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Adding cetuximab to modified FOLFOX did not improve outcomes of resected colon cancer
The addition of the drug cetuximab to the modified sixth version of the FOLFOX regimen, mFOLFOX6, did not improve disease-free survival in patients with stage III resected colon cancer with wild-type KRAS.
Prior research has shown that in the metastatic setting, the addition of cetuximab (Erbitux, Imclone) to chemotherapy provides an additional benefit than chemotherapy alone.
“The reasons for the lack of benefit of mFOLFOX6 with cetuximab in the adjuvant setting remain unclear,” the researchers wrote. “New approaches are needed to identify drugs that may be of benefit in adjuvant therapy because, as shown in our trial, promising activity in the metastatic setting did not translate into adjuvant therapy benefit and underscores the importance of performing clinical trials.”
In the study, researchers randomly assigned 2,686 patients to receive 12 biweekly cycles of mFOLFOX6 with or without cetuximab. All patients had undergone resection of stage III colon cancer. Disease-free survival was the primary endpoint. The trial was halted after a planned interim analysis.
The median range of follow-up was 28 months. The trial showed no benefit to adding cetuximab to treatment, as 3-year disease-free survival was similar between both groups of patients regardless of KRAS mutation status.
In addition, those patients assigned to cetuximab had significantly higher grade-3 or higher adverse events (OR=2.4; 95% CI, 2.1-2.8) and failure to complete 12 cycles (OR=1.6; 95% CI, 1.4-1.9).