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 (

 = .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.

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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.

Dr. O'Connor Discusses Rationale for CORRELATE Trial in mCRC

Juan Manuel O’Connor, MD, head, Department Gastrointestinal Oncology, Department of Clinical Oncology, Institute Alexander Fleming, Buenos Aires, discusses regorafenib (Stivarga) dosing in the treatment of patients with metastatic colorectal cancer (mCRC).

The final results from the prospective, observational CORRELATE study reported the real-world dosing data for regorafenib in patients with mCRC with the aim of addressing safety. Of the 2037 patients evaluated, results showed that 57% started treatment at 160 mg, 30% of patients began at 120 mg, and 13% began at ≤80 mg.

O’Connor says that these findings mean that there were many doctors who used a starting dose that was different than the recommended dose. He added that it is important to keep the ReDOS data in mind when discussing CORRELATE. The ReDOS study evaluated a dose-escalation strategy of regorafenib beginning at 80 mg and ending at 160 mg for previously treated patients with mCRC. Positive survival data led to the NCCN-recommended starting dose of regorafenib at 80 mg/daily on days 1 to 7, escalating to 120 mg/daily on days 8 to 14, and concluding with 160 mg/daily on days 15 to 21.

Juan Manuel O’Connor, MD, head, Department Gastrointestinal Oncology, Department of Clinical Oncology, Institute Alexander Fleming, Buenos Aires, discusses regorafenib (Stivarga) dosing in the treatment of patients with metastatic colorectal cancer. 

Dr. O'Connor Discusses Regorafenib Dosing in mCRC

Juan Manuel O’Connor, MD, head, Department Gastrointestinal Oncology, Department of Clinical Oncology, Institute Alexander Fleming, Buenos Aires, discusses real-world results with regorafenib (Stivarga) in the treatment of patients with metastatic colorectal cancer (mCRC).

In a presentation of the final results from the prospective, observational CORRELATE study at the 2018 ESMO Congress, real-world dosing data were revealed for regorafenib in patients with mCRC. Of the 1037 patients eligible for evaluation, results indicated that 57% started treatment at 160 mg, 30% of patients began at 120 mg, and 13% began at ≤80 mg.

The take-home message of the study, says O’Connor, is that despite the differences in starting dose, there was no impact on the median overall survival and median progression-free survival. Moving forward, it is important to consider data from the real-world setting, states O’Connor, as there may be differences in the data demonstrated in clinical trials versus the clinic.

Juan Manuel O'Connor, MD

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Dr. O'Connor Discusses Rationale for CORRELATE Trial in mCRC

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