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Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group
Univ Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlands.
Haukeland Hosp, Dept Oncol, Bergen, Norway;Haukeland Hosp, Dept Clin Sci, Bergen, Norway.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology. Uppsala Univ, Dept Immunol Genet & Pathol, Uppsala, Sweden.ORCID iD: 0000-0002-5440-791x
Ctr Trials Res Canc Grp, Cardiff, S Glam, Wales.ORCID iD: 0000-0003-3915-7243
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2018 (English)In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 100, p. 35-45Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
ELSEVIER SCI LTD , 2018. Vol. 100, p. 35-45
Keywords [en]
Colorectal cancer, Metastatic disease, Patient characteristics, Prognosis, Stratification, Clinical trials, Delphi survey
National Category
Cancer and Oncology
Identifiers
URN: urn:nbn:se:uu:diva-361483DOI: 10.1016/j.ejca.2018.05.010ISI: 000439473900005PubMedID: 29936065OAI: oai:DiVA.org:uu-361483DiVA, id: diva2:1251510
Available from: 2018-09-27 Created: 2018-09-27 Last updated: 2018-09-27Bibliographically approved

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