Punção ou biópsia axilar em câncer de mama como preditor de tratamento (omissão da cirurgia axilar): ensaio propspectivo unicêntrico da região norte do Estado do Ceará

Abstract

According to data from the World Health Organization, cancer rates have doubled in the last decade, with breast cancer being one of the most common in the world. In Brazil, it is one of the most prevalent, second only to skin cancer. According to data from the National Cancer Institute of Brazil, 73,610 new cases of breast cancer were predicted for the three-year period 2023-2025. With technological advances, associated with a better knowledge of breast biology and genomics, new methods of evaluating the breast and axilla are enabling surgical deescalation, thus requiring a better evaluation of the axilla before surgery. Among the methodologies employed, physical examination is a flawed method, even when performed by experienced hands, and Ultrasound (US), in addition to being operator and equipment dependent, has a variable sensitivity rate of 23% to 76%. Fine needle aspiration (FNA) or core needle biopsy (CORE), another method of axillary evaluation, is low cost, can provide prognostic information and has been emerging as a predictor of treatment. This prospective, phase 1, real-life trial aimed to analyze the agreement between USPAAF and USCORE in predicting axillary metastases and to identify the omission of axillary surgery in patients with high-penetrance mutations or breast carcinoma in situ (DCIS) or invasive (cT1-4, cN0-2 axillary) when associated with negative USPAAF or USCORE scores. In the methodology employed, all patients underwent physical examination, ultrasonography, and ultrasound-guided axillary puncture or biopsy, and marking with charcoal or metal clip was performed to identify the punctured or biopsied lymph node. All patients underwent surgery (sentinel lymph node and/or axillary dissection). Statistical analysis was performed using Cohen's Kappa index, and the caret and ggplot2 packages were used to generate tables and graphs. It was approved by the Ethics Committee of the Universidade Vale do Acaraú (Opinion: 6,493,146; CAAE: 1 5394423.4.0000.5053). The results were 363 lymph nodes (LN) dissected from 43 patients. The median age was 57 years, estrogen or progesterone hormone receptors were present in 60.4% and the majority were nuclear Grade 1 or 2 tumors (63%). A total of 76 lymph nodes were assessed by US and 72 procedures were carried out, of which 66 were punctures and 06 core biopsies. Fourteen patients underwent neoadjuvant chemotherapy and 29 did not. The rate of axillary involvement was higher in tumors over 3cm (41.7%), versus (13.6%) in tumors up to 2cm. The Luminal subtype had 46.2% positive axillae in the pathology, versus 21.4% in the HER 2/ TN group. Of the 07 patients with mutations or DCIS, only 01 (14%) had a positive axilla at surgery (pN0). The initial invasive tumors, classified as cT1 and with (negative EF and US) had 12.5% (1/8) involvement. The cT1 -2 tumors and with (EF and US and USPAAF/USCORE negative) had 8.3% (01/12) compromise and in the 43 women (with mutations or DCIS or invasive tumors) and with the three scores (EF and US and USPAAF/USCORE) negative, the rate of compromised lymph nodes was 10% and surgery could have been avoided in 41.6% (18/43) of these women. The sensitivity found for physical examination (PE) alone was 33.3% and for US 53.3%. The association of USPAAF/USCORE with EF and US increased the sensitivity from 66.67% to 80%. In conclusion, using EF or US or USPAAF/USCORE exclusively presents limitations in the detection of axillary metastases. The addition of the USPAAF/USCORE scores increased the sensitivity and with the three negative scores the rate of axillary involvement was 10%, providing the possibility of surgical omission, however further studies are needed to establish them as a predictive tool for treatment.