在波兰女性队列中，体重变化和体重指数并非戈沙妥珠单抗治疗转移性三阴性乳腺癌生存结局的预后标志物。
Weight change and BMI are not prognostic markers of survival outcomes in sacituzumab govitecan therapy for mTNBC in the Polish female cohort.
作者信息
Pienia̧żek Małgorzata, Polakiewicz-Gilowska Anna, Las-Jankowska Manuela, Wronowicz Jakub, Jarza̧b Michał, Łacko Aleksandra, Ziobro Marek, Püsküllüoǧlu Mirosława
机构信息
Department of Oncology, Wroclaw Medical University, Plac Hirszfelda 12, Wrocław 53-413, Poland.
Lower Silesian Comprehensive Cancer Center, Plac Hirszfelda 12, Wrocław 53-413, Poland.
出版信息
Ther Adv Med Oncol. 2025 Aug 19;17:17588359251363104. doi: 10.1177/17588359251363104. eCollection 2025.
BACKGROUND
Body mass index (BMI) and weight change are commonly explored as prognostic factors in breast cancer. However, their impact on outcomes with sacituzumab govitecan (SG) in metastatic triple-negative breast cancer (mTNBC) remains poorly defined.
OBJECTIVES
To evaluate the association between baseline BMI, weight change during treatment, and clinical outcomes-including survival and adverse events (AEs)-in a real-world Polish cohort of women with mTNBC receiving SG therapy.
DESIGN
A retrospective, multicenter cohort study.
METHODS
A total of 83 women with mTNBC treated with SG across four oncology centers in Poland between August 2021 and September 2024 were analyzed. BMI was categorized by World Health Organization (WHO) criteria: underweight (BMI < 18.5 kg/m), normal weight (18.5-24.9 kg/m), overweight (25.0-29.9 kg/m), and obese (⩾30.0 kg/m). Weight changes were recorded from baseline to last treatment cycle, indicating loss or gain. Median progression-free survival (mPFS) and median overall survival (mOS) were assessed using multivariate Cox regression models (significance level α = 0.05). AEs were classified, using the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE), version 5.0, and compared across BMI and weight stability categories.
RESULTS
The mPFS was 4.07 months (95% CI: 3.05-6.18), and the mOS was 8.01 months (95% CI: 6.05-9.75). The median follow-up time was 7.42 months (95% CI: 6.07-8.96). Neither baseline BMI nor weight change significantly influenced PFS (BMI = 0.09, weight change: = 0.68) or OS (BMI: = 0.09, weight change: = 0.21). No BMI categories predicted disease progression or mortality. In addition, there were no significant differences in the frequency or severity of AEs (neutropenia, diarrhea, nausea, or hepatic toxicity) based on BMI or weight stability ( > 0.05).
CONCLUSION
In this real-world Polish cohort of women with mTNBC treated with SG, neither BMI nor weight changes were prognostic indicators for survival or AE profiles. These findings underscore the necessity for identifying more reliable prognostic biomarkers in this patient population.
背景
体重指数（BMI）和体重变化通常作为乳腺癌的预后因素进行研究。然而，它们对转移性三阴性乳腺癌（mTNBC）患者使用戈沙妥珠单抗（SG）治疗结局的影响仍不明确。
目的
评估波兰mTNBC真实世界队列中接受SG治疗的女性患者的基线BMI、治疗期间体重变化与临床结局（包括生存率和不良事件（AE））之间的关联。
设计
一项回顾性、多中心队列研究。
方法
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例mTNBC女性患者。根据世界卫生组织（WHO）标准对BMI进行分类：体重过轻（BMI＜18.5kg/m²）、正常体重（18.5 - 24.9kg/m²）、超重（25.0 - 29.9kg/m²）和肥胖（≥30.0kg/m²）。记录从基线到最后一个治疗周期的体重变化，表明体重减轻或增加。使用多变量Cox回归模型评估中位无进展生存期（mPFS）和中位总生存期（mOS）（显著性水平α = 0.05）。根据美国国立癌症研究所不良事件通用术语标准（NCI - CTCAE）第5.0版对AE进行分类，并在BMI和体重稳定性类别之间进行比较。
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）。中位随访时间为7.42个月（95%CI：6.07 - 8.96）。基线BMI和体重变化均未显著影响PFS（BMI：P = 0.09，体重变化：P = 0.68）或OS（BMI：P = 0.09，体重变化：P = 0.21）。没有BMI类别能够预测疾病进展或死亡。此外，基于BMI或体重稳定性，AE（中性粒细胞减少、腹泻、恶心或肝毒性）的频率或严重程度没有显著差异（P＞0.05）。
结论
在这个接受SG治疗的波兰mTNBC女性真实世界队列中，BMI和体重变化均不是生存或AE谱的预后指标。这些发现强调了在该患者群体中识别更可靠预后生物标志物的必要性。
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