According to results recently presented at the 2004 Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting, Neulasta® administered during the first and subsequent cycles of chemotherapy significantly reduces the risk of neutropenia and associated complications in breast cancer patients.
One of the most common treatment modalties that is used in breast cancer is chemotherapy; however, chemotherapy is associated with unpleasant and sometimes life-threatening side effects. Chemotherapy not only destroys 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 presently FDA approved for patients who are receiving chemotherapy that is associated with a significant risk of developing neutropenia accompanied by fever (febrile neutropenia). It 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®. Research is also directed at evaluating the use of Neulasta® to 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.
Researchers from Memphis, Tennessee recently conducted a clinical trial to compare the use of Neulasta® to placebo (inactive substitute) in patients with breast cancer undergoing chemotherapy. This trial included 928 patients who were being treated with Taxotere®-based chemotherapy. Half of the patients received Neulasta® on the first and subsequent cycles of chemotherapy, while the other half received placebo. Only 1% of patients who were treated with Neulasta® developed febrile neutropenia, compared with 17% of patients who received placebo. Febrile neutropenia occurred most often in the first cycle of chemotherapy (65%) in the group of patients who received placebo. Additionally, only 1% of patients treated with Neulasta® required hospitalization, compared with 14% of patients who received placebo. Anti-infectives delivered into a vein (intravenous) were required in only 2% of patients treated with Neulasta®, compared with 10% of patients who received placebo.
The researchers concluded that the preventive use of Neulasta® significantly decreases febrile neutropenia, hospitalizations, and intravenous anti-infective use when used in the first and subsequent cycles of chemotherapy that is only moderately associated with the development of febrile neutropenia in breast cancer patients. The presenter also stated that results of this trial provide evidence that preventive use of agents such as Neulasta® may ultimately become more widely used in patients undergoing chemotherapy.
Proceedings from the 2004 Multinational Association of Supportive Care in Cancer (MASCC) Annual Meeting. Schwarzberg L, et al. Abstract #A-52.
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