eprintid: 10054713 rev_number: 25 eprint_status: archive userid: 608 dir: disk0/10/05/47/13 datestamp: 2018-08-24 14:46:33 lastmod: 2021-12-10 01:15:34 status_changed: 2018-08-24 14:46:33 type: article metadata_visibility: show creators_name: Goey, KKH creators_name: Sorbye, H creators_name: Glimelius, B creators_name: Adams, RA creators_name: Andre, T creators_name: Arnold, D creators_name: Berlin, JD creators_name: Bodoky, G creators_name: de Gramont, A creators_name: Diaz-Rubio, E creators_name: Eng, C creators_name: Falcone, A creators_name: Grothey, A creators_name: Heineman, V creators_name: Hochster, HS creators_name: Kaplan, RS creators_name: Kopetz, S creators_name: Labianca, R creators_name: Lieu, CH creators_name: Meropol, NJ creators_name: Price, TJ creators_name: Schilsky, RL creators_name: Schmoll, H-J creators_name: Shacham-Shmueli, E creators_name: Shi, Q creators_name: Sobrero, AF creators_name: Souglakos, J creators_name: van Cutsem, E creators_name: Zalcberg, J creators_name: van Oijen, MGH creators_name: Punt, CJA creators_name: Koopman, M title: Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group ispublished: pub divisions: UCL divisions: B02 divisions: D65 divisions: J38 keywords: Science & Technology, Life Sciences & Biomedicine, Oncology, Colorectal cancer, Metastatic disease, Patient characteristics, Prognosis, Stratification, Clinical trials, Delphi survey, CLINICAL-TRIALS, SURVIVAL, BEVACIZUMAB, METAANALYSIS note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. 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. date: 2018-06-22 date_type: published publisher: ELSEVIER SCI LTD official_url: https://doi.org/10.1016/j.ejca.2018.05.010 oa_status: green full_text_type: other language: eng primo: open primo_central: open_green article_type_text: Article verified: verified_manual elements_id: 1563888 doi: 10.1016/j.ejca.2018.05.010 lyricists_name: Kaplan, Richard lyricists_id: RKAPL47 actors_name: Kaplan, Richard actors_id: RKAPL47 actors_role: owner full_text_status: public publication: European Journal of Cancer volume: 100 pagerange: 35-45 pages: 11 issn: 1879-0852 citation: Goey, KKH; Sorbye, H; Glimelius, B; Adams, RA; Andre, T; Arnold, D; Berlin, JD; ... Koopman, M; + view all <#> Goey, KKH; Sorbye, H; Glimelius, B; Adams, RA; Andre, T; Arnold, D; Berlin, JD; Bodoky, G; de Gramont, A; Diaz-Rubio, E; Eng, C; Falcone, A; Grothey, A; Heineman, V; Hochster, HS; Kaplan, RS; Kopetz, S; Labianca, R; Lieu, CH; Meropol, NJ; Price, TJ; Schilsky, RL; Schmoll, H-J; Shacham-Shmueli, E; Shi, Q; Sobrero, AF; Souglakos, J; van Cutsem, E; Zalcberg, J; van Oijen, MGH; Punt, CJA; Koopman, M; - view fewer <#> (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 <https://doi.org/10.1016/j.ejca.2018.05.010>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10054713/1/Goey_Consensus%20statement%20prognostic%20factors%20mCRC%20trials_EJC2018%20final%20pre-pub.pdf document_url: https://discovery.ucl.ac.uk/id/eprint/10054713/8/supplementary%20material%20EJC%2010696.pdf