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Purpose <p>This study aimed to evaluate the prognostic significance of baseline laboratory parameters and inflammatory indices in patients with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) in the second line and beyond, potentially aiding personalized patient management.</p> Methods <p>This retrospective cohort study analyzed data from 83 female patients with mTNBC who initiated SG therapy at four Polish oncology centers between August 2021 and September 2024. Hematological parameters—white blood cell count (WBC), hemoglobin (Hb), platelets (Plt) and inflammatory indices—neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) were assessed at baseline and before each dose of first four SG cycles. Median progression-free survival (mPFS) and overall survival (mOS) were estimated, and, as the&#xa0;primary objectives, associations between baseline laboratory variables and survival outcomes were assessed using multivariate Cox regression models (<i>α</i> = 0.05). Secondary objectives included assessing their associations with patient and disease characteristics, prior treatment lines, and adverse events (AEs), which were classified using the National Cancer Institute Common Terminology Criteria for AEs (NCI‐CTCAE), version 5.0.</p> Results <p>The mPFS was 4.07&#xa0;months (95% CI 3.05–6.18), while the mOS was 8.01&#xa0;months (95% CI 6.05–9.75). Lower baseline Hb was significantly associated with shorter PFS (HR = 0.82, <i>p</i> = 0.03) but not OS. Elevated baseline NLR predicted worse OS (HR = 1.18, <i>p</i> = 0.03), while PLR and SII lacked prognostic significance. Changes in blood parameters within initial four SG cycles showed no significant correlations with survival outcomes. Furthermore, baseline hematological markers and inflammatory indices showed no significant association with clinical characteristics, prior therapy lines, tumor burden, or the occurrence and severity of AEs.</p> Conclusions <p>Baseline Hb and NLR were identified as independent prognostic biomarkers in patients with mTNBC receiving SG treatment, predicting PFS and OS, respectively. Other inflammatory indices (PLR, SII) did not demonstrate prognostic relevance. Prospective validation in larger cohorts is essential to confirm these findings and potentially guide personalized treatment strategies.</p>

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Baseline hemoglobin and neutrophil-to-lymphocyte ratio as prognostic biomarkers in patients with metastatic triple negative breast cancer treated with sacituzumab govitecan in second line and beyond: a real-world analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月27日

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  • Małgorzata Pieniążek,
  • Anna Polakiewicz-Gilowska,
  • Manuela Las-Jankowska,
  • Jakub Wronowicz,
  • Michał Jarząb,
  • Aleksandra Łacko,
  • Mirosława Püsküllüoğlu

摘要

Purpose

This study aimed to evaluate the prognostic significance of baseline laboratory parameters and inflammatory indices in patients with metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) in the second line and beyond, potentially aiding personalized patient management.

Methods

This retrospective cohort study analyzed data from 83 female patients with mTNBC who initiated SG therapy at four Polish oncology centers between August 2021 and September 2024. Hematological parameters—white blood cell count (WBC), hemoglobin (Hb), platelets (Plt) and inflammatory indices—neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) were assessed at baseline and before each dose of first four SG cycles. Median progression-free survival (mPFS) and overall survival (mOS) were estimated, and, as the primary objectives, associations between baseline laboratory variables and survival outcomes were assessed using multivariate Cox regression models (α = 0.05). Secondary objectives included assessing their associations with patient and disease characteristics, prior treatment lines, and adverse events (AEs), which were classified using the National Cancer Institute Common Terminology Criteria for AEs (NCI‐CTCAE), version 5.0.

Results

The mPFS was 4.07 months (95% CI 3.05–6.18), while the mOS was 8.01 months (95% CI 6.05–9.75). Lower baseline Hb was significantly associated with shorter PFS (HR = 0.82, p = 0.03) but not OS. Elevated baseline NLR predicted worse OS (HR = 1.18, p = 0.03), while PLR and SII lacked prognostic significance. Changes in blood parameters within initial four SG cycles showed no significant correlations with survival outcomes. Furthermore, baseline hematological markers and inflammatory indices showed no significant association with clinical characteristics, prior therapy lines, tumor burden, or the occurrence and severity of AEs.

Conclusions

Baseline Hb and NLR were identified as independent prognostic biomarkers in patients with mTNBC receiving SG treatment, predicting PFS and OS, respectively. Other inflammatory indices (PLR, SII) did not demonstrate prognostic relevance. Prospective validation in larger cohorts is essential to confirm these findings and potentially guide personalized treatment strategies.