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Early Growth Factor Support Reduces Incidence of Febrile Neutropenia and Infection-Related Mortality in Patients Receiving Chemotherapy.

ORLANDO, Fla. -- An analysis of 14 randomized clinical trials demonstrate that granulocyte colony-stimulating factors (G-CSFs) administered in the first and subsequent cycles of chemotherapy reduce the incidence of febrile neutropenia (low white blood cell count with fever) and infection-related mortality in cancer patients. Further, the use of G-CSFs appears to increase the delivered dose intensity of chemotherapy. The meta-analysis was presented today at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). (Abstract #8117)

"This systematic review reports, for the first time, a 48 percent reduction in the relative risk of death from infection in the 10 reporting studies where patients received prophylactic white blood cell boosters. Across all 14 studies, the relative risk of febrile neutropenia was reduced by 46 percent," said Gary Lyman, MD, University of Rochester School of Medicine and Dentistry, Rochester, New York. "The data underscore the benefits of early use of the colony-stimulating growth factors to help protect chemotherapy patients from infection, as well as to help patients endure stronger doses of chemotherapy with the potential to improve treatment outcome."

The primary cause of chemotherapy delays and dose reductions is neutropenia, a shortage of infection-fighting white blood cells and a common and potentially serious side effect of chemotherapy. Approximately half of the 1.3 million chemotherapy patients in the United States are at risk for developing neutropenia. Chemotherapy drugs are designed to destroy cancer cells, but unfortunately healthy cells are also killed, including the white blood cells that protect against infection. When a patient's white blood cell count drops too low, they are at increased risk of developing infection resulting in chemotherapy delays until the white blood cells are replenished.

The analysis included data from 14 randomized, controlled clinical trials involving more than 3,000 patients with varying tumor types and chemotherapy regimens. The objective of the analysis was to determine the impact of prophylactic use of G-CSFs for the prevention of neutropenia and its complications. In addition to significant reductions observed in the incidence of febrile neutropenia and infection-related mortality, the analysis also found among the eight reporting studies that patients receiving white blood cell boosters received 95 percent of their full chemotherapy dose on schedule compared to 88 percent among control patients. Previous studies have demonstrated that receiving less than 85 percent of the recommended dose intensity is associated with less than optimal survival rates in cancer patients.

About the ANC Study Group

The Awareness of Neutropenia in Chemotherapy (ANC) Study Group was formed in September 2000 to study further the clinical, economic and quality of life impact of neutropenia on cancer patients and to develop prediction models for neutropenic complications. Directed by three leading U.S. hematologists and oncologists including Gary Lyman, M.D., M.P.H., David Dale, M.D., and Jeffrey Crawford, M.D., the group collaborates with academic and community oncologists throughout the United States. The ANC Study Group receives grant support from Amgen.
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Date:May 15, 2005
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