Gladkov, O., Moiseyenko, V., Bondarenko, I.N., Shparyk, Y., Barash, S., Adar, L., & Avisar, N. (2016). A phase III study of balugrastim versus pegfilgrastim in breast cancer patients receiving chemotherapy with doxorubicin and docetaxel. Oncologist, 21, 7–15.

To evaluate the efficacy and safety of balugrastim compared to pegfilgrastim

Patients were randomized to receive either once per cycle 40–50 mg balugrastim or 6 mg pegfilgrastim by subcutaneous injection 24 hours after administration of chemotherapy. Blood samples were obtained twice weekly after post-nadir absolute neutrophil count (ANC) was greater than two, and temperature was measured twice daily.

• N = 238
• MEAN AGE = 49.9 years
• MALES: 0.04%, FEMALES: 99.6%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer. Approximately one-third had metastatic disease.
• OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded if they had received more than one prior chemotherapy cycle.

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: Russia and Ukraine

• PHASE OF CARE: Active antitumor treatment

• Open-label randomized noninferiority trial

• Duration of severe neutropenia defined as ANC < 0.5 x 10⁹/L
• Incidence of febrile neutropenia (oral temp ≥ 38.2 C)
• Time to ANC nadir
• Duration and depth of ANC nadir
• Time to ANC recovery
• National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0

Difference in duration of severe neutropenia was less than one day between balugrastim and pegfilgrastim, and was similar in both dosages of balugrastim. Duration and incidence of severe neutropenia were reduced in subsequent cycles in all groups. There were no significant differences in incidence of febrile neutropenia. In cycle one, time to ANC recovery was shorted in the balugrastim group (2.0–2.1 days versus 2.6 days, p = 0.005). Adverse effects were similar in both groups. Presence of antibodies to the medication was similar in both groups.

A single fixed dose of balugrastim was not inferior to pegfilgrastim for management of neutropenia.

• Risk of bias (no blinding)

Balugrastim is an effective alternative to pegfilgrastim in patients with breast cancer receiving myelosuppressive chemotherapy. A single fixed dose per cycle was as effective as pegfilgrastim. Further research comparing various colony-stimulating factors (CSFs) and biosimilar agents are needed to continue to identify the most acceptable and cost-effective methods for hematopoetic support in patients receiving myelosuppressive chemotherapy with a high risk of febrile neutropenia.