• Kaitlyn K H Goey, Halfdan Sørbye, Bengt Glimelius, Richard A Adams, Thierry André, Dirk Arnold, Jordan D Berlin, György Bodoky, Aimery de Gramont, Eduardo Díaz-Rubio, Cathy Eng, Alfredo Falcone, Axel Grothey, Volker Heinemann, Howard S Hochster, Richard S Kaplan, Scott Kopetz, Roberto Labianca, Christopher H Lieu, Neal J Meropol, Timothy J Price, Richard L Schilsky, Hans-Joachim Schmoll, Einat Shacham-Shmueli, Qian Shi, Alberto F Sobrero, John Souglakos, Eric Van Cutsem, John Zalcberg, van Oijen Martijn G H MGH Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands., Punt Cornelis J A CJA Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands., and Miriam Koopman.
• Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
• Eur. J. Cancer. 2018 Sep 1; 100: 35-45.

BackgroundPatient 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.MethodsWe 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.ResultsThirty 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.ConclusionsThis 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.Copyright © 2018 Elsevier Ltd. All rights reserved.

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