@article{discovery10054713,
           month = {June},
            year = {2018},
           title = {Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group},
       publisher = {ELSEVIER SCI LTD},
         journal = {European Journal of Cancer},
          volume = {100},
            note = {This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions.},
           pages = {35--45},
        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.},
            issn = {1879-0852},
          author = {Goey, KKH and Sorbye, H and Glimelius, B and Adams, RA and Andre, T and Arnold, D and Berlin, JD and Bodoky, G and de Gramont, A and Diaz-Rubio, E and Eng, C and Falcone, A and Grothey, A and Heineman, V and Hochster, HS and Kaplan, RS and Kopetz, S and Labianca, R and Lieu, CH and Meropol, NJ and Price, TJ and Schilsky, RL and Schmoll, H-J and Shacham-Shmueli, E and Shi, Q and Sobrero, AF and Souglakos, J and van Cutsem, E and Zalcberg, J and van Oijen, MGH and Punt, CJA and Koopman, M},
             url = {https://doi.org/10.1016/j.ejca.2018.05.010},
        keywords = {Science \& Technology, Life Sciences \& Biomedicine, Oncology, Colorectal cancer, Metastatic disease, Patient characteristics, Prognosis, Stratification, Clinical trials, Delphi survey, CLINICAL-TRIALS, SURVIVAL, BEVACIZUMAB, METAANALYSIS}
}