Avoiding Axillary Sentinel Lymph Node Biopsy after Neoadjuvant Systemic Therapy in Breast Cancer: Rationale for the Prospective, Multicentric EUBREAST-01 Trial

Cancers - Tập 12 Số 12 - Trang 3698
Toralf Reimer1, Äenne Glass2, Edoardo Botteri3, Sibylle Loibl4, Oreste ­Gentilini5
1Department of Obstetrics and Gynecology, University of Rostock, 18055 Rostock, Germany
2Institute of Biostatistics, University of Rostock, 18055 Rostock, Germany
3Department of Research, Cancer Registry of Norway, 0304 Oslo, Norway
4German Breast Group, 63236 Neu-Isenburg, Germany
5Breast Surgery Unit, San Raffaele University and Research Hospital, 20132 Milan, Italy

Tóm tắt

Currently, axillary surgery for breast cancer is considered only as staging procedure, since the risk of developing metastasis depends on the biological behavior of the primary. The postsurgical therapy should be considered on the basis of biologic tumor characteristics rather than nodal involvement. Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to de-escalate surgery in patients who have a pCR. European Breast Cancer Research Association of Surgical Trialists (EUBREAST)-01 is a clinical trial in which only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) will be included and type of surgery will be defined according to the response to NAST rather than on the classical T (for tumor size in the breast) and N (for axillary lymph node involvement) status. In the discussed trial, axillary surgery will be eliminated completely (no axillary sentinel lymph node biopsy) for initially clinical node-negative (cN0) patients with radiologic complete remission and a breast pCR in the lumpectomy specimen. The trial design is a multicenter single-arm study with a limited number of patients (n = 267), which might give practice-changing results in a short period of time, sparing the time and the costs of a randomized comparison.

Từ khóa


Tài liệu tham khảo

Schwartz, 2002, Proceeding of the consensus conference of the role of sentinel lymph node biopsy in carcinoma or the breast April 19–22, 2001, Philadelphia, PA, USA, Breast J., 8, 124, 10.1046/j.1524-4741.2002.08315.x

Lyman, 2005, American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer, J. Clin. Oncol., 23, 7703, 10.1200/JCO.2005.08.001

Krag, 2010, 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., 11, 927, 10.1016/S1470-2045(10)70207-2

Wascher, 2008, Long-term morbidity of sentinel node biopsy versus complete axillary dissection for unilateral breast cancer, Ann. Surg. Oncol., 15, 1996, 10.1245/s10434-008-9909-y

Masuda, 2017, Adjuvant capecitabine for breast cancer after preoperative chemotherapy, N. Engl. J. Med., 376, 2147, 10.1056/NEJMoa1612645

Huang, 2019, Trastuzumab emtansine for residual invasive HER2-positive breast cancer, N. Engl. J. Med., 380, 617, 10.1056/NEJMoa1814017

Curigliano, 2017, De-escalating and escalating treatments for early-stage breast cancer: The St. Gallen International Expert Consensus Conference on the primary therapy of early breast cancer 2017, Ann. Oncol., 28, 1700, 10.1093/annonc/mdx308

Lyman, 2014, Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update, J. Clin. Oncol., 32, 1365, 10.1200/JCO.2013.54.1177

(2020, October 30). Interdisciplinary German S3-Guideline for Screening, Diagnosis, Therapy and Follow-up in Breast Cancer. Version 4.0, December 2017, AWMF Registry Number 032-045OL. Available online: www.awmf.org.

Pilewskie, 2017, Axillary nodal management following neoadjuvant chemotherapy: A review, JAMA Oncol., 3, 549, 10.1001/jamaoncol.2016.4163

Hunt, 2009, Sentinel lymph node surgery after neoadjuvant chemotherapy is accurate and reduces the need for axillary dissection in breast cancer patients, Ann. Surg., 250, 558, 10.1097/SLA.0b013e3181b8fd5e

Mamounas, 2012, Predictors of locoregional recurrence after neoadjuvant chemotherapy: Results from combined analysis of National Surgical Adjuvant Breast and Bowel Project B-18 and B-27, J. Clin. Oncol., 30, 3960, 10.1200/JCO.2011.40.8369

Morrow, 2017, Leveraging the benefits of systemic therapy to tailor surgery, JAMA Surg., 152, 671, 10.1001/jamasurg.2017.0565

Tadros, 2017, Identification of patients with documented pathologic complete response in the breast after neoadjuvant chemotherapy for omission of axillary surgery, JAMA Surg., 152, 665, 10.1001/jamasurg.2017.0562

Houssami, 2012, Meta-analysis of the association of breast cancer subtype and pathologic complete response to neoadjuvant chemotherapy, Eur. J. Cancer, 48, 3342, 10.1016/j.ejca.2012.05.023

Van der Noordaa, M.E.M., van Duijnhoven, F.H., Cuijpers, F.N.E., van Werkhoven, E., Wiersma, T.G., Elkhuizen, P.H.M., Winter-Warnars, G., Dezentje, V., Sonke, G.S., and Groen, E.J. (2020). Toward omitting sentinel lymph node biopsy after neoadjuvant chemotherapy in patients with clinically node-negative breast cancer. Br. J. Surg.

Barron, 2018, Association of low nodal positivity rate among patients with erbB2-positive or triple-negative breast cancer and breast pathologic complete response to neoadjuvant chemotherapy, JAMA Surg., 153, 1120, 10.1001/jamasurg.2018.2696

Samiei, 2020, Correlation between pathologic complete response in the breast and absence of axillary lymph node metastases after neoadjuvant systemic therapy, Ann. Surg., 271, 574, 10.1097/SLA.0000000000003126

Tolaney, 2015, Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer, N. Engl. J. Med., 372, 134, 10.1056/NEJMoa1406281

Qiu, 2011, Sentinel lymph node biopsy in early breast cancer, Breast Care, 6, 185, 10.1159/000329193

Kuehn, 2005, A concept for the clinical implementation of sentinel lymph node biopsy in patients with breast carcinoma with special regard to quality assurance, Cancer, 103, 451, 10.1002/cncr.20786

(2020, October 30). Guidelines of the AGO Breast Committee, Version 2020.1. Available online: http://www.ago-online.de/leitlinien-empfehlungen/leitlinien-empfehlungen/kommission-mamma.

Fowler, 2017, Imaging neoadjuvant therapy response in breast cancer, Radiology, 285, 358, 10.1148/radiol.2017170180

Nishino, 2009, New response evaluation criteria in solid tumors: Revised RECIST guideline (version 1.1), Eur. J. Cancer, 45, 228, 10.1016/j.ejca.2008.10.026

Yuan, 2010, Accuracy of MRI in prediction of pathologic complete remission in breast cancer after preoperative therapy: A meta-analysis, Am. J. Radiol., 195, 260

Semiglazov, 2015, RECIST for response (clinical and imaging) in neoadjuvant clinical trials in operable breast cancer, J. Natl. Cancer Inst. Monogr., 2015, 21, 10.1093/jncimonographs/lgv021

NCCN (National Comprehensive Cancer Network) (2020, October 30). NCCN Practice Guidelines in Oncology: Breast Cancer. Available online: http://www.nccn.org.

Untch, 2012, Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes, J. Clin. Oncol., 30, 1796, 10.1200/JCO.2011.38.8595

Stachs, A., Göde, K., Hartmann, S., Stengel, B., Nierling, U., Dieterich, M., Reimer, T., and Gerber, B. (2013). Accuracy of axillary ultrasound in preoperative nodal staging of breast cancer—Size of metastases as limiting factor. Springerplus, 2.

Bossuyt, 2015, Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration, Ann. Oncol., 26, 1280, 10.1093/annonc/mdv161

Sedlmayer, 2013, DEGRO practical guidelines: Radiotherapy of breast cancer, I. Strahlenther Onkol., 189, 825, 10.1007/s00066-013-0437-8

Haviland, 2013, The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up result of two randomised controlled trials, Lancet Oncol., 14, 1086, 10.1016/S1470-2045(13)70386-3

Haviland, 2020, Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects from a multicenter, non-inferiority, randomized, phase 3 trial, Lancet, 395, 1613, 10.1016/S0140-6736(20)30932-6

Sedlmayer, 2013, Is the simultaneously integrated boost (SIB) technique for early breast cancer ready to be adopted for routine adjuvant radiotherapy?, Strahlenther Onkol., 189, 193, 10.1007/s00066-012-0300-3

Agresti, 2014, Axillary lymph node dissection versus no dissection in patients with T1N0 breast cancer: A randomized clinical trial (INT09/98), Cancer, 120, 885, 10.1002/cncr.28499

Nogi, 2017, Long-term follow-up of node-negative breast cancer patients evaluated via sentinel node biopsy after neoadjuvant chemotherapy, Clin. Breast Cancer, 17, 644, 10.1016/j.clbc.2017.05.002

Galimberti, 2016, Sentinel node biopsy after neoadjuvant treatment in breast cancer: Five-year follow-up of patients with clinically node-negative or node-positive disease before treatment, Eur. J. Surg. Oncol., 42, 361, 10.1016/j.ejso.2015.11.019

Weaver, 2011, Effect of occult metastases on survival in node-negative breast cancer, N. Engl. J. Med., 364, 412, 10.1056/NEJMoa1008108

Frisell, 2017, Ten-year report on axillary recurrence after negative sentinel node biopsy for breast cancer from the Swedish multicentre cohort study, Br. J. Surg., 104, 238, 10.1002/bjs.10411