淋巴瘤患者化疗后预防性给予美泊利珠单抗。

Prophylactic administration of mecapegfilgrastim after chemotherapy in patients with lymphoma.

机构信息

Department of Hematology, Affiliated Shanxi Tumor Hospital of Shanxi Medical University, Taiyuan, China.

出版信息

Ann Palliat Med. 2021 Dec;10(12):12055-12060. doi: 10.21037/apm-21-3209.

DOI:10.21037/apm-21-3209

PMID:35016412

Abstract

BACKGROUND

Neutropenia is a common and serious complication encountered during chemotherapy treatment of cancer patients. The incidence of neutropenia increases the risk of infection and can influence the chemotherapy treatment in terms of drug dosage and treatment duration. Mecapegfilgrastim is a novel, long-acting pegylated recombinant human granulocyte-colony stimulating factor (PEG-rhG-CSF) designed to prevent the incidence of neutropenia. The study aims to observe the effectiveness and safety of mecapegfilgrastim as prophylaxis for chemotherapy-induced neutropenia in patients with lymphoma.

METHODS

Ninety-one patients with lymphoma were enrolled and received mecapegfilgrastim as either primary or secondary prophylaxis. The incidence of grade III/IV neutropenia, the duration of grade III/IV neutropenia in the overall population, and the differences between the primary and secondary prophylaxis groups were investigated. Adverse events were also recorded.

RESULTS

During the first chemotherapy cycle, the incidence of grade III and grade IV neutropenia was 5% and 7%, respectively. Of the 71 patients who received mecapegfilgrastim as primary prophylaxis, the incidence of grade III and grade IV neutropenia was 4% and 1%, respectively. Of the 20 patients who received mecapegfilgrastim as secondary prophylaxis, the incidence of grade III and grade IV neutropenia was 10% and 25%, respectively. The mean duration of grade III neutropenia was 0.85 days. The mean duration of grade III neutropenia in patients who received mecapegfilgrastim as primary prophylaxis was one day less than patients who received mecapegfilgrastim as secondary prophylaxis. Fever and bone/muscle pain were the most frequently observed adverse events.

CONCLUSIONS

Mecapegfilgrastim is more effective in reducing the incidence of grade III/IV neutropenia and the mean duration of febrile neutropenia (FN) when used as primary prophylaxis rather than secondary prophylaxis in patients with lymphoma. The toxicity of mecapegfilgrastim was tolerable.

摘要

背景

中性粒细胞减少症是癌症患者化疗治疗中常见且严重的并发症。中性粒细胞减少症的发生率增加了感染的风险，并可能影响化疗治疗的药物剂量和治疗持续时间。美泊利珠单抗是一种新型长效聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF），旨在预防中性粒细胞减少症的发生。本研究旨在观察美泊利珠单抗作为淋巴瘤患者化疗诱导性中性粒细胞减少症预防药物的有效性和安全性。

方法

共纳入 91 例淋巴瘤患者，接受美泊利珠单抗作为一线或二线预防用药。观察总体人群中 III/IV 级中性粒细胞减少症的发生率、III/IV 级中性粒细胞减少症的持续时间，以及一线和二线预防组之间的差异。同时记录不良事件。

结果

在第一个化疗周期中，III 级和 IV 级中性粒细胞减少症的发生率分别为 5%和 7%。71 例接受美泊利珠单抗一线预防的患者中，III 级和 IV 级中性粒细胞减少症的发生率分别为 4%和 1%。20 例接受美泊利珠单抗二线预防的患者中，III 级和 IV 级中性粒细胞减少症的发生率分别为 10%和 25%。III 级中性粒细胞减少症的平均持续时间为 0.85 天。接受美泊利珠单抗一线预防的患者 III 级中性粒细胞减少症的平均持续时间比接受美泊利珠单抗二线预防的患者少一天。发热和骨/肌肉痛是最常观察到的不良事件。