Małgorzata Pieniążek, Anna Polakiewicz-Gilowska, Manuela Las-Jankowska, Jakub Wronowicz, Michał Jarząb, Aleksandra Łacko, Mirosława Püsküllüoğlu
{"title":"基线血红蛋白和中性粒细胞与淋巴细胞比率作为转移性三阴性乳腺癌患者在二线及以上接受sacituzumab govitecan治疗的预后生物标志物:一项现实世界分析","authors":"Małgorzata Pieniążek, Anna Polakiewicz-Gilowska, Manuela Las-Jankowska, Jakub Wronowicz, Michał Jarząb, Aleksandra Łacko, Mirosława Püsküllüoğlu","doi":"10.1007/s10549-025-07825-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Małgorzata Pieniążek, Anna Polakiewicz-Gilowska, Manuela Las-Jankowska, Jakub Wronowicz, Michał Jarząb, Aleksandra Łacko, Mirosława Püsküllüoğlu\",\"doi\":\"10.1007/s10549-025-07825-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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>\",\"PeriodicalId\":9133,\"journal\":{\"name\":\"Breast Cancer Research and Treatment\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-09-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast Cancer Research and Treatment\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10549-025-07825-0\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast Cancer Research and Treatment","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10549-025-07825-0","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:本研究旨在评估基线实验室参数和炎症指数对转移性三阴性乳腺癌(mTNBC)患者在二线及以上接受sacituzumab govitecan (SG)治疗的预后意义,可能有助于个性化患者管理。方法:这项回顾性队列研究分析了2021年8月至2024年9月期间在波兰四个肿瘤中心接受SG治疗的83名mTNBC女性患者的数据。血液学参数-白细胞计数(WBC),血红蛋白(Hb),血小板(Plt)和炎症指数-中性粒细胞与淋巴细胞比率(NLR),血小板与淋巴细胞比率(PLR)和全身免疫炎症指数(SII)在基线和前四个SG周期的每次剂量前进行评估。估计中位无进展生存期(mPFS)和总生存期(mOS),并作为主要目标,使用多变量Cox回归模型评估基线实验室变量与生存结局之间的相关性(α = 0.05)。次要目标包括评估其与患者和疾病特征、既往治疗线和不良事件(ae)的关联,这些不良事件使用美国国家癌症研究所不良事件通用术语标准(NCI-CTCAE) 5.0版进行分类。结果:mPFS为4.07个月(95% CI 3.05-6.18), mOS为8.01个月(95% CI 6.05-9.75)。较低的基线Hb与较短的PFS显著相关(HR = 0.82, p = 0.03),但与OS无关。基线NLR升高预示较差的OS (HR = 1.18, p = 0.03),而PLR和SII缺乏预后意义。最初4个SG周期内血液参数的变化与生存结果无显著相关性。此外,基线血液学指标和炎症指标与临床特征、既往治疗线、肿瘤负荷或ae的发生和严重程度没有显著相关性。结论:基线Hb和NLR被确定为接受SG治疗的mTNBC患者的独立预后生物标志物,分别预测PFS和OS。其他炎症指数(PLR, SII)未显示预后相关性。在更大的队列中进行前瞻性验证对于确认这些发现和潜在地指导个性化治疗策略至关重要。
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.
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.
期刊介绍:
Breast Cancer Research and Treatment provides the surgeon, radiotherapist, medical oncologist, endocrinologist, epidemiologist, immunologist or cell biologist investigating problems in breast cancer a single forum for communication. The journal creates a "market place" for breast cancer topics which cuts across all the usual lines of disciplines, providing a site for presenting pertinent investigations, and for discussing critical questions relevant to the entire field. It seeks to develop a new focus and new perspectives for all those concerned with breast cancer.