Dr. Grothey on the Time Course of Regorafenib-Associated AEs

Axel Grothey, MD, Professor of Oncology and Consultant in the Division of Medical Oncology in the Department of Oncology, Mayo Clinic, Rochester, Minnesota, discusses the time course of adverse events (AEs) following treatment with regorafenib, as observed in the CORRECT study.

The phase III CORRECT trial examined the oral multikinase inhibitor regorafenib following progression on standard treatments for patients with metastatic colorectal cancer. The trial found a significant overall survival prolongation of 6.4 months compared with 5.0 months in patients who received a placebo (HR = 0.77; P = .0052). The results were the basis for the FDA approval of the agent in September 2012 (Read About the Approval).

One of the critical issues associated with regorafenib, as a multikinase inhibitor, are the AEs, Grothey explains. The most frequent regorafenib-related side effects include: hand—foot skin reaction, fatigue, diarrhea, hypertension, and rash/desquamation.

In the safety analysis of the CORRECT trial, Grothey explains, the frequency of regorafenib-related AEs peaked during the first cycle of treatment and gradually began to taper off. This gradual decline is due in part to dose reductions, Grothey explains; however, even in patients who did not receive a reduced dose the incidence and severity of AEs still tapered off.

Grothey believes these findings indicate that special care is needed during the first cycle of treatment with regorafenib. Additionally, once the first cycle of treatment is finished regorafenib can be safely continued at a maintenance dose.

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