Scholarlink

<p>Chimeric antigen receptor (CAR) T-cell therapy has significantly advanced treatment outcomes for hematological malignancies; however, therapy-associated toxicities are often severe and sex-related differences in toxicity remain under-investigated. Here, we extract data from FDA Adverse Event Reporting System (FAERS) to evaluate sex-associated differences in CAR T-cell therapy toxicities. Among 7700 cases, females show higher reporting odds of cytokine release syndrome (CRS), with a reporting odds ratio (ROR) of 1.10 and a confidence interval (CI) of [1.00, 1.20], as well as leukemias (ROR = 1.34; CI [1.05, 1.70]). Elevated reporting odds in females are observed across multiple organ systems. Comparisons across cancer treatments indicate that sex-associated reporting patterns in CAR T-cell therapy cannot be attributed to baseline sex differences across cancer therapies. Stratified analyses further identify heterogeneity by cancer type and CAR T product. These results highlight distinct sex-associated toxicity patterns and may support incorporating sex into toxicity management.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

A retrospective pharmacovigilance analysis based on the FAERS database reveals sex-associated differences in toxicities of CAR T-cell therapy

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月5日

查看全文
  • Yuan Liu,
  • Jingwen Yang,
  • Madiha Iqbal,
  • Mehmet Uyanik,
  • Mei Luo,
  • Liqi Yang,
  • Yanyan Lou,
  • Lixia Diao,
  • Olalekan O. Oluwole,
  • Javid J. Moslehi,
  • Douglas B. Johnson,
  • Leng Han

摘要

Chimeric antigen receptor (CAR) T-cell therapy has significantly advanced treatment outcomes for hematological malignancies; however, therapy-associated toxicities are often severe and sex-related differences in toxicity remain under-investigated. Here, we extract data from FDA Adverse Event Reporting System (FAERS) to evaluate sex-associated differences in CAR T-cell therapy toxicities. Among 7700 cases, females show higher reporting odds of cytokine release syndrome (CRS), with a reporting odds ratio (ROR) of 1.10 and a confidence interval (CI) of [1.00, 1.20], as well as leukemias (ROR = 1.34; CI [1.05, 1.70]). Elevated reporting odds in females are observed across multiple organ systems. Comparisons across cancer treatments indicate that sex-associated reporting patterns in CAR T-cell therapy cannot be attributed to baseline sex differences across cancer therapies. Stratified analyses further identify heterogeneity by cancer type and CAR T product. These results highlight distinct sex-associated toxicity patterns and may support incorporating sex into toxicity management.