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. 2023 Jul;102(7):1915-1925.
doi: 10.1007/s00277-023-05228-z. Epub 2023 Apr 20.

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

Massimo Martino  1   2 , Mercedes Gori  3 , Gaetana Porto  4   5 , Maria Pellicano  5 , Ludovica Santoro  4   5 , Chiara Verduci  4   5 , Filippo Antonio Canale  4   5 , Barbara Loteta  4   5 , Tiziana Moscato  4   5 , Caterina Alati  6 , Maria Consuelo Ieracitano  7 , Amelia Cuzzocrea  7 , Maria Altomonte  7 , Maria Teresa Florenzano  7 , Antonella Morabito  7 , Giuseppe Irrera  4   5 , Virginia Naso  4   5 , Marta Pugliese  4   5 , Giuseppe Console  4   5 , Anna Ferreri  4   5 , Lucrezia Imbalzano  4   5 , Giovanni Tripepi  8 , Annalisa Pitino  3
Affiliations

Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation

Massimo Martino et al. Ann Hematol. 2023 Jul.

Erratum in

Abstract

Multiple myeloma (MM) is the main indication for autologous stem cell transplantation (ASCT). Novel supportive therapies (e.g., granulocyte colony-stimulating factor) have significantly improved post-ASCT-related mortality; however, data on biosimilar pegfilgrastim-bmez (BIO/PEG) in this setting is lacking. This prospective cohort study compared Italian patients with MM who received BIO/PEG post-ASCT with data collected retrospectively from historical control groups from the same center who received either filgrastim-sndz (BIO/G-CSF) or pegfilgrastim (PEG; originator). The primary endpoint was time to neutrophil engraftment (three consecutive days with an absolute neutrophil count ≥ 0.5 × 109/L). Secondary endpoints included incidence and duration of febrile neutropenia (FN). Of the 231 patients included, 73 were treated with PEG, 102 with BIO/G-CSF, and 56 with BIO/PEG. Median age was 60 years and 57.1% were male. Neutrophil engraftment was reached after a median of 10 days in the BIO/PEG and PEG groups and 11 days in the BIO/G-CSF group. Among patients who achieved neutrophil engraftment earlier than this (i.e., day 9), 58% (29/50) were on PEG; of those who achieved it later (i.e., day 11), 80.8% (59/73) were on BIO/G-CSF. FN incidence was higher with BIO/G-CSF (61.4%) versus PEG (52.1%) or BIO/PEG (37.5%) (p = 0.02 among groups). Patients on BIO/PEG had less frequent grade 2-3 diarrhea (5.5%) compared with BIO/G-CSF (22.5%) or PEG (21.9%); grade 2-3 mucositis was most frequent in the BIO/G-CSF group. In conclusion, pegfilgrastim and its biosimilar displayed an advantageous efficacy and safety profile compared with biosimilar filgrastim in patients with MM post-ASCT.

Keywords: Autologous stem cell transplant; Biosimilars; Engraftment; Granulocyte colony-stimulating factor; Multiple myeloma; Pegfilgrastim.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Absolute number of patients reaching neutrophil engraftment (absolute neutrophil count ≥ 0.5 × 109/L) across all three treatment groups over time. ASCT, autologous stem cell transplantation; BIO/G-CSF, biosimilar granulocyte colony-stimulating factor (filgrastim-sndz); BIO/PEG, biosimilar pegfilgrastim (pegfilgrastim-bmez); n, number; PEG, pegfilgrastim
Fig. 2
Fig. 2
Kaplan–Meier survival analysis of time to neutrophil engraftment (absolute neutrophil count ≥0.5 × 109/L) by treatment group. BIO/G-CSF, biosimilar granulocyte colony-stimulating factor (filgrastim-sndz); BIO/PEG, biosimilar pegfilgrastim (pegfilgrastim-bmez); PEG, pegfilgrastim
See this image and copyright information in PMC

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