Graciano Noiver, López Lucelly, Rodriguez Carlos A, Montoya Katherine, Cortés Javier
Faculty of Medicine, Universidad Pontificia Bolivariana, Medellín, Colombia.
Breast Cancer and Gynecologic Oncology Unit, Instituto de Cancerología Las Américas-AUNA, Medellín, Colombia.
Breast Cancer Res Treat. 2025 Sep 16. doi: 10.1007/s10549-025-07814-3.
Patients with triple-negative breast cancer (TNBC) who do not achieve pathological complete response (non-pCR) after neoadjuvant chemotherapy (NACT) have a high-risk of relapse. While adjuvant capecitabine (AdjCape) has demonstrated improved overall survival (OS) and disease-free survival (DFS) in Asian populations, its effectiveness in non-Asian settings remains uncertain. We aimed to evaluate the effect of AdjCape on survival outcomes using real-world data from a Latin American population.
We conducted a retrospective cohort study (2008-2024) including 360 women with non-metastatic TNBC and non-pCR treated at a single institution. Propensity score matching (PSM) was applied to adjust for baseline differences. Cox regression models assessed the association of AdjCape with OS and DFS, and stratified analyses identified subgroups with differential treatment effects.
Among 360 patients, 106 (29.4%) received AdjCape. After PSM, 187 patients (72 AdjCape, 115 controls) were analyzed. AdjCape was not associated with improved OS (HR 0.79, 95% CI 0.51-1.23, p = 0.302) or DFS (HR 0.81, 95% CI 0.53-1.23, p = 0.321). However, significant benefit was observed in patients with high residual tumor burden (pT3-pT4: OS HR 0.29, p = 0.020; DFS HR 0.37, p = 0.044) and in those not receiving radiotherapy (DFS HR 0.47, p = 0.038).
AdjCape did not improve OS or DFS in the overall TNBC non-pCR cohort but may offer benefit in patients with extensive residual disease or those not treated with radiotherapy. These findings highlight the need for individualized treatment strategies and further evaluation of capecitabine in the context of modern therapies.
新辅助化疗(NACT)后未达到病理完全缓解(非pCR)的三阴性乳腺癌(TNBC)患者复发风险高。虽然辅助性卡培他滨(AdjCape)在亚洲人群中已显示出改善总生存期(OS)和无病生存期(DFS)的效果,但其在非亚洲地区的有效性仍不确定。我们旨在利用拉丁美洲人群的真实世界数据评估AdjCape对生存结局的影响。
我们进行了一项回顾性队列研究(2008 - 2024年),纳入了在单一机构接受治疗的360例非转移性TNBC且非pCR的女性患者。应用倾向评分匹配(PSM)来调整基线差异。Cox回归模型评估AdjCape与OS和DFS的关联,分层分析确定具有不同治疗效果的亚组。
在360例患者中,106例(29.4%)接受了AdjCape。PSM后,对187例患者(72例AdjCape组,115例对照组)进行了分析。AdjCape与改善OS(风险比[HR]0.79,95%置信区间[CI]0.51 - 1.23,p = 0.302)或DFS(HR 0.81,95% CI 0.53 - 1.23,p = 0.321)无关。然而,在残留肿瘤负荷高的患者(pT3 - pT4:OS HR 0.29,p = 0.020;DFS HR 0.37,p = 0.044)和未接受放疗的患者(DFS HR 0.47,p = 0.038)中观察到显著益处。
AdjCape在总体TNBC非pCR队列中未改善OS或DFS,但可能对有广泛残留疾病或未接受放疗的患者有益。这些发现凸显了个性化治疗策略的必要性以及在现代治疗背景下对卡培他滨进行进一步评估的需求。