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Dr. George Demetri, from Dana-Farber Cancer Institute, Discusses Regorafenib for Patients with GIST Trial Results.
George Demetri, MD, Director of the Ludwig Center and Sarcoma Center at Dana-Farber Cancer Institute and Harvard Medical School in Boston, discusses results from a phase III trial investigating the oral targeted therapy regorafenib for patients with gastrointestinal stromal tumors (GIST) that developed a resistance to imatinib or sunitinib.
The study randomized 199 patients with GIST to receive placebo or regorafenib, a new multikinase inhibitor. Demetri notes that he was pleased to see that regorafenib was able to increase progression-free survival to 4.8 months, compared to only 0.9 months for those receiving placebo.
The trial was designed to allow patients to crossover to the investigational arm following disease progression. This resulted in the final overall survival benefit being roughly similar in both groups.
Demetri notes that patients who initially received the placebo and crossed over to regorafenib experienced similar response rates to the patients who received regorafenib for the full trial. Both the regulators and investigators involved in the trial felt that allowing crossover was best for the patients.
On February 25, 2013, the FDA approved regorafenib for patients with GIST (Read About the Approval).