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Introduction <p>The prognostic implications of tumor-infiltrating lymphocytes (TILs) and their temporal changes (ΔTILs) during neoadjuvant chemotherapy (NAC) in hormone receptor-positive/ HER2-negative early breast cancer (HR+/HER2− eBC) remains clinically ambiguous. Our study investigates the association between TILs levels, longitudinal TILs evolution, and survival outcomes in a NAC-treated HR+/HER2− eBC cohort.</p> Methods <p>In this retrospective cohort analysis of 576&#xa0;HR+/HER2- eBC patients (April 2011-December 2021), TILs were categorized as low (&lt; 10%) or high (≥ 10%) using predefined thresholds. Multivariable Cox proportional hazards models evaluated invasive disease-free survival (iDFS) and overall survival (OS). ΔTILs patterns were analyzed in residual tumors.</p> Results <p>The cohort (median follow-up 68.1 months) comprised 393 TILs-low (68.2%) and 183 TILs-high (31.8%) tumors. Compared to TILs-low tumors, TILs-high tumors were associated with a higher Ki-67 index (≥ 20%) (<i>P</i> = 0.022), even though they were more frequently of smaller baseline size (&lt; 3&#xa0;cm) (<i>P</i> = 0.022). Elevated pre-NAC TILs independently predicted inferior iDFS (HR = 1.47, 95% CI 1.06–2.04, <i>P</i> = 0.021) and OS (HR = 1.64, 95% CI 1.11–2.43, <i>P</i> = 0.013). Post-NAC TILs escalation (low to high) conferred the worse prognosis versus sustained low TILs (iDFS: HR = 2.97, 95% CI 1.93–4.55, <i>P</i> &lt; 0.001; OS: HR = 3.43, 95% CI 2.02–5.85, <i>P</i> &lt; 0.001). Conversely, TILs reduction (high to low) correlated with improved survival over persistent high TILs (iDFS: HR = 0.51, 95% CI 0.30–0.86, <i>P</i> = 0.012; OS: HR = 0.54, 95%CI 0.31–0.96, <i>P</i> = 0.034).</p> Conclusion <p>In HR+/HER2− eBC, elevated pre-treatment TILs are independently associated with inferior survival outcomes, while chemotherapy-induced TILs reduction in residual disease correlates with significant prognostic improvement.</p>

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Dynamic tumor-infiltrating lymphocytes predicts survival in HR+/HER2− early breast cancer: a pre-to-post neoadjuvant chemotherapy study

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  • 发表日期：

    2025年11月14日

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  • Yibin Qiu,
  • Renren Zhang,
  • Shunyi Liu,
  • Long Wu,
  • Yali Wang,
  • Weifeng Cai,
  • Peng He,
  • Qindong Cai,
  • Yuxiang Lin,
  • Wenhui Guo,
  • Chuan Wang,
  • Jie Zhang

摘要

Introduction

The prognostic implications of tumor-infiltrating lymphocytes (TILs) and their temporal changes (ΔTILs) during neoadjuvant chemotherapy (NAC) in hormone receptor-positive/ HER2-negative early breast cancer (HR+/HER2− eBC) remains clinically ambiguous. Our study investigates the association between TILs levels, longitudinal TILs evolution, and survival outcomes in a NAC-treated HR+/HER2− eBC cohort.

Methods

In this retrospective cohort analysis of 576 HR+/HER2- eBC patients (April 2011-December 2021), TILs were categorized as low (< 10%) or high (≥ 10%) using predefined thresholds. Multivariable Cox proportional hazards models evaluated invasive disease-free survival (iDFS) and overall survival (OS). ΔTILs patterns were analyzed in residual tumors.

Results

The cohort (median follow-up 68.1 months) comprised 393 TILs-low (68.2%) and 183 TILs-high (31.8%) tumors. Compared to TILs-low tumors, TILs-high tumors were associated with a higher Ki-67 index (≥ 20%) (P = 0.022), even though they were more frequently of smaller baseline size (< 3 cm) (P = 0.022). Elevated pre-NAC TILs independently predicted inferior iDFS (HR = 1.47, 95% CI 1.06–2.04, P = 0.021) and OS (HR = 1.64, 95% CI 1.11–2.43, P = 0.013). Post-NAC TILs escalation (low to high) conferred the worse prognosis versus sustained low TILs (iDFS: HR = 2.97, 95% CI 1.93–4.55, P < 0.001; OS: HR = 3.43, 95% CI 2.02–5.85, P < 0.001). Conversely, TILs reduction (high to low) correlated with improved survival over persistent high TILs (iDFS: HR = 0.51, 95% CI 0.30–0.86, P = 0.012; OS: HR = 0.54, 95%CI 0.31–0.96, P = 0.034).

Conclusion

In HR+/HER2− eBC, elevated pre-treatment TILs are independently associated with inferior survival outcomes, while chemotherapy-induced TILs reduction in residual disease correlates with significant prognostic improvement.