Neulasta® Used during First and Subsequent Chemotherapy Cycles Drastically Reduces Infection in Breast Cancer Patients

According to results presented at the 27th annual San Antonio Breast Cancer Symposium (SABCS), administration of Neulasta® 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.

Recent results of a clinical trial evaluating Neulasta® in women with breast cancer were presented at the SABCS. This trial, the largest randomized placebo-controlled study to date evaluating Neulasta®, demonstrated that administration of Neulasta® during the initial chemotherapy cycle reduced the risk of developing fever and neutropenia and reduced the need for intravenous treatment of the infection and hospitalization of women being treated with chemotherapy. This trial included 912 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) or placebo (inactive substitute). Administration of Neulasta® prior to the first cycle of chemotherapy reduced the incidence of febrile neutropenia by 90%, reduced the hospitalization rate by 89%, and reduced the incidence of intravenous (in a vein) anti-infective use by 83% compared to placebo during the first cycle of treatment. Patients who received Neulasta® in chemotherapy cycles 2-4 also fared better than those treated with placebo, with a reduced incidence of febrile neutropenia (less than 1% vs. 6%, respectively), a reduced incidence of hospitalization (less than 1% vs. 5%, respectively), and a reduced incidence of intravenous anti-infective use (less than 1% vs. 4%, respectively).

The researchers concluded that the one-time administration of Neulasta® during the first and subsequent cycles of chemotherapy drastically reduces the risk of infection, hospitalization and intravenous anti-infectives in all cycles of chemotherapy in patients with breast cancer undergoing treatment with Taxotere®-based regimens. Patients with breast cancer may wish to speak with their physician regarding their individual risks and benefits of treatment with Neulasta®.

Reference: Vogel C, et al. Phase 3 study shows majority of neutropenia with related fever and hospitalization occurs in first treatment cycle for breast cancer patients not receiving Neulasta®. Proceedings from the 27th annual San Antonio Breast Cancer Symposium. December 2004. Abstract #5044.

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