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November 21, 2007

NEJM STUDY CONFIRMS ROLE OF NEW ORAL COMBINED THERAPY IN EXTENDING SURVIVAL, DELAYING DISEASE PROGRESSION IN MULTIPLE MYLOMA PATIENTS

Physician-Researchers Encouraged by Superior Results Of Novel Drug Therapy Trial
Multiple myeloma is a cancer that often develops resistance to standard therapy. However, a new multi-center study that included physican-reseachers from Loyola University Chicago Stritch School of Medicine (SSOM) indicates that patients may have longer survival rates and delayed disease progression with a new combined drug therapy. The study, released today in the New England Journal of Medicine (NEJM), shows that the oral cancer drug lenalidomide (Revlimid®) plus dexamethasone is superior to dexamethasone alone in treating patients with multiple myeloma. Cancer specialists at Loyola University Health System’s Cardinal Bernardin Cancer Center took part in the North American arm of the multi-national study as part of Loyola’s continued commitment to bringing the latest standards of care to cancer patients through research and front-line therapies. The newly published research showed that patients treated with the new combination therapy (177 patients in this “lenalidomide” plus dexamethasone group) not only showed increased time to “disease progression” (a established point at which the disease became markedly worse), but the combination therapy also increased overall survival time in these patients over those treated with dexamethasone alone (176 patients in this dexamethasone-alone group). The median time to disease progression in those treated with lenalidomide plus dexamethasone was 11.1 months versus 4.7 months in the dexamethasone-only group. Overall survival rate also was significantly longer for those patients in the lenalidomide plus dexamethasone group than for those in the dexamethasone-only group (29.6 months as compared to 20.2 months respectively). The superior results of the combined therapy were observed in all measures of myeloma studied, showing significant improvement in patients where previous treatments had failed. “Our involvement as investigators in such studies and our additional work here at the Cardinal Bernardin Cancer Center give us opportunities to closely evaluate each patient and determine the best treatment regimen for his or her condition,” explained Dr. Patrick Stiff, professor of medicine in the Department of Hematology & Oncology at Stritch. “In the case of lenalidomide,” he added, “this may mean using the drug as part of an initial treatment for myeloma with newly diagnosed patients, which research has shown may in some cases also to be beneficial.” “The results of this trial show that the combined therapy of lenalidomide and dexamethasone is clinically meaningful, with an excellent efficacy and favorable safety profile. In addition, since the new combination therapy is an oral therapy, it allows patients to take the drug at home, which can make their treatment experience easier,” Dr. Stiff explained. “This research certainly will change the way we manage multiple myeloma, with probable positive impact on the course of the disease,” he added. Multiple myeloma is a cancer of the bone marrow that affects the normal production of red and white blood cells. In persons with multiple myeloma, the plasma cells (a special type of white blood cell) become malignant and disrupt the normal cells in the bone marrow. The overgrowth of malignant cells in the bone marrow also can weaken the bones, especially in the back and ribs, and cause pain and bone fractures. Multiple myeloma affects about three out of every 100,000 persons each year. At this time, the cause is unknown. However, new drug treatments have been developed to control the disease in more patients, resulting in longer survival. “Lenalidomide represents a significant addition to the arsenal of drug therapies used to combat the disease,” noted Dr. Kevin Barton, assistant professor of molecular oncology, Department of Medicine, SSOM. “Our participation in this multi-center study,” he added, “underscores Loyola’s appreciation of the patients who become a part of these crucial clinical trials -- trials that are so important to the work that Loyola and other members of the medical community do to develop effective, patient-centered treatments for individuals suffering from this aggressive form of cancer.” U.S. News & World Report recently ranked Loyola as one of the top 50 hospitals nationwide for cancer in the magazine’s 2007 annual “America’s Best Hospitals” issue.
Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus, Loyola University Hospital, is a 569-licensed-bed facility. It houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children’s Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 264-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.

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