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Clinical activity of FOLFIRI plus cetuximab according to extended gene mutation status by next-generation sequencing:

F Ciardiello1, N Normanno2, E Maiello3

  • 1Department of Clinical and Experimental Medicine 'F. Magrassi', Medical Oncology, Second University of Naples, Naples.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|June 20, 2014
PubMed
Abstract

Insights

Next-generation sequencing (NGS) is feasible for metastatic colorectal cancer (mCRC) patients, identifying gene mutations that predict benefit from FOLFIRI plus cetuximab treatment.

Area of Science:

  • Oncology
  • Genomics
  • Molecular Diagnostics

Background:

  • Antiepidermal growth factor receptor (anti-EGFR) antibody treatment is limited to metastatic colorectal cancer (mCRC) patients with RAS wild-type tumors.
  • Next-generation sequencing (NGS) offers comprehensive assessment of gene alterations, potentially providing predictive and prognostic information.

Purpose of the Study:

  • To evaluate the feasibility and utility of NGS in mCRC patients treated with FOLFIRI plus cetuximab.
  • To identify gene mutations associated with treatment response and outcomes.

Main Methods:

  • The CAPRI-GOIM trial enrolled 340 KRAS exon 2 wild-type mCRC patients receiving first-line FOLFIRI plus cetuximab.
  • Tumor samples from 182 patients underwent NGS to analyze mutations in 22 colon cancer-related genes.

Main Results:

  • NGS identified mutations in 68.1% of tumors across 14 genes, including TP53, KRAS, NRAS, PIK3CA, and BRAF.
  • Patients with KRAS/NRAS wild-type tumors showed higher objective response rates (ORR) and longer progression-free survival (PFS) compared to those with mutations.
  • KRAS exon 2 mutations were found in 15.9% of samples initially classified as wild-type.

Conclusions:

  • NGS analysis is feasible in mCRC and reveals significant intra- and inter-tumor heterogeneity.
  • NGS can identify patients likely to benefit from FOLFIRI plus cetuximab therapy.
  • The study highlights the importance of comprehensive genomic profiling beyond KRAS exon 2 for guiding anti-EGFR therapy.
Keywords:
BRAFKSA/NRASPIK3CAcetuximabcolorectal cancernext-generation sequencing

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