Tokyo, Japan, Nihon University School of Medicine, Tokyo, Japan, Aizawa Hospital, Matsumoto, Japan, Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan, Department of Medical Oncology, Japan Labour Health and Welfare Organization Okayama Rosai Hospital, Okayama, Japan, Department of Surgery, Hakodate Goryoukaku Hospital, Hakodate, Japan, Department of Medical Oncology, Kohnan Hospital, Kobe, Japan, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo, Japan, Department of Clinical Medicine, Kitasato University School of Pharmacy, Tokyo, Japan, Japan Clinical Cancer Research Organization, Tokyo, Japan
Research Funding
Other
Background: Carcinoembryonic antigen (CEA) decrease was faster and greater in cetuximab (cet) treatment than bevacizumab treatment and correlated with prolonged survival in mCRC pts receiving FOLFIRI plus cet (Michl M, et al. Ann Oncol 2016). We investigated if the CEA decrease is a surrogate for DpR reported to be associated with clinical outcomes. Methods: This study evaluated the association between the percentage of CEA decrease or DpR and clinical outcomes in pts with KRAS exon 2 wild-type from 2 phase II trials of 1st-line therapy; JACCRO CC-05 of cet plus FOLFOX (n= 57, UMIN000004197) and CC-06 of cet plus SOX (n= 61, UMIN000007022). The association was analyzed using Spearman’s rank correlation coefficient. The cut-off value of 75% CEA decrease was used for CEA response to discriminate CEA responders according to the previous report. The DpR was defined as the percentage of tumor shrinkage at the nadir as compared with the baseline values. Results: In total of 113 pts of the 2 trials in the full analysis set, 92 were eligible for analyses of both CEA and DpR. In the population consists of 92 evaluable pts, median progression-free survival (PFS) was 9.1 months, and median overall survival (OS) was 36.2 months. Median CEA decrease was 67.4% and median time to CEA nadir was 2.8 months similar to median time to DpR of 3.0 months. The DpR was associated with PFS and OS (rs= 0.56; P< 0.0001, rs= 0.39; P= 0.0090, respectively); moreover, CEA decrease correlated with PFS (rs= 0.56, P< 0.0001) as well as OS (rs= 0.35, P= 0.019). CEA responders showed significantly longer PFS [11.8 vs. 5.5 months; hazard ratio (HR) 0.46; 95% Cl, 0.28–0.73; P= 0.0009] and numerically longer OS (36.2 vs. 23.5 months; HR 0.57; 95% CI, 0.30-1.05; P= 0.072) than CEA non-responders. The CEA decrease was statistically significantly associated with DpR (rs= 0.44, P< 0.0001). Conclusions: Our study demonstrates that DpR and CEA response both correlated with clinical outcomes of 1st-line treatment with cet plus oxaliplatin-based chemotherapy. The CEA decrease may serve as a surrogate for DpR in 1st-line cet treatment.
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Abstract Details
Session Type
Poster Session
Session Title
Poster Session C: Cancers of the Colon, Rectum, and Anus
Track
Cancers of the Colon, Rectum, and Anus
Sub Track
Translational Research
Citation
J Clin Oncol 35, 2017 (suppl 4S; abstract 648)
DOI
10.1200/JCO.2017.35.4_suppl.648
Abstract #
648
Poster Bd #
F22
Abstract Disclosures
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