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Comparative Study
. 2020 Sep;9(17):6102-6110.
doi: 10.1002/cam4.3261. Epub 2020 Jul 7.

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

Ka-Won Kang  1 , Byung-Hyun Lee  1 , Min Ji Jeon  1 , Eun Sang Yu  1 , Dae Sik Kim  1 , Se Ryeon Lee  1 , Hwa Jung Sung  1 , Chul Won Choi  1 , Yong Park  1 , Byung Soo Kim  1
Affiliations
Comparative Study

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

Ka-Won Kang et al. Cancer Med. 2020 Sep.

Abstract

Our aim was to compare the efficacy and safety of two recently developed biosimilars of pegfilgrastim, a pegylated form of the recombinant human granulocyte-colony stimulating factor (G-CSF) analog filgrastim with those of the reference pegfilgrastim. We retrospectively analyzed data from patients diagnosed with diffuse large B-cell lymphoma (DLBCL) who were treated with first-line R-CHOP chemotherapy and received pegylated G-CSF for primary prophylaxis. The following pegylated G-CSFs were analyzed in this study: reference pegfilgrastim (Neulasta® ) and two of its biosimilars (tripegfilgrastim; Dulastin® and pegteograstim; Neulapeg® ). In total, 296 patients were enrolled. The number of patients with at least one episode of neutropenia during R-CHOP chemotherapy was the lowest in the reference cohort (pegfilgrastim: 127 of 193 patients, 65.8%; tripegfilgrastim: 64 of 69 patients, 92.8%; pegteograstim: 28 of 34 patients, 82.4%, P < .001). The number of patients with at least one episode of febrile neutropenia was also lowest in the reference cohort (pegfilgrastim: 67 of 193 patients, 34.7%; tripegfilgrastim: 38 of 69 patients, 55.1%; pegteograstim: 16 of 34 patients, 47.1%, P = .009). There were no differences in the duration of neutropenia and febrile neutropenia or treatment outcomes (rate of complete response or relapse and survival). There were no reports of grade 3 or higher adverse events requiring discontinuation of prophylactic pegylated G-CSF in any group. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored.

Keywords: biosimilar; febrile neutropenia; neutropenia; pegylated granulocyte-colony stimulating agent.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

FIGURE 1
FIGURE 1
Incidence of neutropenia and febrile neutropenia during first‐line R‐CHOP chemotherapy. ***P < .001; **P < .01; and *P < .05 after Bonferroni correction
FIGURE 2
FIGURE 2
Duration of neutropenia and febrile neutropenia during first‐line R‐CHOP chemotherapy. The boundaries of the box indicate the minimum and maximum, and the line within the box marks the median
FIGURE 3
FIGURE 3
Progression‐free survival and overall survival according to the type of the pegylated G‐CSF treatment
See this image and copyright information in PMC

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