According to results recently published in the Journal of Clinical Oncology, administration of Neulasta® (pegfilgrastim) in the first and subsequent cycles of chemotherapy drastically reduces the rate of infection, hospitalization and intravenous anti-infective use in women with breast cancer.
One of the most common treatment modalities used in breast cancer is chemotherapy; however, chemotherapy is associated with unpleasant and sometimes life-threatening side effects. Chemotherapy destroys not only cancer cells, but also normal cells that grow rapidly, such as blood cells forming in the bone marrow, cells in the hair follicles, or cells in the mouth and intestines. Neutropenia occurs when white blood cells (immune cells) are destroyed by chemotherapy, leaving the immune system unable to fight bacterial, viral and fungal infections. Chemotherapy-induced neutropenia can become a serious condition for several reasons: the majority of patients who develop neutropenia will require a dose reduction in their treatment, which may reduce survival rates; patients who develop neutropenia may require hospitalization; and even minor infections can become life-threatening.
Neulasta® is an agent that stimulates the production of immune cells in the body. The action of Neulasta® reduces or even completely prevents the development of neutropenia and its associated complications in patients undergoing chemotherapy. Neulasta® is currently FDA-approved for patients who are receiving chemotherapy that is associated with a significant risk of developing febrile neutropenia (neutropenia accompanied by fever). Neulasta® has been designed so that only one injection is given per chemotherapy cycle. Researchers continue to evaluate which patients benefit the most from treatment with Neulasta®, as well as to determine whether its use can completely prevent the development of neutropenia associated with chemotherapy. Currently, most physicians reserve the use of Neulasta® for patients who are considered to be at high risk for developing neutropenia or for patients who have already developed neutropenia. However, recent research suggests that the development of neutropenia and its associated complications may be greatest during the first cycle of chemotherapy, resulting in a need for prevention of neutropenia during the initial cycle of chemotherapy treatment.
Recently, researchers performed a clinical trial in 88 clinical research sites throughout North America and Europe to evaluate Neulasta® administration during the first chemotherapy cycle and each subsequent cycle in breast cancer patients being treated with chemotherapy. This trial, the largest randomized placebo-controlled study to date evaluating Neulasta®, demonstrated that administration of Neulasta® during the initial chemotherapy cycle significantly reduced the risk of patients developing fever and neutropenia, the need for intravenous antibiotics for treatment of infection and the need for hospitalization. This trial included 928 women with breast cancer who were undergoing chemotherapy treatment that included the chemotherapy drug Taxotere® (docetaxel). Approximately half of the patients received Neulasta® administered once per chemotherapy cycle (for up to 4 cycles) and the other half received placebo (inactive substitute). Only 1% of patients treated with Neulasta® developed febrile neutropenia, compared to 17% of patients that received placebo. Approximately 67% of all cases of febrile neutropenia that occurred in patients not treated with Neulasta®, occurred during the first cycle of chemotherapy, demonstrating the need for Neulasta® during the first cycle of therapy. For every cycle of chemotherapy, the incidence of febrile neutropenia, hospitalization and anti-infective use was lower in the group of patients treated with Neulasta® compared to those who received placebo.
The researchers concluded that the one-time administration of Neulasta® during the first and each subsequent cycle of chemotherapy reduces the risk of infection, hospitalization and intravenous anti-infective use in all cycles of chemotherapy. Patients with breast cancer planning to undergo chemotherapy treatment should speak with their physician regarding the potential benefit of treatment with Neulasta®.
Reference: Vogel C, Wojtukiewicz M, Carroll R, et al. First and Subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. Journal of Clinical Oncology. 2005;23:1178-1184.
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