ArticleBreast cancer research and treatment2021
Cyclin-dependent kinase 4/6 inhibitors and interstitial lung disease in the FDA adverse event reporting system: a pharmacovigilance assessment.
Article in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 1 of them a synthesis that pooled it.
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Who cites it
61 citing papers in PubMed, 1 synthesis or guideline pooled it, 103 citations in OpenAlex.
- Analysis of interstitial lung disease in pharmacovigilance databases: Coding challenges and interpretation biases-An update.British journal of clinical pharmacology · 2026Pooled it
- Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial.The oncologist · 2023Trial
- From data mining to mechanistic prediction: a study on drug-induced lung injury integrating FAERS, machine learning, and network toxicology.Archives of toxicology · 2026Article
- A Retrospective Observational Study of Safety and Effectiveness of Abemaciclib in Chinese Patients with Breast Cancer.Advances in therapy · 2026Observational
- A hypermetabolic pulmonary lesion in a patient with breast cancer.Breathe (Sheffield, England) · 2026Article
- Drug-Induced Pneumonitis Secondary to Ribociclib in a Patient With Metastatic Breast Cancer.Cureus · 2026Article
- The Incidence of Abemaciclib-induced Interstitial Lung Disease: A Single-center Retrospective Study in Japan.The Kobe journal of medical sciences · 2025Article
- Management of trastuzumab deruxtecan-related adverse events in breast cancer: Italian expert panel recommendations.Future oncology (London, England) · 2025Article
- Cyclin-Dependent Kinase 4/6 Inhibitors Combined with Radiotherapy in Curative Breast Cancer Patients Induced Pneumonitis: A Case Report.Life (Basel, Switzerland) · 2025Article
- Disproportionality analysis of interstitial lung disease associated with novel antineoplastic agents during breast cancer treatment: a pharmacovigilance study.EClinicalMedicine · 2025Article
- The Incidence and Clinical Characteristics of Interstitial Lung Disease Associated with CDK4/6 Inhibitors in Breast Cancer Patients: A Retrospective Multicenter Study.Medicina (Kaunas, Lithuania) · 2025Article
- Disproportionality analysis of Raynaud's phenomenon associated with calcitonin gene-related peptide inhibitors using the Food and Drug Administration adverse event reporting system.Scientific reports · 2025Article
- Evaluating risk factors for Trastuzumab-Deruxtecan Pneumonitis in patients with metastatic breast cancer.Breast cancer research : BCR · 2025Article
- Interstitial lung disease following combined CDK4/6 inhibitor therapy and radiotherapy in advanced breast cancer: a case report.Frontiers in medicine · 2025Article
- Toxicity profiles of cyclin-dependent kinase 4/6 inhibitors: safety analysis from clinical trials and the FDA adverse event reporting system.Frontiers in oncology · 2025Article
- Cyclophosphamide for anticancer therapy-induced interstitial lung disease in the modern era: a retrospective cohort study.Frontiers in oncology · 2025Article
- Unusual presentation of luminal breast carcinoma metastatic to the brain and coma: a case report of dramatic response to abemaciclib and literature review.Therapeutic advances in medical oncology · 2025Article
- A post-marketing disproportionality analysis of the safety of ribociclib based on the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- Updates in Drug-Related Pneumonitis Due to Targeted Oncologic Therapies.Journal of immunotherapy and precision oncology · 2024Review
- Comparative analysis of adverse events associated with CDK4/6 inhibitors based on FDA's adverse event reporting system: a case control pharmacovigilance study.BMC pharmacology & toxicology · 2024Article
1 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWe assessed pulmonary toxicity of cyclin-dependent kinase (CDK)4/6 inhibitors by analyzing the publicly available FDA Adverse Event Reporting System (FAERS).
methodsReports of interstitial lung disease (ILD) were characterized in terms of demographic information, including daily dose, latency, concomitant drugs known to be associated with ILD, and causality assessment (adapted WHO system). Disproportionality analyses were carried out by calculating reporting odds ratios (RORs) with 95% confidence interval (CI), accounting for major confounders, including notoriety and competition biases.
resultsILD reports (N = 161) represented 2.1% and 0.3% of all reports for abemaciclib and palbocilcib/ribociclib, respectively, with negligible proportion of concomitant pneumotoxic drugs. Increased reporting was found for CDK4/6 inhibitors when compared to other drugs (ROR = 1.50; 95%CI = 1.28-1.74), and abemaciclib vs other anticancer agents (4.70; 3.62-5.98). Sensitivity analyses confirmed a strong and consistent disproportionality for abemaciclib. Higher-than-expected reporting emerged for palbociclib (1.38; 1.07-1.77) and ribociclib (2.39; 1.34-3.92) only when removing Japan reports. ILD occurred at recommended daily doses, with median latency ranging from 50 (abemaciclib) to 253 (ribociclib) days. Causality was highly probable in 55% of abemaciclib cases, probable in 68% of palbociclib cases.
conclusionsIncreased reporting of ILD with CDK4/6 inhibitors calls for further comparative population-based studies to characterize and quantify the actual risk, taking into account drug- and patient-related risk factors. These findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals through FAERS and other real-world data, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of CDK4/6 inhibitors when diagnosing a lung injury.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.