Regorafenib - an experimental drug improves survival rate of colorectal cancer patients, reveals phase III clinical trial study.
"For years, patients with metastatic colorectal cancer have faced a devastating impasse when standard chemotherapies have failed to halt the growth of tumors and physicians have run out of effective drugs to offer them," says Dr. 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 phase III, randomized, placebo-controlled trial, conducted simultaneously in the United States, Europe, 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 has the effect of slowing cell proliferation and blood vessel growth and tempering a variety of biological pathways that are activated in tumors.
The trial, whose largest group of study participants in the United States was at Mayo Clinic, finished more than a year ahead of schedule.
"Patients with metastatic colorectal cancer who have failed all approved standard therapies have a poor prognosis," says Dr. Grothey. "This is the first and only agent in this setting that has demonstrated statistically significant overall survival benefit."