Punching Gut Cancer

Gastrointestinal stromal tumors respond to Stivarga

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) A cancer you don’t hear about much attacks the tissues that connect digestive organs. These are called GIST, which is easier to say than "gastrointestinal stromal tumors". Scientists have found a drug that helps kicks GIST in the gut.

A recently approved drug – Stivarga (regorafenib) – seems to slow advanced GIST from getting worse. Stivarga has been shown to keep the soft tissue cancer from progressing for almost five (4.8) months.

"Find out what second line therapies are used to treat your cancer."

GIST is a rare soft tissue cancer that’s diagnosed in 4,000 and 5,000 Americans every year. It usually starts in the stomach or small intestine. The disease doesn’t respond to chemotherapy, so most of these tumors that haven’t started to spread are taken out with surgery.

Two drugs are currently used to treat advanced GIST. Gleevec (imatinib) is usually given first. But GIST tumors tend to outsmart Gleevec after about two years. At that point, patients move to the second line therapy - Sutent (sunitinib). Again, though, this drug usually stops working after another year.

Once Gleevec and Sutent no longer work, there are currently no more options for patients with GIST.

George D. Demetri, MD, and colleagues experimented with the oral medication regorafenib in treating GIST that can’t be operated on and has become resistant to Gleevec and Sutent.

Dr. Demetri is an associate professor of medicine at Harvard Medical School and director of the Center for Sarcoma and Bone Oncology in the Department of Medical Oncology at the Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston, Massachusetts.

In this phase III trial, Dr. Demetri and colleagues enrolled 199 patients with advanced GIST. They were assigned to receive either regorafenib (133) or a placebo (66).

Those who received regorafenib lived 4.8 months without their cancer getting worse compared to 0.9 months for those who got a sugar pill. The study didn’t find a difference in overall survival between the groups, and that’s probably because most on the placebo were switched to the regorafenib group.

All of the folks treated with regorafenib had side effects, with 60 percent of the study members reporting them to be serious adverse events.

"It's encouraging to have developed this third targeted drug to manage a disease that was uniformly untreatable before 2000," said in a press release.

Regorafenib was approved in September 2012 to treat metastatic (has spread) colorectal cancer.

Treatment with Stivarga for colon cancer costs $9,350 for a 28-day treatment course.

This study was published November 22 in The Lancet.

Bayer HealthCare Pharmaceuticals, which funded this study along with the National Cancer Institute, has filed for US Food and Drug Administration approval of regorafenib for the treatment of GIST.

Reviewed by: 
Review Date: 
December 12, 2012
Last Updated:
February 12, 2013