Dr. Bekaii-Saab on the ReDOS Study in Metastatic Colorectal Cancer

Tanios Bekaii-Saab, MD, medical oncologist, Mayo Clinic, discusses the ReDOS study of regorafenib (Stivarga) in patients with metastatic colorectal cancer (mCRC).

In the phase II ReDOS study, patients were randomized to either arm A, which escalated regorafenib from 80 mg to 120 mg to 160 mg on a weekly basis, or arm B, which was the control arm of 160 mg.

The primary endpoint of the study was a composite of efficacy and toxicity, says Bekaii-Saab. The study was powered to see about a 15% difference between arm A and arm B, but there was close to a 20% difference between arms. It resulted in a positive study with a statistically significant P value, favoring the dose-escalation schema in arm A. Patients who went from 80 mg to 120 mg to 160 mg saw a survival close to 9.5 months, whereas patients who received 160 mg upfront saw a survival of 5.9 months.

The dose-escalation strategy provides more control of disease and longer survival, says Bekaii-Saab. The quality of life is also non-compromised in the dose-escalation strategy versus the full dose. Based on these findings, the NCCN guidelines now include the dose-escalation schema as an option for patients with refractory mCRC.