TY - JOUR
T1 - A Novel Less-invasive Approach for Axillary Staging After Neoadjuvant Chemotherapy in Patients With Axillary Node-positive Breast Cancer by Combining Radioactive Iodine Seed Localization in the Axilla With the Sentinel Node Procedure (RISAS)
T2 - A Dutch Prospective Multicenter Validation Study
AU - van Nijnatten, Thiemo J A
AU - Simons, Janine M
AU - Smidt, Marjolein L
AU - van der Pol, Carmen C
AU - van Diest, Paul J
AU - Jager, Agnes
AU - van Klaveren, David
AU - Kam, Boen L R
AU - Lobbes, Marc B I
AU - de Boer, Maaike
AU - Verhoef, Kees
AU - Koppert, Linetta B
AU - Luiten, Ernest J T
N1 - Funding Information:
The present study received grant support from the Alpe d'Huzes/Dutch Cancer Society (KWF Kankerbestrijding) fund (grant AZB 2015-8023).
Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2017/8
Y1 - 2017/8
N2 - Background: In 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 Methods: In 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. Conclusion: The 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.
AB - Background: In 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 Methods: In 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. Conclusion: The 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.
KW - 125I
KW - Axillary lymph node dissection
KW - CN
KW - NAC
KW - Sentinel lymph node biopsy
UR - http://www.scopus.com/inward/record.url?scp=85018415899&partnerID=8YFLogxK
U2 - 10.1016/j.clbc.2017.04.006
DO - 10.1016/j.clbc.2017.04.006
M3 - Article
C2 - 28487053
AN - SCOPUS:85018415899
SN - 1526-8209
VL - 17
SP - 399
EP - 402
JO - Clinical breast cancer
JF - Clinical breast cancer
IS - 5
ER -