Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, PD-1, Beta-blocker, NSCLC, PD-L1, Real-world Study
Brief summary
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.
Detailed description
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.
Interventions
DRUGAnti-PD-1/PD-L1 Therapy (Standard of Care)
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.
DRUGBeta-blocker (Concomitant Exposure)
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.
Sponsors
Affiliated Hospital of Nantong University
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Best overall response during the first 12 months after initiation of anti-PD-1/PD-L1 therapy | 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. |
| Overall Survival | From initiation of anti-PD-1/PD-L1 therapy to death from any cause, assessed up to 36 months | Overall survival is defined as the time from initiation of anti-PD-1/PD-L1 therapy to death from any cause. |
Countries
China
Contacts
STUDY_DIRECTORZhiyuan Tang, Doctor
Affilication Hospital of Nantong University
Outcome results
None listed