The trial initially recruited 735 patients independent of KRAS status, but was amended to include only KRAS wild-type tumors after it became known that cetuximab was not active in these patients. At the ASCO 2011 meeting, Dr. Heinemann reported no difference in efficacy or survival between the two strategies in the subgroup of patients with KRAS-mutated tumors.
Among patients with wild-type tumors, the median treatment duration was shorter with cetuximab at 4.7 months vs. 5.3 months with bevacizumab. This is not surprising given the potential for skin issues with cetuximab, but that the toxicity profiles were manageable for both combinations, he said in an interview.
Dr. Heinemann reported honoraria, other remuneration and research funding from the study sponsor, Merck, and honoraria and other remuneration from Roche. Several of his coauthors reported honoraria, other remuneration, and research funding from Merck. Merck distributes cetuximab outside of the United States.
Heinemann, V., et al. "Randomized comparison of FOLFIRI plus cetuximab versus FOLFIRIE plus bevacizumab as first-line treatment of KRAS-wildtype metastatic colorectal cancer: German AIO study KRK-0303 (FIRE-3)." LBA3506.