Juan Manuel O’Connor, MD, head, Department Gastrointestinal Oncology, Department of Clinical Oncology, Institute Alexander Fleming, Buenos Aires, discusses the rationale for the CORRELATE trial in metastatic colorectal cancer.
Juan Manuel O’Connor, MD, head, Department Gastrointestinal Oncology, Department of Clinical Oncology, Institute Alexander Fleming, Buenos Aires, discusses the rationale for the CORRELATE trial in metastatic colorectal cancer(mCRC). Final results from the study were presented at the 2018 ESMO Congress.
The FDA approved dose of regorafenib (Stivarga) in patients with mCRC is 160 mg daily, O’Connor says. However, there may be differences between the real-world setting and patients enrolled in the clinical trial that led to the approval, he notes. CORRELATE was a prospective, observational study designed to assess the safety of the standard dose.
Results showed that of the 2037 patients evaluated, 57% started treatment at 160 mg, 30% of patients began at 120 mg, and 13% began at ≤80 mg, suggesting that many clinicians use their own dosing strategy rather than the standard. Investigators noted that dose reductions were most frequent in the group who started at 160 mg, and treatment modifications were mostly due to treatment-emergent adverse events (TEAEs).
The safety profile of regorafenib has led to studies evaluating dose escalation as a way to limit TEAEs. The NCCN revised its guidelines regarding regorafenib, based on findings from the ReDOS trial. ReDOS evaluated a dose-escalation strategy of regorafenib beginning at 80 mg and ending at 160 mg for previously treated patients with mCRC. Results showed a median overall survival of 9.0 months in the dose-escalation arm compared to 5.9 months in the standard arm (P = .0943). The overall survival rate at 6 months (66.5% vs 49.8%) and at 12 months (34.4% vs 26.7%) favored the escalation arm.