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<p>Immune checkpoint inhibitors (ICI) improve survival in triple-negative breast cancer (TNBC) but cause late-onset toxicity, with unknown incidence in breast cancer. This retrospective study included 700 patients (61%, <i>n</i> = 424 early-stage; 39%, <i>n</i> = 276 metastatic; 77% TNBC) from four NCI-designated centers treated with ICI between 2014–2021. Chart review identified immune toxicities, defined as ICI-related, as noted by the oncology provider or steroid-treated. 61% (<i>n</i> = 430) had toxicity: 37% (<i>n</i> = 257) early (≤90 days after ICI start), 34% (<i>n</i> = 240) delayed (&gt;90 days), 10% (<i>n</i> = 67) both. Of the delayed, 144 (60%) were on-treatment, 56 (23%) off-treatment, 40 (17%) both. Twenty-two (9.2%) had off-treatment toxicity &gt;1 year post-ICI. Median onset: 138 days (range 90–1380) on-treatment; 76 days (21–1144) off-treatment. Risk increased with more ICI cycles, especially &gt;4 (early OR 1.104; metastatic OR 1.06; <i>p</i> &lt; 0.0001) and higher baseline eosinophils (OR 3.46, <i>p</i> = 0.0484). Metastatic disease (OR 0.18, <i>p</i> &lt; 0.0001) and early toxicity (OR 0.53, <i>p</i> = 0.0008) reduced risk. Findings support the need for high clinical suspicion for late toxicity.</p>

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Multi-institutional analysis of incidence and risks for late-onset immune toxicity in breast cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月3日

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  • Saya Jacob,
  • Samantha Fisch,
  • Carolyne Face,
  • Kelly Blum,
  • Madhuri Chengappa,
  • Saliha Chaudhry,
  • Alexis LeVee,
  • Nikita V. Baclig,
  • Andrew Soliman,
  • Laura A. Huppert,
  • Zoe Quandt,
  • Laura Quintal,
  • Dame Idossa,
  • Michelle Melisko,
  • A. Jo Chien,
  • Mi-Ok Kim,
  • Joanne Mortimer,
  • Kelly McCann,
  • Anne Blaes,
  • Hope S. Rugo

摘要

Immune checkpoint inhibitors (ICI) improve survival in triple-negative breast cancer (TNBC) but cause late-onset toxicity, with unknown incidence in breast cancer. This retrospective study included 700 patients (61%, n = 424 early-stage; 39%, n = 276 metastatic; 77% TNBC) from four NCI-designated centers treated with ICI between 2014–2021. Chart review identified immune toxicities, defined as ICI-related, as noted by the oncology provider or steroid-treated. 61% (n = 430) had toxicity: 37% (n = 257) early (≤90 days after ICI start), 34% (n = 240) delayed (>90 days), 10% (n = 67) both. Of the delayed, 144 (60%) were on-treatment, 56 (23%) off-treatment, 40 (17%) both. Twenty-two (9.2%) had off-treatment toxicity >1 year post-ICI. Median onset: 138 days (range 90–1380) on-treatment; 76 days (21–1144) off-treatment. Risk increased with more ICI cycles, especially >4 (early OR 1.104; metastatic OR 1.06; p < 0.0001) and higher baseline eosinophils (OR 3.46, p = 0.0484). Metastatic disease (OR 0.18, p < 0.0001) and early toxicity (OR 0.53, p = 0.0008) reduced risk. Findings support the need for high clinical suspicion for late toxicity.