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

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Fältnamn	Indikatorer	Metadata
000		06768naa a2200745 4500
001		oai:DiVA.org:uu-361483
003		SwePub
008		180927s2018 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3614832 URI
024	7	a https://doi.org/10.1016/j.ejca.2018.05.0102 DOI
040		a (SwePub)uu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Goey, Kaitlyn K. H.u Univ Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlands4 aut
245	1 0	a Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer :b Supported by the ARCAD Group
264	1	b ELSEVIER SCI LTD,c 2018
338		a print2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
653		a Colorectal cancer
653		a Metastatic disease
653		a Patient characteristics
653		a Prognosis
653		a Stratification
653		a Clinical trials
653		a Delphi survey
700	1	a Sorbye, Halfdanu Haukeland Hosp, Dept Oncol, Bergen, Norway;Haukeland Hosp, Dept Clin Sci, Bergen, Norway4 aut
700	1	a Glimelius, Bengtu Uppsala universitet,Experimentell och klinisk onkologi,Uppsala Univ, Dept Immunol Genet & Pathol, Uppsala, Sweden4 aut0 (Swepub:uu)bengglim
700	1	a Adams, Richard A.u Ctr Trials Res Canc Grp, Cardiff, S Glam, Wales4 aut
700	1	a Andre, Thierryu UMPC Paris 06, Sorbonne Univ, Hop St Antoine, Dept Med Oncol, Paris, France4 aut
700	1	a Arnold, Dirku Asklepios Klin Altona, Asklepios Tumorzentrum Hamburg, Hamburg, Germany4 aut
700	1	a Berlin, Jordan D.u Vanderbilt Univ, Vanderbilt Ingram Canc Ctr, Nashville, TN USA4 aut
700	1	a Bodoky, Györgyu St Laszlo Hosp, Dept Med Oncol, Budapest, Hungary4 aut
700	1	a de Gramont, Aimeryu Inst Hosp Franco Britannique, Dept Med Oncol, Paris, France4 aut
700	1	a Diaz-Rubio, Eduardou Univ Complutense, Hosp Clin San Carlos, Dept Med Oncol, CIBERONC, Madrid, Spain4 aut
700	1	a Eng, Cathyu MD Anderson Canc Ctr, Dept Med Oncol, Houston, TX USA4 aut
700	1	a Falcone, Alfredou Univ Pisa, Dept Med Oncol, Pisa, Italy4 aut
700	1	a Grothey, Axelu Mayo Clin, Div Med Oncol, Rochester, MN USA4 aut
700	1	a Heineman, Volkeru Univ Clin Munich, Comprehens Canc Ctr, Med Dept 3, Munich, Germany4 aut
700	1	a Hochster, Howard S.u Rutgers Canc Inst New Jersey, New Brunswick, NJ USA4 aut
700	1	a Kaplan, Richard S.u UCL, MRC, Clin Trials Unit, London, England4 aut
700	1	a Kopetz, Scottu MD Anderson Canc Ctr, Dept Med Oncol, Houston, TX USA4 aut
700	1	a Labianca, Robertou Osped Giovanni 23, Canc Ctr, Bergamo, Italy4 aut
700	1	a Lieu, Christopher H.u Univ Colorado, Div Med Oncol, Denver, CO 80202 USA4 aut
700	1	a Meropol, Neal J.u Flatiron Hlth, New York, NY USA;Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA4 aut
700	1	a Price, Timothy J.u Queen Elizabeth Hosp, Dept Med Oncol, Woodville, SA, Australia4 aut
700	1	a Schilsky, Richard L.u Amer Soc Clin Oncol, Alexandria, VA USA4 aut
700	1	a Schmoll, Hans-Joachimu Martin Luther Univ Halle Wittenberg, Univ Clin Halle, Div Clin Oncol Res, Halle, Germany4 aut
700	1	a Shacham-Shmueli, Einatu Sheba Med Ctr, Canc Ctr, Tel Hashomer, Israel4 aut
700	1	a Shi, Qianu Mayo Clin, Dept Hlth Sci Res, Rochester, MN USA4 aut
700	1	a Sobrero, Alberto F.u Policlin San Martino IRCCS, Genoa, Italy4 aut
700	1	a Souglakos, Johnu Univ Gen Hosp Heraklion, Dept Med Oncol, Iraklion, Greece4 aut
700	1	a van Cutsem, Ericu Univ Hosp Gasthuisberg Leuven, Dept Digest Oncol, Leuven, Belgium;Katholieke Univ Leuven, Leuven, Belgium4 aut
700	1	a Zalcberg, Johnu Monash Univ, Dept Epidemiol & Prevent Med, Melbourne, Vic, Australia4 aut
700	1	a van Oijen, Martijn G. H.u Univ Amsterdam, Acad Med Ctr, Dept Med Oncol, Amsterdam, Netherlands4 aut
700	1	a Punt, Cornelis J. A.u Univ Amsterdam, Acad Med Ctr, Dept Med Oncol, Amsterdam, Netherlands4 aut
700	1	a Koopman, Miriamu Univ Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlands4 aut
710	2	a Univ Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlandsb Haukeland Hosp, Dept Oncol, Bergen, Norway;Haukeland Hosp, Dept Clin Sci, Bergen, Norway4 org
773	0	t European Journal of Cancerd : ELSEVIER SCI LTDg 100, s. 35-45q 100<35-45x 0959-8049x 1879-0852
856	4	u https://discovery.ucl.ac.uk/10054713/1/Goey_Consensus%20statement%20prognostic%20factors%20mCRC%20trials_EJC2018%20final%20pre-pub.pdf
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-361483
856	4 8	u https://doi.org/10.1016/j.ejca.2018.05.010

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