Among patients with gastrointestinal stromal tumors (GIST) that were resistant to both Gleevec® (imatinib) and Sutent® (sunitinib), treatment with Nexavar® (sorafenib) resulted in tumor shrinkage or stable disease in 68% of patients. The results of this Phase II clinical trial were presented at the 2011 Gastrointestinal Cancers Symposium.

GIST is a type of soft tissue sarcoma that develops in the stomach, small intestine, or other parts of the gastrointestinal tract. Treatment of early GIST often involves surgery. Advanced GIST tends to respond well to the targeted drug Gleevec, but resistance to Gleevec eventually develops in most patients. Another drug—Sutent—may be used to treat GIST that has become resistant to Gleevec, but treatment options are limited for patients who are resistant to both Gleevec and Sutent.

Nexavar is a drug that is currently used for the treatment of certain patients with kidney or liver cancer. To evaluate Nexavar for the treatment of GIST that is resistant to both Gleevec and Sutent, researchers conducted a Phase II clinical trial among 38 patients. All study participants were treated with Nexavar.

• Nexavar controlled the cancer in 68% of patients: 13% of patients experienced tumor shrinkage (a partial response) and 55% of patients experienced stable disease.
• One-year overall survival was 44% and two-year overall survival was 21%.
• Side effects of Nexavar included high blood pressure, fatigue, and hand-foot syndrome (pain, swelling, numbness, tingling, or redness of the hands or feet). Side effects led to dose reductions in 63% of patients.

These results suggest that treatment with Nexavar may benefit patients with GIST that has become resistant to standard therapies. In a prepared statement, the senior author of the study commented “These results give us hope that we can find additional treatment options for these patients.”

Reference: Campbell NP, Wroblewski K, Maki RG et al. Final results of a University of Chicago phase II consortium trial of sorafenib (SOR) in patients (pts) with imatinib (IM) and sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST). Presented at the 2011 Gastrointestinal Cancers Symposium, January 20-22, San Francisco, CA. Abstract 4.

Tags: Gastrointestinal Stromal Tumors, News Tips and Features