Department of Pharmacology, Toranomon Hospital, Tokyo, Japan.
Department of Hematology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan.
Int J Hematol. 2022 Dec;116(6):856-862. doi: 10.1007/s12185-022-03438-1. Epub 2022 Aug 17.
In this study, the efficacy and safety of filgrastim biosimilar (F-BS) were retrospectively compared to those of filgrastim original in the treatment of malignant lymphoma with CHASE (± R) or DeVIC(± R) in 78 patients. The median number of filgrastim doses was 11 in the F-BS group and 8 in the filgrastim group after CHASE (± R) (p = 0.8), and 10 in the F-BS group and 10 in the filgrastim group after DeVIC (± R) (p = 0.45). The median days until neutrophil recovery to ≥ 1000/μL was 10 days with F-BS versus 10 days with filgrastim after CHASE ± R (p = 0.59), and 9 days with F-BS versus 10 days with filgrastim after DeVIC ± R (p = 0.828). Febrile neutropenia (FN) was observed in 5 patients (41.7%) in the F-BS group and 9 (52.9%) in the filgrastim group after CHASE ± R therapy (p = 0.616), and in 11 patients (36.7%) in the F-BS group and 9 (47.4%) in the filgrastim group after DeVIC ± R (p = 0.462). The present results suggest that the efficacy and safety of F-BS are comparable to those of filgrastim original, with no significant differences in clinical factors. Use of F-BS also reduced medical costs per course of CHASE ± R therapy by 170.22 US dollars.
在这项研究中,回顾性比较了在 78 例恶性淋巴瘤患者中使用 CHASE(±R)或 DeVIC(±R)时,培非格司亭生物类似药(F-BS)与培非格司亭原研药的疗效和安全性。在 CHASE(±R)后,F-BS 组的培非格司亭剂量中位数为 11 次,培非格司亭组为 8 次(p=0.8),F-BS 组和培非格司亭组在 DeVIC(±R)后分别为 10 次和 10 次(p=0.45)。中性粒细胞恢复至≥1000/μL 的中位天数,F-BS 组为 10 天,培非格司亭组为 10 天(p=0.59),F-BS 组为 9 天,培非格司亭组为 10 天(p=0.828)。在 F-BS 组中有 5 例(41.7%)和培非格司亭组中有 9 例(52.9%)患者出现发热性中性粒细胞减少症(FN)(p=0.616),在 F-BS 组中有 11 例(36.7%)和培非格司亭组中有 9 例(47.4%)患者出现发热性中性粒细胞减少症(FN)(p=0.462)。本研究结果表明,F-BS 的疗效和安全性与培非格司亭原研药相当,临床因素无显著差异。F-BS 的使用也使 CHASE(±R)治疗方案的每疗程医疗费用降低了 170.22 美元。