ACCRU News & Releases – April 23, 2018

Each year, approximately 1.3 million patients are diagnosed with colorectal cancer worldwide, and more than 600,000 patients die from the disease. A recently completed Academic and Community Cancer Research United (ACCRU) phase II trial is helping to establish a standard dosing strategy for regorafenib, an oral multi kinase inhibitor. Regorafenib has been shown to improve survival in patients with metastatic colorectal cancer, which is cancer that has spread from the colon to other parts of the body. Results from the ACCRU trial show that a strategy of starting with a lower dose and increasing it weekly was superior to using the higher dose throughout treatment.

“While regorafinib was approved by the Food and Drug Administration in 2012, side effects such as Palmar-planter erythrodysesthesia syndrome (also known as hand-foot syndrome), hypertension and fatigue have widely limited its use. With limited data on appropriate dosing, providers have used a variety of dosing schedules in clinical practice. We designed the trial to address the need for a more definitive approach to using regorafenib. Our results show that by gradually increasing the dose of regorafenib over the course of treatment, we maximize the benefit of the therapy with fewer side effects,” says Tanios Bekaii-Saab, M.D., principal investigator for the trial and an oncologist at Mayo Clinic’s campus in Arizona.

The phase II randomized trial enrolled more than 120 patients with metastatic colorectal cancer. Results showed that a weekly dose escalation strategy of regorafenib from 80 mg to 160 mg per day was found to be relatively superior to a starting dose of 160 mg/day. Further data on outcomes of preemptive versus reactive clobetasol strategies are undergoing analysis.

According to Dr. Saab, other trials are underway evaluating the use of regorafenib to treat patients with advanced colorectal cancer. “Once we have more data, we may potentially be able to offer patients regorafenib earlier in their treatment to maximize the benefit of the therapy,” says Dr. Saab.