Background: 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.Methods: 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.Results: 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 (allp> 0.05). Neuropathy developed in 53.5% of patients, mostly grade 1.Conclusions: Adjuvant TH therapy shows favorable long-term outcomes in early-stage HER2-positive breast cancer.
背景：约15%-20%的早期乳腺癌存在HER2过表达，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明确，尤其对于肿瘤较小且淋巴结阴性的患者，过度治疗和毒性的担忧持续存在。本研究旨在评估接受曲妥珠单抗联合紫杉醇辅助治疗的早期HER2阳性乳腺癌患者的总生存期（OS）、无复发生存期（RFS）及治疗相关神经病变。 方法：本多中心研究回顾性分析了2016年11月至2023年7月期间接受曲妥珠单抗联合紫杉醇（TH方案）辅助治疗的129例18-75岁早期HER2阳性乳腺癌患者。研究收集了人口统计学信息、病理特征及治疗相关数据。总生存期（OS）定义为主要研究终点，无复发生存期（RFS）、疾病控制率（DCR）及治疗相关神经病变作为次要终点进行评估。 结果：中位随访时间为70.9个月。2年及5年OS率均为95.3%，5年RFS率为96.8%。在肿瘤大小（T1 vs. T2）、激素受体状态、Ki-67指数、肿瘤分级、辅助内分泌治疗或放疗使用方面，OS与RFS均未观察到统计学显著差异（均p>0.05）。53.5%的患者出现神经病变，多数为1级。 结论：辅助TH方案治疗在早期HER2阳性乳腺癌中显示出良好的长期预后。
肿瘤(癌症)患者之家