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Phase III Trial of ...
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
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- Tveit, Kjell Magne (author)
- Oslo University Hospital, Norway
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- Guren, Tormod (author)
- Uppsala Hospital, Sweden Karolinska Institute, Sweden
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- Glimelius, Bengt (author)
- Uppsala universitet,Enheten för onkologi
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- Pfeiffer, Per (author)
- Odense University Hospital, Denmark
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- Sorbye, Halfdan (author)
- Haukeland Hospital, Norway University of Bergen, Norway
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- Pyrhonen, Seppo (author)
- Turku University Hospital, Finland
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- Sigurdsson, Fridbjorn (author)
- National University Hospital Reykjavik, Iceland
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- Kure, Elin (author)
- University of Oslo, Norway
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Ikdahl, Tone (author)
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Skovlund, Eva (author)
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- Fokstuen, Tone (author)
- Karolinska Institute, Sweden
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- Hansen, Flemming (author)
- Aarhus University Hospital, Denmark
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- Hofsli, Eva (author)
- St Olavs Hospital, Norway
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- Birkemeyer, Elke (author)
- Stavanger University Hospital, Norway
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- Johnsson, Anders (author)
- Lund 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
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- Starkhammar, Hans (author)
- Östergötlands Läns Landsting,Linköpings universitet,Onkologi,Hälsouniversitetet,Onkologiska kliniken US
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- Yilmaz, Mette Karen (author)
- Aalborg University Hospital, Denmark
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- Keldsen, Nina (author)
- Herning Regional Hospital, Denmark
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- Erdal, Anne Berit (author)
- Haukeland Hospital, Norway University of Bergen, Norway
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Dajani, Olav (author)
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Dahl, Olav (author)
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- Christoffersen, Thoralf (author)
- University of Oslo, Norway
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(creator_code:org_t)
- American Society of Clinical Oncology: JCO, 2012
- 2012
- English.
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In: Journal of Clinical Oncology. - : American Society of Clinical Oncology: JCO. - 0732-183X .- 1527-7755. ; 30:15, s. 1755-1762
- Related links:
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http://www.ncbi.nlm....
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http://dx.doi.org/10...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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http://kipublication...
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https://urn.kb.se/re...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- MEDICINE
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Tveit, Kjell Mag ...
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Guren, Tormod
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Glimelius, Bengt
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Pfeiffer, Per
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Sorbye, Halfdan
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Pyrhonen, Seppo
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show more...
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Sigurdsson, Frid ...
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Kure, Elin
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Ikdahl, Tone
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Skovlund, Eva
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Fokstuen, Tone
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Hansen, Flemming
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Hofsli, Eva
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Birkemeyer, Elke
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Johnsson, Anders
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Starkhammar, Han ...
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Yilmaz, Mette Ka ...
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Keldsen, Nina
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Erdal, Anne Beri ...
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Dajani, Olav
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Dahl, Olav
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Christoffersen, ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Journal of Clini ...
- By the university
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Uppsala University
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Lund University
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Karolinska Institutet
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Linköping University