Gallagher Kristalyn K, Iles Kathleen, Kuzmiak Cherie, Louie Raphael, McGuire Kandace P, Ollila David W
From the Department of Surgery, Division of Surgical Oncology and Endocrine Surgery (Gallagher, Ollila), University of North Carolina at Chapel Hill, Chapel Hill, NC.
Department of Surgery, Division of General Surgery (Iles), University of North Carolina at Chapel Hill, Chapel Hill, NC.
J Am Coll Surg. 2022 Apr 1;234(4):538-545. doi: 10.1097/XCS.0000000000000098.
This is a prospective, single-institution study to evaluate feasibility and accuracy of radar-localized reflector (RLR)-targeted axillary dissection (TAD) in node-positive breast cancer patients after neoadjuvant systemic therapy (NST).
Patients with biopsy-proven T1-2, N1-3 disease were eligible. Before NST, a marker clip and/or RLR was placed into the positive node. After NST, RLR was inserted if not placed previously. All patients underwent RLR TAD followed by axillary lymph node dissection (ALND). Primary end points of the trial were feasibility of RLR TAD and false negative rate (FNR).
Between 2017 and 2021, 101 patients with N1-3 disease underwent NST. Five patients withdrew from the study, 1 was ineligible, and there were 9 technical failures, thus our final study cohort comprised 86 patients. RLR TAD was performed with probe guidance and confirmed with intraoperative specimen radiograph. After RLR TAD, ALND was performed. Median number of RLR TAD nodes removed was 2 (range 1-10), and the RLR TAD nodes remained positive in 56 patients. Median number of ALND nodes removed was 18 (range 4-46). Accounting for 9 technical failures, feasibility was 90%. All technical failures occurred with attempted placement of RLR after NST. Feasibility rate was 100% when RLR placement occurred at diagnosis. Of the evaluable 86 patients, RLR TAD accurately predicted axillary status in 83 patients, with FNR of 5.1%.
We demonstrate high accuracy of RLR TAD, especially when RLR is placed before NST. For patients who present with N1-3 disease, this is another step towards axillary surgery de-escalation strategies.
这是一项前瞻性单机构研究，旨在评估新辅助全身治疗（NST）后，针对淋巴结阳性乳腺癌患者的雷达定位反射器（RLR）靶向腋窝淋巴结清扫术（TAD）的可行性和准确性。
活检证实为T1-2、N1-3期疾病的患者符合条件。在NST之前，将标记夹和/或RLR置于阳性淋巴结中。NST之后，如果之前未放置RLR，则进行插入。所有患者均接受RLR TAD，随后进行腋窝淋巴结清扫术（ALND）。该试验的主要终点是RLR TAD的可行性和假阴性率（FNR）。
2017年至2021年期间，101例N1-3期疾病患者接受了NST。5例患者退出研究，1例不符合条件，有9例技术失败，因此我们的最终研究队列包括86例患者。RLR TAD在探头引导下进行，并通过术中标本射线照片确认。RLR TAD之后，进行ALND。切除的RLR TAD淋巴结中位数为2个（范围1-10个），56例患者的RLR TAD淋巴结仍为阳性。切除的ALND淋巴结中位数为18个（范围4-46个）。计入9例技术失败，可行性为90%。所有技术失败均发生在NST后尝试放置RLR时。诊断时放置RLR，可行性率为100%。在可评估的86例患者中，RLR TAD准确预测了83例患者的腋窝状态，FNR为5.1%。
我们证明了RLR TAD的高准确性，尤其是在NST之前放置RLR时。对于出现N1-3期疾病的患者，这是朝着腋窝手术降阶梯策略迈出的又一步。
