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Goey, Kaitlyn K. H.; Sorbye, Halfdan; Glimelius, Bengt; Adams, Richard A.; Andre, Thierry; Arnold, Dirk; Berlin, Jordan D.; Bodoky, Gyorgy; de Gramont, Aimery; Diaz-Rubio, Eduardo; Eng, Cathy; Falcone, Alfredo; Grothey, Axel; Heineman, Volker; Hochster, Howard S.; Kaplan, Richard S.; Kopetz, Scott; Labianca, Roberto; Lieu, Christopher H.; Meropol, Neal J.; Price, Timothy J.; Schilsky, Richard L.; Schmoll, Hans-Joachim; Shacham-Shmueli, Einat; Shi, Qian; Sobrero, Alberto F.; Souglakos, John; Cutsem, Eric van; Zalcberg, John; Oijen, Martijn G. H. van; Punt, Cornelis J. A.; Koopman, Miriam (2018): Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group. In: European Journal of Cancer, Vol. 100: pp. 35-45
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Abstract

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.