Dr. Bekaii-Saab Discusses Regorafenib Use in mCRC

Tanios Bekaii-Saab, MD
Published: Friday, Aug 24, 2018



Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, discusses regorafenib (Stivarga) use in metastatic colorectal cancer (mCRC).

Since 2012, regorafenib has been FDA approved for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with an anti-VEGF therapy, and, if KRAS wild-type, with an anti-EGFR therapy. In recent years, the dosing of this agent has come into question.

Bekaii-Saab says that he and his colleagues developed the ReDOS study to address the differing strategies on regorafenib dosing in mCRC. This study escalated regorafenib from an initial dose of 80 mg to the standard dose of 160 mg and compared it with the standard dose. Results of this phase II study showed a median overall survival of 9.0 months in the dose-escalation arm versus 5.9 months in the standard arm (P = .0943).

The NCCN now recommends a dosing schedule of 80 mg/daily on days 1 to 7, escalating to 120 mg/daily on days 8 to 14, and concluding with 160 mg/daily on days 15 to 21.


Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, discusses regorafenib (Stivarga) use in metastatic colorectal cancer (mCRC).

Since 2012, regorafenib has been FDA approved for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with an anti-VEGF therapy, and, if KRAS wild-type, with an anti-EGFR therapy. In recent years, the dosing of this agent has come into question.

Bekaii-Saab says that he and his colleagues developed the ReDOS study to address the differing strategies on regorafenib dosing in mCRC. This study escalated regorafenib from an initial dose of 80 mg to the standard dose of 160 mg and compared it with the standard dose. Results of this phase II study showed a median overall survival of 9.0 months in the dose-escalation arm versus 5.9 months in the standard arm (P = .0943).

The NCCN now recommends a dosing schedule of 80 mg/daily on days 1 to 7, escalating to 120 mg/daily on days 8 to 14, and concluding with 160 mg/daily on days 15 to 21.



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