Risk Stratification and Factors Associated with Heart Failure Hospitalization During Osimertinib Therapy.
4 affiliations
- 1Endowed Course of Advanced Medical Care Community Pharmacy, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu-shi 501-1196, Gifu, Japan.
- 2Department of Pharmacy, Toyota Memorial Hospital, 1-1 Heiwa-cho, Toyota-shi 471-8513, Aichi, Japan.
- 3Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4 Daigakunishi, Gifu-shi 501-1196, Gifu, Japan.
- 4Department of Pharmacy, Kanagawa Prefectural Ashigarakami Hospital, 866-1 Matsudasoryo, Matsuda-machi, Ashigarakami-gun 258-0003, Kanagawa, Japan.
Abstract
Background
Osimertinib is the standard of care for epidermal growth factor receptor mutation-positive non-small cell lung cancer, but heart failure hospitalization (HFH) remains a concern, and no practical tool exists to stratify HFH risk during therapy.Methods
In this retrospective cohort study using a Japanese claims database, 5802 patients newly initiating osimertinib were followed for HFH during treatment. Baseline predictors assessed before the index date were selected by 10-fold cross-validated least absolute shrinkage and selection operator (LASSO) logistic regression and internally validated by bootstrapping (B = 500), repeating predictor selection in each resample. Cumulative incidence functions and Fine-Gray models treated death as a competing event; cause-specific Cox models served as sensitivity analyses.Results
HFH occurred in 169 patients (2.9%) during a median on-treatment follow-up of 9.3 months, with 268 competing deaths. LASSO retained seven predictors. The apparent concordance index (C-index) was 0.731 (95% confidence interval, 0.691-0.771) and the optimism-corrected C-index 0.718. Observed incidence increased 10.2-fold across predicted-risk deciles (1.03-10.50%). Fine-Gray and Cox estimates closely matched the logistic model.Conclusions
Baseline cardiovascular vulnerability stratifies HFH risk during osimertinib therapy. The nomogram, not externally validated, is best used as a screening aid to identify patients who may benefit from intensified cardiovascular monitoring.
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BibTeX
@article{sugimoto2026risk,
title = {{Risk Stratification and Factors Associated with Heart Failure Hospitalization During Osimertinib Therapy.}},
author = {Tomoya Sugimoto and Yoshihiro Noguchi and Rikuto Masuda and Sorami Tani and Tomohiko Harada and Yukio Toyama and Mitsuru Saguchi and Tomoaki Yoshimura},
journal = {Current oncology (Toronto, Ont.)},
year = {2026},
month = sep,
doi = {10.3390/curroncol33100586},
url = {https://europepmc.org/article/MED/42930153},
note = {CC BY},
}
RIS
TY - JOUR
TI - Risk Stratification and Factors Associated with Heart Failure Hospitalization During Osimertinib Therapy.
AU - Tomoya Sugimoto
AU - Yoshihiro Noguchi
AU - Rikuto Masuda
AU - Sorami Tani
AU - Tomohiko Harada
AU - Yukio Toyama
AU - Mitsuru Saguchi
AU - Tomoaki Yoshimura
PY - 2026
DA - 2026/09/29
JO - Current oncology (Toronto, Ont.)
DO - 10.3390/curroncol33100586
UR - https://europepmc.org/article/MED/42930153
AB - Background Osimertinib is the standard of care for epidermal growth factor receptor mutation-positive non-small cell lung cancer, but heart failure hospitalization (HFH) remains a concern, and no practical tool exists to stratify HFH risk during therapy.Methods In this retrospective cohort study using a Japanese claims database, 5802 patients newly initiating osimertinib were followed for HFH during treatment. Baseline predictors assessed before the index date were selected by 10-fold cross-validated least absolute shrinkage and selection operator (LASSO) logistic regression and internally validated by bootstrapping (B = 500), repeating predictor selection in each resample. Cumulative incidence functions and Fine-Gray models treated death as a competing event; cause-specific Cox models served as sensitivity analyses.Results HFH occurred in 169 patients (2.9%) during a median on-treatment follow-up of 9.3 months, with 268 competing deaths. LASSO retained seven predictors. The apparent concordance index (C-index) was 0.731 (95% confidence interval, 0.691-0.771) and the optimism-corrected C-index 0.718. Observed incidence increased 10.2-fold across predicted-risk deciles (1.03-10.50%). Fine-Gray and Cox estimates closely matched the logistic model.Conclusions Baseline cardiovascular vulnerability stratifies HFH risk during osimertinib therapy. The nomogram, not externally validated, is best used as a screening aid to identify patients who may benefit from intensified cardiovascular monitoring.
SN - 1198-0052
SN - 1718-7729
ER -