Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy in Patients Presenting with Locally Advanced Breast Cancer: A Prospective Study

局部晚期乳腺癌患者新辅助化疗后前哨淋巴结活检：一项前瞻性研究

• 批准号: 10656553
• 负责人: Andrea Barrio
• 金额: $ 8.85万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10656553
• 关键词: Adjuvant Chemotherapy; Aftercare; Axilla; Axillary Lymph Node Dissection; Axillary lymph node group; Biopsy; Breast; Chest wall structure; Clinical; Clip; Colloids; Combined Modality Therapy; Data; Databases; Diagnosis; Disease; Dyes; Eligibility Determination; Excision; Failure; Feasibility Studies; Frequencies; Future; Goals; Grant; In complete remission; Institution; Isosulfan Blue; Locally Advanced Malignant Neoplasm; Lymphedema; Maps; Memorial Sloan-Kettering Cancer Center; Methods; Modernization; Morbidity - disease rate; Neoadjuvant Therapy; Neoplasm Metastasis; Nodal; Operative Surgical Procedures; Pathologic; Patients; Pilot Projects; Policies; Population; Positive Axillary Lymph Node; Positive Lymph Node; Preparation; Procedures; Prospective Studies; Quality of life; Research; Retrieval; Retrospective Studies; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Skin; Staging; Sulfur; Surgical Management; Survivors; Technetium 99m; Time; Tracer; Tumor Burden; Widespread Disease; Woman; advanced breast cancer; advanced disease; arm; burden of illness; chemotherapy; draining lymph node; follow-up; improved; malignant breast neoplasm; patient population; patient subsets; prospective; risk minimization; standard of care; tumor

Project Summary/Abstract Sentinel lymph node biopsy (SLNB), which involves removal of the first few draining lymph nodes, is the standard method for staging the axilla in patients with clinically node-negative (cN0) breast cancer undergoing neoadjuvant chemotherapy (NAC) and is widely accepted, with minimal morbidity. In patients with clinically positive nodes, axillary lymph node dissection (ALND), or removal of the majority of axillary lymph nodes, was once the standard of care; however, NAC can eradicate disease in the axillary nodes, with nodal pathologic complete response (pCR) rates of 40%, thus reducing the need for ALND and consequently minimizing the risk of lymphedema. Initial small retrospective studies showed that SLNB was inaccurate in this population, with false-negative rates (FNRs) of 21%-33%. More recently, 4 prospective multi-institutional trials showed that patients presenting with limited axillary nodal metastases (cN1) can be reliably staged with SLNB after NAC, with FNRs of <10% with the use of dual-tracer mapping and retrieval of ≥3 sentinel lymph nodes. Patients presenting with locally advanced breast cancer (LABC)—defined as disease in the breast with skin or chest wall involvement (cT4) and/or extensive disease in the nodes (cN2/N3)—have not been considered candidates for SLNB, owing to their heavy disease burden at presentation and the limited evidence that SLNB is accurate after NAC in this patient population. Furthermore, it was presumed that the substantial tumor burden in patients with LABC would result in low rates of pCR to NAC, precluding surgical downstaging. However, a recent retrospective study of 321 patients with LABC treated at Memorial Sloan Kettering Cancer Center demonstrated high nodal pCR rates (38%), with similar rates between patients with cN1 (43%), cN2 (36%), and cN3 (32%) disease (p=0.23). The magnitude of reduction in tumor burden with modern NAC in patients presenting with LABC suggests that a substantial number of women may not benefit from ALND and may be subjected to unnecessary morbidity. These patients may be candidates for SLNB after NAC, provided that the procedure accurately predicts axillary nodal status in this population. We hypothesize that a heavy disease burden in the breast or the regional nodes at presentation is not a contraindication to SLNB in patients whose disease is downstaged with NAC. We propose a multi-institutional, prospective, single-arm trial to evaluate the feasibility and FNR of SLNB after NAC in patients presenting with LABC. Eligible patients whose disease is reduced to cN0 after NAC will undergo SLNB with dual-tracer mapping followed by ALND to assess the FNR of SLNB. Study findings could lead to significant advances in the surgical management of the axilla after NAC in patients with LABC, reducing the need for ALND and improving quality of life of survivors.

项目摘要/摘要 前哨淋巴结活检（SLNB）涉及去除前几个排水淋巴结，是 临床淋巴结阴性（CN0）乳腺癌患者的腋窝分期的标准方法 新辅助化学疗法（NAC），被广泛接受，发病率最低。在临床上 阳性淋巴结，腋窝淋巴结清扫术（ALND）或去除大多数腋窝淋巴结， 一旦成为护理标准；但是，NAC可以在腋窝淋巴结中使用淋巴结病理 完全响应（PCR）40％，从而减少了对ALND的需求，从而最大程度地降低了风险 淋巴水肿。最初的小回顾性研究表明，SLNB在该人群中不准确， 假阴性率（FNR）为21％-33％。最近，有4项前瞻性多机构试验表明 在NAC之后，可以用SLNB可靠地上演腋结节转移有限的患者（CN1）的患者 使用双追踪映射和检索≥3个哨兵淋巴结的FNR <10％。患者 呈现局部晚期乳腺癌（LABC） - 在乳房中定义为皮肤或胸部 壁参与（CT4）和/或节点中的广泛疾病（CN2/N3） - 不被视为候选者 对于SLNB，由于其剧烈疾病在演讲时燃烧，并且有限的证据表明SLNB准确 在该患者人群中NAC之后。此外，有人提出了患者的大量肿瘤燃烧 使用LABC会导致PCR率低至NAC，从而排除了手术下降阶段。但是，最近 对321例LABC患者的回顾性研究在纪念Sloan Kettering Cancer Center接受治疗 表现出高节点PCR率（38％），CN1患者（43％），CN2（36％），率相似 和CN3（32％）疾病（p = 0.23）。患者肿瘤燃烧的肿瘤燃烧幅度减少的大小 与LABC展示表明，大量女性可能不会从ALND中受益，并且可能是 受到不必要的发病率。这些患者可能是NAC后SLNB的候选者 程序准确地预测了该人群中的腋窝淋巴结状态。我们假设一种严重的疾病 在乳房中燃烧或在演示时的区域淋巴结中并不是患者的SLNB的禁忌症 NAC使疾病陷入困境。我们提出了一项多机构的，前瞻性的单臂试验，以评估 NAC后SLNB的可行性和FNR，患有LABC的患者。疾病的符合条件的患者 NAC后还原为CN0，将使用双跟踪映射进行SLNB，然后进行ALND评估FNR SLNB。研究结果可能会导致NAC后腋窝手术管理的重大进展 LABC患者减少了对ALND的需求，并提高了生存的生活质量。