Jean-Marc Classe1, Cecile Loaec2, P Gimbergues3, S Alran4, C Tunon de Lara5, P F Dupre6, Roman Rouzier4, C Faure7, N Paillocher2, M P Chauvet8, G Houvenaeghel9, M Gutowski10, P De Blay11, J L Verhaeghe12, E Barranger13, C Lefebvre14, C Ngo15, G Ferron16, C Palpacuer17, L Campion17. 1. Department of Surgical Oncology, Institut de Cancerologie de l'ouest, Saint-Herblain, Loire Atlantique, France. jean-marc.classe@ico.unicancer.fr. 2. Department of Surgical Oncology, Institut de Cancerologie de l'ouest, Saint-Herblain, Loire Atlantique, France. 3. Department of Surgical Oncology, Centre Jean Perrin, Clermont-Ferrand, France. 4. Department of Surgical Oncology, Institut Curie, Paris, Saint-cloud, France. 5. Institut Bergonié, Bordeaux, France. 6. Department of Gynecology, Centre Hospitalier Universitaire, Brest, France. 7. Department of Surgical Oncology, Centre Leon Berard, Lyon, France. 8. Department of Surgical Oncology, Centre Oscar Lambret, Lille, France. 9. Department of Surgical Oncology, Institut Paoli Calmette, Marseille, France. 10. Department of Surgical Oncology, Centre Val d'Aurelle, Montpellier, France. 11. Department of Gynecology and Obstetrics, Centre Hospitalier General, La Roche sur Yon, France. 12. Department of Surgical Oncology, Centre Alexis Vautrin, Nancy, France. 13. Department of Surgical Oncology, Centre Lacassagne, Nice, France. 14. Department of Gynecology and Obstetrics, Centre Hospitalier Universitaire, Angers, France. 15. Department of Gynecology, Centre Hospitalier Europeen Georges Pompidou, Paris, France. 16. Department of Surgical Oncology, Institut Universitaire du Cancer-Centre Claudius Regaud, Toulouse, France. 17. Biometrics, Institut de Cancerologie de l'ouest, Saint-Herblain, France.
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.
PURPOSE: GANEA2 study was designed to assess accuracy and safety of sentinel lymph node (SLN) after neo-adjuvant chemotherapy (NAC) in breast cancerpatients. METHODS: Early breast cancerpatients 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.
Authors: Giacomo Montagna; Anita Mamtani; Andrea Knezevic; Edi Brogi; Andrea V Barrio; Monica Morrow Journal: Ann Surg Oncol Date: 2020-06-02 Impact factor: 5.344