| アブストラクト | INTRODUCTION: CDK4/6 inhibitors-abemaciclib, palbociclib, and ribociclib-are standard treatments for hormone receptor-positive, ERBB2 (HER2)-negative metastatic breast cancer. However, older adults are underrepresented in clinical trials, and age-related safety data remain limited in real-world settings. MATERIALS AND METHODS: We conducted a pharmacovigilance analysis using 44,100 individual case safety reports (ICSRs) from the FDA Adverse Event Reporting System (FAERS) involving patients aged >/=65 years treated with CDK4/6 inhibitors. Primary endpoints included serious adverse events (SAEs) and fatal outcomes. A secondary analysis compared adverse events between patients aged <65 and 65-85 years, calculating odds ratios (ORs) for selected toxicities, including death, disease progression, diarrhea, and myelosuppression. RESULTS: Among older patients, 71.2 % of reports involved SAEs and 5.3 % were fatal. Abemaciclib was linked to higher risk of death in those aged 65-85 compared to younger adults (OR 1.53; 95 % CI 1.18-1.99), but lower odds of myelosuppression (OR 0.37; 95 % CI 0.26-0.53). Palbociclib showed similar death risk across age groups (OR 0.98; 95 % CI 0.92-1.05) and reduced risk of disease progression in older adults (OR 0.72; 95 % CI 0.61-0.84). Ribociclib showed no significant age-related difference in fatality (OR 1.01; 95 % CI 0.87-1.17) but had the highest overall death risk (OR 9.14 vs palbociclib; 95 % CI 7.70-10.84). DISCUSSION: Real-world data reveal drug- and age-specific toxicity differences. Ribociclib and abemaciclib pose higher risks in older adults compared to palbociclib, supporting the need for personalized treatment and careful monitoring in older patients. |
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| ジャーナル名 | Journal of geriatric oncology |
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| Pubmed追加日 | 2025/12/12 |
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| 投稿者 | Petrelli, Fausto; Iaculli, Alessandro; Parati, Maria Chiara; Borgonovo, Karen; Ghilardi, Mara; Lonati, Veronica; Angeli, Irene; Dottorini, Lorenzo |
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| 組織名 | Oncology Unit, ASST Bergamo Ovest, Treviglio (BG), Italy. Electronic address:;faupe@libero.it.;Oncology Unit, ASST Bergamo Est, Seriate (BG), Italy.;Oncology Unit, ASST Bergamo Ovest, Treviglio (BG), Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41380504/ |
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