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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 ...

  • ELSEVIER SCI LTD,2018
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:uu-361483
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-361483URI
  • https://doi.org/10.1016/j.ejca.2018.05.010DOI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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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  • Sorbye, HalfdanHaukeland Hosp, Dept Oncol, Bergen, Norway;Haukeland Hosp, Dept Clin Sci, Bergen, Norway (author)
  • Glimelius, BengtUppsala universitet,Experimentell och klinisk onkologi,Uppsala Univ, Dept Immunol Genet & Pathol, Uppsala, Sweden(Swepub:uu)bengglim (author)
  • Adams, Richard A.Ctr Trials Res Canc Grp, Cardiff, S Glam, Wales (author)
  • Andre, ThierryUMPC Paris 06, Sorbonne Univ, Hop St Antoine, Dept Med Oncol, Paris, France (author)
  • Arnold, DirkAsklepios Klin Altona, Asklepios Tumorzentrum Hamburg, Hamburg, Germany (author)
  • Berlin, Jordan D.Vanderbilt Univ, Vanderbilt Ingram Canc Ctr, Nashville, TN USA (author)
  • Bodoky, GyörgySt Laszlo Hosp, Dept Med Oncol, Budapest, Hungary (author)
  • de Gramont, AimeryInst Hosp Franco Britannique, Dept Med Oncol, Paris, France (author)
  • Diaz-Rubio, EduardoUniv Complutense, Hosp Clin San Carlos, Dept Med Oncol, CIBERONC, Madrid, Spain (author)
  • Eng, CathyMD Anderson Canc Ctr, Dept Med Oncol, Houston, TX USA (author)
  • Falcone, AlfredoUniv Pisa, Dept Med Oncol, Pisa, Italy (author)
  • Grothey, AxelMayo Clin, Div Med Oncol, Rochester, MN USA (author)
  • Heineman, VolkerUniv Clin Munich, Comprehens Canc Ctr, Med Dept 3, Munich, Germany (author)
  • Hochster, Howard S.Rutgers Canc Inst New Jersey, New Brunswick, NJ USA (author)
  • Kaplan, Richard S.UCL, MRC, Clin Trials Unit, London, England (author)
  • Kopetz, ScottMD Anderson Canc Ctr, Dept Med Oncol, Houston, TX USA (author)
  • Labianca, RobertoOsped Giovanni 23, Canc Ctr, Bergamo, Italy (author)
  • Lieu, Christopher H.Univ Colorado, Div Med Oncol, Denver, CO 80202 USA (author)
  • Meropol, Neal J.Flatiron Hlth, New York, NY USA;Case Western Reserve Univ, Case Comprehens Canc Ctr, Cleveland, OH 44106 USA (author)
  • Price, Timothy J.Queen Elizabeth Hosp, Dept Med Oncol, Woodville, SA, Australia (author)
  • Schilsky, Richard L.Amer Soc Clin Oncol, Alexandria, VA USA (author)
  • Schmoll, Hans-JoachimMartin Luther Univ Halle Wittenberg, Univ Clin Halle, Div Clin Oncol Res, Halle, Germany (author)
  • Shacham-Shmueli, EinatSheba Med Ctr, Canc Ctr, Tel Hashomer, Israel (author)
  • Shi, QianMayo Clin, Dept Hlth Sci Res, Rochester, MN USA (author)
  • Sobrero, Alberto F.Policlin San Martino IRCCS, Genoa, Italy (author)
  • Souglakos, JohnUniv Gen Hosp Heraklion, Dept Med Oncol, Iraklion, Greece (author)
  • van Cutsem, EricUniv Hosp Gasthuisberg Leuven, Dept Digest Oncol, Leuven, Belgium;Katholieke Univ Leuven, Leuven, Belgium (author)
  • Zalcberg, JohnMonash Univ, Dept Epidemiol & Prevent Med, Melbourne, Vic, Australia (author)
  • van Oijen, Martijn G. H.Univ Amsterdam, Acad Med Ctr, Dept Med Oncol, Amsterdam, Netherlands (author)
  • Punt, Cornelis J. A.Univ Amsterdam, Acad Med Ctr, Dept Med Oncol, Amsterdam, Netherlands (author)
  • Koopman, MiriamUniv Utrecht, Univ Med Ctr Utrecht, Dept Med Oncol, Utrecht, Netherlands (author)
  • 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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