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https://doi.org/10.20471/LO.2019.47.01.06
Clinical impact of sentinel lymph node biopsy after neoadjuvant systemic treatment in luminal B, HER-2 positive and triple-negative breast cancer patients with initially involved axillary lymph node(s) : Protocol for prospective, non-randomised, observational clinical trial
Ana Car Peterko
orcid.org/0000-0003-3148-0126
; Department of General Surgery and Surgical Oncology, Clinical Hospital Center Rijeka, Rijeka, Croatia;
Manuela Avirović
orcid.org/0000-0002-6601-7521
; Department of General Pathology and Pathologic Anatomy, University of Rijeka, Faculty of Medicine, Rijeka, Croatia;
Diana Mance
orcid.org/0000-0001-6746-8693
; Department of Radiology, Clinical Hospital Center Rijeka, Rijeka, Croatia;
Petra Valković Zujić
; Physics Department, University of Rijeka, Rijeka, Croatia;
Ingrid Belac Lovasić
; Department of Radiotherapy and Oncology, Clinical Hospital Center Rijeka, Rijeka, Croatia;
Franjo Lovasić
orcid.org/0000-0002-5487-9829
; Department of General Surgery and Surgical Oncology, Clinical Hospital Center Rijeka, Rijeka, Croatia;
Abstract
Background: Upon St. Gallen consensus conference (1) and updated version of NCCN guidelines (2) from 2017, in May 2017 in Clinical Hospital Center Rijeka sentinel lymph node biopsy (SLNB) was introduced in clinical practice for axillary staging of breast cancer patients that achieved complete clinical axillary remission after neoadjuvant systemic oncologic treatment.
This trial aims to evaluate the clinical impact of SLNB performance after neoadjuvant systemic treatment (NAST) in initially node-positive breast cancer patients and to determine the prognostic value of the axillary complete pathological response.
Patients and Methods: Breast cancer patients in clinical stage T1-T3 N0-N2 M0, surgically treated in our institution from September 2018 till May 2022 would be included in this trial and divided into three groups according to protocol. SLNB would be performed in all patients presenting with cN0 stage at the time of surgery, including those patients who shift from cN1-N2 to cN0 during NAST. All patients involved in this trial would be monitored for five postoperative years
in order to determine following parameters: rates of local and regional recurrence, rate of disease progression to M1 stage, regional recurrence-free survival, disease progression-free survival, cancer related mortality rate, and overall survival.
Results: Results gained from this trial would be compared among groups and with our previous data of patients in equivalent stage treated in period from 2011 till 2014 when all patients were primary surgically treated, therefore axillary lymph node dissection (ALND) was performed for all node-positive patients.
Conclusion: Hopefully, the results of this trial would provide enough evidence that SLNB performance after NAST does not have a negative impact on clinical outcome in breast cancer patients who had reached complete clinical axillary remission. In addition, we would try to determine the prognostic value of the axillary complete pathologic response.
ClinicalTrials.gov: This protocol has been registered at clinicaltrials.gov with ID: NCT03719833
Abbreviations: SLNB=sentinel lymph node biopsy, ALND=axillary lymph node dissection, NAST=neoadjuvant systemic treatment, US=ultrasound, MRI= magnetic resonance imaging, RRR=regional recurrence rate, RRFS=regional recurrence- free survival, DFS=disease free survival, CSMR=cancer specific mortality rate, OS=overall survival
Keywords
sentinel lymph node biopsy; neoadjuvant therapy; node-positive; complete response; regional recurrence
Hrčak ID:
224366
URI
Publication date:
6.8.2019.
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