Bongiovanni, A., Monti, M., Foca, F., Recine, F., Riva, N., Di Iorio, V., . . . Ibrahim, T. (2017). Recombinant granulocyte colony-stimulating factor (rG-CSF) in the management of neutropenia induced by anthracyclines and ifosfamide in patients with soft tissue sarcomas (NEUSAR). Supportive Care in Cancer, 25, 111–117. 

To test the safety and efficacy of biosimilar granulocyte–colony-stimulating factor (G-CSFs) filgrastim as prophylactic treatment for the reduction of severe chemotherapy-induced neutropenia in patients undergoing treatment for early and advanced soft-tissue sarcoma with anthracycline and ifosfamide–based chemotherapy

G-CSFs were administered in one of three forms (biosimilar filgrastim, originator filgrastim, or lenograstim) as primary prophylactic treatment for patients with a 20% or greater risk for febrile neutropenia per the European Organization for Research and Treatment of Cancer's (EORTC's) clinical guidelines based on the administration of epirubicin and ifosfamide (EI) treatment for soft-tissue sarcomas.

• N = 67   
• MEDIAN AGE = 60 years
• AGE RANGE = 28–78 years
• MALES: 41.8%, FEMALES: 58.2%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Soft-tissue sarcoma, primary or metastatic
• OTHER KEY SAMPLE CHARACTERISTICS: Patients treated with EI from 2003–2013 were included in the study.

• SITE: Not stated/unknown   
• SETTING TYPE: Multiple settings    
• LOCATION: Not clearly specified. PI is from a cancer research institute in Italy.

PHASE OF CARE: Active antitumor treatment

Retrospective analyses

Outcome measures included overall survival, neutropenia, and sepsis. A cost analysis was also conducted. Dependent variables included patient demographic information (age, sex, body mass index, and setting) and type of G-CSF administered.

No statistically significant differences were found between the administration of biosimilar filgrastim, originator filgrastim, or lenograstim for the outcome variables. A difference existed in the cost-savings model with the cumulative cost of treatment with biosimilar filgrastim (€35.82 on day 3 to €131.34 on day 11) compared to originator filgrastim (€170.97 on day 3 to €626.89 on day 11) and lenograstim (€193.02 on day 3 to €707.74 on day 11). However, statistically significant differences were not reported.

The use of prophylactic biosimilar filgrastim is equally effective yet less expensive than originator filgrastim or lengrastim for overall survival, neutropenia, and sepsis in patients undergoing treatment for early and advanced soft-tissue sarcoma with anthracycline and ifosfamide–based chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable

Understanding that biosimilar filgrastim is equally effective yet more economical than originator filgrastim or lengrastim can help guide treatment decision making for patients with advanced soft-tissue sarcoma at risk for chemotherapy-induced neutropenia.