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.
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Acknowledgements
We received financial support from the French National Institute of Oncology (National Program for Hospital Clinical Research 2009, INCA) (Grant No. NCT01221688). We thank Valerie Pacteau (Clinical project manager, Institut de Cancerologie de l’Ouest Gauducheau), Camille Berneur (data manager, Institut de Cancerologie de l’Ouest Gauducheau), Wilfried Blot and Emilie Debeaupuis (Clinical research associates, Institut de Cancerologie de l’Ouest Gauducheau) for study support and Adrian Chess and Bryce Van Denderen (Ecomod, UK) for English revision.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Classe, JM., Loaec, C., Gimbergues, P. et al. Sentinel lymph node biopsy without axillary lymphadenectomy after neoadjuvant chemotherapy is accurate and safe for selected patients: the GANEA 2 study. Breast Cancer Res Treat 173, 343–352 (2019). https://doi.org/10.1007/s10549-018-5004-7
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DOI: https://doi.org/10.1007/s10549-018-5004-7