Abstract PD4-06: How often does retrieval of a clipped lymph node change adjuvant therapy recommendations? A prospective consecutive patient cohort

Abstract

Objectives and Rationale: For breast cancer patients receiving neoadjuvant chemotherapy (NAC) and undergoing pre-NAC axillary lymph node biopsy, NCCN guidelines recommend biopsy marker (clip) placement. This recommendation is based on reports that retrieval of the clipped node after NAC minimizes the false negative rate of sentinel lymph node biopsy (SLNB). Prior studies examining this practice in cN1 patients have reported that the clipped node is a non-SLN 20% of the time. There is limited data regarding if the clipped node needs to be retrieved among cN0 patients, and how often the post-NAC pathologic status of the clipped node has potential to change adjuvant therapy decisions. Here we aim to determine: 1) how often the clipped node is a non-SLN among both cN0 and cN1 patients, and 2) how often the retrieved, clipped node is a non-SLN and is the only positive node after NAC, potentially impacting adjuvant treatment recommendations. Methods: A consecutive cohort of 147 patients treated with NAC and surgery at our institution between January 2019-May 2020 was prospectively examined. Prior to NAC, all patients underwent routine axillary ultrasound (AxUS). For those with an abnormal appearing node, biopsy was performed of the most suspicious lymph node and a clip was placed. All cN0 patients underwent SLNB without localization of the clipped node. Patients who converted from cN1 to cN0 underwent radioactive seed localization of the clipped node and SLNB with dual tracers (radioactive tracer and blue dye). All lymph nodes were analyzed by IHC. Any residual disease, including ITCs, was considered pathologic node positive (ypN+). Patients with DCIS/unknown breast tumor histology (N = 3), those without AxUS (N = 9), those treated with neoadjuvant endocrine therapy (N = 9) and cN1 patients without a clip (N = 2) were excluded. Descriptive analyses were performed to examine the rate of ypN+ disease among cN0 and cN1 patients, and how often the clipped node was a non-SLN containing residual disease. In the cN0 population, if the clipped node was not obtained during SLNB it was considered a non-SLN. Results: Of 124 patients meeting study criteria, 61 were cN0 and 63 cN1. Among cN0 patients, 21 (34%) had suspicious lymph nodes on AxUS which were biopsied (negative) and clipped. All cN0 patients underwent successful SLNB, with a median of 2 SLNs removed (range 1-10). Of these, 5 (8%) were ypN+. Of the 21 patients with clipped nodes, 14 (67%) of the clipped nodes were non-SLN. If <3 SLNs were sampled, the clipped non-SLN rate was 82% (9/11). If ≥3 were sampled, the clipped non-SLN rate was 50% (5/10). Among patients with clipped nodes and ypN+ disease, there were no cases in which the clipped node was the only positive node. Among 63 cN1 patients with clipped nodes, 55 (87%) converted to cN0 and underwent SLNB. SLNB was successful in 52/55 (95%) and a median of 3 SLNs were removed (range 1-8). Overall, 28/55 (51%) were ypN+. Of the 52 with successful SLNB, 15 (29%) of the clipped nodes were non-SLN. If <3 SLNs were sampled, the clipped non-SLN rate was 46% (6/13). If ≥3 were sampled, the clipped non-SLN rate was 23% (9/39). In one of 52 (2%) patients, the clipped non-SLN was the only positive node. Conclusions: In this prospective study, among cN0 patients with negative pre-NAC lymph node biopsies, the clipped node was frequently a non-SLN and pathologic status of the clipped node alone did not impact management. Among cN1 patients suitable for SLNB after NAC, although the clipped node was a non-SLN 29% of the time, it was the only positive node in only one patient. The finding that the post-NAC pathologic status of the clipped lymph node alone potentially changed adjuvant treatment recommendations in only 2% (1/52) of patients warrants further investigation. Citation Format: Anna Weiss, Claire King, Samantha Grossmith, Leah Portnow, Sughra Raza, Faina Nakhlis, Laura Dominici, Elizabeth A. Mittendorf, Tari A. King. How often does retrieval of a clipped lymph node change adjuvant therapy recommendations? A prospective consecutive patient cohort [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD4-06.

The Clinical Relevance of Target Lymph Node Biopsy after Primary Systemic Therapy in Initially Node-Positive Breast Cancer Patients

“…In the current study, additional removal of the TLN to the SLN after PST in breast cancer patients with initially suspicious axillary lymph nodes had an impact on the postoperative recommendation regarding systemic therapy in only one of 63 cases. This confirms the results of a prospective study presented at SABCS 2020, in which TLNB in addition to SLNB did not result in a change in adjuvant systemic therapy in 104 patients [ 14 ]. Contrary to our assumption, the comparatively high proportion of discordant TLN and SLN of 48.8% in the current study and the significantly higher number of removed TAD nodes in these cases also did not result in a greater impact of TLN on systemic therapy after surgery.…”

“…Recently, a study presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) showed that, in 104 breast cancer patients with clinical nodal downstaging after PST, removal of the TLN in addition to SLNB did not result in a change in adjuvant systemic therapy recommendation in any case. However, at least three SLNs were removed in 83% of the cases analyzed and the concordance rate (CR) of TLN and SLN was 83% [ 14 ]. In the German CLIP-study, on average, only 1.6 SLNs were removed, resulting in a CR of 35.7% for SLN and TLN [ 15 ], and in the European multicentric TATTOO study a CR of only 59.7% was determined [ 16 ].…”

Gezielte Entfernung axillärer Lymphknoten nach Kohlenstoffmarkierung bei Patientinnen mit primär systemisch behandeltem Mammakarzinom

“…Weiterhin hatte keine der bisher publizierten TAD-Studien einen onkologischen Endpunkt. Eine aktuelle prospektive Kohortenstudie zeigt bei 78 Patientinnen, dass die zusätzliche Entfernung des TLN zum SLN nur in einem Fall dazu führte, dass eine ALND durchgeführt wurde und dies auf die weitere Therapie-Empfehlung keinen Einfluss hatte 27 . Somit bleibt die Frage nach einem akzeptablen Cut-off für die FNR unklar.…”

Targeted Removal of Axillary Lymph Nodes After Carbon Marking in Patients with Breast Cancer Treated with Primary Chemotherapy

“…Moreover, none of the TAD studies published hitherto had an oncological endpoint. A recent prospective cohort study in 78 patients shows that removal of the TLN in addition to the SLN led in only one case to ALND being performed and that this had no influence on the further treatment recommendation 27 . The question of an acceptable cut-off for the FNR thus remains unclear.…”

“…Weiterhin hatte keine der bisher publizierten TAD-Studien einen onkologischen Endpunkt. Eine aktuelle prospektive Kohortenstudie zeigt bei 78 Patientinnen, dass die zusätzliche Entfernung des TLN zum SLN nur in einem Fall dazu führte, dass eine ALND durchgeführt wurde und dies auf die weitere Therapieempfehlung keinen Einfluss hatte 27 . Somit bleibt die Frage nach einem akzeptablen Cut-off für die FNR unklar.…”