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Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group

Goey, Kaitlyn K.H., Sørbye, Halfdan, Glimelius, Bengt, Adams, Richard A., André, Thierry, Arnold, Dirk, Berlin, Jordan D., Bodoky, György, de Gramont, Aimery, Díaz-Rubio, Eduardo, Eng, Cathy, Falcone, Alfredo, Grothey, Axel, Heinemann, 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, Van Cutsem, Eric, Zalcberg, John, van Oijen, Martijn G.H., Punt, Cornelis J.A. and Koopman, Miriam 2018. Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group. European Journal of Cancer 100 , pp. 35-45. 10.1016/j.ejca.2018.05.010

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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.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Medicine
Centre for Trials Research (CNTRR)
Publisher: Elsevier
ISSN: 0959-8049
Date of Acceptance: 17 May 2018
Last Modified: 13 Sep 2018 10:45
URI: http://orca.cf.ac.uk/id/eprint/114785

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