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Purpose <p>Immune-related adverse events (irAEs) have emerged as a potential surrogate marker for immunotherapy response across tumor types. We evaluated the association between irAEs and pathologic complete response (pCR) in a racially diverse cohort of patients with triple-negative breast cancer (TNBC) treated with neoadjuvant chemoimmunotherapy.</p> Methods <p>We conducted a retrospective analysis of 46 patients with early-stage TNBC treated with neoadjuvant chemoimmunotherapy between January 2021 and March 2023 at a single NCI-designated Comprehensive Cancer Center. irAEs, tumor-infiltrating lymphocytes (TILs), and clinicopathologic characteristics were abstracted from the medical record. Associations with pCR were analyzed using Fisher’s exact and Wilcoxon rank-sum tests.</p> Results <p>Among 46 patients, the median age was 60.5&#xa0;years. Most identified as Black (n = 27, 58.7%) or Hispanic (n = 14, 30.4%). irAEs occurred in 13 patients (28.2%), most commonly hypothyroidism, rash, and arthritis. The pCR rate was 55.8% (24/43 evaluable patients). Patients who developed irAEs were more likely to achieve pCR (84.6% vs. 45.2%, p = 0.039). Higher TILs (median 29%) were associated with pCR both as a continuous variable (p = 0.004) and categorically (p = 0.002), but not with irAE development (p = 0.341). pCR was more common among Hispanic patients (p = 0.005), and inversely associated with Black race (p = 0.003) and older age (p = 0.028).</p> Conclusion <p>IrAEs may serve as a surrogate for treatment response to neoadjuvant chemoimmunotherapy in early TNBC. Additionally, racial and age-based differences in treatment response suggest underlying immunologic or biologic variation. These findings highlight the importance of diverse cohort representation in immunotherapy studies and warrant validation in prospective trials.</p>

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Impact of immune-related adverse events on response to neoadjuvant chemoimmunotherapy in triple-negative breast cancer: a single-institution retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月23日

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  • Michelle Sterpi,
  • Nechama Dreyfus,
  • Yungtai Lo,
  • Susan Fineberg,
  • Harjot Gill,
  • Della Makower

摘要

Purpose

Immune-related adverse events (irAEs) have emerged as a potential surrogate marker for immunotherapy response across tumor types. We evaluated the association between irAEs and pathologic complete response (pCR) in a racially diverse cohort of patients with triple-negative breast cancer (TNBC) treated with neoadjuvant chemoimmunotherapy.

Methods

We conducted a retrospective analysis of 46 patients with early-stage TNBC treated with neoadjuvant chemoimmunotherapy between January 2021 and March 2023 at a single NCI-designated Comprehensive Cancer Center. irAEs, tumor-infiltrating lymphocytes (TILs), and clinicopathologic characteristics were abstracted from the medical record. Associations with pCR were analyzed using Fisher’s exact and Wilcoxon rank-sum tests.

Results

Among 46 patients, the median age was 60.5 years. Most identified as Black (n = 27, 58.7%) or Hispanic (n = 14, 30.4%). irAEs occurred in 13 patients (28.2%), most commonly hypothyroidism, rash, and arthritis. The pCR rate was 55.8% (24/43 evaluable patients). Patients who developed irAEs were more likely to achieve pCR (84.6% vs. 45.2%, p = 0.039). Higher TILs (median 29%) were associated with pCR both as a continuous variable (p = 0.004) and categorically (p = 0.002), but not with irAE development (p = 0.341). pCR was more common among Hispanic patients (p = 0.005), and inversely associated with Black race (p = 0.003) and older age (p = 0.028).

Conclusion

IrAEs may serve as a surrogate for treatment response to neoadjuvant chemoimmunotherapy in early TNBC. Additionally, racial and age-based differences in treatment response suggest underlying immunologic or biologic variation. These findings highlight the importance of diverse cohort representation in immunotherapy studies and warrant validation in prospective trials.