Regorafenib is an oral tumour deactivation agent that inhibits multiple protein kinases, including those involved in tumour angiogenesis, oncogenesis and the tumour microenvironment.1,2
The safety and efficacy of regorafenib were evaluated in the double-blind, phase III CORRECT study involving 760 patients with metastatic colorectal cancer that had progressed after failure of standard therapy.1,2
Patients were randomised to receive best supportive care plus regorafenib 160mg (n=505) or placebo (n=255) once daily for the first 3 weeks of each monthly treatment cycle. Treatment was continued until disease progression or unacceptable toxicity occured. The primary outcome measure was overall survival.1,2
Regorafenib produced a significant improvement in overall survival compared with placebo, of 6.4 versus 5 months (HR 0.77, 95% CI 0.64–0.94, p=0.0052). A significant improvement in progression-free survival, a secondary endpoint, was also observed (HR 0.494, p<0.000001).1,2
The most common adverse effects observed in patients receiving regorafenib were hand-foot skin reaction, fatigue, diarrhoea, hypertension and rash.1,2
- Stivarga Summary of Product Characteristics, August 2013.
- Grothey A et al. Lancet 2013; 381: 303–12.
Further information: Bayer plc