Sagara, Y., Sato, K., Fukuma, E., Higaki, K., Mizutani, M., Osaki, A., . . . Saeki, T. (2013). The efficacy and safety of FSK0808, filgrastim biosimilar: A multicenter, non-randomized study in Japanese patients with breast cancer. Japanese Journal of Clinical Oncology, 43, 865–873.

To assess the efficacy and safety of daily FSK0808 injections to treat neutropenia in patients with breast cancer

Daily injections of FSK0808 were used to treat neutropenia experienced by patients in the course of chemotherapy treatment.

• N = 104  
• AGE RANGE = 20–70 years
• AVERAGE AGE = 51.1 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Pre- and post-menopausal patients with breast cancer receiving fluorouracil, epirubicin, and cyclophosphamide (FEC100) before and after surgical intervention.

• SITE: Multi-site 
• SETTING TYPE: Outpatient 
• LOCATION: Japan

• PHASE OF CARE: Active treatment

• Multi-center, non-randomized study

Efficacy was measured by drawing blood to calculate the patients’ absolute neutrophil count. Vital signs also were performed to assess patients for fever.

The study showed that FSK0808 reduced the recovery time from neutropenia caused by the treatment of breast cancer with FEC100. The average of 2.2 days of neutropenia was comparable to the 2.1 days reported in a comparative study that used filgrastim. Adverse drug reactions were similar to those experienced with filgrastim, and most events were mild.

FSK080 is safe and well tolerated in patients with breast cancer going through chemotherapy and successfully stimulated neutrophil recovery.

• Risk of bias (no control group)
• Risk of bias (no blinding) 
• Risk of bias (no random assignment)

This study shows that FSK0808 is a safe and viable alternative to filgrastim, meaning that nurses will have to familiarize themselves with the use and side effects of this new medication.