# Diagnostic Accuracy of Radioactive Iodine Seed Placement in the Axilla With Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Node-Positive Breast Cancer

## Metadatos

- **Autores:** Simons JM et al. (RISAS Study Group, Netherlands)
- **Revista:** JAMA Surgery
- **Año:** 2022
- **PMID:** 36069889
- **PMCID:** PMC9453629
- **DOI:** [10.1001/jamasurg.2022.3907](https://doi.org/10.1001/jamasurg.2022.3907)
- **Fuente:** PubMed Central (open access)

## Relevancia

Estudio diagnostico prospectivo multicentrico (RISAS, 14 centros holandeses, 212 pacientes) que valida la diseccion axilar dirigida (TAD) combinando la marcacion con semilla de yodo-125 (MARI) y el ganglio centinela (SLNB) tras NAC en pacientes con cancer de mama cN+. Resultado clave: tasa de falsos negativos 3,5% y VPN 92,8%, claramente superior a SLNB aislado (FNR 17,9%) y MARI aislado (FNR 7,0%). Es la evidencia diagnostica de referencia para sustentar la omision de la linfadenectomia axilar tras conversion cN+ a ypN0 mediante TAD.

## Abstract

This diagnostic study investigates the accuracy of targeted axillary dissection (radioactive iodine seed placement in the axilla with sentinel lymph node biopsy [RISAS]) after neoadjuvant chemotherapy in patients who have clinically node-positive breast cancer.

Key Points

Question

What is the diagnostic accuracy of targeted axillary dissection after neoadjuvant chemotherapy in patients who have clinically node-positive breast cancer?

Findings

In this multicenter diagnostic study including 212 patients, the false-negative rate of targeted axillary dissection (ie, radioactive iodine seed placement in the axilla with sentinel lymph node biopsy [RISAS] procedure) was 3.5%. The negative predictive value was 92.8%, meaning that residual disease was missed in only 1 of 14 patients with a pathologic complete response in the RISAS nodes.

Meaning

These findings suggest the potential for worldwide implementation of targeted axillary dissection to enable response-based management of the axilla and to guide adjuvant (systemic) treatment strategies.

Importance

Several less-invasive staging procedures have been proposed to replace axillary lymph node dissection (ALND) after neoadjuvant chemotherapy (NAC) in patients with initially clinically node-positive (cN+) breast cancer, but these procedures may fail to detect residual disease. Owing to the lack of high-level evidence, it is not yet clear which procedure is most optimal to replace ALND.

Objective

To determine the diagnostic accuracy of radioactive iodine seed placement in the axilla with sentinel lymph node biopsy (RISAS), a targeted axillary dissection procedure.

Design, Setting, and Participants

This was a prospective, multicenter, noninferiority, diagnostic accuracy trial conducted from March 1, 2017, to December 31, 2019. Patients were included within 14 institutions (general, teaching, and academic) throughout the Netherlands. Patients with breast cancer clinical tumor categories 1 through 4 (cT1-4; tumor diameter <2 cm and up to >5 cm or extension to the chest wall or skin) and pathologically proven positive axillary lymph nodes (ie, clinical node categories cN1, metastases to movable ipsilateral level I and/or level II axillary nodes; cN2, metastases to fixed or matted ipsilateral level I and/or level II axillary nodes; cN3b, metastases to ipsilateral level I and/or level II axillary nodes with metastases to internal mammary nodes) who were treated with NAC were eligible for inclusion. Data were analyzed from July 2020 to December 2021.

Intervention

Pre-NAC, the marking of a pathologically confirmed positive axillary lymph node with radioactive iodine seed (MARI) procedure, was performed and after NAC, sentinel lymph node biopsy (SLNB) combined with excision of the marked lymph node (ie, RISAS procedure) was performed, followed by ALND.

Main Outcomes and Measures

The identification rate, false-negative rate (FNR), and negative predictive value (NPV) were calculated for all 3 procedures: RISAS, SLNB, and MARI. The noninferiority margin of the observed FNR was 6.25% for the RISAS procedure.

Results

A total of 212 patients (median [range] age, 52 [22-77] years) who had cN+ breast cancer underwent the RISAS procedure and ALND. The identification rate of the RISAS procedure was 98.2% (223 of 227). The identification rates of SLNB and MARI were 86.4% (197 of 228) and 94.1% (224 of 238), respectively. FNR of the RISAS procedure was 3.5% (5 of 144; 90% CI, 1.38-7.16), and NPV was 92.8% (64 of 69; 90% CI, 85.37-97.10), compared with an FNR of 17.9% (22 of 123; 90% CI, 12.4%-24.5%) and NPV of 72.8% (59 of 81; 90% CI, 63.5%-80.8%) for SLNB and an FNR of 7.0% (10 of 143; 90% CI, 3.8%-11.6%) and NPV of 86.3% (63 of 73; 90% CI, 77.9%-92.4%) for the MARI procedure. In a subgroup of 174 patients in whom SLNB and the MARI procedure were successful and ALND was performed, FNR of the RISAS procedure was 2.5% (3 of 118; 90% CI, 0.7%-6.4%), compared with 18.6% (22 of 118; 90% CI, 13.0%-25.5%) for SLNB (< .001) and 6.8% (8 of 118; 90% CI, 3.4%-11.9%) for the MARI procedure (= .03).

Conclusions and Relevance

Results of this diagnostic study suggest that the RISAS procedure was the most feasible and accurate less-invasive procedure for axillary staging after NAC in patients with cN+ breast cancer.

## Full text

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## Cita

Simons JM et al. (RISAS Study Group, Netherlands). Diagnostic Accuracy of Radioactive Iodine Seed Placement in the Axilla With Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Node-Positive Breast Cancer. *JAMA Surgery*. 2022. PMID: 36069889. PMCID: PMC9453629. DOI: [10.1001/jamasurg.2022.3907](https://doi.org/10.1001/jamasurg.2022.3907)
