Detection of BRAF V600 Mutations in Melanoma: Evaluation of Concordance between the Cobas 4800 BRAF V600 Mutation Test and the Methods Used in French National Cancer Institute (INCa) Platforms in a Real-Life Setting

authors

  • Mourah Samia
  • Denis Marc G.
  • Escande Narducci Fabienne
  • Solassol Jérôme
  • Merlin Jean-Louis
  • Sabourin Jean-Christophe
  • Scoazec Jean-Yves
  • Ouafik l'Houcine
  • Emile Jean-François
  • Heller Remy
  • Souvignet Claude
  • Bergougnoux Loïc
  • Merlio Jean-Philippe

keywords

  • ASSAY
  • THERAPY
  • IMPROVED SURVIVAL
  • PV600E
  • VEMURAFENIB
  • OPEN-LABEL
  • INHIBITION
  • PERFORMANCE
  • METASTATIC MELANOMA
  • MALIGNANT-MELANOMA

document type

ART

abstract

Vemurafenib is approved for the treatment of metastatic melanoma in patients with BRAF V600 mutation. In pivotal clinical trials, BRAF testing has always been done with the approved cobas 4800 BRAF test. In routine practice, several methods are available and are used according to the laboratories usual procedures. A national, multicenter, non-interven-tional study was conducted with prospective and consecutive collection of tumor samples. A parallel evaluation was performed in routine practice between the cobas 4800 BRAF V600 mutation test and home brew methods (HBMs) of 12 national laboratories, labelled and funded by the French National Cancer Institute (INCa). For 420 melanoma samples tested, the cobas method versus HBM showed a high concordance (93.3%; kappa = 0.86) in BRAF V600 genotyping with similar mutation rates (34.0% versus 35.7%, respectively). Overall, 97.4% and 98.6% of samples gave valid results using the cobas and HBM, respectively. Of the 185 samples strictly fulfilling the cobas guidelines, the concordance rate was even higher (95.7%; kappa = 0.91; 95%CI [0.85; 0.97]). Out of the 420 samples tested, 28 (6.7%) showed discordance between HBM and cobas. This prospective study shows a high concordance rate between the cobas 4800 BRAF V600 test and home brew methods in the routine detection of BRAF V600E mutations.

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