Zhou, C., Huang, Y., Wang, D., An, C., Zhou, F., Li, Y., . . . Song, X. (2016). A randomized multicenter phase III study of single administration of mecapegfilgrastim (HHPG-19K), a pegfilgrastim biosimilar, for prophylaxis of chemotherapy-induced neutropenia in patients with advanced non–small-cell lung cancer (NSCLC). Clinical Lung Cancer, 17, 119–127. 

To determine if mecapegfilgrastim, a biosimilar, is as effective as pegfilgrastim in preventing febrile neutropenia (FN) in patients with advanced non-small cell lung cancer

One hundred fifty-one patients were split into three groups—two with two different doses of mecapegfilgrastim and one with normal saline (control). After the initial cycle, the control group received recombinant human granulocyte–colony-stimulating factor (rhG-CSF), while the other two groups continued their doses of mecapegfilgrastim.

• N = 146 
• MEAN AGE = 55.89 years 
• MALES: 69.2%, FEMALES: 30.8% 
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving platinum-based chemotherapy

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment

• Double-blind, three-group, randomized trial followed by an open-label

• Neutropenia grade 3 or 4 (absolute neutrophil count [ANC] 1–0.5 x 10⁹/l)
• FN temperature of 38.5 degrees with neutropenia as above
• Duration of neutropenia from nadir to ANC 2 x10⁹/L
• Depth of ANC nadir

For the first phase of the study, both mecapegfilgrastim arms showed a lower incidence of grade 3 or greater neutropenia (p < 0.0001 and p = 0.0001). For the second phase, which was unblinded, the incidence of FN was lower across all cycles with both doses of the biosimilar (p < 0.023 and p < 0.0001) compared to placebo. No significant differences existed in FN incidence in those cycles when compared to G-CSF. Time to ANC recovery was significantly lower with the biosimilar compared to placebo and no different from the time to recovery with G-CSF.

Both doses of mecapegfilgrastim were effective in reducing neutropenia within each cycle of chemotherapy compared to rhG-CSF.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Findings not generalizable

As more biosimilars make their way to the market, studies such as this will be important in determining the care nurses provide to their patients. Nurses need to be aware of current literature and the implications for their patients. This study showed that the biosimilar CSF was more effective than placebo and as effective as G-CSF.