A Retrospective Observational Cohort Study Evaluating the Association Between Concomitant Beta-blocker Exposure and Clinical Outcomes of Standard Anti-PD-1/PD-L1 Therapy in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This retrospective real-world cohort study evaluated whether concomitant long-term beta-blocker exposure during routine clinical care was associated with clinical outcomes in patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy. Patients were categorized according to documented concomitant long-term beta-blocker exposure during the treatment course. Clinical outcomes, including progression-free survival, objective response rate, and overall survival, were compared between exposure groups. This was a non-interventional observational study; anti-PD-1/PD-L1 treatment and beta-blocker use were determined by routine clinical practice rather than by the study protocol.
详细描述
Background:
Emerging evidence suggests that beta-adrenergic signaling may contribute to T-cell dysfunction and resistance to immune checkpoint blockade. This retrospective real-world cohort study was designed to investigate whether concomitant long-term beta-blocker exposure during routine clinical care was associated with treatment outcomes in patients with advanced NSCLC receiving standard anti-PD-1/PD-L1 inhibitor therapy.
Study Design:
Clinical data and follow-up information were collected retrospectively from eligible patients treated in routine clinical practice at the Affiliated Hospital of Nantong University during the predefined study period. Patients were categorized into exposure cohorts according to whether they had documented concomitant long-term beta-blocker use during anti-PD-1/PD-L1 treatment. The study did not assign treatment or medication exposure; all therapies and concomitant medications were prescribed according to standard clinical indications and physician judgment.
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer;
- •Received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care;
- •Available baseline clinical records and follow-up data sufficient for assessment of treatment exposure and clinical outcomes;
排除标准
- •Incomplete baseline clinical records or follow-up data that preclude assessment of treatment exposure or clinical outcomes;
- •Concomitant participation in an interventional therapeutic clinical trial affecting the same treatment course, if applicable;
- •Other major clinical conditions or competing malignancies that preclude valid outcome assessment, according to the prespecified study protocol
研究组 & 干预措施
Standard Anti-PD-1/PD-L1 Therapy Without Long-term Beta-blocker Exposure
Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had no documented long-term beta-blocker exposure during the relevant treatment period.
干预措施: Anti-PD-1/PD-L1 Therapy (Standard of Care) (Drug)
Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure
Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had documented concomitant long-term beta-blocker exposure during the relevant treatment period. Beta-blockers were prescribed for routine clinical indications and were not assigned by the study protocol.
干预措施: Anti-PD-1/PD-L1 Therapy (Standard of Care) (Drug)
Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure
Patients with advanced NSCLC who received standard anti-PD-1/PD-L1 inhibitor therapy during routine clinical care and had documented concomitant long-term beta-blocker exposure during the relevant treatment period. Beta-blockers were prescribed for routine clinical indications and were not assigned by the study protocol.
干预措施: Beta-blocker (Concomitant Exposure) (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From initiation of anti-PD-1/PD-L1 therapy to first documented disease progression or death from any cause, assessed up to 36 months
Progression-free survival is defined as the time from initiation of anti-PD-1/PD-L1 therapy to the first documented disease progression or death from any cause, whichever occurs first.
Progression free survival
时间窗: 2022-2025
Time from randomization until first documented disease progression per RECIST v1.1 (based on CT scans) or death from any cause. Tumor assessments by CT will be performed every 12 weeks (approximately every 3 cycles) during the first year, and annually thereafter until progression. The Kaplan-Meier method will be used to estimate the median PFS and its 95% confidence interval for each group, and survival curves will be plotted. Intergroup comparisons will be performed using the log-rank test. Additionally, a Cox proportional hazards model will be constructed to estimate the hazard ratio and its 95% confidence interval.
次要结局
- Objective Response Rate(Best overall response during the first 12 months after initiation of anti-PD-1/PD-L1 therapy)
- Overall Survival(From initiation of anti-PD-1/PD-L1 therapy to death from any cause, assessed up to 36 months)