Gray Jhanelle E, Salomonsen Rachel J, Diaz Perez Ignacio, Wang Alice, Cai Ling, Wetherill Graham, Xiao Yang, Fielden Claire, Georgoulia Nefeli
H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA.
AstraZeneca, Gaithersburg, MD, USA.
Drugs Real World Outcomes. 2025 May 6. doi: 10.1007/s40801-025-00487-w.
Immunotherapy has altered the treatment landscape for resectable non-small cell lung cancer, increasing the complexity of treatment planning. Understanding treatment patterns and outcomes prior to the advent of immunotherapy can provide context for assessing the benefit of immunotherapies and other novel agents.
We aimed to characterize real-world demographics, clinical characteristics, treatment patterns, and clinical outcomes of patients with early-stage non-small cell lung cancer before widespread immunotherapy use.
Analyses included patients from the US CancerLinQ Discovery database diagnosed with stage I-III non-small cell lung cancer between 2014 and 2020 without known EGFR mutations who underwent surgical resection within 140 days of diagnosis. The primary outcome was treatment patterns by disease stage.
Analyses included 3077 patients with stage I (n = 1673), II (n = 853), and III (n = 551) disease. Most (92.8%, 52.3%, and 36.5% of stage I, II, and III patients) received surgery without systemic therapy. Among stage I, II, and III patients, 7.2%, 44.8%, and 46.6% received adjuvant therapy only. Of stage II and III patients, 2.0% and 10.2% received neoadjuvant therapy only, and 0.9% and 6.7% received both (stage I patients who received neoadjuvant only or perioperative therapy were excluded because of low numbers [n = 4]). Five-year overall survival rates were 73.4%, 61.9%, and 50.5% in stage I, II, and III patients; 5-year real-world relapse-free survival rates were 35.4%, 23.1%, and 14.0%. In an exploratory multivariate analysis, neoadjuvant treatment was associated with improved overall survival and real-world relapse-free survival in stage II-III patients (stage I patients not evaluable). Adjuvant treatment was associated with improved real-world relapse-free survival, but not overall survival, in stage II-III patients.
Most patients received surgery alone, though the proportion receiving systemic treatment increased with disease stage. Modest 5-year, real-world relapse-free survival rates indicate a need for more effective neoadjuvant or adjuvant treatments in this setting.
免疫疗法改变了可切除非小细胞肺癌的治疗格局，增加了治疗计划的复杂性。了解免疫疗法出现之前的治疗模式和结果可为评估免疫疗法及其他新型药物的获益情况提供背景信息。
我们旨在描述在广泛应用免疫疗法之前早期非小细胞肺癌患者的真实世界人口统计学特征、临床特征、治疗模式及临床结局。
分析纳入来自美国CancerLinQ发现数据库的患者，这些患者在2014年至2020年间被诊断为I-III期非小细胞肺癌，无已知表皮生长因子受体（EGFR）突变，且在诊断后140天内接受了手术切除。主要结局是按疾病分期的治疗模式。
分析纳入了3077例I期（n = 1673）、II期（n = 853）和III期（n = 551）疾病患者。大多数（I期、II期和III期患者分别为92.8%、52.3%和36.5%）接受了手术，未接受全身治疗。在I期、II期和III期患者中，分别有7.2%、44.8%和46.6%仅接受辅助治疗。在II期和III期患者中，分别有2.0%和10.2%仅接受新辅助治疗，0.9%和6.7%同时接受新辅助和辅助治疗（接受单纯新辅助治疗或围手术期治疗的I期患者因例数少[n = 4]被排除）。I期、II期和III期患者的5年总生存率分别为73.4%、61.9%和50.5%；5年真实世界无复发生存率分别为35.4%、23.1%和14.0%。在一项探索性多变量分析中，新辅助治疗与II-III期患者（I期患者不可评估）的总生存率提高及真实世界无复发生存率改善相关。辅助治疗与II-III期患者真实世界无复发生存率改善相关，但与总生存率无关。
大多数患者仅接受了手术治疗，不过接受全身治疗的比例随疾病分期增加。适度的5年真实世界无复发生存率表明在此情况下需要更有效的新辅助或辅助治疗。
