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Related Concept Videos

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Increased Cardiovascular Risk With Lorlatinib in Patients With ALK-Mutated Lung Cancer: A Real-World Comparative

Chien-Yu Lin1,2, Po-Lan Su2,3, Chin-Wei Kuo1,2

  • 1Institute of Clinical Medicine, College of Medicine National Cheng Kung University Tainan Taiwan.

Journal of the American Heart Association
|December 11, 2025
PubMed
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Lorlatinib increases cancer therapy-related cardiovascular disease risk in ALK-positive lung cancer patients. Routine monitoring is crucial, especially for older individuals and those with arrhythmias.

Keywords:
ALK rearrangementcancer therapy–related cardiovascular diseasescardio‐oncologylorlatinibnon–small cell lung cancer

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Area of Science:

  • Oncology
  • Cardiology
  • Pharmacology

Background:

  • Anaplastic lymphoma kinase (ALK) rearrangements define a subset of advanced non-small cell lung cancer (NSCLC) patients who benefit from targeted therapies.
  • While ALK inhibitors improve survival, cancer therapy-related cardiovascular diseases (CTRCVDs) risk is a significant concern.
  • Third-generation ALK inhibitors like lorlatinib offer superior progression-free survival but require careful cardiovascular risk assessment compared to second-generation agents (alectinib, brigatinib).

Purpose of the Study:

  • To compare the CTRCVDs risk between lorlatinib and brigatinib/alectinib in ALK-mutated NSCLC patients.
  • To assess incidence trends of CTRCVDs in patients receiving ALK tyrosine kinase inhibitors.
  • To identify clinical risk factors associated with ALK tyrosine kinase inhibitor-related CTRCVDs.

Main Methods:

  • Retrospective cohort study of 946,848 adult lung cancer patients (2010-2024) using the TriNetX database.
  • Comparison of CTRCVDs risk (myocardial infarction, stroke, arterial embolism, heart failure) between lorlatinib and brigatinib/alectinib in 744 propensity score-matched ALK-mutated patients.
  • Kaplan-Meier analysis and Cox proportional hazards models were used to evaluate outcomes over 2 years.

Main Results:

  • Lorlatinib use was associated with a significantly increased risk of CTRCVDs (HR, 3.00; P<0.001) compared to brigatinib/alectinib.
  • CTRCVDs incidence increased from 2.2% at 6 months to 6.6% at 3 years with lorlatinib, versus 1.7% and 2.2% with brigatinib/alectinib.
  • Independent predictors for CTRCVDs included advanced age (HR, 1.02; P=0.04), history of atrial fibrillation/flutter (HR, 2.39; P=0.002), and lorlatinib use (HR, 2.42; P<0.001).

Conclusions:

  • Lorlatinib treatment significantly elevates CTRCVDs risk in ALK-positive NSCLC patients.
  • Advanced age and pre-existing atrial arrhythmias are key risk factors for developing CTRCVDs.
  • Routine cardiovascular monitoring is essential for patients on ALK tyrosine kinase inhibitors, particularly older individuals and those with arrhythmias.