Chen Hanxiao, Ma Xiangjuan, Liu Jie, Yang Yu, Fang Yong, Wang Liping, Fang Jian, Zhao Jun, Zhuo Minglei
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department I of Thoracic Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department II of Thoracic Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China.
Chin J Cancer Res. 2022 Aug 30;34(4):353-364. doi: 10.21147/j.issn.1000-9604.2022.04.04.
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).
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 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.
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.
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.
阿替利珠单抗联合化疗已延长了全球广泛期小细胞肺癌（ES-SCLC）患者的生存期，尽管中国缺乏真实世界（RW）数据。本研究旨在评估阿替利珠单抗联合依托泊苷/铂类（EP）的疗效和临床结局。
本回顾性研究收集了2019年1月至2022年4月期间来自5家医疗机构6个肿瘤科的数据。对于一线治疗，阿替利珠单抗联合EP与单独使用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）以及SCLC进展模式和不良事件（AE）。
初步分析纳入了225例患者的数据，其中133例接受EP联合阿替利珠单抗（阿替利珠单抗组），92例单独接受EP（EP组）。阿替利珠单抗组的PFS持续时间[7.10个月；95%置信区间（95%CI），6.53 - 9.00]超过了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），在接受阿替利珠单抗维持治疗的个体中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，两组均未确定中位OS。骨髓抑制是阿替利珠单抗组中检测到的最常见AE（58.6%）。阿替利珠单抗组有19例患者发生免疫相关AE（14.3%），仅1例3级脑炎。
中国的这项真实世界研究表明，阿替利珠单抗联合EP治疗ES-SCLC可改善临床结局，尤其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的影响有待进一步的随访研究。
