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Purpose <p>Plasma abemaciclib concentrations vary among individuals, and their association with hematologic toxicity has been reported in real-world settings. The incidence of interstitial lung disease (ILD), a serious adverse event of abemaciclib, is higher in clinical practice than in clinical trials. Here, to assess the potential usefulness of abemaciclib concentration monitoring, we conducted a prospective exploratory study of the association between plasma abemaciclib concentration, age, and the occurrence of adverse events in breast cancer patients.</p> Methods <p>Patients with hormone receptor-positive breast cancer who initiated abemaciclib with endocrine therapy between December 2022 and May 2025 were included. Plasma abemaciclib concentrations were measured using liquid chromatography-tandem mass spectrometry, and adverse events of grade ≥ 3 or those leading to treatment interruption were identified.</p> Results <p>A total of 322 plasma samples from 23 patients were analyzed. The median age was 52 years (range: 34–79), including four aged ≥ 65. Thirteen had metastatic disease, and six out of ten completed two-year adjuvant therapy. During a median follow-up of 344 days (range: 29–732), ILD occurred in five patients (21.7%). Abemaciclib concentrations on day 15 of cycle 1 were significantly higher in patients with ILD than in those without (<i>p</i> = 0.005, Mann–Whitney U test). A positive correlation was observed between age and concentration on day 15 of cycle 1 (Pearson’s correlation coefficient = 0.54, <i>p</i> = 0.008), with increased variability in older patients.</p> Conclusion <p>Abemaciclib concentrations tend to be higher in elderly patients and may be associated with increased risk of ILD. These findings support the potential usefulness of abemaciclib concentration monitoring from a safety perspective in real-world practice.</p>

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Prospective monitoring of plasma abemaciclib in breast cancer patients: associations with age and adverse events

  • 期刊论文

  • 发表日期：

    2026年1月3日

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  • Keisuke Ikegami,
  • Reiko Ando Makihara,
  • Yuki Katsuya,
  • Takuma Suzuki,
  • Makoto Maeda,
  • Yuki Kojima,
  • Kazuki Sudo,
  • Tatsunori Shimoi,
  • Kan Yonemori,
  • Noboru Yamamoto,
  • Satoko Hori,
  • Hironobu Hashimoto

摘要

Purpose

Plasma abemaciclib concentrations vary among individuals, and their association with hematologic toxicity has been reported in real-world settings. The incidence of interstitial lung disease (ILD), a serious adverse event of abemaciclib, is higher in clinical practice than in clinical trials. Here, to assess the potential usefulness of abemaciclib concentration monitoring, we conducted a prospective exploratory study of the association between plasma abemaciclib concentration, age, and the occurrence of adverse events in breast cancer patients.

Methods

Patients with hormone receptor-positive breast cancer who initiated abemaciclib with endocrine therapy between December 2022 and May 2025 were included. Plasma abemaciclib concentrations were measured using liquid chromatography-tandem mass spectrometry, and adverse events of grade ≥ 3 or those leading to treatment interruption were identified.

Results

A total of 322 plasma samples from 23 patients were analyzed. The median age was 52 years (range: 34–79), including four aged ≥ 65. Thirteen had metastatic disease, and six out of ten completed two-year adjuvant therapy. During a median follow-up of 344 days (range: 29–732), ILD occurred in five patients (21.7%). Abemaciclib concentrations on day 15 of cycle 1 were significantly higher in patients with ILD than in those without (p = 0.005, Mann–Whitney U test). A positive correlation was observed between age and concentration on day 15 of cycle 1 (Pearson’s correlation coefficient = 0.54, p = 0.008), with increased variability in older patients.

Conclusion

Abemaciclib concentrations tend to be higher in elderly patients and may be associated with increased risk of ILD. These findings support the potential usefulness of abemaciclib concentration monitoring from a safety perspective in real-world practice.