背景:Trilaciclib,与安慰剂加卡铂相比,依托泊苷,±阿替珠单抗(PEA),在广泛期小细胞肺癌(ES-SCLC)患者中,严重中性粒细胞减少症(SN)的发生率显着降低。尽管有这些发现,现实世界的效用仍然有限。
方法:一项单中心准实验研究比较了ES-SCLC患者的三拉西尼+PEA(PEAT)和PEA。PEAT接受者的研究期为2021年4月1日至2022年7月31日,PEA接受者为2020年2月1日至2021年2月28日。评估的主要终点是第1周期后和治疗期间SN的发生率。次要终点包括与脊髓保留和患者预后相关的指标。
结果:在34例PEAT和44例PEA患者中,基线特征相似,除了PEAT队列中的中位年龄较高(69岁vs64岁)和男性较多(64.7%vs38.6%).与PEA组(18%)相比,PEAT组的SN率(3%)较低,在多变量分析中具有统计学意义(p=0.015)。此外,PEAT队列还显示红细胞输血需求显着降低(3%vs23%;p=0.02),3-4级贫血(6%对25%;p=0.03),和3-4级血小板减少症(0%对11%,p=0.045)。
结论:Trilaciclib,结合PEA,在不影响ES-SCLC患者生存结局的前提下,安全性得到改善.这些发现强调了在现实世界的临床环境中加入trilaciclib以增强患者护理的潜在益处。
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).
CONCLUSIONS: 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.