(CHICAGO, IL) – Regorafenib, an oral multikinase inhibitor, prolongs progression-free survival and overall survival among patients with metastatic colorectal cancer that has progressed after all approved standard therapies, according to the phase 3 CORRECT trial presented at the 2012 American Society of Clinical Oncology Annual Meeting.
The CORRECT trial was conducted to evaluate regorafenib in patients with mCRC whose disease had progressed after all approved standard therapies, explained Eric Van Cutsem, MD, PhD, Digestive Oncology Unit, Leuven Cancer Institute, University Hospital Gasthuisberg, Leuven, Belgium. Inclusion criteria included documented mCRC and progression during or ≤3 months after last standard therapy. Patients were randomized 2:1 to receive best supportive care plus either regorafenib 160mg once daily for 3 weeks (followed by 1 week off) (n=505) or placebo (n=255). The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, disease control rate, safety, and quality of life.
Overall survival was significantly longer among regorafenib patients compared with placebo-arm patients (6.4 vs 5.0 months; HR=0.77; P=0.0052). Progression free survival, a secondary study end point, was also superior with regorafenib (HR=0.49; P<0.000001). Median progression free survival was 1.9 vs 1.7 months. Grade 3+ adverse events among patients administered regorafenib included hand/foot skin reaction (16.6%), fatigue (9.6%), hypertension (7.2%), diarrhea (7.2%), and rash/desquamation (5.8%).
Dr. Van Cutsem and colleagues concluded that comparable overall survival and progression-free survival benefits were observed in exploratory subgroup analyses by region, age, time from diagnosis of mCRC to randomization, prior lines of treatment, and KRAS status.
“There were no significant differences in health-related quality of life between the placebo arm and regorafenib arm,” Dr. Van Cutsem concluded.