Dr. Bekaii-Saab Discusses the ReDOS Study in Metastatic CRC

Tanios Bekaii-Saab, MD
Published: Tuesday, Feb 06, 2018



Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, discusses the phase II regorafenib (Stivarga) dose optimization study (ReDOS) in metastatic colorectal cancer (mCRC).

The premise of ReDOS began with the idea that regorafenib is an active drug, demonstrating activity in 2 studies—CORRECT and CONCUR. But, Bekaii-Saab says that there were some limitations to understanding the dosing strategy, given some of the toxicities that have limited their use in actual practice. The study randomized patients with mCRC to either the dose-escalation arm, which began at 80 mg per day and increased weekly up to 160 mg per day if no significant drug-related toxicities occurred, or the standard dose of 160 mg of regorafenib daily.

Through the ACCRU network, investigators developed ReDOS in an effort to inform clinical practice by asking the question, what is the best strategy to treat our patients effectively? After the initial dose of 80 mg, investigators assessed patients for toxicities, then increased the dose to 120 mg, and by the third week, the goal was to get the patients 160 mg—the optimal dose. Then, whatever that dose was in the third week, investigators proceeded to the second cycle.
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Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, discusses the phase II regorafenib (Stivarga) dose optimization study (ReDOS) in metastatic colorectal cancer (mCRC).

The premise of ReDOS began with the idea that regorafenib is an active drug, demonstrating activity in 2 studies—CORRECT and CONCUR. But, Bekaii-Saab says that there were some limitations to understanding the dosing strategy, given some of the toxicities that have limited their use in actual practice. The study randomized patients with mCRC to either the dose-escalation arm, which began at 80 mg per day and increased weekly up to 160 mg per day if no significant drug-related toxicities occurred, or the standard dose of 160 mg of regorafenib daily.

Through the ACCRU network, investigators developed ReDOS in an effort to inform clinical practice by asking the question, what is the best strategy to treat our patients effectively? After the initial dose of 80 mg, investigators assessed patients for toxicities, then increased the dose to 120 mg, and by the third week, the goal was to get the patients 160 mg—the optimal dose. Then, whatever that dose was in the third week, investigators proceeded to the second cycle.



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