%0 Journal Article
%@ 1879-0852
%A Goey, KKH
%A Sorbye, H
%A Glimelius, B
%A Adams, RA
%A Andre, T
%A Arnold, D
%A Berlin, JD
%A Bodoky, G
%A de Gramont, A
%A Diaz-Rubio, E
%A Eng, C
%A Falcone, A
%A Grothey, A
%A Heineman, 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, H-J
%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
%D 2018
%F discovery:10054713
%I ELSEVIER SCI LTD
%J European Journal of Cancer
%K Science & Technology, Life Sciences & Biomedicine, Oncology, Colorectal cancer, Metastatic disease, Patient characteristics, Prognosis, Stratification, Clinical trials, Delphi survey, CLINICAL-TRIALS, SURVIVAL, BEVACIZUMAB, METAANALYSIS
%P 35-45
%T Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group
%U https://discovery.ucl.ac.uk/id/eprint/10054713/
%V 100
%X Background  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.    Methods  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.    Results  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.    Conclusions  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.
%Z This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.