e12580 Background: Axillary lymph node dissection is a redundant method of surgical treatment and axillary staging for a large number of patients receiving neoadjuvant therapy with positive lymph nodes before NCT. Methods: The study included 212 patients with breast cancer (cT1-3N1M0) who received treatment at the breast tumors department of the N.N. Petrov NMRC of Oncology from 2019 to 2021 All patients included in the study had the cN1 initial status of the axillary lymph nodes. All patients underwent neoadjuvant systemic therapy and subsequent sentinel lymph node biopsy (SLNB). In patients with pathomorphologically proven metastatic lymph nodes (cN1) even at the initial diagnosis, lymph node marking was performed before the start of NCT and targeted axillary lymph node dissection after the completion of neoadjuvant systemic therapy. In the same patients, after SLNB and targeted axillary lymph node dissection, a complete (standard) axillary lymph node dissection was performed to determine the false-negative rate and the oncological safety of the procedure. Results: The identification rate of only one sentinel lymph node was 21% (40 out of 193 patients), two sentinel lymph nodes - 30% (58 out of 193 patients), more than 3 - 49% (95 out of 193 patients). When only 1 sentinel lymph node was found, the false-negative rate of SLNB was 20.0% (4 of 20) (95% CI, 5.7 to 43.7). When two sentinel lymph nodes were found, the false-negative rate of SLNB was 20.0% (6 of 30) (95% CI, 7.7 to 38.6). When three sentinel lymph nodes were found, the false negative rate of SLNB was 4.7% (2 of 43) (95% CI, 0 to 15.8). Among 45 patients who had a microseed with the iodine-125 radioisotope installed before the start of treatment, the frequency of identifying a marked node was 100%. In 19 patients, tumor cells were found in the lymph nodes. The false-negative rate of targeted axillary dissection in combination with SLNB was 5.3% (1 of 19) (95% CI, 0 to 26.0). Conclusions: Targeted axillary dissection and sentinel lymph nodes biopsy, provided that 3 SLNs are removed, are reliable methods for identifying patients in whom systemic therapy is guaranteed to achieve complete response of regional lymph nodes (ypN0), thereby relieving patients of the need to perform a crippling complete axillary lymph node dissection. Clinical trial information: 3/198.
Materials and methods. The effect of melatonin (MLT) and metformin (MTF) on the efficacy of neoadjuvant hormone therapy with toremifene was investigated in 54 patients with estrogen receptor-positive, locally advanced breast cancer (ER + BC). The average age of women was 67 years. The patients had no diabetes mellitus. The first group of patients (n = 19) received toremifene 120 mg per day, the second group (n = 16) - toremifene in combination with MLT 3 mg orally every night, the third group (n = 19) - toremifene in combination with MTF 850 mg twice daily. Randomization was performed - 1: 1: 1. The duration of therapy in all study groups was 4 months. After the end of treatment, all patients were undergone surgery. Further adjuvant treatment depended on the results of the postoperative pathomorphological conclusion. The primary endpoint was a decrease in the Ki-67% level (a surrogate marker for the effectiveness of hormone therapy), the secondary endpoints were the objective response, a pathological response in the tumor and lymph nodes, and the quality of life. Results. In all patients (n = 54), the frequency of decrease Ki-67 level and the frequency of objective response were 57% and 50%, respectively. At the same time, the incidence of Ki-67% level decrease in the «toremifene» group was 42%, in the «toremifene+MLT» group - 56%, in the «toremifene+MTF» group - 74%. Multifactor analysis showed that the addition of MTF to toremifene increases the chances of reducing Ki-67 compared with control 4.2 times (RR 4.23 [95% CI 1,04417,139], p = 0.043). It is important that only in the patients of the «toremifene+MTF» group a significant correlation was found between the Ki-67 index decrease in the tumor and the BMI value above the norm (p = 0.015). A complete pathomorphological response in the tumor and lymph nodes was not achieved in any patient. The objective response in the study groups was 31.6%, 86.7% and 47.3%, respectively. The addition of MLT to hormone therapy with toremifene significantly increased the frequency of the objective response from 31.6% to 86.7% (x2 = 10.32, p = 0.001). The inclusion into neoadjuvant hormone therapy with toremifene of MLT or MTF did not reduce the quality of life of patients, while in 50% of patients in the «toremifene+MLT» group there was an improvement in sleep.
Резюме Tрижды негативный рак молочной железы (ТНРМЖ) составляет примерно 15%-20% от всех диагностированных случаев рака молочной железы и характеризуется отсутствием экспрессии рецепторов эстрогена (ЭР), рецепторов прогестерона (ПР), а также отсутствием экспрессии белка человеческого эпидермального фактора роста (HER2) белка. Гетерогенность трижды негативного рака молочной железы является основным препятствием в лечении данного подтипа опухоли. Хотя рецепторы эстрогенов (ЭР) и рецептор человеческого эпидермального фактора роста (HER2) являются основными терапевтическими мишенями при раке молочной железы, рецептор андрогена (AR) в последнее время получил развитие в качестве молекулярной мишени в лечении опухолей, резистентных к стандартным способам лечения.
Additional covering of the lower pole with allomaterial or its synthetic analogues during immediate breast reconstruction is being performed at the N. N. Petrov National Medical Research Oncology Center, Ministry of Health of Russia, for last 7 years. Initially, epidermal flap was the only option for lower pole coverage; later acellular dermal matrix was used as part of clinical approbation. Average complication rate ranges from 20–35 % due to blood circulatory (supply) disorders.Since 2018, a titanised mesh been used as an additional coverage of the lower pole in the department of breast tumors. Through coating characteristics and its structure the frequency of fatal complications significally decreased.
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