Dr. Overman Discusses ReDOS Study in mCRC

Michael J. Overman, MD, associate professor, Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, discusses the ReDOS study in patients with metastatic colorectal cancer (mCRC).

ReDOS aimed to establish the optimal dosing strategy of regorafenib (Stivarga), a targeted agent in the treatment of patients with mCRC. While effective, this drug has some toxicity concerns including, but not limited to, hand/foot syndrome and fatigue. Traditionally, in a study like this, researchers have started with a very high dose and worked their way down to a lower dose. Overman says this approach tends to leave physicians with a starting dose that is lower than necessary. For this study, investigators used an escalation strategy, starting with a lower dose and quickly vamped up to a higher dose.

In the dose-escalation arm, patients began at 80 mg daily and increased every week up to 160 mg daily if no dose-limiting toxicities occurred. The control arm was treated with regorafenib at the standard dose of 160 mg daily. The primary endpoint was to assess the patients who made it to the third cycle of therapy, Overman says. Based on the findings, he concludes that this dose-escalation strategy is an effective approach for patients because the standard of care for regorafenib is tough to tolerate.