Journal Basic Info

  • Impact Factor: 1.995**
  • H-Index: 8
  • ISSN: 2474-1647
  • DOI: 10.25107/2474-1647
**Impact Factor calculated based on Google Scholar Citations. Please contact us for any more details.

Major Scope

  •  General Surgery
  •  Pediatric Surgery
  •  Colon and Rectal Surgery
  •  Vascular Surgery
  •  Oral and Maxillofacial Surgery
  •  Minimally Invasive Surgery
  •  Gynecological Surgery
  •  Breast Surgery

Abstract

Citation: Clin Surg. 2020;5(1):2755.Research Article | Open Access

Safely Avoiding Axillary Lymphadenectomy after Neoadjuvant Chemotherapy for Patients with Proven Axillary Lymph Node Involvement Early Breast Cancer? The French Multicenter Prospective Ongoing GANEA 3 Study

Loaec C1*, Frenel JS2, Renaudeau C1, Bordes V1, Campion L3,4 and Classe JM1

1Department of Surgical Oncology, Institute of Cancer Research, René Gauducheau Centre, France
2Department of Medical Oncology, Institute of Cancer Research, René Gauducheau Centre, France
3Department of Biometrics, Institute of Cancer Research, René Gauducheau Centre, France
4CRCINA, University of Nantes, INSERM UMR1232, France

*Correspondance to: Loaec C├ęcile 

 PDF  Full Text DOI: 10.25107/2474-1647.2755

Abstract

Background and Objective: After Neoadjuvant Chemotherapy (NAC) more than one third of patients presenting with initially axillary node involvement achieved a Pathological Complete Nodal Response (pCR). In this situation, omitting Axillary Lymph Node Dissection (ALND) could enable to decrease post-operative morbidity. GANEA 3 is a prospective multi institutional trial aimed at assessing the feasibility of selecting patients with an initially proven positive axillary node, with a low risk of lymph node involvement after NAC. Methods: Before NAC, all patients undergo an axillary Ultrasound (US) assessment. A fine needle aspiration of suspicious is performed. Patients with proven axillary lymph node involvement are included. The initially positive axillary lymph node is targeted with a clip under US monitoring. After NAC, surgery of the breast and axilla is scheduled. Surgeon performs three axillary resections: initially involved clipped node, sentinel lymph node biopsy and a complementary ALND. Breast tumour size, (mammography, MRI) breast tumor characteristics, axillary status, before and after NAC are compared. Univariate and multivariate analysis will allow generating a Nomogram able to select patients with the lowest risk of post NAC persistent axillary involvement. Taking into account previous results of post NAC lymph node involvement from GANEA 2 trial, 385 prospectively included patients are required during a period of 3 yrs of inclusion. Results: Twenty French surgical teams participate in the GANEA 3 trial. The GANEA 3 trial was approved by the national scientific committee and the national ethical committee. Informed consent was obtained from each participating patient. The trial was registered with ClinicalTrials. gov (NCT03630913). At the end of January 2020, one year after the inclusion of the first patient, 125 patients are already included. Conclusion: GANEA 3 trials will be able to safely identify patients for which ALND could be safely avoided after NAC. It will be an important step of surgical de-escalation after NAC.

Keywords

Breast cancer; Neoadjuvant chemotherapy; Axillary lymph node involvement; Sentinel lymph node biopsy; Pathological complete response

Cite the article

Loaec C, Frenel JS, Renaudeau C, Bordes V, Campion L, Classe JM. Safely Avoiding Axillary Lymphadenectomy after Neoadjuvant Chemotherapy for Patients with Proven Axillary Lymph Node Involvement Early Breast Cancer? The French Multicenter Prospective Ongoing GANEA 3 Study. Clin Surg. 2020; 5: 2755..

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