(1) Background: The independent negative prognostic value of isolated tumor cells or micro-metastases in axillary lymph nodes has been established in triple-negative breast cancers (BC). However, the prognostic significance of pN0(i+) or pN1mi in HER2-positive BCs treated by primary surgery remains unexplored. Therefore, our objective was to investigate the impact of pN0(i+) or pN1mi in HER2-positive BC patients undergoing up-front surgery on their outcomes. (2) Methods: We retrospectively analyzed 23,650 patients treated in 13 French cancer centers from 1991 to 2013. pN status was categorized as pN0, pN0(i+), pN1mi, and pNmacro. The effect of pN0(i+) or pN1mi on outcomes was investigated both in the entire cohort of patients and in pT1a-b tumors. (3) Results: Of 1771 HER2-positive BC patients included, pN status distributed as follows: 1047 pN0 (59.1%), 60 pN0(i+) (3.4%), 118 pN1mi (6.7%), and 546 pN1 macro-metastases (30.8%). pN status was significantly associated with sentinel lymph node biopsy, axillary lymph node dissection, age, ER status, tumor grade, and size, lymphovascular invasion, adjuvant systemic therapy (ACt), and radiation therapy. With 61 months median follow-up (mean 63.2; CI 95% 61.5–64.9), only pN1 with macro-metastases was independently associated with a negative impact on overall, disease-free, recurrence-free, and metastasis-free survivals in multivariate analysis. In the pT1a-b subgroup including 474 patients, RFS was significantly decreased in multivariate analysis for pT1b BC without ACt (HR 2.365, 1.04–5.36,p= 0.039) and for pN0(i+)/pN1mi patients (HR 2.518, 1.03–6.14,p= 0.042). (4) Conclusions: Survival outcomes were not adversely affected by pN0(i+) and pN1mi in patients with HER2-positive BC. However, in the case of pT1a-b HER2-positive BC, a negative impact on RFS was observed specifically for patients with pN0(i+) and pN1mi diseases, particularly among those with pT1b tumors without ACt. Our findings highlight the importance of considering the pN0(i+) and pN1mi status in the decision-making process when discussing trastuzumab-based ACt for these patients.
（1）背景：在三阴性乳腺癌中，腋窝淋巴结孤立肿瘤细胞或微转移的独立阴性预后价值已得到确认。然而，对于接受初次手术治疗的HER2阳性乳腺癌患者，pN0(i+)或pN1mi状态的预后意义尚未明确。因此，本研究旨在探讨pN0(i+)或pN1mi状态对接受前期手术的HER2阳性乳腺癌患者预后的影响。 （2）方法：我们回顾性分析了1991年至2013年间法国13个癌症中心收治的23,650例患者。将pN状态分为pN0、pN0(i+)、pN1mi和pNmacro（宏转移）。分别在整体患者队列及pT1a-b肿瘤亚组中，研究了pN0(i+)或pN1mi状态对预后的影响。 （3）结果：在纳入的1771例HER2阳性乳腺癌患者中，pN状态分布如下：pN0 1047例（59.1%）、pN0(i+) 60例（3.4%）、pN1mi 118例（6.7%）、pN1宏转移546例（30.8%）。pN状态与前哨淋巴结活检、腋窝淋巴结清扫、年龄、ER状态、肿瘤分级与大小、淋巴血管侵犯、辅助全身治疗及放疗显著相关。中位随访61个月（平均63.2个月，95% CI 61.5–64.9）的多变量分析显示，仅伴有宏转移的pN1状态与总生存期、无病生存期、无复发生存期和无转移生存期的降低独立相关。在包含474例患者的pT1a-b亚组中，多变量分析显示：未接受辅助全身治疗的pT1b乳腺癌患者（HR 2.365，95% CI 1.04–5.36，p=0.039）以及pN0(i+)/pN1mi状态患者（HR 2.518，95% CI 1.03–6.14，p=0.042）的无复发生存期显著缩短。 （4）结论：在HER2阳性乳腺癌患者中，pN0(i+)和pN1mi状态未对生存结局产生不利影响。然而，在pT1a-b期HER2阳性乳腺癌中，pN0(i+)和pN1mi状态（特别是未接受辅助全身治疗的pT1b肿瘤患者）对无复发生存期存在负面影响。本研究结果强调，在为这类患者制定基于曲妥珠单抗的辅助全身治疗方案时，应充分考虑pN0(i+)和pN1mi状态在临床决策中的重要性。
肿瘤(癌症)患者之家