Fan HuiQi, Guan Song, Ren Kai, Li Xue, Wang Jun, Bi Nan, Zhao Lujun
Department of Radiation Oncology, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, China.
Department of Radiation Oncology, Beijing Tuberculosis and Thoracic Tumor Research Institute/Beijing Chest Hospital, Cancer Research Center, Capital Medical University, Beijing, China.
Front Oncol. 2025 Jul 21;15:1580396. doi: 10.3389/fonc.2025.1580396. eCollection 2025.
Chemoradiotherapy combined with consolidation immunotherapy is the standard of care for unresectable stage III non-small cell lung cancer; however, the optimal number of cycles of consolidation immunotherapy remains unknown. This study aimed to investigate the optimal duration of consolidation immunotherapy after chemoradiotherapy.
We conducted a real-world, multicenter, retrospective study of patients with unresectable stage III non-small cell lung cancer who underwent consolidation immunotherapy between February 2018 and December 2022 following chemoradiotherapy. The inclusion criteria were as follows: (1) age ≥18 years and Karnofsky Performance Scale (KPS) score ≥70; (2) histopathologically confirmed stage III non-small cell lung cancer; and (3) received consolidation immunotherapy after chemoradiotherapy. The exclusion criteria were as follows: (1) patients with EGFR or ALK gene mutations; (2) history of other cancers; (3) tumor progression prior to immunotherapy; (4) immunotherapy concurrently with chemoradiotherapy; and (5) discontinuation of immunotherapy due to detection of disease progression. Univariate analysis was performed via the Cox proportional risk model. The correlations between immunotherapy duration and survival outcomes were determined via Kaplan-Meier and log-rank analyses. The study endpoints in this study were overall survival (OS) and progression-free survival (PFS).
The median number of cycles of consolidation immunotherapy was 10 (interquartile range: 4, 19). The 1-year OS rates were 91.3% and 100% for patients with ≤ 10 and >10 cycles of immunotherapy, respectively (P<0.001), and the 1-year PFS rates were 53.4% and 98.4%, respectively (P<0.001). And the 1-year OS rates of patients with ≤ 4, > 4 - ≤ 10, > 10 - ≤ 19, and >19 cycles of consolidation immunotherapy were 89.1%, 93.8%, 100%, and 100%, respectively (≤ 4 vs. 4-10: p=0.068; 4-10 vs. 10-19: p=0.023; 10-19 vs. >19: p= 0.435). The 1-year PFS rates were 48.3%, 59.4%, 96.7%, and 100%, respectively (≤ 4 vs. 4-10: P=0.394; 4-10 vs. 10-19: P=0.002; 10-19 vs. >19: P=0.019). In radiotherapy modality subgroup analyses (stratified by histology, immunotherapy type, and concurrent chemoradiotherapy), immunotherapy cycle number significantly predicted prognosis in all subgroups (all p < 0.05).
In patients with locally advanced non-small cell lung cancer who received consolidation immunotherapy after chemoradiotherapy, the number of cycles of immunotherapy was significantly associated with prognosis. These results need to be further validated in a large prospective study.
放化疗联合巩固性免疫治疗是不可切除的III期非小细胞肺癌的标准治疗方案;然而,巩固性免疫治疗的最佳疗程数仍不清楚。本研究旨在探讨放化疗后巩固性免疫治疗的最佳持续时间。
我们对2018年2月至2022年12月期间接受放化疗后进行巩固性免疫治疗的不可切除III期非小细胞肺癌患者进行了一项真实世界、多中心、回顾性研究。纳入标准如下:(1)年龄≥18岁且卡氏功能状态评分(KPS)≥70;(2)组织病理学确诊为III期非小细胞肺癌;(3)放化疗后接受巩固性免疫治疗。排除标准如下:(1)EGFR或ALK基因突变患者;(2)其他癌症病史;(3)免疫治疗前肿瘤进展;(4)免疫治疗与放化疗同时进行;(5)因疾病进展检测而停止免疫治疗。通过Cox比例风险模型进行单因素分析。通过Kaplan-Meier和对数秩分析确定免疫治疗持续时间与生存结局之间的相关性。本研究的研究终点为总生存期(OS)和无进展生存期(PFS)。
巩固性免疫治疗的中位疗程数为10(四分位间距:4,19)。免疫治疗疗程数≤10和>10的患者1年总生存率分别为91.3%和100%(P<0.001),1年无进展生存率分别为53.4%和98.4%(P<0.001)。巩固性免疫治疗疗程数≤4、>4至≤10、>10至≤19和>19的患者1年总生存率分别为89.1%、93.8%、100%和100%(≤4与4-10:p=0.068;4-10与10-19:p=0.023;10-19与>19:p=0.435)。1年无进展生存率分别为48.3%、59.4%、96.7%和100%(≤4与4-10:P=0.394;4-10与10-19:P=0.002;10-19与>19:P=0.019)。在放疗方式亚组分析中(按组织学、免疫治疗类型和同步放化疗分层),免疫治疗疗程数在所有亚组中均显著预测预后(所有p<0.05)。
在放化疗后接受巩固性免疫治疗的局部晚期非小细胞肺癌患者中,免疫治疗疗程数与预后显著相关。这些结果需要在大型前瞻性研究中进一步验证。