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.
Relevance: early breast cancer is detected in more than 60% of cases. Maintaining the quality of life of patients with early breast cancer at the highest possible level is a priority, along with the treatment of patients. Under a complex antitumor treatment as well as after its completion, more than 60% of patients with early breast cancer report the occurrence of functional disorders.An important aspect is to improve the effectiveness of the rehabilitation process of patients with early breast cancer taking into account scientifically-based and proven recommendations.Objective: to evaluate the event-free survival rate (EFS) of patients with EBC undergoing rehabilitation within a biopsychosocial approach.Materials and methods: 228 patients with breast cancer who received complex treatment from 2015 to 2019 were included in the study. The prospective part of the study included 114 patients with early breast cancer undergoing rehabilitation measures within the biopsychosocial approach. The control group which was selected retrospectively, using the method of "pairwise selection", included 114 patients with early breast cancer comparable in age, stage of the disease, volume of surgical treatment and menopausal status, undergoing physical and psychological rehabilitation prescribed by a doctor. Patients in both groups were stratified depending on preoperative chemotherapy. EFS was calculated over a 2-year follow-up period. Events that were censored were a disease progression, the appearance of metastases, the occurrence of another cancer, a new concomitant disease, an exacerbation of the concomitant pathology and death.Results: Rehabilitation measures within the biopsychosocial model improve the indicators of EFS in the group of patients with EBC: EFS was 18.3 months against 14.5 months in the control group (HR=0.91, 95% CI [0.83; 0.99]; p=0.0034). In a multi-factor analysis the key factors affecting EFS were neoadjuvant chemotherapy (HR=0.79, 95% CI [0.69; 0.94]; p=0.0025), age (HR=0.87, 95% CI [0.71;1.09]; p=0.0027) and menopausal status (HR=0.85, 95% CI [0.84; 0.95]; p=0.0022) (table 1). Conclusions: Rehabilitation measures within the biopsychosocial model improve the indicators of EFS in the group of patients with early breast cancer, the key factors affecting EFS were neoadjuvant chemotherapy, age and menopausal status. Table 1 Multi-factor analysis of event-free survival of patients with early breast cancer in the group of biopsychosocial model of rehabilitation versus control group.CharacteristicNumber of patientsHR (95% CI)Preoperative chemotherapyyes1520,84 (0,77; 1,1)no760,79 (0,69; 0,94)Menopauseyes1300,84 (0,77; 1,04)no980,85 (0,84; 0,95)Age group25-44610,87 (0,71; 1,09)45-601030,89 (0,74; 1,1)61-75641,01 (0,82; 1,24)EventDisease progression281,11 (0,86; 1,26)Exacerbation of the concomitant pathology160,83 (0,74; 0,96) Citation Format: Valeria Kluge, Tatiana Semiglazova, Petr Krivorotko, Elena Melnikova, Vladislav Semiglazov, Kristina Kondrateva, Svetlana Nazarova, Margarita Tynkasova, Bahtiyar Adhamov, Roman Pesotsky, Konstantin Zernov, Valentina Chulkova, Boris Kasparov, Denis Kovlen, Vladimir Semiglazov, Alexey Belyaev. Biopsychosocial approach in the rehabilitation of patients with early breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-62.
Introduction The aim of the study was to prove efficacy and safety of de-escalation of traditional breast surgery in BC patients who develop cCR after neoadjuvant systemic therapy. Refusal of surgery was offered to exceptional responders after vacuum-assisted tumor bed biopsy and sentinel lymph node biopsy confirmed absence of residual disease (pCR). Materials and methods A single-center prospective study was run in the NMRC n.a. N.N. Petrov. Starting from August of 2020, 35 patients with early сT1-2N0-1M0 (stage Ia-IIb) triple-negative and HER2-positive (both ER+ and ER-) unifocal tumours without DCIS in core-biopsy specimen enrolled in the study. Primary lesions were marked with a single clip in the centre. In cases with nodal involvement (cN1) the affected lymph nodes were also clipped. Patients with triple-negative breast cancer received 4 cycles of AC q21d followed by 12 cycles of weekly paclitaxel and carboplatin AUC 2.0. HER2-positive patients received 4 cycles of AC followed by 4 cycles of docetaxel combined with trastuzumab and pertuzumab q21d. Breast US, mammography and SPECT were used at baseline and at response evaluation. Vacuum-assisted biopsy was performed with 7G needle and US-guidance in the OR simultaneously with the SLNB. VAB protocol included retrieval of the tumor clip as first stage. Subsequently surrounding tissues were sampled, and markers were placed to guide radiotherapy. In case residual tumor was found patients received standard breast-conserving surgery. In case the sentinel lymph nodes were found to be positive, standard level II axillary clearance was performed. HER2-positive patients with pCR confirmed by VAB and SLNB received adjuvant trastuzumab up to one year. HER2-positive patients with residual breast or nodal involvement received trastuzumab emtansine up to one year. In case ER+, all patients received appropriate endocrine-therapy. In case of residual in-breast or nodal involvement patients with triple-negative breast cancer received standart capecitabine. Results The interim analysis included 25 patients in both groups. The median follow-up of disease-free survival for patients is 12 months. In the triple-negative group 12 patients achieved cCR. All patients went on to receive VAB and SLNB. After VAB and SLNB pCR was confirmed 11 patients (91.7%). 1 patient had invasive residual tumor with less than 5% cellularity. FNR in this group was 8.3% (1/12). Patient with invasive residual tumor received standard breast-conserving surgery. All the patients in the TNBC group were also found to be (sn)ypN0. In the HER2-positive group cCR was achieved 13 patients. All patients went on to receive VAB and SLNB. After VAB and SLNB pCR was confirmed 10 patients (77%). 3 patients had invasive residual tumor with less than 5% cellularity. FNR in this group was 23% (3/13). Patients with invasive residual tumor received standard breast-conserving surgery. All HER2-positive patients were found to be (sn)ypN0. One patient with HER2-positive subtype experienced a local reccurence in the postoperative zone 16 months after surgery. Initially, this patient achieved cCR and undergone VAB with SLNB. On final pathomorphologic examination isolated focuses of DCIS were found (ypTisN0). Standard breast-conserving surgery was performed and histologically only DCIS was found. This patient recieved 1-year of Trastuzumab and standard radiotherapy with boost. After the histologic confirmation of local reccurence patient underwent nipple-sparring mastectomy with reconstruction and nowadays she is recieveing therapy with trastuzumab emtansine (T-DM1). Conclusion All visualization modalities fail to provide reliable information on the true rate of pCR. Contemporary systemic therapy regimens after accurate selection of patients, following the inclusion criteria, allows to achieve pCR in 75-90%, thereby reducing the risk of FNR after VAB. The trial continues to enroll patients and further follow-up is needed. Citation Format: Petr Krivorotko, Sergey Yerechshenko, Alexander Emelyanov, Ekaterina Busko, Tengiz Tabagua, Viktoria Mortada, Konstantin Zernov, Alexander Komyakhov, Kirill Nikolaev, Elena Zhiltsova, Larisa Gigolaeva, Roman Pesotsky, Diana Enaldieva, Yana Bondarchuk, Nikolay Amirov, Valentin Channov, Sergey Novikov, Zhanna Bryantseva, Anna Artemyeva, Viktoriya Smirnova, Tatiana Semiglazova, Alexey Belyaev, Vladimir Semiglazov. Refusal of Breast Surgery in Breast Cancer Patients With cCR After Neoadjuvant Systemic Therapy and Vacuum-assisted Biopsy (VAB) and SLNB Confirmed pCR. An interim report of the prospective non-randomized trial. NCT04293796. [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-20-03.
Background. BRCA-associated triple negative breast cancer (TNBC) is considered one of the most aggressive subtypes of breast cancer with high sensitivity to chemotherapy, which leads to increased interest in finding new treatment options for patients with this subtype of breast cancer. Aim. To determine the role of adding a platinum drug to standard systemic neoadjuvant therapy (NAC) for patients with primary BRCA-associated TNBC with clinical stage T1–3N0–3M0, and to evaluate the effect of platinum-based drugs on recurrence-free survival in patients of this category. Materials and methods. The study included 75 patients diagnosed with primary BRCA-associated TNBC. They were divided into 2 groups depending on the NAC provided, and then they were subdivided depending on the completion of the course of ongoing NAC, the final pathomorphological result and the presence of recurrence. Results. Group I included 48 (64 %) patients who received the AC–T regimen; in group II (n = 27 (36 %)) patients received NAC according to the AC–TCarb regimen. Patients of group II showed a higher frequency of achieving pathological complete response (pCR) compared with patients of group I (73.7 % versus 41.2 %, respectively, p = 0.0433). Taking into account the NAC regimens being carried out, patients of group I had a slightly higher risk of recurrence compared to patients of group II (p = 0.099). Conclusion. In patients with primary BRCA-associated TNBC, the addition of platinum compounds to the systemic NAC resulted in achieving of pCR in 73.7 % cases compared with 41.2 % pCR after the standard anthracycline-taxane NAC, which entails a reduced risk recurrence in this category of patients. Performing a full course of planned NAC has a positive trend in achieving pCR in patients of this category.
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