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接受生物类似物非格司亭预防化疗引起的/发热性中性粒细胞减少症的非小细胞肺癌患者的治疗模式和结局:MONITOR-GCSF 研究结果。

Treatment patterns and outcomes in patients with non-small cell lung cancer receiving biosimilar filgrastim for prophylaxis of chemotherapy-induced/febrile neutropaenia: Results from the MONITOR-GCSF study.

机构信息

Cancer Center, Clinique de Genolier, Genolier, Switzerland.

Hexal AG, Holzkirchen, Germany.

出版信息

Eur J Cancer Care (Engl). 2019 Jul;28(4):e13034. doi: 10.1111/ecc.13034. Epub 2019 Apr 10.

Abstract

OBJECTIVE

Real-world evidence data on the use of granulocyte colony-stimulating factor (G-CSF) in patients with non-small cell lung cancer (NSCLC) are limited. MONITOR-GCSF is a pan-European, multicentre, prospective, non-interventional study designed to describe patient characteristics, treatment patterns and clinical outcomes in patients receiving biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropaenia (CIN) and febrile neutropaenia (FN).

METHODS

In this subanalysis, patient characteristics, treatment patterns, and outcomes are described for 345 patients with stage 3 or 4 NSCLC, receiving up to six chemotherapy cycles. Patients were treated with biosimilar filgrastim as per their treating physician's best judgement.

RESULTS

CIN (any grade) occurred in 13.6% of patients in Cycle 1 and in 36.5% of patients in all cycles. FN occurred in 1.4% of patients in Cycle 1 and in 5.2% of patients in all cycles. Grade 3-4 FN occurred in 1.2% of patients in Cycle 1 and in 3.8% of patients in all cycles.

CONCLUSION

Results show that in real-life practice in patients with NSCLC, biosimilar filgrastim has similar effectiveness and safety to the known effectiveness and safety profile of reference filgrastim, supporting the use of biosimilar filgrastim for the real-world treatment of neutropaenia in patients with NSCLC.

摘要

目的

粒细胞集落刺激因子(G-CSF)在非小细胞肺癌(NSCLC)患者中的实际应用证据有限。MONITOR-GCSF 是一项泛欧、多中心、前瞻性、非干预性研究,旨在描述接受生物类似物非格司亭预防化疗引起的中性粒细胞减少症(CIN)和发热性中性粒细胞减少症(FN)的患者的特征、治疗模式和临床结局。

方法

本亚分析中,对 345 例 3 或 4 期 NSCLC 患者的特征、治疗模式和结局进行了描述,这些患者接受了最多 6 个化疗周期的治疗。患者根据其治疗医生的最佳判断接受生物类似物非格司亭治疗。

结果

第 1 周期 CIN(任何级别)的发生率为 13.6%,所有周期 CIN 的发生率为 36.5%。第 1 周期 FN 的发生率为 1.4%,所有周期 FN 的发生率为 5.2%。第 1 周期 3-4 级 FN 的发生率为 1.2%,所有周期 FN 的发生率为 3.8%。

结论

结果表明,在 NSCLC 患者的实际治疗中,生物类似物非格司亭与参考非格司亭已知的有效性和安全性相当,支持生物类似物非格司亭在真实世界中用于治疗 NSCLC 患者的中性粒细胞减少症。

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