atezolizumab联合依托泊苷/铂治疗大分期小细胞肺癌的临床结果:中国一项真实世界、多中心、回顾性对照研究

Hanxiao Chen, Xiangjuan Ma, Jie Liu, Yu Yang, Yong Fang, Liping Wang, Jian Fang, Jun Zhao, Minglei Zhuo
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引用次数: 6

摘要

目的:Atezolizumab联合化疗延长了全球范围内广泛期小细胞肺癌(ES-SCLC)患者的生存期,尽管中国缺乏真实世界(RW)数据。本研究旨在评估atezolizumab联合依托泊苷/铂(EP)的疗效和临床结果。方法:本回顾性研究收集了2019年1月至2022年4月5家医疗机构的6个肿瘤科的数据。对于一线治疗,atezolizumab联合EP与单独EP,我们主要评估无进展生存期(PFS);评估其他疗效指标,包括总生存期(OS)、客观缓解率(ORR)、SCLC进展模式和不良事件(ae)。结果:主要分析包括225例患者的数据,其中133例接受EP和atezolizumab (atezolizumab组),92例单独接受EP (EP组)。atezolizumab组PFS持续时间[7.10个月;95%可信区间(95% CI), 6.53-9.00]超过EP组(6.50个月;95% ci, 4.83-7.53)。总体而言,风险比(HR)为0.69 (95% CI, 0.49-0.97) (P=0.029);特别是,在接受≥4个化疗周期的患者中,HR为0.54 (95% CI, 0.36-0.80),而在接受阿特唑单抗维持治疗的患者中,HR为0.33 (95% CI, 0.20-0.56)。两组的ORR和疾病控制率(DCR)相似。由于OS数据不完整,两组的中位OS均未确定。在atezolizumab组中,骨髓抑制是最常见的AE(58.6%)。atezolizumab组19例患者发生免疫相关不良事件(14.3%),只有1例3级脑炎。结论:这项在中国进行的RW研究表明,atezolizumab联合EP治疗ES-SCLC的临床结果有所改善,特别是在化疗敏感人群中。这些结果与IMpower133研究的结果一致,尽管这种治疗方式对OS的影响需要进一步的随访研究。
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Clinical outcomes of atezolizumab in combination with etoposide/platinum for treatment of extensive-stage small-cell lung cancer: A real-world, multicenter, retrospective, controlled study in China.

Objective: Atezolizumab along with chemotherapy has prolonged the survival of patients with extensive-stage small-cell lung cancer (ES-SCLC) worldwide, although real-world (RW) data are lacking in China. This study was designed to evaluate the efficacy and clinical outcomes of atezolizumab plus etoposide/platinum (EP).

Methods: Data obtained in this retrospective study were captured from six oncology units of five medical facilities from January 2019 to April 2022. For first-line treatments, atezolizumab combined with EP vs. EP alone, we primarily evaluated progression-free survival (PFS); other efficacy indicators, including overall survival (OS), objective response rate (ORR), and patterns of SCLC progression and adverse events (AEs) were assessed.

Results: The primary analysis included data from 225 patients, of whom 133 received EP along with atezolizumab (atezolizumab group) and 92 received EP alone (EP group). The PFS duration of the atezolizumab group [7.10 months; 95% confidence interval (95% CI), 6.53-9.00] exceeded that of the EP group (6.50 months; 95% CI, 4.83-7.53). Overall, the hazard ratio (HR) was 0.69 (95% CI, 0.49-0.97) (P=0.029); particularly, the HR was 0.54 (95% CI, 0.36-0.80) among patients undergoing ≥4 chemotherapy cycles and 0.33 (95% CI, 0.20-0.56) among individuals with atezolizumab maintenance. The ORR and disease-control rate (DCR) were similar between the two groups. Because of incomplete OS data, the median OS was not determined for either group. Bone marrow suppression was the most common AE detected (58.6%) in the atezolizumab group. Immune-related AEs occurred in 19 patients in the atezolizumab group (14.3%), with only one case of grade 3 encephalitis.

Conclusions: This RW study in China demonstrated improved clinical outcomes of atezolizumab along with EP for ES-SCLC, particularly in the chemosensitive population. These results align with the results of the IMpower133 study, although the impact of this treatment modality on OS warrants additional follow-up studies.

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