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特立西布在广泛期小细胞肺癌(ES-SCLC)中的应用:在真实环境中是否观察到临床获益?

Trilaciclib use in extensive-stage small cell lung cancer (ES-SCLC): are clinical benefits seen in the real-world setting?

机构信息

Department of Pharmacy, Massachusetts General Hospital, Boston, MA, USA.

School of Pharmacy and Pharmaceutical Sciences, Northeastern University, 140 The Fenway, Room 220, Boston, MA, USA.

出版信息

Support Care Cancer. 2024 Aug 31;32(9):622. doi: 10.1007/s00520-024-08828-1.

DOI:10.1007/s00520-024-08828-1
PMID:39215800
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11365831/
Abstract

BACKGROUND

Trilaciclib, in comparison to placebo plus carboplatin, etoposide, ± atezolizumab (PEA), has shown significant reductions in incidence of severe neutropenia (SN) among patients with extensive-stage small cell lung cancer (ES-SCLC). Despite these findings, real-world utility remains limited.

METHODS

A single-center quasi-experimental study compared trilaciclib + PEA (PEAT) versus PEA in ES-SCLC patients. The study period ranged from April 1, 2021 to July 31, 2022, for the PEAT recipients and February 1, 2020, to February 28, 2021, for PEA recipients. The primary endpoint evaluated was incidence of SN after cycle 1 and during the treatment period. Secondary endpoints included measures related to myelopreservation and patient outcomes.

RESULTS

Among 34 PEAT and 44 PEA patients, baseline characteristics were similar, except for a higher median age (69 vs 64 years) and more males (64.7% vs 38.6%) in the PEAT cohort. The PEAT cohort exhibited a lower SN rate (3%) versus the PEA cohort (18%), with statistical significance demonstrated on multivariate analysis (p = 0.015). Additionally, the PEAT cohort also demonstrated significant reductions in red blood cell transfusion requirements (3% vs 23%; p = 0.02), grade 3-4 anemia (6% vs 25%; p = 0.03), and grade 3-4 thrombocytopenia (0% vs 11%, p = 0.045).

CONCLUSION

Trilaciclib, in combination with PEA, demonstrated an improvement in the safety profile without compromising survival outcomes in ES-SCLC patients. These findings underscore the potential benefits of incorporating trilaciclib in real-world clinical settings for enhanced patient care.

摘要

背景

与安慰剂加卡铂、依托泊苷、±阿替利珠单抗(PEA)相比,替拉西利可显著降低广泛期小细胞肺癌(ES-SCLC)患者严重中性粒细胞减少症(SN)的发生率。尽管有这些发现,但实际应用仍然有限。

方法

一项单中心准实验研究比较了替拉西利+PEA(PEAT)与 ES-SCLC 患者的 PEA。研究期间为 2021 年 4 月 1 日至 2022 年 7 月 31 日(PEAT 组)和 2020 年 2 月 1 日至 2021 年 2 月 28 日(PEA 组)。主要终点评估是第 1 周期和治疗期间的 SN 发生率。次要终点包括与骨髓保护和患者结局相关的措施。

结果

在 34 例 PEAT 和 44 例 PEA 患者中,除了 PEAT 组的中位年龄(69 岁比 64 岁)和男性比例(64.7%比 38.6%)较高外,两组的基线特征相似。PEAT 组 SN 发生率(3%)低于 PEA 组(18%),多变量分析显示差异有统计学意义(p=0.015)。此外,PEAT 组的红细胞输血需求(3%比 23%;p=0.02)、3-4 级贫血(6%比 25%;p=0.03)和 3-4 级血小板减少症(0%比 11%,p=0.045)也显著降低。

结论

替拉西利联合 PEA 可改善安全性,而不影响 ES-SCLC 患者的生存结局。这些发现强调了在真实临床环境中纳入替拉西利以增强患者护理的潜在益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/1e3b35a8462d/520_2024_8828_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/b6f810576bb2/520_2024_8828_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/5348fdd991e5/520_2024_8828_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/1e3b35a8462d/520_2024_8828_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/b6f810576bb2/520_2024_8828_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/5348fdd991e5/520_2024_8828_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/592f/11365831/1e3b35a8462d/520_2024_8828_Fig3_HTML.jpg

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本文引用的文献

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Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials.化疗前使用 Trilaciclib 可减少小细胞肺癌患者因化疗引起的骨髓抑制的支持性护理干预:三项随机 2 期试验的汇总分析。
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Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies.
特立西利布对广泛期小细胞肺癌患者化疗引起的骨髓抑制和患者报告结局的影响:来自三项 II 期随机、双盲、安慰剂对照研究的汇总结果。
Clin Lung Cancer. 2021 Sep;22(5):449-460. doi: 10.1016/j.cllc.2021.03.010. Epub 2021 Mar 26.
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Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial.化疗前使用曲拉西利联合阿替利珠单抗治疗新诊断的广泛期小细胞肺癌患者:一项多中心、随机、双盲、安慰剂对照的II期试验。
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