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Consensus statement...
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Goey, Kaitlyn K. H.Univ Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlands
(author)
Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer : Supported by the ARCAD Group
- Article/chapterEnglish2018
Publisher, publication year, extent ...
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ELSEVIER SCI LTD,2018
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-361483
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-361483URI
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https://doi.org/10.1016/j.ejca.2018.05.010DOI
Supplementary language notes
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Language:English
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Summary in:English
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Classification
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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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.
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Added entries (persons, corporate bodies, meetings, titles ...)
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Sorbye, HalfdanHaukeland Hosp, Dept Oncol, Bergen, Norway;Haukeland Hosp, Dept Clin Sci, Bergen, Norway
(author)
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Glimelius, BengtUppsala universitet,Experimentell och klinisk onkologi,Uppsala Univ, Dept Immunol Genet & Pathol, Uppsala, Sweden(Swepub:uu)bengglim
(author)
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Adams, Richard A.Ctr Trials Res Canc Grp, Cardiff, S Glam, Wales
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Andre, ThierryUMPC Paris 06, Sorbonne Univ, Hop St Antoine, Dept Med Oncol, Paris, France
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Arnold, DirkAsklepios Klin Altona, Asklepios Tumorzentrum Hamburg, Hamburg, Germany
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Berlin, Jordan D.Vanderbilt Univ, Vanderbilt Ingram Canc Ctr, Nashville, TN USA
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Bodoky, GyörgySt Laszlo Hosp, Dept Med Oncol, Budapest, Hungary
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de Gramont, AimeryInst Hosp Franco Britannique, Dept Med Oncol, Paris, France
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Diaz-Rubio, EduardoUniv Complutense, Hosp Clin San Carlos, Dept Med Oncol, CIBERONC, Madrid, Spain
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Eng, CathyMD Anderson Canc Ctr, Dept Med Oncol, Houston, TX USA
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Falcone, AlfredoUniv Pisa, Dept Med Oncol, Pisa, Italy
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Grothey, AxelMayo Clin, Div Med Oncol, Rochester, MN USA
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Heineman, VolkerUniv Clin Munich, Comprehens Canc Ctr, Med Dept 3, Munich, Germany
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Hochster, Howard S.Rutgers Canc Inst New Jersey, New Brunswick, NJ USA
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Kaplan, Richard S.UCL, MRC, Clin Trials Unit, London, England
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Kopetz, ScottMD Anderson Canc Ctr, Dept Med Oncol, Houston, TX USA
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Labianca, RobertoOsped Giovanni 23, Canc Ctr, Bergamo, Italy
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Lieu, Christopher H.Univ Colorado, Div Med Oncol, Denver, CO 80202 USA
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Meropol, Neal J.Flatiron Hlth, New York, NY USA;Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA
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Price, Timothy J.Queen Elizabeth Hosp, Dept Med Oncol, Woodville, SA, Australia
(author)
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Schilsky, Richard L.Amer Soc Clin Oncol, Alexandria, VA USA
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Schmoll, Hans-JoachimMartin Luther Univ Halle Wittenberg, Univ Clin Halle, Div Clin Oncol Res, Halle, Germany
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Shacham-Shmueli, EinatSheba Med Ctr, Canc Ctr, Tel Hashomer, Israel
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Shi, QianMayo Clin, Dept Hlth Sci Res, Rochester, MN USA
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Sobrero, Alberto F.Policlin San Martino IRCCS, Genoa, Italy
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Souglakos, JohnUniv Gen Hosp Heraklion, Dept Med Oncol, Iraklion, Greece
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van Cutsem, EricUniv Hosp Gasthuisberg Leuven, Dept Digest Oncol, Leuven, Belgium;Katholieke Univ Leuven, Leuven, Belgium
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Zalcberg, JohnMonash Univ, Dept Epidemiol & Prevent Med, Melbourne, Vic, Australia
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van Oijen, Martijn G. H.Univ Amsterdam, Acad Med Ctr, Dept Med Oncol, Amsterdam, Netherlands
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Punt, Cornelis J. A.Univ Amsterdam, Acad Med Ctr, Dept Med Oncol, Amsterdam, Netherlands
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Koopman, MiriamUniv Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlands
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Univ Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, NetherlandsHaukeland Hosp, Dept Oncol, Bergen, Norway;Haukeland Hosp, Dept Clin Sci, Bergen, Norway
(creator_code:org_t)
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In:European Journal of Cancer: ELSEVIER SCI LTD100, s. 35-450959-80491879-0852
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Goey, Kaitlyn K. ...
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Sorbye, Halfdan
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Glimelius, Bengt
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Adams, Richard A ...
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Andre, Thierry
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Arnold, Dirk
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Berlin, Jordan D ...
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Bodoky, György
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de Gramont, Aime ...
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Diaz-Rubio, Edua ...
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Eng, Cathy
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Falcone, Alfredo
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Grothey, Axel
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Heineman, Volker
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Hochster, Howard ...
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Kaplan, Richard ...
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Kopetz, Scott
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Labianca, Robert ...
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Lieu, Christophe ...
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Meropol, Neal J.
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Price, Timothy J ...
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Schilsky, Richar ...
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Schmoll, Hans-Jo ...
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Shacham-Shmueli, ...
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Shi, Qian
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Sobrero, Alberto ...
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Souglakos, John
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van Cutsem, Eric
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Zalcberg, John
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van Oijen, Marti ...
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Punt, Cornelis J ...
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Koopman, Miriam
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