Dirk Arnold, MD, director, Department of Medical Oncology at Klinik für Tumorbiologie, Freiburg, Germany, discusses the phase IIIb CONSIGN study, which looked at treatment with regorafenib for previously treated patients with metastatic colorectal cancer (mCRC).
The CONSIGN trial reported on 2,872 patients from more than 180 institutions; it is a truly worldwide initiative, said Arnold. In this "real world" experience, the median treatment duration with regorafenib was 2.5 months. Patients received a median of 3 cycles of regorafenib (range, 1–33) at a median daily dose of 160mg (range, 74–166).
The trial was a follow-up to the phase III CORRECT trial, which demonstrated a median progression-free survival (PFS) of 2.0 months with regorafenib compared with 1.7 months with placebo (HR, 0.49; 95% CI, 0.42-0.58; P <.0001). Based on findings from this study, the FDA approved regorafenib in September 2012.
The CONSIGN trial confirmed the results of the CORRECT trial, demonstrating a median PFS of 2.7 months (95% CI, 2.6-2.7). Adverse events were also similar between the two studies. Overall, 87% of patients required dose modifications, with 46% experiencing an adverse event that required a dose reduction.