• Thiemo J A van Nijnatten, Janine M Simons, Marjolein L Smidt, Carmen C van der Pol, Paul J van Diest, Agnes Jager, David van Klaveren, Boen L R Kam, Marc B I Lobbes, Maaike de Boer, Kees Verhoef, Linetta B Koppert, and Luiten Ernest J T EJT Department of Surgery, Amphia Hospital Breda, Breda, The Netherlands. Electronic address: eluiten@amphia.nl..
• Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands; Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.
• Clin. Breast Cancer. 2017 Aug 1; 17 (5): 399-402.

BackgroundIn 1 of 3 patients with initial lymph node-positive (cN+) breast cancer, neoadjuvant chemotherapy (NAC) results in an axillary pathologic complete response (ax-pCR). This urges the need for a less-invasive axillary staging method. Recently introduced less-invasive procedures have been insufficient in accurately identifying ax-pCR. Therefore, we propose a novel less-invasive axillary staging procedure: the Radioactive Iodine Seed localization in the Axilla with the Sentinel node procedure (RISAS), a combination of the procedure of marking axillary lymph nodes with radioactive iodine seeds (MARI) and sentinel lymph node biopsy (SLNB).Patients And MethodsIn the present open single-arm multicenter validation study, 225 cN+ (biopsy-proven) patients will undergo the RISAS procedure, in which a positive lymph node is marked by an iodine-125 seed before NAC. After NAC completion, this iodine-125 seed-marked lymph node is removed, together with any additional sentinel lymph nodes. The RISAS procedure is subsequently followed by completion axillary lymph node dissection (ALND). The RISAS lymph nodes will be compared with the lymph nodes from the completion ALND specimen. The primary endpoint is accuracy of the RISAS procedure. The identification rate, false-negative rate, negative predictive value, and possible concordance between the MARI and SLNB will be reported.ConclusionThe present prospective multicenter RISAS trial will enable us to validate the combination of MARI and SLNB for assessing the axillary response to NAC in cN+ patients. If RISAS proves to be an accurate axillary staging procedure, ALND could safely be abandoned in the case of ax-pCR confirmed using the RISAS procedure.Copyright © 2017 Elsevier Inc. All rights reserved.

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