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Abstract
Evaluation of: Colucci G, Giuliani F, Garufi C et al. Cetuximab plus FOLFOX-4 in untreated patients with advanced colorectal cancer: a Gruppo Oncologico dell’Italia Meridionale Multicenter Phase II study. Oncology 79, 415–422 (2010).
This Phase II clinical trial investigates the activity and safety of FOLFOX–cetuximab in the first-line treatment of colorectal cancer. This turns out to be an active regimen which allows a high rate of conversion and radical metastectomy. Overall response rate is concordant with those previously reported. The toxicity profile is also similar, and cutaneous toxicity severity seems to be a marker of activity. Retrospectively, the authors analyze the status of KRAS and BRAF in a subgroup of patients, only in 50%. KRAS appears mutated in 37%, and BRAF does not present as mutated in any of the remaining wild-type KRAS patients. KRAS mutation correlates with shorter overall survival and possibly time to progression. The sample is too small to find mutations in BRAF, or to convincingly establish the role of both biomarkers. These data demonstrate an active regimen that is first in line to be confirmed in larger Phase III trials.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.