trilaciclib对接受化疗的中国广泛期小细胞肺癌(ES-SCLC)患者的骨髓保护作用--一项真实世界研究。

IF 2.1 3区 医学 Q3 RESPIRATORY SYSTEM Journal of thoracic disease Pub Date : 2024-11-30 Epub Date: 2024-11-20 DOI:10.21037/jtd-24-893
Yongxing Chen, Chong Meng, Lirong Liu, Kai Liu, Tao Chen, Chen Yang
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引用次数: 0

摘要

背景:Trilaciclib是一种静脉短效周期蛋白依赖性激酶4/6抑制剂,于2021年2月在美国被批准用于预防广泛期小细胞肺癌(ES-SCLC)患者接受铂/依托泊苷(EP)或拓扑替康(TPT)为基础的治疗中化疗诱导的骨髓抑制(CIM)。Trilaciclib的使用在中国的现实环境中获得了优先审查和批准。因此,本研究旨在收集实际数据,评估trilaciclib对中国ES-SCLC患者CIM的保护作用。方法:这项单组、非介入性的真实世界研究邀请了中国海南博鳌接受trilaciclib联合铂和依托泊苷±抗程序性细胞死亡配体-1[抗pd -(L)1]抗体(EP组)或trilaciclib联合TPT (TPT组)治疗的所有ES-SCLC患者参加研究。主要终点是严重(4级)中性粒细胞减少症(SN)的发生率,次要终点包括其他骨髓保护作用、安全性和抗肿瘤活性。结果:在2021年8月至2022年12月期间,共有30名接受trilaciclib化疗的患者同意参加这项现实世界的研究。在入选患者中,26例患者接受EP方案治疗,其中18例患者联合抗pd -(L)1抗体,4例患者接受TPT治疗。EP组和TPT组SN发生率为6.7%,两组各1例。三级血液学毒性发生率为30% (9/30),EP组19.2% (5/26),TPT组100%(4/4)。4级血液学毒性发生率为5/30 (16.7%),EP组为3/26 (11.5%),TPT组为2/4(50%)。总体而言,静脉或口服抗生素的发生率为6/30 (20%),EP组为4/26 (15.4%),TPT组为2/4(50%)。未报告与trilaciclib相关的≥3级不良事件、严重不良事件(SAEs)和特殊利益不良事件。结论:对于ES-SCLC,在含ep方案(联合或不联合PD-(L)1)或TPT之前使用Trilaciclib可降低中国患者CIM的发生率。骨髓保护、抗肿瘤和安全性的效果均与全球研究和中国三期安慰剂对照研究(TRACES)的数据一致。
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Myeloprotection effects of trilaciclib in Chinese patients with extensive stage small cell lung cancer (ES-SCLC) receiving chemotherapy-a real-world study.

Background: Trilaciclib, an intravenous short acting cyclin-dependent kinase 4/6 inhibitor, has been approved for the prevention of chemotherapy-induced myelosuppression (CIM) in patients with extensive stage small cell lung cancer (ES-SCLC) receiving platinum/etoposide (EP) or topotecan (TPT)-based therapy in United States (US) since February 2021. Trilaciclib use received the priority review and approval in a real-world setting in China. This study thus aimed to collect real-world data and evaluate the protective effect of trilaciclib on CIM in Chinese patients with ES-SCLC.

Methods: This single-arm, noninterventional real world study invited all patients with ES-SCLC who received trilaciclib with the platinum and etoposide ± anti-programmed cell death ligand-1 [anti-PD-(L)1] antibodies (EP group) or trilaciclib with TPT (TPT group) in Boao, Hainan China to participate in the study. The primary endpoint was the incidence of the severe (grade four) neutropenia (SN), and the secondary endpoints included other myeloprotection effects, safety and anti-tumor activity.

Results: Between August 2021 and December 2022, a total of 30 patients who received trilaciclib with chemotherapy consented to participate in this real-world study. Among the enrolled patients, 26 patients were treated with EP regimen, of these, 18 patients were combined with anti-PD-(L)1 antibodies, and 4 patients were treated with TPT. The incidence of SN was 6.7%, with one patient each in EP group and TPT group. The incidence of grade three hematological toxicities was 30% (9/30), with 19.2% (5/26) in the EP group, and 100% (4/4) in the TPT group. The incidence of grade four hematological toxicities was 5/30 (16.7%), with 3/26 (11.5%) and 2/4 (50%) in EP and TPT group, respectively. Overall, the incidence of those who received intravenous or oral antibiotics was 6/30 (20%), with 4/26 (15.4%) in the EP group, and 2/4 (50%) in the TPT group. No ≥ grade three adverse events, serious adverse events (SAEs), and adverse events of special interest associated with trilaciclib were reported.

Conclusions: Trilaciclib decreased the incidence of CIM in Chinese patients when administered prior to an EP-containing regimen [combined with or without PD-(L)1] or TPT for ES-SCLC. The effect of myeloprotection, anti-tumor and safety were all consistent with the studies conducted globally and data from the Chinese Phase three placebo-controlled study (TRACES).

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来源期刊
Journal of thoracic disease
Journal of thoracic disease RESPIRATORY SYSTEM-
CiteScore
4.60
自引率
4.00%
发文量
254
期刊介绍: The Journal of Thoracic Disease (JTD, J Thorac Dis, pISSN: 2072-1439; eISSN: 2077-6624) was founded in Dec 2009, and indexed in PubMed in Dec 2011 and Science Citation Index SCI in Feb 2013. It is published quarterly (Dec 2009- Dec 2011), bimonthly (Jan 2012 - Dec 2013), monthly (Jan. 2014-) and openly distributed worldwide. JTD received its impact factor of 2.365 for the year 2016. JTD publishes manuscripts that describe new findings and provide current, practical information on the diagnosis and treatment of conditions related to thoracic disease. All the submission and reviewing are conducted electronically so that rapid review is assured.
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