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| Name | Class |
|---|---|
| The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China | OTHER |
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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.
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:
The primary objective was to assess the association between concomitant long-term beta-blocker exposure and progression-free survival. Secondary objectives included evaluation of objective response rate and overall survival. The study was intended to provide real-world observational evidence regarding the clinical relevance of beta-blocker exposure in the setting of standard anti-PD-1/PD-L1 therapy for advanced NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1/PD-L1 Therapy (Standard of Care) | Drug | Standard anti-PD-1/PD-L1 inhibitor therapy administered as part of routine clinical care. Treatment regimen, schedule, and duration were determined by treating physicians according to standard practice and were not assigned by the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 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. | From initiation of anti-PD-1/PD-L1 therapy to first documented disease progression or death from any cause, assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Objective response rate is defined as the proportion of patients achieving complete response or partial response according to RECIST version 1.1 based on available radiologic assessments in routine clinical care. | Best overall response during the first 12 months after initiation of anti-PD-1/PD-L1 therapy |
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Inclusion Criteria:
Exclusion Criteria:
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This retrospective study included eligible patients with advanced non-small cell lung cancer who received standard anti-PD-1/PD-L1 inhibitor therapy in routine clinical practice at the Affiliated Hospital of Nantong University during the predefined study period. Clinical records and follow-up information were collected retrospectively. Patients were categorized into exposure cohorts according to documented concomitant long-term beta-blocker use during the anti-PD-1/PD-L1 treatment course.
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| Name | Affiliation | Role |
|---|---|---|
| Zhiyuan Tang, Doctor | Affilication Hospital of Nantong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pharmacy, Affiliated Hospital of Nantong University | Nantong | Jiangsu | 226000 | China |
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| Beta-blocker (Concomitant Exposure) | Drug | Documented concomitant long-term beta-blocker use during the anti-PD-1/PD-L1 treatment course as prescribed for routine clinical indications. Beta-blocker exposure was not assigned by the study protocol. |
|
| Overall Survival |
Overall survival is defined as the time from initiation of anti-PD-1/PD-L1 therapy to death from any cause. |
| From initiation of anti-PD-1/PD-L1 therapy to death from any cause, assessed up to 36 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000319 | Adrenergic beta-Antagonists |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D018674 | Adrenergic Antagonists |
| D018663 | Adrenergic Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
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