%K Science & Technology, Life Sciences & Biomedicine, Oncology, Colorectal cancer, Metastatic disease, Patient characteristics, Prognosis, Stratification, Clinical trials, Delphi survey, CLINICAL-TRIALS, SURVIVAL, BEVACIZUMAB, METAANALYSIS
%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.
%D 2018
%O This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
%I ELSEVIER SCI LTD
%A KKH Goey
%A H Sorbye
%A B Glimelius
%A RA Adams
%A T Andre
%A D Arnold
%A JD Berlin
%A G Bodoky
%A A de Gramont
%A E Diaz-Rubio
%A C Eng
%A A Falcone
%A A Grothey
%A V Heineman
%A HS Hochster
%A RS Kaplan
%A S Kopetz
%A R Labianca
%A CH Lieu
%A NJ Meropol
%A TJ Price
%A RL Schilsky
%A H-J Schmoll
%A E Shacham-Shmueli
%A Q Shi
%A AF Sobrero
%A J Souglakos
%A E van Cutsem
%A J Zalcberg
%A MGH van Oijen
%A CJA Punt
%A M Koopman
%V 100
%T Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group
%J European Journal of Cancer
%L discovery10054713
%P 35-45