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

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. MeropolTimothy J. Price, Richard L. Schilsky, Hans Joachim Schmoll, Einat Shacham-Shmueli, Qian Shi, Alberto F. Sobrero, John Souglakos, Eric Van Cutsem, John Zalcberg, Martijn G.H. van Oijen, Cornelis J.A. Punt, Miriam Koopman

Research output: Contribution to journalArticle

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)35-45
Number of pages11
JournalEuropean Journal of Cancer
Volume100
DOIs
StatePublished - Sep 2018

Keywords

  • Clinical trials
  • Colorectal cancer
  • Delphi survey
  • Metastatic disease
  • Patient characteristics
  • Prognosis
  • Stratification

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Goey, K. K. H., Sørbye, H., Glimelius, B., Adams, R. A., André, T., Arnold, D., Berlin, J. D., Bodoky, G., de Gramont, A., Díaz-Rubio, E., Eng, C., Falcone, A., Grothey, A., Heinemann, V., Hochster, H. S., Kaplan, R. S., Kopetz, S., Labianca, R., Lieu, C. H., ... Koopman, M. (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, 35-45. https://doi.org/10.1016/j.ejca.2018.05.010