真实世界实践中年轻和老年 IIA-IIIB 期非小细胞肺癌患者新辅助免疫化疗疗效和安全性的比较。
Comparison of efficacy and safety of neoadjuvant immunochemotherapy in young and elderly patients with IIA-IIIB non-small-cell lung cancer in real-world practice.
机构信息
Department of Thoracic Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine, No. 79 Qingchun Road, Hangzhou, 310003, China.
Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, Hangzhou, 310003, China.
出版信息
BMC Pulm Med. 2024 Nov 29;24(1):592. doi: 10.1186/s12890-024-03417-8.
OBJECTIVE
There is currently no consensus over whether neoadjuvant immunochemotherapy is more effective in young patients than in elderly patients with IIA-IIIB non-small-cell lung cancer (NSCLC). In this study, we compare the efficacy and safety of neoadjuvant immunochemotherapy in young and elderly patients with IIA-IIIB NSCLC.
METHODS
This retrospective study consecutively included IIA-IIIB NSCLC patients who received 2-4 cycles preoperative immunochemotherapy at the Department of Thoracic Surgery, the First Affiliated Hospital, Zhejiang University School of Medicine from 2019 to 2022. The 1:1 propensity score match analysis was conducted to balance the confounding factors between the young patient group (< 65 years old) and elderly patient group (≥ 65 years old). The follow-up period would not end until at least 1 year after surgery or patient's decision to abandon treatment. The primary endpoint was pathological response, while the secondary endpoints were objective response rate (ORR), adverse events (AEs), disease-free survival (DFS) and overall survival (OS).
RESULTS
A total of 179 patients were included in our study: <65 years group (71 patients) and ≥ 65 years group (108 patients). After a 1:1 propensity score matching,132 patients (66 pairs) were analyzed to compare the efficacy and safety between the two groups. The ORR in the young patient group and elderly patient group was 72.7% and 71.2% (P = 1.000), respectively. The incidence of grade 3-4 AEs in the elderly patient group was similar to the young patient group (13.6% vs. 16.7%, P = 0.627). About 62.1% (41/66) in the young patient group and 54.5% (36/66) in the elderly patient group eventually underwent surgery. The rate of major pathological response (MPR) in the young patient group and elderly patient group was 68.3% and 55.6% (P = 0.903), respectively. The rate of pathological complete response (pCR) in the young patient group was significantly higher than that in the elderly patient group (46.3% vs. 22.2%, P = 0.027). The median DFS in the young patient group was not reached and 32.2 months in the elderly patient group (P = 0.071). The 1-year DFS rate, 2-year DFS rate and 3-year DFS rate in the young patient group were 90.2%, 85.4% and 80.5%, with that in the elderly patient group 86.1%, 69.4% and 66.7%. The median OS in the young patient group was 42.4 months and not reached in the elderly patient group (P = 0.067). The 1-year OS rate, 2-year OS rate and 3-year OS rate in the young patient group were 97.6%, 90.2% and 90.2%, with that in the elderly patient group 88.9%, 80.6% and 72.2%.
CONCLUSIONS
For IIA-IIIB NSCLC, neoadjuvant immunochemotherapy in young patients can produce a higher percentage of patients with a pCR than in elderly patients. However, the survival benefits and incidence of AEs are similar in young and elderly patients.
目的
目前对于非小细胞肺癌（NSCLC）IIA-IIIB 期的年轻患者和老年患者，新辅助免疫化疗的疗效是否存在差异尚无定论。本研究旨在比较 IIA-IIIB 期 NSCLC 年轻患者和老年患者新辅助免疫化疗的疗效和安全性。
方法
本回顾性研究连续纳入了 2019 年至 2022 年期间在浙江大学医学院附属第一医院胸外科接受 2-4 周期术前免疫化疗的 IIA-IIIB NSCLC 患者。采用 1:1 倾向评分匹配分析以平衡年轻患者组（<65 岁）和老年患者组（≥65 岁）之间的混杂因素。随访时间至少为手术后 1 年或患者决定放弃治疗。主要终点为病理缓解，次要终点为客观缓解率（ORR）、不良事件（AE）、无疾病生存期（DFS）和总生存期（OS）。
结果
本研究共纳入 179 例患者：<65 岁组（71 例）和≥65 岁组（108 例）。经过 1:1 倾向评分匹配后，对 132 例患者（66 对）进行分析，比较两组之间的疗效和安全性。年轻患者组和老年患者组的 ORR 分别为 72.7%和 71.2%（P=1.000）。老年患者组的 3-4 级 AE 发生率与年轻患者组相似（13.6%比 16.7%，P=0.627）。约 62.1%（41/66）的年轻患者组和 54.5%（36/66）的老年患者组最终接受了手术。年轻患者组和老年患者组的主要病理缓解（MPR）率分别为 68.3%和 55.6%（P=0.903）。年轻患者组的病理完全缓解（pCR）率明显高于老年患者组（46.3%比 22.2%，P=0.027）。年轻患者组的中位 DFS 未达到，而老年患者组为 32.2 个月（P=0.071）。年轻患者组的 1 年 DFS 率、2 年 DFS 率和 3 年 DFS 率分别为 90.2%、85.4%和 80.5%，老年患者组分别为 86.1%、69.4%和 66.7%。年轻患者组的中位 OS 为 42.4 个月，老年患者组未达到（P=0.067）。年轻患者组的 1 年 OS 率、2 年 OS 率和 3 年 OS 率分别为 97.6%、90.2%和 90.2%，老年患者组分别为 88.9%、80.6%和 72.2%。
结论
对于 IIA-IIIB 期 NSCLC，新辅助免疫化疗在年轻患者中产生 pCR 的比例高于老年患者。然而，年轻患者和老年患者的生存获益和 AE 发生率相似。
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