WASHINGTON-Older cancer patients who received the colony-stimulating factor (CSF) pegfilgrastim (Neulasta) during each cycle of chemotherapy, including the first, had significantly less febrile neutropenia than patients who received it only after the first cycle, according to the results of a large, community-based clinical trial. Those receiving the drug in the first cycle also had fewer hospitalizations and other neutropenia-related complications, said Lodovico Balducci, MD, head of the senior adult oncology program at H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Dr. Balducci reported the findings at the Geriatric Oncology Consortium annual meeting (abstract 3).
The trial included patients 65 years of age and older who were undergoing treatment for non-Hodgkin's lymphoma or lung, breast, or ovarian cancers in community practices. Dr. Balducci presented the findings for 686 patients with solid tumors. The patients were randomized to receive either pegfilgrastim in all chemotherapy cycles or no pegfilgrastim in cycle 1 with subsequent use at the physician's discretion. In the latter group, 42% received the CSF in cycles 2 to 6.
Febrile neutropenia occurred in 4% of the patients receiving pegfilgrastim in all cycles, compared with 10% of those who received it only after the first cycle and at the physician's discretion. In addition, just 30% of the patients receiving pegfilgrastim in all cycles had grade 3-4 neutropenia vs 80% of patients in the other group. Patients taking pegfilgrastim in all cycles also had fewer hospitalizations, chemotherapy dose reductions, and serious adverse events, and they required less treatment with anti-infective drugs.
Dr. Balducci emphasized the importance of taking pegfilgrastim during the first cycle of chemotherapy, when febrile neutropenia is most likely to occur. Currently, common practice is to wait and see whether febrile neutropenia develops during the first cycle and, if it does, then to give growth factor support in subsequent cycles. First-cycle use of CSF, he said, is now under study in a large phase III trial, the FIRST trial, conducted by the Awareness of Neutropenia in Chemotherapy Study Group and led by investigators from the University of Rochester Medical Center, New York.
The National Comprehensive Cancer Network issued guidelines in March 2005 advocating use of CSF to prevent febrile neutropenia in patients with a 20% risk of developing the condition. Many commonly used chemotherapy regimens are associated with a 10% to 20% risk, and many others fall in the 20% to 40% range. Age and comorbidities, common in elderly patients, can increase the risk, Dr. Balducci pointed out. The FDA recently approved a label change for Neulasta expanding its indication for use in the first chemotherapy cycle in patients receiving myelosuppressive agents associated with at least a 17% risk of febrile neutropenia. Previously, the indication was for chemotherapy regimens associated with a more than 30% to 40% risk.