%0 Journal Article
%T Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group.
%A Goey KKH
%A Sørbye H
%A Glimelius B
%A Adams RA
%A André T
%A Arnold D
%A Berlin JD
%A Bodoky G
%A de Gramont A
%A Díaz-Rubio E
%A Eng C
%A Falcone A
%A Grothey A
%A Heinemann V
%A Hochster HS
%A Kaplan RS
%A Kopetz S
%A Labianca R
%A Lieu CH
%A Meropol NJ
%A Price TJ
%A Schilsky RL
%A Schmoll HJ
%A Shacham-Shmueli E
%A Shi Q
%A Sobrero AF
%A Souglakos J
%A Van Cutsem E
%A Zalcberg J
%A van Oijen MGH
%A Punt CJA
%A Koopman M
%J Eur J Cancer
%V 100
%N 0
%D 09 2018
%M 29936065
%F 10.002
%R 10.1016/j.ejca.2018.05.010
%X Patient characteristics and stratification factors are key features influencing trial outcomes. However, there is substantial heterogeneity in reporting of patient characteristics and use of stratification factors in phase 3 trials investigating systemic treatment of metastatic colorectal cancer (mCRC). We aimed to develop a minimum set of essential baseline characteristics and stratification factors to include in such trials.<BR>We performed a modified, two-round Delphi survey among international experts with wide experience in the conduct and methodology of phase 3 trials of systemic treatment of mCRC.<BR>Thirty mCRC experts from 15 different countries completed both consensus rounds. A total of 14 patient characteristics were included in the recommended set: age, performance status, primary tumour location, primary tumour resection, prior chemotherapy, number of metastatic sites, liver-only disease, liver involvement, surgical resection of metastases, synchronous versus metachronous metastases, (K)RAS and BRAF mutation status, microsatellite instability/mismatch repair status and number of prior treatment lines. A total of five patient characteristics were considered the most relevant stratification factors: RAS/BRAF mutation status, performance status, primary tumour sidedness and liver-only disease.<BR>This survey provides a minimum set of essential baseline patient characteristics and stratification factors to include in phase 3 trials of systemic treatment of mCRC. Inclusion of these patient characteristics and strata in study protocols and final study reports will improve interpretation of trial results and facilitate cross-study comparisons.