A medication for people with advanced colorectal cancer who have exhausted all other treatment options appears to slow tumor growth and extend life, according to new data.
Bayer HealthCare, the makers of regorafenib, said it would seek Food and Drug Administration approval of the medication this year. If approved, regorafenib would be the first new treatment for colorectal cancer in more than five years.
Although chemotherapy and other medications can extend life in people with metastatic cancer (cancer that has spread throughout the body), alternatives are needed when those drugs stop working, said Dr. Heinz-Josef Lenz, a professor at USC Keck School of Medicine and an investigator in the regorafenib trial.
"I think this is a new tool in the armamentarium for patients with this disease," Lenz said of the findings, reported Tuesday. "In colon cancers, we've seen significant changes. Patients who have been treated for years are in good shape, and when they fail one treatment they demand more treatment."
The new data are from a phase-three study of 760 patients with advanced, metastasized colorectal cancer who had failed on all other therapies. The patients were randomized to receive regorafenib or a placebo along with medications to maintain comfort.
The patients were not taking any other cancer medications. Most colorectal cancer patients with advanced disease who receive only supportive care die in a few months.
Patients receiving regorafenib survived for 6.4 months on average compared with five months for those who were given the placebo. Moreover, 44% of patients on regorafenib had prolonged periods in which the cancer was not growing.
There was a lot of variability: Some patients had dramatic responses, such as one year of survival, while others did not benefit, said lead investigator Dr. Axel Grothey, a professor of oncology at the Mayo Clinic in Rochester, Minn. Grothey is presenting the data this week at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology meeting in San Francisco.
Regorafenib is a type of medication called an angiogenesis inhibitor. It shuts down the process by which tumors induce the growth of new blood vessels in order to survive. The drug appears to block a number of different molecular pathways that affect angiogenesis.
"For colon cancer patients, this is an important step," Lenz said. "This shows if you continue to inhibit angiogenesis in different ways, patients have a significant overall survival benefit."