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Sökning: onr:"swepub:oai:DiVA.org:uu-176828" > Phase III Trial of ...

  • Tveit, Kjell MagneOslo University Hospital, Norway (författare)

Phase III Trial of Cetuximab With Continuous or Intermittent Fluorouracil, Leucovorin, and Oxaliplatin (Nordic FLOX) Versus FLOX Alone in First-Line Treatment of Metastatic Colorectal Cancer : The NORDIC-VII Study

  • Artikel/kapitelEngelska2012

Förlag, utgivningsår, omfång ...

  • American Society of Clinical Oncology: JCO,2012
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-176828
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-176828URI
  • https://doi.org/10.1200/JCO.2011.38.0915DOI
  • https://lup.lub.lu.se/record/2519831URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:124686504URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-78817URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agencies|Kjell Magne Tveit||Merck Serono||sanofi-aventis||Bengt Glimelius||Eli Lilly||Per Pfeiffer||Roche||Halfdan Sorbye||Seppo Pyrhonen||Anders Johnsson||Fridbjorn Sigurdsson||Merck Serono (Darmstadt, Germany)||sanofi-aventis (Oslo, Norway)||Norwegian Cancer Society||Swedish Cancer Society (Cancerfonden)||
  • Purpose: The NORDIC-VII multicenter phase III trial investigated the efficacy of cetuximab when added to bolus fluorouracil/folinic acid and oxaliplatin (Nordic FLOX), administered continuously or intermittently, in previously untreated metastatic colorectal cancer (mCRC). The influence of KRAS mutation status on treatment outcome was also investigated. Patients and Methods: Patients were randomly assigned to receive either standard Nordic FLOX (arm A), cetuximab and FLOX (arm B), or cetuximab combined with intermittent FLOX (arm C). Primary end point was progression-free survival (PFS). Overall survival (OS), response rate, R0 resection rate, and safety were secondary end points. Results: Of the 571 patients randomly assigned, 566 were evaluable in intention-to-treat (ITT) analyses. KRAS and BRAF mutation analyses were obtained in 498 (88%) and 457 patients (81%), respectively. KRAS mutations were present in 39% of the tumors; 12% of tumors had BRAF mutations. The presence of BRAF mutations was a strong negative prognostic factor. In the ITT population, median PFS was 7.9, 8.3, and 7.3 months for the three arms, respectively (not significantly different). OS was almost identical for the three groups (20.4, 19.7, 20.3 months, respectively), and confirmed response rates were 41%, 49%, and 47%, respectively. In patients with KRAS wild-type tumors, cetuximab did not provide any additional benefit compared with FLOX alone. In patients with KRAS mutations, no significant difference was detected, although a trend toward improved PFS was observed in arm B. The regimens were well tolerated. Conclusion: Cetuximab did not add significant benefit to the Nordic FLOX regimen in first-line treatment of mCRC.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Guren, TormodUppsala Hospital, Sweden Karolinska Institute, Sweden (författare)
  • Glimelius, BengtUppsala universitet,Enheten för onkologi(Swepub:uu)bengglim (författare)
  • Pfeiffer, PerOdense University Hospital, Denmark (författare)
  • Sorbye, HalfdanHaukeland Hospital, Norway University of Bergen, Norway (författare)
  • Pyrhonen, SeppoTurku University Hospital, Finland (författare)
  • Sigurdsson, FridbjornNational University Hospital Reykjavik, Iceland (författare)
  • Kure, ElinUniversity of Oslo, Norway (författare)
  • Ikdahl, Tone (författare)
  • Skovlund, Eva (författare)
  • Fokstuen, ToneKarolinska Institute, Sweden (författare)
  • Hansen, FlemmingAarhus University Hospital, Denmark (författare)
  • Hofsli, EvaSt Olavs Hospital, Norway (författare)
  • Birkemeyer, ElkeStavanger University Hospital, Norway (författare)
  • Johnsson, AndersLund University,Lunds universitet,Bröstcancer-genetik,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Breastcancer-genetics,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,University of Lund Hospital, Sweden(Swepub:lu)onk-ajo (författare)
  • Starkhammar, HansÖstergötlands Läns Landsting,Linköpings universitet,Onkologi,Hälsouniversitetet,Onkologiska kliniken US(Swepub:liu)hanst87 (författare)
  • Yilmaz, Mette KarenAalborg University Hospital, Denmark (författare)
  • Keldsen, NinaHerning Regional Hospital, Denmark (författare)
  • Erdal, Anne BeritHaukeland Hospital, Norway University of Bergen, Norway (författare)
  • Dajani, Olav (författare)
  • Dahl, Olav (författare)
  • Christoffersen, ThoralfUniversity of Oslo, Norway (författare)
  • Oslo University Hospital, NorwayUppsala Hospital, Sweden Karolinska Institute, Sweden (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Journal of Clinical Oncology: American Society of Clinical Oncology: JCO30:15, s. 1755-17620732-183X1527-7755

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