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非髓系恶性肿瘤患者中使用甲磺酸培非格司亭预防中性粒细胞减少症:一项真实世界研究

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study.

作者信息

Ma Jun, Huang Huiqiang, Fu Peifen, Xu Nong, Mao Chenyu, Cheng Gang, Yan Haijiao, Li Yongqing, Shi Yanxia, Wang Yongsheng, Yao Yumin, Chen Liang, Chen Yong, Zhang Ningling, Zhang Guifang, Ren Zhangxia, Li Zengjun, Song Lihua, Xu Ruihua, Qin Shukui

机构信息

Harbin Institute of Hematology and Oncology, Harbin, China.

Department of Internal Medicine IV, Sun Yat-sen University Cancer Center, Guangzhou, China.

出版信息

Ann Transl Med. 2021 May;9(10):893. doi: 10.21037/atm-21-2449.

Abstract

BACKGROUND

Chemotherapy-induced neutropenia is commonly encountered in clinical practice. The management of neutropenia has been evolving from short-acting granulocyte colony-stimulating factors (G-CSFs) to long-acting G-CSFs. However, an evaluation of the safety and effectiveness of long-acting G-CSFs in clinical practice is still lacking.

METHODS

This multicenter, non-interventional study was aimed at exploring the safety and effectiveness of mecapegfilgrastim in different cancer patients in China. All patients provided written informed consent prior to the study and were treated according to routine clinical practice. Different prophylactic strategies (primary or secondary prophylaxis) were also compared.

RESULTS

This study included 638 patients from May 2019 to November 2020. More than half of the participants were breast cancer patients. The mean age of all the patients was 56 years. White blood cell increase (6.2%) was the most frequently reported adverse event (AE) possibly related to the study drug. No unexpected AEs were reported. Grade ≥3 neutropenia in chemotherapy treatment cycle 1 was reported in 36 (5.6%) patients. Incidence of grade ≥3 neutropenia in cycle 1 in the primary and secondary prophylaxis subgroups were of 4.3% and 9.2%, respectively. A decreasing trend of severe neutropenia incidence was observed from cycle 1 to cycle 4.

CONCLUSIONS

Mecapegfilgrastim was generally well tolerated, and no unexpected AEs were observed in this study. Primary administration of mecapegfilgrastim led to a lower incidence of neutropenia than did secondary administration. Continuous administration of mecapegfilgrastim could keep the incidence of neutropenia to a relatively low level.

摘要

背景

化疗引起的中性粒细胞减少在临床实践中很常见。中性粒细胞减少的管理已从短效粒细胞集落刺激因子(G-CSF)发展到长效G-CSF。然而,仍缺乏对长效G-CSF在临床实践中的安全性和有效性的评估。

方法

这项多中心、非干预性研究旨在探索培非格司亭在中国不同癌症患者中的安全性和有效性。所有患者在研究前均提供了书面知情同意书,并按照常规临床实践进行治疗。还比较了不同的预防策略(一级或二级预防)。

结果

本研究纳入了2019年5月至2020年11月期间的638例患者。超过一半的参与者为乳腺癌患者。所有患者的平均年龄为56岁。白细胞升高(6.2%)是最常报告的可能与研究药物相关的不良事件(AE)。未报告意外不良事件。在第1个化疗周期中,36例(5.6%)患者报告了≥3级中性粒细胞减少。一级预防和二级预防亚组中第1周期≥3级中性粒细胞减少的发生率分别为4.3%和9.2%。从第1周期到第4周期观察到严重中性粒细胞减少发生率呈下降趋势。

结论

培非格司亭总体耐受性良好,本研究中未观察到意外不良事件。培非格司亭的一级给药导致中性粒细胞减少的发生率低于二级给药。持续使用培非格司亭可将中性粒细胞减少的发生率保持在相对较低的水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/deca/8184427/c2cc666f7ec6/atm-09-10-893-f1.jpg

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