BACKGROUND: Targeted axillary dissection (TAD) is an established method for axillary staging in patients with breast cancer after neoadjuvant chemotherapy (NAC). TAD consists of sentinel lymph node biopsy and initially pathological lymph node excision, which must be marked by a reliable marker before NAC. METHODS: The IMTAD study is a prospective multicentre trial comparing three localisation markers for lymph node localisation (clip + iodine seed, magnetic seed, carbon suspension) facilitating subsequent surgical excision in the form of TAD. The primary outcome was to prospectively compare the reliability, accuracy, and safety according to complication rate during marker implantation and detection and marker dislodgement. RESULTS: One hundred eighty-nine patients were included in the study-in 135 patients clip + iodine seed was used, in 30 patients magnetic seed and in 24 patients carbon suspension. The complication rate during the marker implantation and detection were not statistically significant between individual markers (p = 0.263; p = 0.117). Marker dislodgement was reported in 4 patients with clip + iodine seed localisation (3.0%), dislodgement did not occur in other localisation methods (p = 0.999). The false-negativity of sentinel lymph node (SLN) was observed in 8 patients, the false-negativity of targeted lymph nodes (TLN) wasn´t observed at all, the false-negativity rate (FNR) from the subcohort of ypN + patients for SLN is 9.6% and for TLN 0.0%. CONCLUSION: The IMTAD study indicated, that clip + iodine seed, magnetic seed and carbon suspension are statistically comparable in terms of complications during marker implantation and detection and marker dislodgement proving their safety, accuracy, and reliability in TAD. The study confirmed, that the FNR of the TLN was lower than the FNR of the SLN proving that the TLN is a better marker for axillary lymph node status after NAC. TRIAL REGISTRATION: NCT04580251. Name of registry: Clinicaltrials.gov. Date of registration: 8.10.2020.

Department of Surgery EUC Clinic Zlín Zlín Czech Republic

Department of Surgery Silesian Hospital in Opava Opava Czech Republic

Department of Surgery University Hospital Ostrava Ostrava Czech Republic

Department of Surgical Oncology Faculty of Medicine Masaryk University Brno Czech Republic

Department of Surgical Oncology Masaryk Memorial Cancer Institute Brno Czech Republic

Department of Surgical Studies Faculty of Medicine University of Ostrava Ostrava Czech Republic

Faculty of Public Policies The Institute of Paramedical Health Studies Silesian University Opava Czech Republic

Oncogynecology Centre The Institute for the Care of Mother and Child Prague Czech Republic

Tomáš Baťa University in Zlín Zlín Czech Republic

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Axillary Overtreatment in Patients with Breast Cancer After Neoadjuvant Chemotherapy in the Current Era of Targeted Axillary Dissection

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ClinicalTrials.gov
NCT04580251