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Dr. Ruben Mesa, from Mayo Clinic, Arizona, Discusses the COMFORT Ruxolitinib Trials
Ruben A. Mesa, MD, Professor of Medicine, Chair, Division of Hematology & Medical Oncology, Mayo Clinic, Arizona, discusses the phase III Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment (COMFORT) trials, which led to the FDA approval of ruxolitinib (Jakafi) for patients with myelofibrosis.
COMFORT-I was a placebo controlled studied that randomized patients 1:1 to receive either ruxolitinib or placebo. This trial enrolled patients in Australia and North America. The second trial, COMFORT-II, was conducted in Europe and randomized patients 2:1 to receive either ruxolitinib or best available therapy. In general, this resulted in most patients receiving hydroxyurea or glucocorticoids. Combined, the trials evaluated 528 patients.
In both trials ruxolitinib was greatly superior at improving splenomegaly, the swelling of the spleen associated with myelofibrosis. Only 1 patient receiving the placebo and none with best available therapy experienced a reduction in spleen size. Patients on both trials accomplished a marked reduction in disease-related symptoms and an improvement in quality of life.