- Starting regorafenib at a dose of 80 mg/day, with weekly 40 mg escalation to reach 160 mg/day, was similarly effective and less toxic than the standard dosing strategy (160 mg/day) in refractory metastatic colorectal cancer.
Why this matters
- Various dosing regimens are used to reduce the fatigue and hand-foot skin reaction that often accompany regorafenib use, but none are supported by clinical evidence.
- Open-label, multicenter, phase 2 study (ReDOS; n=116).
- Patients were randomly assigned 1:1:1:1 to standard dose or dose escalation, plus preemptive or reactive clobetasol use.
- Funding: Bayer HealthCare Pharmaceuticals.
- The researchers combined the preemptive and reactive groups because of the absence of a significant interaction (P=.74).
- OS was better in the escalation group, although the result did not reach statistical significance (aHR, 0.742; P=.18).
- More subjects in the dose escalation group initiated cycle 3 (43% vs 26%; 1-sided P=.043).
- The most common grade 3-4 adverse events included fatigue (13% dose escalation vs 18% in the standard dose group), hand-foot skin reaction (15% vs 16%), abdominal pain (17% vs 6%), and hypertension (7% vs 15%).
- Small sample size.