CHAPEL HILL -- Cancer patients now have help with one of the most painful side effects of high-dose chemotherapy and radiotherapy.
Results of a multicenter clinical trial reported in today’s (Dec. 16) issue of the New England Journal of Medicine showed that palifermin caused significant reduction in the rate, duration and severity of the oral mucositis, or mouth sores, that occur after intensive chemotherapy and radiotherapy given during stem cell transplant therapy for blood cancers.
Depending on the treatment used, mucositis can affect nearly 100 percent of patients undergoing these intensive therapies.
"This is a major advance in the care of patients receiving high-dose therapy and stem cell transplantation, especially with treatments that cause severe mouth sores," said Dr. Tom Shea, professor of medicine in the University of North Carolina at Chapel Hill’s School of Medicine, director of UNC’s Bone Marrow and Stem Cell Transplantation Program and member of UNC Lineberger Comprehensive Cancer Center.
"This drug clearly reduces the frequency and severity of one of the most painful complications of transplant for many patients receiving this type of care," Shea added
UNC Hospitals and UNC Lineberger represented one of the 13 study sites for the trial sponsored by Amgen Inc.
The 212 cancer patients involved in this phase three trial were given either a placebo injection and standard care for mucositis, or injections of palifermin, a recombinant human keratinocyte growth factor manufactured by Amgen.
The study compared the rate of severe oral mucositis in the groups receiving palifermin with those treated with the placebo. There was a marked improvement in several key study outcomes: a 63 percent rate of severe mouth sores in the palifermin group versus 98 percent in the placebo group.
The duration of mucositis was reduced to an average of six days in the palifermin group versus nine days in the placebo group. The use of intravenous narcotics for pain relief was reduced by 60 percent in the palifermin group, and the use of intravenous-administered nutrition was reduced from 55 percent of participants in the placebo group to 31 percent of participants in the palifermin group.
Studies are under way to test the value of the medication in other treatment settings in which mucositis is likely to occur, Shea said.
Lead author of the study was Dr. Ricardo Spielberger of City of Hope National Medical Center in Duarte, Calif. Other participating institutions were UNC; Loyola University Medical Center in Maywood, Ill.; Fred Hutchinson Cancer Research Center in Seattle; State University of New York Upstate Medical University in Syracuse; the University of Minnesota at Minneapolis; Memorial Sloan-Kettering Cancer Center in New York City; Georgetown University Cancer Center in Washington, D.C.; the Northwest Marrow Transplant Center in Portland, Ore.; Sinai Hospital of Baltimore; the Medical College of Virginia in Richmond; the Texas Transplant Institute in San Antonio; the School of Dentistry and the Division of Hematology-Oncology at the University of California at Los Angeles; and Amgen in Thousand Oaks, Calif.
UNC Lineberger is one of 38 comprehensive cancer centers designated by the National Cancer Institute. Center faculty members treat cancer patients, conduct research into the causes of cancer, direct statewide programs in cancer prevention and train future physicians, nurses, scientists and public health professionals.
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