Regorafenib slows tumour progression and improves survival in patients with metastatic colorectal cancer, according to the results of an international Phase III clinical trial presented at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology.
“For years, patients with metastatic colorectal cancer have faced a devastating impasse when standard chemotherapies have failed to halt the growth of tumours and physicians have run out of effective drugs to offer them,” said lead author Axel Grothey.
“This is the first novel agent in eight years to show improvement in overall survival of colon cancer patients who have run out of treatment options.”
Researchers tested regorafenib in a randomised, placebo-controlled trial, conducted simultaneously in the Europe, the USA, Japan, Australia and China.
They looked at survival outcomes in 760 patients whose cancer had progressed despite standard chemotherapy regimens.
Regorafenib is a multi-kinase inhibitor, which slows cell proliferation and blood vessel growth and tempers a variety of biological pathways that are activated in tumours.
Researchers found that patients with metastatic colon cancer who were treated with the drug showed a 29% increase in overall survival when compared to those treated with placebo.
The median length of survival for patients treated with the drug increased from 5 months to 6.5 months.
Overall, regorafenib reduced patients’ risk of dying from cancer during the trial by 23%.
“Patients with metastatic colorectal cancer who have failed all approved standard therapies have a poor prognosis,” said Dr. Grothey.
“This is the first and only agent in this setting that has demonstrated statistically significant overall survival benefit.”