Abstract
Introduction. Current opinion is that surgery is diagnostic rather than curative and does not affect long-term outcomes in breast cancer (BC) patients with complete pathomorphological response (pCR) after neoadjuvant systemic therapy (NST). As a minimally invasive method for diagnosing pCR in BC, vacuum-assisted biopsy (VAB) of the tumour bed has shown promising results. This paper presents a retrospective analysis of the outcomes of patients with triple-negative and HER2-positive BC who achieved pCR after NST according to different types of invasive breast surgery, including patients who underwent VAB alone without subsequent breast surgery.
Materials and methods. From 1 January 2021 to 1 July 2023, we analysed 3247 patients who underwent surgery at the Department of Breast Tumours at the N.N. Petrov NMRC of Oncology. Patients were included in the study if they had unifocal invasive HER2+ and TNBC (cT1-2N0-1M0) with histologically confirmed pathological complete response (ypT0N0) to NST. Exclusion criteria were an intraductal component detected by trephine bone marrow core biopsy and germline mutations in BRCA1/2. According to the planned analysis, all patients were divided into three groups: the breast-conserving surgery (BCS) group, the mastectomy (ME) group and the VAB group. Primary endpoint was 2-year ipsilateral breast tumour recurrence-free survival [IBTR-FS]. Secondary endpoints included 2-year disease-free survival (DFS) and complication rates.
Results. Of the 3 247 patients analyzed, 81 patients who met the inclusion criteria were included in the final analysis. There were 39 patients in the BCS group, 19 patients in the ME group, and 23 patients in the VAB group. The median follow-up was 24 months. The median survival was not reached for any of the endpoints. 2-year IBTR-FS was 100 % in the BCS group vs. 100 % in the ME group vs. 91.3 % in the VAB group [p = 0.159]. 2-year DFS was 97.4 % in the BCS group vs 94.7 % in the ME group vs 87.0 % in the VAB group [p = 0.396]. There was no difference in the hazard ratio (HR) for recurrence between the different types of surgery. When measuring HR adjusted for lymph node status (cN) and disease stage, there was a statistically significant higher risk in the VAB group [HR adjusted for cN: 12.236, (95 % CI, 1.163-128.773), p = 0.037; HR adjusted for stage: 17.071, (95 % CI, 1.255-232.173), p = 0.033].
Conclusion. To determine the safety of VAB use, further observational studies and large randomised prospective trials are needed. There was no significant difference in the incidence of complications between the different types of invasive procedures in this cohort of patients.
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