Etoposide combined with cytarabine and pegfilgrastim for poorly mobilizing patients with multiple myeloma and lymphoma: A prospective multicentre study

Article

作者: Li, Shuangyue ; Du, Xiaohong ; Yang, Min ; Hu, Chao ; Yu, Wenjuan ; Qian, Jiejing ; Tong, Hongyan ; Jin, Jie ; Guo, Qunyi ; Li, Linjie ; Ye, Peipei ; Lu, Ying ; Hong, Pan ; Liu, Xuhui ; Lian, Jiaying ; Jin, Yangjin ; Wang, Huafeng ; Pei, Renzhi ; Huang, Li ; Feng, Weiying ; Zhu, Weiguo ; Chen, Dong ; Shen, Jian ; Cheng, Yixuan ; Shou, Lihong

SummaryA chemotherapy‐based mobilization regimen in patients who mobilize poorly, based on etoposide, cytarabine and pegfilgrastim (EAP), has recently been introduced. The aim of this prospective study was to investigate the efficacy and safety of the EAP regimen in patients with poorly mobilizing multiple myeloma (MM) or lymphoma. This single‐arm clinical trial was performed at eight public hospitals in China and was registered as a clinical trial (NCT05510089). The inclusion criteria were; (1) diagnosis of MM or lymphoma, (2) defined as a ‘poor mobilizer’ and (3) aged 18–75 years. The EAP regimen consisted of etoposide 75 mg/m2/day on days 1–2, cytarabine 300 mg/m2 every 12 h on days 1–2 and pegfilgrastim 6 mg on day 6. The primary endpoint of the study was the ratio of patients achieving adequate mobilization (≥2.0 × 106 CD34+ cells/kg). From 1 September 2022 to 15 August 2023, a total of 58 patients were enrolled, 53 (91.4%) achieved adequate mobilization, while 41 (70.7%) achieved optimal mobilization with a median number of cumulative collected CD34+ cells was 9.2 (range 2.1–92.7) × 106/kg and the median number of apheresis per patient of 1.2. The median time from administration of the EAP regimen to the first apheresis was 12 days. Approximately 8.6% of patients required plerixa for rescue, which was successful. Twelve (20.7%) of the 58 patients suffered grade 2–3 infections, while 25 (43.1%) required platelet transfusions. The duration of neutrophil and platelet engraftment was 11 days. In conclusion, these results suggest that the EAP mobilization regimen might be a promising option for poorly mobilizing patients with MM or lymphoma.

2009-06-01·BioDrugs3区 · 医学

Twenty Years of Clinical Experience

3区 · 医学

Review

作者: Michael Green ; William Renwick ; Ruth Pettengell

Neutropenia is a serious hematologic toxicity of myelosuppressive chemotherapy. The discovery that granulocyte colony-stimulating factor (G-CSF) could stimulate the production of neutrophils was followed by the purification and molecular cloning of filgrastim (Neupogen), the human recombinant form of the protein, between 1984 and 1986. In this article, we review 20 years of clinical literature with filgrastim and the more recent experience with pegfilgrastim (Neulasta) to support the delivery of chemotherapy. The earliest clinical studies of filgrastim showed that it produces immediate transient leukopenia followed by a sustained, dose-dependent increase in circulating neutrophils. In the two registrational studies of filgrastim, the cumulative incidence of febrile neutropenia (FN) was reduced by about 50% compared with placebo. Subsequent clinical trials and meta-analyses established that primary prophylaxis with filgrastim (beginning in the first cycle of chemotherapy) reduced the incidence of FN, FN-related hospitalizations, intravenous anti-infective use, infection-related mortality, and the need for chemotherapy dose modification, compared with placebo or no treatment, in many tumor types. Pegfilgrastim, formed by the addition of a polyethylene glycol molecule to filgrastim, has comparable efficacy to filgrastim when administered only once per chemotherapy cycle. High-level evidence indicates that both filgrastim and pegfilgrastim improve the likelihood of completing dose-dense and dose-intense chemotherapy. The most recent guidelines from three international cancer organizations, the European Organization for Research and Treatment of Cancer, the American Society of Clinical Oncology, and the US National Comprehensive Cancer Network, are in agreement that filgrastim or pegfilgrastim should be given prophylactically when the risk of FN with a chemotherapy regimen is > or =20%, or when the risk is 10-20% and the patient has other risk factors for FN. The development of filgrastim and pegfilgrastim has revolutionized oncology practice. Prophylactic use of these agents has enabled development of more aggressive chemotherapy regimens, including dose-dense chemotherapy, and treatment of a broader range of patients.

2008-01-01·Advanced Drug Delivery Reviews1区 · 医学

Formulation of Neulasta® (pegfilgrastim)

1区 · 医学

Review

作者: Deirdre Murphy Piedmonte ; Michael J. Treuheit

Neulasta (pegfilgrastim) is a PEGylated version of its parent molecule NEUPOGEN (Filgrastim). This work describes the formulation development for Neulasta (pegfilgrastim), and the analytical techniques used to monitor degradation during these studies. Stability was assessed as a function of pH, protein concentration, buffer type, tonicity modifiers and surfactant concentration under both accelerated conditions and quiescent long-term storage. The stability of Neulasta (pegfilgrastim) to agitation and successive freeze-thaw cycles was also assessed. Neulasta (pegfilgrastim), at a protein concentration of 10 mg/mL formulated in 10 mM acetate, pH 4.0 with 5% sorbitol and 0.004% polysorbate 20, is stable for two years stored at 2-8 degrees C.

100 项与 Pegfilgrastim(CuraTeQ) 相关的药物交易

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