Cetuximab in treatment of metastatic colorectal cancer: final survival analyses and extended RAS data from the NORDIC-VII study

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Cetuximab in treatment of metastatic colorectal cancer : final survival analyses and extended RAS data from the NORDIC-VII study

Guren, Tormod Kyrre (author): Oslo Univ Hosp, Dept Oncol, Oslo, Norway.;KG Jebsen Colorectal Canc Res Ctr, Oslo, Norway.

Thomsen, Maria (author): Oslo Univ Hosp, Dept Oncol, Oslo, Norway.;Univ Oslo, Fac Med, Inst Clin Med, Oslo, Norway.

Kure, Elin H. (author): Oslo Univ Hosp, Inst Canc Res, Dept Canc Genet, Oslo, Norway.

Sorbye, Halfdan (author): Haukeland Hosp, Dept Oncol, Bergen, Norway.;Univ Bergen, Dept Clin Sci, Bergen, Norway.

Glimelius, Bengt (author): Uppsala universitet,Experimentell och klinisk onkologi

Pfeiffer, Per (author): Odense Univ Hosp, Dept Oncol, Odense, Denmark.;Univ Southern Denmark, Inst Clin Res, Odense, Denmark.

Osterlund, Pia (author): Tampere Univ Hosp, Dept Oncol, Tampere, Finland.

Sigurdsson, Fridbjorn (author): Landspitali, Dept Oncol, Reykjavik, Iceland.

Lothe, Inger Marie Bowitz (author): Oslo Univ Hosp, Dept Pathol, Oslo, Norway.

Dalsgaard, Astrid Marie (author): Univ Oslo, Fac Med, Inst Clin Med, Oslo, Norway.

Skovlund, Eva (author): Norwegian Univ Sci & Technol, Dept Publ Hlth & Nursing, Trondheim, Norway.

Christoffersen, Thoralf (author): Univ Oslo, Fac Med, Inst Clin Med, Dept Pharmacol, Oslo, Norway.

Tveit, Kjell Magne (author): Oslo Univ Hosp, Dept Oncol, Oslo, Norway.;KG Jebsen Colorectal Canc Res Ctr, Oslo, Norway.;Univ Oslo, Fac Med, Inst Clin Med, Oslo, Norway.

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Oslo Univ Hosp, Dept Oncol, Oslo, Norway;KG Jebsen Colorectal Canc Res Ctr, Oslo, Norway. Oslo Univ Hosp, Dept Oncol, Oslo, Norway.;Univ Oslo, Fac Med, Inst Clin Med, Oslo, Norway. (creator_code:org_t)

2017-04-11
2017
English.
In: British Journal of Cancer. - : NATURE PUBLISHING GROUP. - 0007-0920 .- 1532-1827. ; 116:10, s. 1271-1278

Related links:: https://doi.org/10.1...; show more...; https://uu.diva-port... (primary) (Raw object); https://www.nature.c...; https://urn.kb.se/re...; https://doi.org/10.1...; show less...

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Background: The NORDIC-VII study is a randomised phase III trial of cetuximab plus continuous or intermittent fluorouracil, folinic acid, and oxaliplatin (Nordic FLOX) vs FLOX alone in first-line treatment of metastatic colorectal cancer. The present report presents an updated and final survival analysis with BRAF and extended RAS mutational status, 5 years after the primary analysis.Methods: A total of 566 patients were included in the intention-to-treat (ITT) population of the NORDIC-VII study. Updated survival status was obtained from 176 patients who were alive in the primary survival analyses. Samples from 223 tumours previously found to be KRAS (exon 2) and BRAF (V600E) wild-type, were re-analysed for KRAS (exons 3 and 4) and NRAS (exons 2-4) mutations.Results: Including the extended RAS analyses, RAS and BRAF mutational status was available from 457 patients (81% of the ITT population). RAS was mutated in 46% and BRAF in 12% of the tumours. RAS and BRAF, if mutated, were negative prognostic factors. The updated analyses confirmed the finding of the primary report that cetuximab did not provide any additional benefit when added to FLOX in patients with RAS/BRAF wild-type tumours, neither on progression-free nor overall survival. However, the outcomes in a subset of patients, which, after the first eight treatment cycles, received cetuximab alone, suggested a beneficial effect of cetuximab monotherapy.Conclusions: Adding cetuximab to Nordic FLOX did not provide any clinical benefit, but the data suggested an effect of cetuximab monotherapy in patients with RAS/BRAF wild-type tumours in the NORDIC-VII cohort. The data were compatible with a negative interaction between cetuximab and the Nordic FLOX chemotherapy backbone.

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By the author/editor: Guren, Tormod Ky ...; Thomsen, Maria; Kure, Elin H.; Sorbye, Halfdan; Glimelius, Bengt; Pfeiffer, Per; show more...; Osterlund, Pia; Sigurdsson, Frid ...; Lothe, Inger Mar ...; Dalsgaard, Astri ...; Skovlund, Eva; Christoffersen, ...; Tveit, Kjell Mag ...; show less...

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cancer and Oncol ...

Articles in the publication: British Journal ...

By the university: Uppsala University

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Cetuximab in treatment of metastatic colorectal cancer : final survival analyses and extended RAS data from the NORDIC-VII study

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