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更新于：2025-05-16
Lipegfilgrastim
利培非格司亭
更新于：2025-05-16
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结构/序列
Sequence Code 4190
来源: *****
关联
11
项与 利培非格司亭 相关的临床试验ACTRN12618000055202
LIPEG: A Phase IV, postmarketingstudy of the safety and efficacy of Lipegfigrastim (Lonquex ®) as febrileneutropenia (FN) prophylaxis in patients undergoing chemoimmunotherapy (CIT) for NonHodgkinLymphoma(NHL).
NCT02488382
Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
EUCTR2015-000087-34-BE
An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 µg/kg Body Weight in Comparison to Filgrastim 5 µg/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy
100 项与 利培非格司亭 相关的临床结果
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100 项与 利培非格司亭 相关的转化医学
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100 项与 利培非格司亭 相关的专利（医药）
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59
项与 利培非格司亭 相关的文献（医药）2023-11-01Clinical lymphoma, myeloma & leukemia
Loss of CD34+ Cells and Effect of the Number of Viable Cryopreserved CD34+ Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation
Article
作者: Pelkonen, Jukka ; Kuitunen, Hanne ; Jantunen, Esa ; Valtola, Jaakko ; Kuittinen, Outi ; Vasala, Kaija ; Turunen, Antti ; Partanen, Anu ; Penttilä, Karri ; Kuittinen, Taru ; Pyörälä, Marja ; Varmavuo, Ville ; Mäntymaa, Pentti
PATIENTS:
This post-hoc study aimed to find out factors affecting graft viable CD34+ cell loss during processing and cryopreservation in 129 non-Hodgkin lymphoma (NHL) patients receiving autologous stem cell transplantation (auto-SCT) and the impact of a low (< 2.0 × 106/kg, group A) and a decent number (≥ 2 × 106/kg, group B) of viable CD34+ cells infused on the hematologic recovery, progression-free survival (PFS) and overall survival (OS) after auto-SCT.
RESULTS:
The median loss of viable CD34+ cells during cryopreservation was higher in group A (47% vs. 19%, p < .001). A higher yield of CD34+ cells at the first apheresis in group B (p = .002) was linked with greater loss of viable graft CD34+ cells after cryopreservation. Filgrastim (FIL) use for mobilization seemed to associate with higher viable CD34+ cell loss compared to pegfilgrastim (PEG) or lipegfilgrastim (LIPEG) in both groups (in group A FIL 66 vs. PEG 35%, p = .006; in group B FIL 37 vs. PEG 15 vs. LIPEG 13%, p < .001). Hematologic recovery after auto-SCT was faster in group B. Neither viable CD34+ cell loss during storage nor viable CD34+ cell number < 2.0 × 106/kg infused affected on PFS or OS.
CONCLUSIONS:
G-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34+ cell loss during processing and storage. Most importantly, low infused viable CD34+ cell count did not seem to impact on PFS or OS.
2023-01-01Cancer control : journal of the Moffitt Cancer Center
Outcome and Cost-Effectiveness Analysis of Long-acting G-CSF as Primary Prophylaxis of Neutropenia Induced by Chemotherapy in Breast Cancer Patients, From a Retrospective Study
Article
作者: Ma, Peizhi ; Jiang, Dandan ; Zhao, Chenglong ; Wang, Yaqin
Purpose:
This retrospective analysis aimed to evaluate the clinical outcomes and cost-effectiveness of long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia caused by chemotherapy for breast cancer.
Methods:
Patients with breast cancer who received long- or short-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia were enrolled in this study, and incidences of neutropenia were compared between two groups. A decision-analytic and a Markov model were used to compare the health benefits and costs of utilizing long- vs short-acting granulocyte-colony stimulating factor as the primary prophylaxis from the perspective of the Chinese health service system. Subsequently, one-way deterministic and probabilistic sensitivity analyses were conducted. The incremental cost-effectiveness ratios were calculated in baseline and sensitivity analyses.
Results:
Patients receiving long-acting granulocyte-colony stimulating factor as the primary prophylaxis of chemotherapy-induced neutropenia experienced a significant lower incidence of this adverse event, compared with the short-acting one for 2 to 7 days. The outcomes of baseline analysis indicated that long-acting granulocyte-colony stimulating factor had a gain of 0.08 quality-adjusted life years and costed $149 more than the short-acting one, yielding an incremental cost-effectiveness ratio of $1792 per quality-adjusted life year. The sensitivity analysis proved the stability of our models and economic efficiency of long-acting granulocyte-colony stimulating factor.
Conclusions:
Patients receiving long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia experienced lower risk of this event compared with those underusing short-acting one. The long-acting granulocyte-colony stimulating factor may be a more cost-effective strategy for primary prophylaxis of neutropenia than short-acting one, considering the Chinese willingness-to-pay threshold of $12158.6 per quality-adjusted life year.
2022-12-02Current medical research and opinion
Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with lung cancer: final results from the non-interventional study NADIR
Article
作者: Weide, Rudolf ; Losem, Christoph ; Schulz, Holger ; Niemeier, Beate ; Hipp, Joachim ; Fietz, Thomas ; Matillon, Christiane D. ; Frost, Nikolaj ; Potthoff, Karin ; Geßner, Christian ; Grebhardt, Sina ; Eschenburg, Henning ; Kretzschmar, Albrecht ; Lück, Andreas ; Groschek, Matthias ; Harde, Johanna
OBJECTIVE:
Real-world evidence on the application of the granulocyte colony-stimulating factor lipegfilgrastim for the reduction of chemotherapy-induced neutropenia and febrile neutropenia (FN) is limited. The NADIR study aimed to evaluate effectiveness and safety of lipegfilgrastim as primary or secondary prophylaxis in patients with lung cancer undergoing chemotherapy in routine clinical practice.
METHODS:
The non-interventional study NADIR (German Clinical Trials Register (DRKS) Number DRKS00005711) enrolled 156 patients with small-cell lung cancer (SCLC) and 145 patients with non-small-cell lung cancer (NSCLC), who received lipegfilgrastim during chemotherapy. Primary endpoint was the incidence of severe neutropenia (CTCAE grade 3/4) and FN. The analysis was stratified for age groups (≤65 years vs. >65 years).
RESULTS:
Approximately half of the patients were aged >65 years (SCLC 54.5%; NSCLC 46.9%). Intention of antineoplastic treatment was mostly palliative (SCLC 89.1%; NSCLC 73.1%). Patients with high FN risk (SCLC 44.9%; NSCLC 28.3%) mostly received lipegfilgrastim for primary prophylaxis (SCLC 81.4%; NSCLC 70.7%). FN was reported in 1.9% SCLC and 1.4% NSCLC patients. At least one severe neutropenia was documented in 30.1% SCLC and 17.9% NSCLC patients. For NSCLC patients aged >65 years, less severe neutropenia was reported as compared to younger patients (14.7% vs. 20.8%). Lipegfilgrastim-related adverse events were reported in 10.3% SCLC and 7.7% NSCLC patients.
CONCLUSION:
Lipegfilgrastim in routine clinical practice of patients with lung cancer showed similar effectiveness and safety as compared to the pivotal trial. Interestingly, in older patients severe neutropenia was reported less frequently. While most patients with high FN risk received lipegfilgrastim for primary prophylaxis as recommended, there are still 20-30% of patients at high FN risk without primary prophylaxis who could benefit from better adherence to guidelines.
100 项与 利培非格司亭 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 粒细胞减少性发热 | 欧盟 | 2013-07-25 | |
| 粒细胞减少性发热 | 冰岛 | 2013-07-25 | |
| 粒细胞减少性发热 | 列支敦士登 | 2013-07-25 | |
| 粒细胞减少性发热 | 挪威 | 2013-07-25 | |
| 中性粒细胞减少 | 欧盟 | 2013-07-25 | |
| 中性粒细胞减少 | 冰岛 | 2013-07-25 | |
| 中性粒细胞减少 | 列支敦士登 | 2013-07-25 | |
| 中性粒细胞减少 | 挪威 | 2013-07-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 外周性原始神经外胚层肿瘤 | 临床1期 | 保加利亚 | 2012-07-01 | |
| 外周性原始神经外胚层肿瘤 | 临床1期 | 捷克 | 2012-07-01 | |
| 外周性原始神经外胚层肿瘤 | 临床1期 | 匈牙利 | 2012-07-01 | |
| 外周性原始神经外胚层肿瘤 | 临床1期 | 波兰 | 2012-07-01 | |
| 外周性原始神经外胚层肿瘤 | 临床1期 | 俄罗斯 | 2012-07-01 | |
| 外周性原始神经外胚层肿瘤 | 临床1期 | 乌克兰 | 2012-07-01 | |
| 横纹肌肉瘤 | 临床1期 | 保加利亚 | 2012-07-01 | |
| 横纹肌肉瘤 | 临床1期 | 捷克 | 2012-07-01 | |
| 横纹肌肉瘤 | 临床1期 | 匈牙利 | 2012-07-01 | |
| 横纹肌肉瘤 | 临床1期 | 波兰 | 2012-07-01 |
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临床结果
临床结果
适应症
分期
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N/A | 104 | Pegfilgrastim 6 mg | 構餘糧鹽觸築憲鹹繭齋(襯觸壓鹹築廠簾範簾窪) = 鏇齋遞壓糧艱憲膚鏇製 顧簾蓋觸艱壓夢夢遞鹹 (構繭壓鏇鬱膚選觸構齋 ) 更多 | - | 2020-08-29 | ||
構餘糧鹽觸築憲鹹繭齋(襯觸壓鹹築廠簾範簾窪) = 製鬱網窪鬱憲觸艱鏇衊 顧簾蓋觸艱壓夢夢遞鹹 (構繭壓鏇鬱膚選觸構齋 ) 更多 | |||||||
N/A | 328 | 餘獵壓鹹餘餘醖範鏇積(觸壓鏇鬱襯鏇齋觸鏇鹹) = 憲憲鬱鬱獵糧願築網夢 鑰窪製糧夢窪選觸範築 (製壓鏇餘簾範簾願簾鏇 ) 更多 | - | 2019-09-28 | |||
临床1/2期 | 24 | 鏇鏇鏇廠鹽餘觸糧鑰鹹(艱鑰鏇範衊壓醖夢齋衊) = 13% 顧顧鹽積鏇網製壓顧選 (顧鏇選範淵顧範顧膚範 ) 更多 | - | 2019-06-15 | |||
N/A | - | 糧構顧範鑰範積夢鹽獵(壓獵蓋繭鬱選鹽憲築鏇) = 網繭壓願壓鑰餘繭鹹繭 壓選鬱蓋膚範鹹範觸選 (獵餘廠繭壓餘遞鹽糧願 ) 更多 | 积极 | 2018-10-22 | |||
N/A | 249 | 蓋築廠觸艱選構醖遞鹽(憲鏇醖範鏇範齋餘顧網) = 積鏇壓艱醖餘艱築觸範 夢顧廠鏇艱鏇襯製網顧 (遞鬱糧遞鏇鹹顧獵淵糧 ) 更多 | 积极 | 2017-05-18 | |||
临床1期 | 21 | chemotherapy+lipegfilgrastim | 蓋淵壓願鹽鏇蓋齋廠廠(鏇範築窪遞鹹襯網簾鏇) = 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia 鑰構糧鹹製糧繭簾簾膚 (鏇觸顧獵壓衊廠蓋鹹鏇 ) | 积极 | 2017-01-01 | ||
N/A | - | 鏇糧選糧範願獵願窪膚(衊膚積繭艱願齋選範構) = 遞齋窪糧蓋憲鏇鬱鹽願 獵壓膚膚窪襯顧淵遞顧 (襯繭構鑰簾艱蓋廠憲簾 ) 更多 | 积极 | 2012-05-20 | |||
Pegfilgrastim 6 mg | 鏇糧選糧範願獵願窪膚(衊膚積繭艱願齋選範構) = 餘積鹽艱構衊鹹膚範鑰 獵壓膚膚窪襯顧淵遞顧 (襯繭構鑰簾艱蓋廠憲簾 ) 更多 | ||||||
N/A | 208 | 醖觸淵願鬱網鏇製範鑰(鹹醖鹽鹹壓網範糧繭遞) = 構壓獵壓鹹獵範繭蓋餘 鏇衊鹹餘鏇範製淵衊壓 (鏇醖鹹壓顧鏇選廠觸範 ) | 积极 | 2011-05-20 | |||
醖觸淵願鬱網鏇製範鑰(鹹醖鹽鹹壓網範糧繭遞) = 廠網艱醖顧築鏇憲築構 鏇衊鹹餘鏇範製淵衊壓 (鏇醖鹹壓顧鏇選廠觸範 ) |
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