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Regorafenib prolonged survival in patients with metastatic colorectal cancer
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Regorafenib, a small-molecule multikinase inhibitor, exhibited significant overall survival benefit for patients with treatment-refractory metastatic colorectal cancer in an international phase 3 trial.
Between April 2010 and March 2011, 1,052 patients with documented metastatic colorectal cancer were screened by researchers in 16 countries — including North America, Europe, Asia and Australia — and at 114 centers for a randomized, placebo-controlled CORRCT trial. Study entry required patients to be aged 18 years or older, regorafenib-naive, and have received therapy that included as many of the following as permissible: fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, cetuximab or panitumumab.
Seven hundred fifty-three patients were randomly assigned to 160 mg oral regorafenib daily (n=500) or placebo (n=253) for the first 3 weeks of each 4-week cycle until disease progression, death, withdrawal or discontinuation as warranted by treating physicians. Overall survival was the primary endpoint; secondary endpoints were progression-free survival.
Median overall survival for the regorafenib cohort was 6.4 months compared with 5 months for the placebo group (HR=0.77; 95% CI, 0.64-0.94). Researchers said the modest difference of 1.4 months survival “translates into a 23% reduction in risk of death during the course of the study in this population of patients with very poor prognosis and a high unmet clinical need.”
Adverse events related to therapy occurred in 93% of the regorafenib patients and 61% of placebo patients, with hand-foot skin reaction (17%), fatigue (10%), diarrhea (7%) and hypertension (7%) the most common grade 3 or 4 events in the regorafenib group.
“The present study provides evidence for a continuing role of targeted treatment after disease progression, with regorafenib offering a potential new line of therapy in this treatment-refractory population,” the researchers said. “In view of these findings, regorafenib could be a new standard of care in late-stage metastatic colorectal cancer.”
Disclosure: The researchers report numerous financial disclosures.
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