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FOLFIRI Plus Regorafenib in Metastatic Colorectal Cancer

By: Kayci Reyer
Posted: Monday, January 14, 2019

According to research published in Cancer, the addition of second-line regorafenib to folinic acid, fluorouracil, and irinotecan (FOLFIRI) treatment “only modestly prolonged” progression-free survival for patients with metastatic colorectal cancer when compared with FOLFIRI monotherapy. Regorafenib alone had been shown to prolong survival in patients with refractory colorectal cancer, noted Richard Goldberg, MD, of the West Virginia University Cancer Institute, Morgantown, and colleagues.

A total of 181 patients with metastatic colorectal cancer were randomly assigned to receive FOLFIRI with either regorafenib (n = 120) or placebo (n = 61). All participants underwent a treatment cycle of 28 days, with FOLFIRI on days 1, 2, 15, and 16 and either regorafenib or placebo on days 4 to 10 and 18 to 24. Of the 181 participants, 117 (65%) received bevacizumab or aflibercept prior to the study.

The cohort receiving regorafenib/FOLFIRI experienced longer progression-free survival (median, 6.1 months vs. 5.3 months) as well as a higher response rate (34% vs. 21%) when compared with the placebo group. The regorafenib arm did not experience an increased overall survival rate. According to the investigators, “The added toxicity cost from this combination leads to frequent dose reductions, which likely account for the lack of an [overall survival] benefit.” Diarrhea and neutropenia were among the grade 3 or 4 adverse events with a greater than 5% increase in the regorafenib group.

“You have to balance the benefit, in terms of slowing tumor progression and improving survival, with quality of life. And that often takes experimentation. That’s why we do studies like this,” commented Dr. Goldberg in an institutional press release.

Disclosure: The study authors’ disclosure information may be found at

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