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Eur J Cancer. 2018 Sep;100:35-45. doi: 10.1016/j.ejca.2018.05.010. Epub 2018 Jun 22.

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

Author information

1
Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
2
Department of Oncology, Haukeland University Hospital, Bergen, Norway; Department of Clinical Science, Haukeland University Hospital, Bergen, Norway.
3
Department of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
4
Centre for Trials Research - Cancer Group, Cardiff, UK.
5
Department of Medical Oncology, Hôpital St Antoine; Sorbonne Universités, UMPC Paris 06, Paris, France.
6
Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg, Germany.
7
Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN, USA.
8
Department of Medical Oncology, St. Laszlo Hospital, Budapest, Hungary.
9
Department of Medical Oncology, Institut Hospitalier Franco Britannique, Levallois-Perret, Paris, France.
10
Department of Medical Oncology, Hospital Clínico San Carlos, Universidad Complutense, CIBERONC, Madrid, Spain.
11
Department of Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.
12
Department of Medical Oncology, University of Pisa, Pisa, Italy.
13
Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.
14
Medical Department III, Comprehensive Cancer Center, University Clinic Munich, Munich, Germany.
15
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
16
Medical Research Council Clinical Trials Unit, University College London, London, UK.
17
Cancer Center, Ospedale Giovanni XXIII, Bergamo, Italy.
18
Division of Medical Oncology, University of Colorado, Denver, USA.
19
Flatiron Health, New York, NY, USA; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA.
20
Department of Medical Oncology, The Queen Elizabeth Hospital, Australia.
21
American Society of Clinical Oncology, Alexandria, VA, USA.
22
Division Clinical Oncology Research, University Clinic Halle, Martin-Luther-University Halle-Wittenberg, Halle, Germany.
23
Cancer Center, Sheba Medical Center, Tel-Hashomer, Israel.
24
Department of Health Science Research, Mayo Clinic, Rochester, MN, USA.
25
Policlinico San Martino IRCCS, Genoa, Italy.
26
Department of Medical Oncology, University General Hospital of Heraklion, Heraklion, Greece.
27
Department of Digestive Oncology, University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.
28
Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.
29
Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
30
Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address: m.koopman-6@umcutrecht.nl.

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.

KEYWORDS:

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

PMID:
29936065
DOI:
10.1016/j.ejca.2018.05.010
[Indexed for MEDLINE]

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