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

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.

Efficacy and safety of biosimilar Peg-filgrastim after autologous stem cell transplant in myeloma and lymphoma patients: a comparative study with biosimilar Filgrastim, Lenograstim, and originator Peg-filgrastim

“…At the same time, we observed a superimposable rate of mucositis and diarrhea among the four patient cohorts and the TRM was quite similar, overall ranging between 1 and 4%. This is quite in contrast to some previous report [ 11 , 39 ] in which the authors showed a lower incidence of mucositis and grade 2–3 diarrhea in patients who received pegylated G-CSFs both in myeloma patients undergoing ASCT and in breast cancer patients, respectively. Multiple factors can potentially explain this difference, keeping in mind that post-transplant gastrointestinal toxicities are usually related to several variables not always easy to predict and control.…”

“…In our study, we observed a slightly lower incidence of febrile neutropenia episodes and documented infections with consequent lower broad-spectrum antibiotic consumption in patients who received biosimilar Peg-filgrastim; however, it is not statistically significant. This trend is consistent with that reported in the study of Martino et al [ 11 ] and other groups [ 19 , 26 – 28 ], where it however reached the statistical significance. Our data about febrile neutropenia episodes and documented infections could be however potentially influenced by the higher number of myeloma patients observed in the biosimilar Peg-filgrastim group.…”

“…Data about biosimilar Peg-Filgrastim are still scarce in this context. Recently, some studies have been published, all together showing a slightly superiority of biosimilar pegylated formulations over the short-acting G-CSFs in myeloma and lymphoma patients undergoing ASCT [ 11 , 21 ]. The physiological reason for the better performance of pegylated G-CSF formulation can be found looking at the pharmacokinetics of Peg-filgrastim.…”

“…Even though the use of biosimilar Peg-filgrastim is progressively increasing in oncohematology field, there are still few data about its efficacy and safety in patients undergoing ASCT and allogeneic hematopoietic stem cell transplant. As for ASCT, a recent study from an Italian transplant center have explored the use of biosimilar Peg-filgrastim among multiple myeloma patients undergoing ASCT suggesting a substantial superimposable efficacy and safety compared to other G-CSFs (originator Peg-filgrastim and biosimilar short-acting filgrastim) [ 11 ]. The aim of this study has been to assess the efficacy and the safety of biosimilar Peg-Filgrastim among a lymphoma and myeloma patient population undergoing ASCT, comparing these data with those derived by our historical control groups of patients receiving other G-CSFs for febrile neutropenia prophylaxis (i.e., biosimilar Filgrastim, originator Peg-filgrastim, and Lenograstim).…”