背景:Mecapegfilgrastim,长效粒细胞集落刺激因子已被批准用于降低感染发生率,特别是发热性中性粒细胞减少症(FN),在中国。
目的:我们进行了一项多中心前瞻性观察性研究,以检查mecapegfilgrastim预防接受化疗的胃肠道患者中性粒细胞减少的安全性和有效性。包括基于S-1/卡培他滨的方案或氟尿嘧啶,亚叶酸,奥沙利铂,和伊立替康(FOLFOXIRI)/氟尿嘧啶,亚叶酸,和奥沙利铂(FOLFOX)/氟尿嘧啶,亚叶酸,奥沙利铂,和伊立替康(FOLFIRINOX)方案。
方法:来自中国40个地点的561例胃肠道患者,2019年5月至2021年11月,包括在内。mecapegfilgrastim的管理由当地医生自行决定。
结果:所有患者中最常见的药物不良反应(ADR)是白细胞增加(2.9%)。观察到贫血的3/4级不良反应(0.2%),白细胞减少(0.2%),中性粒细胞计数下降(0.2%)。在所有周期中接受以S-1/卡培他滨为基础的化疗的116例患者中,任何级别的ADR包括贫血(1.7%),肌痛(0.9%),丙氨酸转氨酶增加(0.9%)。未观察到3/4级ADR。在414个周期的患者谁接受S-1/卡培他滨为基础的方案,只有一个周期(0.2%)出现4级中性粒细胞减少症.在FILFIRINOX中,FOLFOXIRI,和FOLFOX化疗方案,4级中性粒细胞减少症发生在37个周期中的一个(2.7%),85个周期中的四个(4.7%),和两个(1.2%)的167个周期,分别。
结论:在现实世界中,mecapegfilgrastim已被证明可有效预防化疗后胃肠道患者的严重中性粒细胞减少症。这包括常用的中度或高风险FN方案或含有S1/卡培他滨的方案,所有这些都证明了良好的疗效和安全性.
BACKGROUND: Mecapegfilgrastim, a long-acting granulocyte-colony stimulating factor has been approved for reducing the incidence of infection, particularly febrile neutropenia (FN), in
China.
OBJECTIVE: We conducted a multicenter prospective observational study to examine the safety and effectiveness of mecapegfilgrastim in preventing neutropenia in
gastrointestinal patients receiving the chemotherapy, including S-1/capecitabine-based regimens or the fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI)/fluorouracil, leucovorin, and oxaliplatin (FOLFOX)/fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX) regimens.
METHODS: Five hundred and sixty-one
gastrointestinal patients from 40 sites across
China, between May 2019 and November 2021, were included. The administration of mecapegfilgrastim was prescribed at the discretion of local physicians.
RESULTS: The most common adverse drug reactions (ADRs) of any grade for all patients was increased white blood cells (2.9%). Grade 3/4 ADRs were observed for anemia (0.2%), decreased white blood cells (0.2%), and decreased neutrophil count (0.2%). Among the 116 patients who received S-1/capecitabine-based chemotherapy throughout all cycles, ADRs of any grade included anemia (1.7%), myalgia (0.9%), and increased alanine aminotransferase (0.9%). No grade 3/4 ADRs were observed. In 414 cycles of patients who underwent S-1/capecitabine-based regimens, only one (0.2%) cycle experienced grade 4 neutropenia. In the FOLFIRINOX, FOLFOXIRI, and FOLFOX chemotherapy regimens, grade 4 neutropenia occurred in one (2.7%) of 37 cycles, four (4.7%) of 85 cycles, and two (1.2%) of 167 cycles, respectively.
CONCLUSIONS: In a real-world setting, mecapegfilgrastim has proven effective in preventing severe neutropenia in
gastrointestinal patients following chemotherapy. This includes commonly used moderate or high-risk FN regimens or regimens containing S1/capecitabine, all of which have demonstrated favorable efficacy and safety profiles.