Dr. Bekaii-Saab Reflects on the Findings of the ReDOS Trial in mCRC

Tanios Bekaii-Saab, MD
Published: Monday, Aug 06, 2018



Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, reflects on the findings from the ReDOS study in patients with metastatic colorectal cancer (mCRC).

One of the most surprising results of the ReDOS study was the survival benefit, Bekaii-Saab said. Although it was not statistically significant, dose-escalation of regorafenib (Stivarga) in patients with mCRC showed a median overall survival of 9.0 months in the dose-escalation arm versus 5.9 months in the standard arm (P = .0943). These findings led to the updated NCCN guidelines for mCRC, recommending a weekly regorafenib dose-escalation strategy beginning at 80 mg and ending at 160 mg for previously treated patients.

The primary endpoint of the ReDOS study was the percent of patients who finished 2 cycles of regorafenib and were able to move onto cycle 3. Bekaii-Saab says that this endpoint was met and exceeded, with a significant P value. The median progression-free survival (PFS) favored dose-escalation (2.5 vs 2.0 months), and the 6-month PFS was 12.2% (95% CI, 5.4-27.5) in the escalation arm versus 11.8% (95% CI, 5.2-26.6) in the standard arm.
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Tanios Bekaii-Saab, MD, professor of medicine, Mayo Clinic, reflects on the findings from the ReDOS study in patients with metastatic colorectal cancer (mCRC).

One of the most surprising results of the ReDOS study was the survival benefit, Bekaii-Saab said. Although it was not statistically significant, dose-escalation of regorafenib (Stivarga) in patients with mCRC showed a median overall survival of 9.0 months in the dose-escalation arm versus 5.9 months in the standard arm (P = .0943). These findings led to the updated NCCN guidelines for mCRC, recommending a weekly regorafenib dose-escalation strategy beginning at 80 mg and ending at 160 mg for previously treated patients.

The primary endpoint of the ReDOS study was the percent of patients who finished 2 cycles of regorafenib and were able to move onto cycle 3. Bekaii-Saab says that this endpoint was met and exceeded, with a significant P value. The median progression-free survival (PFS) favored dose-escalation (2.5 vs 2.0 months), and the 6-month PFS was 12.2% (95% CI, 5.4-27.5) in the escalation arm versus 11.8% (95% CI, 5.2-26.6) in the standard arm.



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