Regorafenib Improves Survival in Treatment-Refractory Colorectal Cancer

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Compared with placebo, regorafenib improved overall survival in patients with treatment-refractory metastatic colorectal cancer, a recent study published online first in the journal The Lancet Oncology has shown.

For the double-blind, placebo-controlled, parallel-group, phase III trial, researchers enrolled 204 Asian patients with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Participants were randomly assigned 2:1 to receive oral regorafenib 160mg once daily or placebo on days 1-21 of each 28-day cycle plus best supportive care.

Results showed that after a median follow-up of 7.4 months, median overall survival was 8.8 months (95% CI: 7.3-9.8) in the regorafenib group and 6.3 months (95% CI: 4.8-7.6) in the placebo group (HR = 0.55; 95% CI: 0.40-0.77; one-sided P = 0.00016). 

In regard to safety, drug-related adverse events occurred in 97% of participants treated with regorafenib compared with 46% of those treated with placebo. The most common grade 3 or higher adverse events in the regorafenib group were hand-foot skin reaction, hypertension, hyperbilirubinemia, hypophosphatemia, elevated ALT/AST, elevated lipase concentration, and macropapular rash.

The findings suggest that regorafenib is an important treatment for patients with metastatic colorectal cancer whose disease has progressed after standard treatments, which may or may not include targeted treatments.

Imatinib is safe and effective in the treatment of patients with CML over a 10-year period.
Compared with placebo, regorafenib improved overall survival in patients with treatment-refractory metastatic colorectal cancer.
This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT.

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