Cancer Treatment Today

Patients who received cetuximab (Erbitux) in combination with a standard adjuvant therapy for resected stage III colon cancer did not experience improved disease-free survival (DFS) or improved overall survival, according to the results of a trial that will be published in the JAMA. n the multicenter Phase III trial, 2686 patients were randomized into two groups that received cetuximab and 12 biweekly cycles of leucovorin, fluorouracil, and oxaliplatin (FOLFOX) specifically mFOLFOX6 or mFOLFOX6 alone. Of those, 1863 had tumors exhibiting wild-type KRAS mutations. Additionally, 717 patients with mutated KRAS and 106 indeterminate KRAS were enrolled in the study. Cetuximab is approved for patients with metastatic colon cancer, but only those who exhibit wild-type KRAS. The primary endpoint was DFS in patients with wild-type KRAS mutations. After a median follow-up of 28 months (range, 0-68), the three-year DFS for wild-type KRAS mutated patients who received mFOLFOX6 alone was 74.6% compared to 71.5% in those who received mFOLFOX6 and cetuximab (HR, 1.21; 95% CI, 0.98-1.49, P = .08). In patients with mutated KRAS, the DFS was 67.1% in the mFOLFOX6 alone group compared to 65.0% in the mFOLFOX6 plus cetuximab group (HR, 1.12; 95% CI, 0.86-1.46, P = .38), there was no benefit observed in any subgroups.

Although a subsequent study showed non-statistically signifcant advantage in subgroup, ti recommended a full study, rather than routine use of cetuximab for adjuvant therapy.

Alberts SR, Sargent DJ, Nair S, et al. Effect of Oxaliplatin, Fluorouracil, and Leucovorin With or Without Cetuximab on Survival Among Patients With Resected Stage III Colon Cancer: A Randomized Trial. JAMA. 2012; 307(13):1383-1393.

J. Taieb R. Balogoun K. Le Malicot J. Tabernero E. Mini G. Folprecht J.-L. Van Laethem J.-F. Emile C. Mulot S. Fratt, éAdjuvant FOLFOX +/ cetuximab in full RAS and BRAF wildtype stage III colon cancer patients. Annals of Oncology, Volume 28, Issue 4, 1 April 2017, Pages 824830,