Top

Published in:

01-01-2019 | Clinical trial

Sentinel lymph node biopsy without axillary lymphadenectomy after neoadjuvant chemotherapy is accurate and safe for selected patients: the GANEA 2 study

Authors: Jean-Marc Classe, Cecile Loaec, P. Gimbergues, S. Alran, C. Tunon de Lara, P. F. Dupre, Roman Rouzier, C. Faure, N. Paillocher, M. P. Chauvet, G. Houvenaeghel, M. Gutowski, P. De Blay, J. L. Verhaeghe, E. Barranger, C. Lefebvre, C. Ngo, G. Ferron, C. Palpacuer, L. Campion

Published in: Breast Cancer Research and Treatment | Issue 2/2019

Abstract

Purpose

GANEA2 study was designed to assess accuracy and safety of sentinel lymph node (SLN) after neo-adjuvant chemotherapy (NAC) in breast cancer patients.

Methods

Early breast cancer patients treated with NAC were included. Before NAC, patients with cytologically proven node involvement were allocated into the pN1 group, other patient were allocated into the cN0 group. After NAC, pN1 group patients underwent SLN and axillary lymph node dissection (ALND); cN0 group patients underwent SLN and ALND only in case of mapping failure or SLN involvement. The main endpoint was SLN false negative rate (FNR). Secondary endpoints were predictive factors for remaining positive ALND and survival of patients treated with SLN alone.

Results

From 2010 to 2014, 957 patients were included. Among the 419 patients from the cN0 group treated with SLN alone, one axillary relapse occurred during the follow-up. Among pN1 group patients, with successful mapping, 103 had a negative SLN. The FNR was 11.9% (95% CI 7.3–17.9%). Multivariate analysis showed that residual breast tumor size after NAC ≥ 5 mm and lympho-vascular invasion remained independent predictors for involved ALND. For patients with initially involved node, with negative SLN after NAC, no lympho-vascular invasion and a remaining breast tumor size 5 mm, the risk of a positive ALND is 3.7% regardless the number of SLN removed.

Conclusion

In patients with no initial node involvement, negative SLN after NAC allows to safely avoid an ALND. Residual breast tumor and lympho-vascular invasion after NAC allow identifying patients with initially involved node with a low risk of ALND involvement.

Available only for authorised users

Krag D, Weaver D, Ashikaga T et al (1998) The sentinel node in breast cancer: a multicenter validation study. N Engl J Med 339:941–946. https://doi.org/10.1056/NEJM199810013391401 CrossRefPubMed

Mansel RE, Fallowfield L, Kissin M et al (2006) Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. J Natl Cancer Inst 98:599–609. https://doi.org/10.1093/jnci/djj158 CrossRefPubMed

Bear HD, Anderson S, Brown A et al (2003) The effect on tumour response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 21:4165–4174. https://doi.org/10.1200/JCO.2003.12.005 CrossRefPubMed

Shen J, Gilcrease MZ, Babiera GV et al (2007) Feasibility and accuracy of sentinel lymph node biopsy after preoperative chemotherapy in breast cancer patients with documented axillary metastases. Cancer 109:1255–1263. https://doi.org/10.1002/cncr.22540 CrossRefPubMed

Hennessy BT, Hortobagyi GN, Rouzier R et al (2005) Outcome after pathologic complete eradication of cytologically proven breast cancer axillary node metastases following primary chemotherapy. J Clin Oncol 23:9304–9311. https://doi.org/10.1200/JCO.2005.02.5023 CrossRefPubMed

Boughey JC, Suman VJ, Mittendorf EA et al (2013) Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA 310:1455–1461. https://doi.org/10.1001/jama.2013.278932 CrossRefPubMedPubMedCentral

Gianni L, Pienkowski T, Im YH et al (2012) Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol 13(1):25–32. https://doi.org/10.1016/S1470-2045(11)70336-9 CrossRefPubMed

Fisher ER, Wang J, Bryant J et al (2002) Pathobiology of preoperative chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel (NSABP) protocol B-18. Cancer 95:681–695. https://doi.org/10.1002/cncr.10741 CrossRefPubMed

Xing Y, Foy M, Cox DD et al (2006) Meta-analysis of sentinel lymph node biopsy after preoperative chemotherapy in patients with breast cancer. Br J Surg 93:539–546. https://doi.org/10.1002/bjs.5209 CrossRefPubMed

10.

Mamounas EP, Brown A, Anderson S et al (2005) Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 23:2694–2702. https://doi.org/10.1200/JCO.2005.05.188 CrossRefPubMed

11.

El Hage Chehade H, Headon H, Kasem A, Mokbel K (2016) Refining the performance of sentinel lymph node biopsy post-neoadjuvant chemotherapy in patients with pathologically proven pre-treatment node-positive breast cancer: an update for clinical practice. Anticancer Res 36:1461–1471PubMed

12.

Valachis A, Mamounas EP, Mittendorf EA et al (2018) Risk factors for locoregional disease recurrence after breast-conserving therapy in patients with breast cancer treated with neoadjuvant chemotherapy: an international collaboration and individual patient meta-analysis: recurrence after neoadjuvant chemotherapy. Cancer. https://doi.org/10.1002/cncr.31518 PubMedCrossRef

13.

Lyman GH, Temin S, Edge SB et al (2014) Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 32:1365–1383. https://doi.org/10.1200/JCO.2013.54.1177 CrossRefPubMed

14.

Lyman GH, Somerfield MR, Bosserman LD et al (2017) Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology Clinical practice guideline update. J Clin Oncol 35:561–564. https://doi.org/10.1200/JCO.2016.71.0947 CrossRefPubMed

15.

Curigliano G, Burstein HJ, Winer EP et al (2018) 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. https://doi.org/10.1093/annonc/mdx806 CrossRefPubMedPubMedCentral

16.

Krag DN, Anderson SJ, Julian TB et al (2007) 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 8:881–888. https://doi.org/10.1016/S1470-2045(07)70278-4 CrossRefPubMed

17.

McCready DR, Yong WS, Ng AKT et al (2004) Influence of the new AJCC breast cancer staging system on sentinel lymph node positivity and false-negative rates. J Natl Cancer Inst 96:873–875CrossRefPubMed

18.

Classe J-M, Bordes V, Campion L et al (2009) Sentinel lymph node biopsy after neoadjuvant chemotherapy for advanced breast cancer: results of Ganglion Sentinelle et Chimiotherapie Neoadjuvante, a French prospective multicentric study. J Clin Oncol 27:726–732. https://doi.org/10.1200/JCO.2008.18.3228 CrossRefPubMed

19.

Nogi H, Uchida K, Mimoto R et al (2017) Long-term follow-up of node-negative breast cancer patients evaluated via sentinel node biopsy after neoadjuvant chemotherapy. Clin Breast Cancer 17:644–649. https://doi.org/10.1016/j.clbc.2017.05.002 CrossRefPubMed

20.

Kuehn T, Bauerfeind I, Fehm T et al (2013) Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol 14:609–618. https://doi.org/10.1016/S1470-2045(13)70166-9 CrossRefPubMed

21.

Boileau J-F, Poirier B, Basik M et al (2015) Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol 33:258–264. https://doi.org/10.1200/JCO.2014.55.7827 CrossRefPubMed

22.

Fu J-F, Chen H-L, Yang J et al (2014) Feasibility and accuracy of sentinel lymph node biopsy in clinically node-positive breast cancer after neoadjuvant chemotherapy: a meta-analysis. PLoS ONE 9:e105316. https://doi.org/10.1371/journal.pone.0105316 CrossRefPubMedPubMedCentral

23.

Tadros AB, Yang WT, Krishnamurthy S et al (2017) Identification of patients with documented pathologic complete response in the breast after neoadjuvant chemotherapy for omission of axillary surgery. JAMA Surg 152:665. https://doi.org/10.1001/jamasurg.2017.0562 CrossRefPubMedPubMedCentral

24.

Schipper R-J, Moossdorff M, Nelemans PJ et al (2014) A model to predict pathologic complete response of axillary lymph nodes to neoadjuvant chemo(immuno)therapy in patients with clinically node-positive breast cancer. Clin Breast Cancer 14:315–322. https://doi.org/10.1016/j.clbc.2013.12.015 CrossRefPubMed

25.

Vila J, Mittendorf EA, Farante G et al (2016) Nomograms for predicting axillary response to neoadjuvant chemotherapy in clinically node-positive patients with breast cancer. Ann Surg Oncol 23:3501–3509. https://doi.org/10.1245/s10434-016-5277-1 CrossRefPubMed

26.

Jeruss JS, Newman LA, Ayers GD et al (2008) Factors predicting additional disease in the axilla in patients with positive sentinel lymph nodes after neoadjuvant chemotherapy. Cancer 112:2646–2654. https://doi.org/10.1002/cncr.23481 CrossRefPubMedPubMedCentral

27.

Caudle AS, Yang WT, Krishnamurthy S et al (2016) 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 34:1072–1078. https://doi.org/10.1200/JCO.2015.64.0094 CrossRefPubMedPubMedCentral

28.

Donker M, Straver ME, Wesseling J et al (2015) Marking axillary lymph nodes with radioactive iodine seeds for axillary staging after neoadjuvant systemic treatment in breast cancer patients: the MARI procedure. Ann Surg 261:378–382. https://doi.org/10.1097/SLA.0000000000000558 CrossRefPubMed

29.

Choy N, Lipson J, Porter C et al (2015) Initial results with preoperative tattooing of biopsied axillary lymph nodes and correlation to sentinel lymph nodes in breast cancer patients. Ann Surg Oncol 22:377–382. https://doi.org/10.1245/s10434-014-4034-6 CrossRefPubMed

Title: Sentinel lymph node biopsy without axillary lymphadenectomy after neoadjuvant chemotherapy is accurate and safe for selected patients: the GANEA 2 study
Authors: Jean-Marc Classe
Cecile Loaec
P. Gimbergues
S. Alran
C. Tunon de Lara
P. F. Dupre
Roman Rouzier
C. Faure
N. Paillocher
M. P. Chauvet
G. Houvenaeghel
M. Gutowski
P. De Blay
J. L. Verhaeghe
E. Barranger
C. Lefebvre
C. Ngo
G. Ferron
C. Palpacuer
L. Campion
Publication date: 01-01-2019
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 2/2019
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-018-5004-7

Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras

Prof. Fabrice Barlesi

Developed by: Springer Medicine

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 2/2019

Multivariate machine learning models for prediction of pathologic response to neoadjuvant therapy in breast cancer using MRI features: a study using an independent validation set

Which patients with sentinel node-positive breast cancer after breast conservation still receive completion axillary lymph node dissection in routine clinical practice?

A randomized trial of interpersonal psychotherapy, problem solving therapy, and supportive therapy for major depressive disorder in women with breast cancer

Improving the competency of medical students in clinical breast examination through a standardized simulation and multimedia-based curriculum

Surgical trends in breast cancer: a rise in novel operative treatment options over a 12 year analysis

Breast conservation versus mastectomy in patients with T3 breast cancers (> 5 cm): an analysis of 37,268 patients from the National Cancer Database

Keynote webinar | Spotlight on antibody–drug conjugates in cancer