Real-world Association Between Concomitant Beta-blocker Exposure and Anti-PD-1/PD-L1 Treatment Outcomes in Advanced Non-Small Cell Lung Cancer

Affiliated Hospital of Nantong University

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care); Drug: Beta-blocker (Concomitant Exposure)

Study type: Observational

Funder types: Other

Identifiers

NCT05387512

2022-L071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

Standard Anti-PD-1/PD-L1 Therapy Without Long-term Beta-blocker Exposure

Description:

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.

Treatment:

Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care)

Standard Anti-PD-1/PD-L1 Therapy With Concomitant Long-term Beta-blocker Exposure

Description:

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.

Treatment:

Drug: Beta-blocker (Concomitant Exposure)

Drug: Anti-PD-1/PD-L1 Therapy (Standard of Care)