653 - Japanese Cohort Study of First Line Chemotherapy (CT) for Metastatic Colorectal Cancer (MCRC) Containing Fluoropyrimidine, Oxaliplatin and Bevacizumab: Emerald Study, First Report

Abstract

ABSTRACT Background An observational cohort study plays a crucial role to understand the current status of clinical practice and can be utilized as database for multi-purpose outcome research. Such database is available in Europe and the United States based on several cohort studies especially in mCRC, while there is no database available including treatments for mCRC patients in Japan. Methods According to the Japanese Ethical Guideline for Epidemiologic Study, we planned and conducted a large cohort study in Japan. Data from more than 1000 patients were planned to be collected between October 2010 and September 2011 with 2-year follow-up period. Enrollment criteria included documented mCRC and first line CT containing fluoropyrimidine, oxaliplatin and bevacizumab, started treatment in or after January 2010, tumor response image assessment available, safety assessment available and able to offer information outside of originally enrolled studies. The primary objectives are to evaluate overall survival, liver resection rate, R0 liver resection rate; the secondary objectives are to evaluate response rate, progression-free survival, sub-group analysis by treatment regimens and by KRAS gene status, and safety. Results From October 2010 to September 2011, 1270 patients were recruited from 132 centers in Japan. The background of patients were as the following; male/female, 766/504; median age of 65 (range, 21-89); ECOG PS 0/1/2/3, 1045/203/17/5; FOLFOX/ CapeOX/ others with bevacizumab, 563/667/40, KRAS gene status at baseline was wild/mutant/unknown, 286/223/761; CEA median of 13.8 (range, 0.0–90055.0 ng/ml) and comorbidity no/yes, 798/472. Conclusion We have started the large Japanese cohort study which investigates first line CT containing fluoropyrimidine, oxaliplatin and bevacizumab for metastatic colorectal cancer. We performed a preplanned interim analysis. We present the first report of 6-month efficacy and safety data on 500 patients at the ESMO 2012 Congress. The final results will be available in 2013. This study is sponsored by the Public Health Research Center Foundation CSPOR in Japan. Disclosure All authors have declared no conflicts of interest.