NeulastaŽ
According to results recently published in the Journal of Clinical Oncology,
administration of NeulastaŽ (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.
NeulastaŽ is an agent that stimulates the production of immune cells in the
body. The action of NeulastaŽ reduces or even completely prevents the
development of neutropenia and its associated complications in patients
undergoing chemotherapy. NeulastaŽ 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). NeulastaŽ 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 NeulastaŽ, 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 NeulastaŽ 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 NeulastaŽ 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 NeulastaŽ, demonstrated that
administration of NeulastaŽ 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 TaxotereŽ
(docetaxel). Approximately half of the patients received NeulastaŽ administered
once per chemotherapy cycle (for up to 4 cycles) and the other half received
placebo (inactive substitute). Only 1% of patients treated with NeulastaŽ
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 NeulastaŽ, occurred during the first cycle of
chemotherapy, demonstrating the need for NeulastaŽ 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 NeulastaŽ compared to those who received placebo.
The researchers concluded that the one-time administration of NeulastaŽ 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 NeulastaŽ.
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.
Source :
http://patient.cancerconsultants.com/breast_cancer_news.aspx?id=33343