Şahin Çelik Buket, Peker Pınar, Özçelik Ender Eren, Kuzu Ömer Faruk, Gökmen Erhan, Başaran Gül, Evrensel Türkkan
Ege Üniversitesi Tıp Fakültesi Hastanesi, İzmir 35100, Türkiye.
Bursa Uludağ Üniversitesi Tıp Fakültesi Hastanesi, Bursa 16059, Türkiye.
Cancers (Basel). 2025 Jul 8;17(14):2271. doi: 10.3390/cancers17142271.
: Approximately 15-20% of early-stage breast cancers overexpress HER2, which is associated with an increased risk of recurrence. Although adjuvant anti-HER2 therapies have significantly improved patient outcomes, the optimal treatment strategy remains uncertain, particularly for patients with small, lymph node-negative tumors, where concerns about potential overtreatment and toxicity persist. The objective of this study was to evaluate overall survival (OS), recurrence-free survival (RFS), and treatment-related neuropathy in patients with early-stage HER2-positive breast cancer treated with adjuvant trastuzumab and paclitaxel. : A total of 129 patients, aged 18 to 75 years, diagnosed with early-stage HER2-positive breast cancer, were retrospectively analyzed in this multicenter study. All patients had received adjuvant treatment with trastuzumab and paclitaxel (TH regimen) between November 2016 and July 2023. The study involved the collection of demographic information, pathological features, and treatment-related details. Overall survival (OS) was defined as the primary study endpoint, while recurrence-free survival (RFS), disease control rate (DCR), and treatment-related neuropathy were evaluated as secondary outcomes. : The median follow-up time was 70.9 months. The 2-year and 5-year OS rates were 95.3%, and the 5-year RFS rate was 96.8%. No statistically significant differences in OS or RFS were observed in relation to tumor size (T1 vs. T2), hormone receptor status, Ki-67 index, tumor grade, or the use of adjuvant endocrine or radiotherapy (all > 0.05). Neuropathy developed in 53.5% of patients, mostly grade 1. : Adjuvant TH therapy shows favorable long-term outcomes in early-stage HER2-positive breast cancer.
大约15%-20%的早期乳腺癌过度表达HER2,这与复发风险增加相关。尽管辅助抗HER2治疗显著改善了患者预后,但最佳治疗策略仍不确定,尤其是对于肿瘤较小、淋巴结阴性的患者,对潜在过度治疗和毒性的担忧仍然存在。本研究的目的是评估接受辅助曲妥珠单抗和紫杉醇治疗的早期HER2阳性乳腺癌患者的总生存期(OS)、无复发生存期(RFS)和治疗相关神经病变。
在这项多中心研究中,对129例年龄在18至75岁之间、诊断为早期HER2阳性乳腺癌的患者进行了回顾性分析。所有患者在2016年11月至2023年7月期间均接受了曲妥珠单抗和紫杉醇辅助治疗(TH方案)。该研究涉及收集人口统计学信息、病理特征和治疗相关细节。总生存期(OS)被定义为主要研究终点,而无复发生存期(RFS)、疾病控制率(DCR)和治疗相关神经病变被评估为次要结局。
中位随访时间为70.9个月。2年和5年总生存率分别为95.3%,5年无复发生存率为96.8%。在肿瘤大小(T1与T2)、激素受体状态、Ki-67指数、肿瘤分级或辅助内分泌治疗或放疗的使用方面,未观察到总生存期或无复发生存期有统计学显著差异(均>0.05)。53.5%的患者发生了神经病变,大多为1级。
辅助TH治疗在早期HER2阳性乳腺癌中显示出良好的长期疗效。