Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer: Prospective Cohort Study Within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).

التفاصيل البيبلوغرافية
العنوان:	Impact of Imaging-Guided Localization on Performance of Tailored Axillary Surgery in Patients with Clinically Node-Positive Breast Cancer: Prospective Cohort Study Within TAXIS (OPBC-03, SAKK 23/16, IBCSG 57-18, ABCSG-53, GBG 101).
المؤلفون:	Weber WP; Breast Center, University Hospital Basel, Basel, Switzerland. walter.weber@usb.ch.; University of Basel, Basel, Switzerland. walter.weber@usb.ch., Heidinger M; Breast Center, University Hospital Basel, Basel, Switzerland.; University of Basel, Basel, Switzerland., Hayoz S; SAKK Competence Center, Bern, Switzerland., Matrai Z; Department of Oncoplastic Breast Surgery, Hamad Medical Corporation, Doha, Qatar., Tausch C; University of Basel, Basel, Switzerland.; Breast Center Zurich, Zurich, Switzerland., Henke G; Department of Radiation Oncology, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.; Breast Center, St. Gallen Cantonal Hospital, St. Gallen, Switzerland., Zwahlen DR; Department of Radiation Oncology, Cantonal Hospital Winterthur, Winterthur, Switzerland., Gruber G; Institute of Radiotherapy, Klinik Hirslanden, Zurich, Switzerland., Zimmermann F; University of Basel, Basel, Switzerland.; Clinic of Radiation Oncology, University Hospital Basel, Basel, Switzerland., Montagna G; Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Andreozzi M; Breast Center, University Hospital Basel, Basel, Switzerland.; University of Basel, Basel, Switzerland., Goldschmidt M; Breast Center, University Hospital Basel, Basel, Switzerland.; University of Basel, Basel, Switzerland., Schulz A; University of Basel, Basel, Switzerland.; Department of Clinical Research, University Hospital Basel, Basel, Switzerland., Mueller A; SAKK Competence Center, Bern, Switzerland.; Breast Center, Cantonal Hospital Winterthur, Winterthur, Switzerland., Ackerknecht M; University of Basel, Basel, Switzerland.; Department of Biomedicine, University Hospital Basel, Basel, Switzerland., Tampaki EC; Department of Plastic, Reconstructive Surgery and Burn Unit, KAT Athens Hospital and Trauma Center, Athens, Greece., Bjelic-Radisic V; Breast Unit, Helios University Clinic, University Witten/Herdecke, Witten, Germany., Kurzeder C; Breast Center, University Hospital Basel, Basel, Switzerland.; University of Basel, Basel, Switzerland., Sávolt Á; National Institute of Oncology, Budapest, Hungary., Smanykó V; National Tumor Biology Laboratory, National Institute of Oncology, Budapest, Hungary., Hagen D; Breast Center, Cantonal Hospital Winterthur, Winterthur, Switzerland., Müller DJ; Bethesda Spital AG, Basel, Switzerland., Gnant M; Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.; ABCSG, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria., Loibl S; German Breast Group, GBG Forschungs GmbH, Neu-Isenburg, Germany., Fitzal F; ABCSG, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.; Atomos Klinik Waehring, Vienna, Austria., Markellou P; Breast Center, St. Gallen Cantonal Hospital, St. Gallen, Switzerland., Bekes I; Breast Center, St. Gallen Cantonal Hospital, St. Gallen, Switzerland., Egle D; ABCSG, Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.; Breast Cancer Center Tirol, Department of Gynecology, Medical University Innsbruck, Innsbruck, Austria., Heil J; Breast Center Heidelberg, Heidelberg, Germany., Knauer M; Tumor and Breast Center Eastern Switzerland, St. Gallen, Switzerland.
المصدر:	Annals of surgical oncology [Ann Surg Oncol] 2024 Jan; Vol. 31 (1), pp. 344-355. Date of Electronic Publication: 2023 Oct 30.
نوع المنشور:	Randomized Controlled Trial; Clinical Trial, Phase III; Observational Study; Journal Article
اللغة:	English
بيانات الدورية:	Publisher: Springer Country of Publication: United States NLM ID: 9420840 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1534-4681 (Electronic) Linking ISSN: 10689265 NLM ISO Abbreviation: Ann Surg Oncol Subsets: MEDLINE
أسماء مطبوعة:	Publication: 2005- : New York, NY : Springer Original Publication: New York, NY : Raven Press, c1994-
مواضيع طبية MeSH:	Breast Neoplasms/diagnostic imaging , Breast Neoplasms/surgery , Breast Neoplasms*/pathology, Humans ; Female ; Sentinel Lymph Node Biopsy/methods ; Prospective Studies ; Lymphatic Metastasis/pathology ; Lymph Node Excision/methods ; Neoadjuvant Therapy ; Axilla/pathology ; Lymph Nodes/surgery ; Lymph Nodes/pathology
مستخلص:	Background: Tailored axillary surgery (TAS) is a novel surgical concept for clinical node-positive breast cancer. It consists of the removal of the sentinel lymph nodes (LNs), as well as palpably suspicious nodes. The TAS technique can be utilized in both the upfront and neoadjuvant chemotherapy (NACT) setting. This study assessed whether/how imaging-guided localization (IGL) influenced TAS. Patients and Methods: This was a prospective observational cohort study preplanned in the randomized phase-III OPBC-03/TAXIS trial. IGL was performed at the surgeon's discretion for targeted removal of LNs during TAS. Immediate back-up axillary lymph node dissection (ALND) followed TAS according to TAXIS randomization. Results: Five-hundred patients were included from 44 breast centers in six countries, 151 (30.2%) of whom underwent NACT. IGL was performed in 84.4% of all patients, with significant variation by country (77.6-100%, p < 0.001). No difference in the median number of removed (5 vs. 4, p = 0.3) and positive (2 vs. 2, p = 0.6) LNs by use of IGL was noted. The number of LNs removed during TAS with IGL remained stable over time (p = 0.8), but decreased significantly without IGL, from six (IQR 4-6) in 2019 to four (IQR 3-4) in 2022 (p = 0.015). An ALND was performed in 249 patients, removing another 12 (IQR 9-17) LNs, in which a median number of 1 (IQR 0-4) was positive. There was no significant difference in residual nodal disease after TAS with or without IGL (68.0% vs. 57.6%, p = 0.2). Conclusions: IGL did not significantly change either the performance of TAS or the volume of residual nodal tumor burden. Trial Registration: ClinicalTrials.gov Identifier: NCT03513614. (© 2023. The Author(s).)
التعليقات:	Comment in: Ann Surg Oncol. 2024 Feb;31(2):1001-1002. (PMID: 38038789)
References:	Krag DN, Anderson SJ, Julian TB, et al. Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. Lancet Oncol. 2007;8(10):881–8. https://doi.org/10.1016/S1470-2045(07)70278-4 . (PMID: 10.1016/S1470-2045(07)70278-417851130) Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol. 2010;11(10):927–33. https://doi.org/10.1016/S1470-2045(10)70207-2 . (PMID: 10.1016/S1470-2045(10)70207-2208637593041644) Veronesi U, Paganelli G, Viale G, et al. A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med. 2003;349(6):546–53. https://doi.org/10.1056/NEJMoa012782 . (PMID: 10.1056/NEJMoa01278212904519) Galimberti V, Cole BF, Viale G, et al. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(10):1385–93. https://doi.org/10.1016/S1470-2045(18)30380-2 . (PMID: 10.1016/S1470-2045(18)30380-230196031) Donker M, van Tienhoven G, Straver ME, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981–22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014;15(12):1303–10. https://doi.org/10.1016/S1470-2045(14)70460-7 . (PMID: 10.1016/S1470-2045(14)70460-7254396884291166) Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA - J Am Med Assoc. 2017;318(10):918–26. https://doi.org/10.1001/jama.2017.11470 . (PMID: 10.1001/jama.2017.11470) Boughey JC, Suman VJ, Mittendorf EA, et al. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (alliance) clinical trial. JAMA - J Am Med Assoc. 2013;310(14):1455–61. https://doi.org/10.1001/jama.2013.278932 . (PMID: 10.1001/jama.2013.278932) Kuehn T, Bauerfeind I, Fehm T, et al. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol. 2013;14(7):609–18. https://doi.org/10.1016/S1470-2045(13)70166-9 . (PMID: 10.1016/S1470-2045(13)70166-923683750) Boileau JF, Poirier B, Basik M, et al. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol. 2015;33(3):258–63. https://doi.org/10.1200/JCO.2014.55.7827 . (PMID: 10.1200/JCO.2014.55.782725452445) Caudle AS, Yang WT, Krishnamurthy S, et al. Improved axillary evaluation following neoadjuvant therapy for patients with node-positive breast cancer using selective evaluation of clipped nodes: Implementation of targeted axillary dissection. J Clin Oncol. 2016;34(10):1072–8. https://doi.org/10.1200/JCO.2015.64.0094 . (PMID: 10.1200/JCO.2015.64.0094268115284933133) Swarnkar PK, Tayeh S, Michell MJ, Mokbel K. The evolving role of marked lymph node biopsy (Mlnb) and targeted axillary dissection (tad) after neoadjuvant chemotherapy (nact) for node‐positive breast cancer: systematic review and pooled analysis. Cancers (Basel). 2021;13(7). https://doi.org/10.3390/cancers13071539. Banys-Paluchowski M, Gasparri ML, de Boniface J, et al. Surgical management of the axilla in clinically node-positive breast cancer patients converting to clinical node negativity through neoadjuvant chemotherapy: Current status, knowledge gaps, and rationale for the EUBREAST-03 AXSANA study. Cancers (Basel). 2021;13(7). doi: https://doi.org/10.3390/cancers13071565. Kuemmel S, Heil J, Rueland A, et al. A prospective, multicenter registry study to evaluate the clinical feasibility of targeted axillary dissection (TAD) in node-positive breast cancer patients. Ann Surg. 2022;276(5):e553–62. https://doi.org/10.1097/SLA.0000000000004572 . (PMID: 10.1097/SLA.000000000000457233156057) van Nijnatten TJA, Simons JM, Smidt ML, et al. 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): A Dutch prospective multicenter validation study. Clin Breast Cancer. 2017;17(5):399–402. https://doi.org/10.1016/j.clbc.2017.04.006 . (PMID: 10.1016/j.clbc.2017.04.00628487053) Simons J, JA v Nijnatten T, Koppert LB, et al. Abstract GS1-10: Radioactive iodine seed placement in the axilla with sentinel lymph node biopsy after neoadjuvant chemotherapy in breast cancer: Results of the prospective multicenter RISAS trial. Cancer Res. 2021;81(4_Supplement):GS1-10-GS1-10. https://doi.org/10.1158/1538-7445.sabcs20-gs1-10. Hartmann S, Kühn T, de Boniface J, et al. Carbon tattooing for targeted lymph node biopsy after primary systemic therapy in breast cancer: prospective multicentre TATTOO trial. Br J Surg. 2021;108(3):302–7. https://doi.org/10.1093/bjs/znaa083 . (PMID: 10.1093/bjs/znaa08333793745) van der Noordaa MEM, van Duijnhoven FH, Straver ME, et al. Major reduction in axillary lymph node dissections after neoadjuvant systemic therapy for node-positive breast cancer by combining PET/CT and the MARI procedure. Ann Surg Oncol. 2018;25(6):1512–20. https://doi.org/10.1245/s10434-018-6404-y . (PMID: 10.1245/s10434-018-6404-y29511992) Burstein HJ, Curigliano G, Thürlimann B, et al. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Ann Oncol. 2021;32(10):1216-1235. https://doi.org/10.1016/j.annonc.2021.06.023. Gradishar WJ, Moran MS, Abraham J, et al. Breast Cancer, Version 3.2022, NCCN clinical practice guidelines in oncology. J Natl Compr Cancer Netw. 2022;20(6):691–722. https://doi.org/10.6004/jnccn.2022.0030. Henke G, Knauer M, Ribi K, et al. Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial. Trials. 2018;19:667. https://doi.org/10.1186/s13063-018-3021-9 . (PMID: 10.1186/s13063-018-3021-9305143626278139) Weber WP, Matrai Z, Hayoz S, et al. Tailored axillary surgery in patients with clinically node-positive breast cancer: pre-planned feasibility substudy of TAXIS (OPBC-03, SAKK 23/16, IBCSG 57–18, ABCSG-53, GBG 101). Breast. 2021;60:98–110. https://doi.org/10.1016/j.breast.2021.09.004 . (PMID: 10.1016/j.breast.2021.09.004345556768463904) Kuemmel S, Heil J, Bruzas S, et al. Safety of targeted axillary dissection after neoadjuvant therapy in patients with node-positive breast cancer. JAMA Surg. 2023. https://doi.org/10.1001/jamasurg.2023.1772 . (PMID: 10.1001/jamasurg.2023.17723746697110357358) Heidinger M, Knauer M, Tausch C, Weber WP. Tailored axillary surgery: a novel concept for clinically node positive breast cancer. Breast. 2023;69:281–9. https://doi.org/10.1016/j.breast.2023.03.005 . (PMID: 10.1016/j.breast.2023.03.0053692230510034500) von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol. 2008;61(4):344–9. https://doi.org/10.1016/j.jclinepi.2007.11.008 . (PMID: 10.1016/j.jclinepi.2007.11.008) Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147. https://doi.org/10.1136/bmj.h2147 . (PMID: 10.1136/bmj.h214725956159) Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375(5):454–63. https://doi.org/10.1056/NEJMra1510059 . (PMID: 10.1056/NEJMra151005927518663) Brierley JD, Gospodarowicz MK, Wittekind C. TNM Classification of malignant tumours—8th Edition.; 2016.ISBN: 978-1-119-26357-9. Crown A, Sevilimedu V, Morrow M. Palpable adenopathy does not indicate high-volume axillary nodal disease in hormone receptor-positive breast cancer. Ann Surg Oncol. 2021;28(11):6060–8. https://doi.org/10.1245/s10434-021-09943-7 . (PMID: 10.1245/s10434-021-09943-733876360) Angarita S, Ye L, Rünger D, et al. Assessing the burden of nodal disease for breast cancer patients with clinically positive nodes: Hope for more limited axillary surgery. Ann Surg Oncol. 2021;28(5):2609–18. https://doi.org/10.1245/s10434-020-09228-5 . (PMID: 10.1245/s10434-020-09228-533084993) Use of sentinel lymph node biopsy in patients with early-stage, palpable node-positive HR+/HER2- breast cancer having upfront surgery and adjuvant radiation. https://clinicaltrials.gov/ct2/show/NCT04854005 . Accessed 5 Jan 2023. Cardoso F, van’t Veer LJ, Bogaerts J, et al. 70-Gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717–29. https://doi.org/10.1056/NEJMoa1602253. Kalinsky K, Barlow WE, Gralow JR, et al. 21-Gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385(25):2336–47. https://doi.org/10.1056/NEJMoa2108873 . (PMID: 10.1056/NEJMoa2108873349143399096864) Almahariq MF, Levitin R, Quinn TJ, et al. Omission of axillary lymph node dissection is associated with inferior survival in breast cancer patients with residual N1 nodal disease following neoadjuvant chemotherapy. Ann Surg Oncol. 2021;28(2):930–40. https://doi.org/10.1245/s10434-020-08928-2 . (PMID: 10.1245/s10434-020-08928-232712895) Kharouta M, Damico N, Harris EE, Lyons JA. Impact of axillary lymph node dissection (ALND) on survival in patients with ypN1 breast cancer that receive regional nodal irradiation (RNI): A national cancer database (NCDB) analysis. J Clin Oncol. 2020;38(15_suppl):572. https://doi.org/10.1200/jco.2020.38.15_suppl.572. Park Y, Shin YS, Kim K, et al. Omission of axillary lymph node dissection in patients with ypN+ breast cancer after neoadjuvant chemotherapy: a retrospective multicenter study (KROG 21–06). Eur J Surg Oncol. 2022. https://doi.org/10.1016/j.ejso.2022.11.099 . (PMID: 10.1016/j.ejso.2022.11.09936470801) van Loevezijn AA, van der Noordaa MEM, Stokkel MPM, et al. Three-year follow-up of de-escalated axillary treatment after neoadjuvant systemic therapy in clinically node-positive breast cancer: the MARI-protocol. Breast Cancer Res Treat. 2022;193(1):37–48. https://doi.org/10.1007/s10549-022-06545-z . (PMID: 10.1007/s10549-022-06545-z352390728993719)
معلومات مُعتمدة:	P30 CA008748 United States CA NCI NIH HHS
فهرسة مساهمة:	Keywords: Axillary dissection; Axillary staging; Breast cancer; Breast surgery; Sentinel lymph node procedure
سلسلة جزيئية:	ClinicalTrials.gov NCT03513614
تواريخ الأحداث:	Date Created: 20231031 Date Completed: 20231207 Latest Revision: 20240423
رمز التحديث:	20240423
مُعرف محوري في PubMed:	PMC10695869
DOI:	10.1245/s10434-023-14404-4
PMID:	37903951
قاعدة البيانات:	MEDLINE

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تدمد:	1534-4681
DOI:	10.1245/s10434-023-14404-4