Introduction. The increasing need for affordable treatment options for patients with HER2-positive breast cancer necessitates the development of pertuzumab biosimilars to expand access to effective therapies. BCD-178 is a pertuzumab biosimilar that has demonstrated equivalence to reference pertuzumab (RP) based on physicochemical characterization, preclinical in vitro and in vivo and clinical phase I study. The international, multicenter, Phase III clinical trial BCD-178–2/PREFER was conducted to comparatively evaluate the efficacy and safety of BCD-178 and RP in combination with TCHP regimen for neoadjuvant therapy in patients with HER2-positive breast cancer.

Objective. To compare the efficacy and safety of the pertuzumab biosimilar BCD-178 and RP when used in a neoadjuvant setting for patients with HER2-positive breast cancer.

Methods. The study included female patients aged 18–75 years with histologically confirmed invasive HER2-positive breast cancer and the absence of estrogen receptor (ER) and progesterone receptor (PR) expression. Patients were randomized 1:1 to receive either BCD-178 or RP. The primary endpoint was the proportion of patients achieving a total pathological complete response – tpCR (ypT0/is, ypN 0) based on the conclusion of a central independent review after completion of the neoadjuvant therapy phase.

Results. A total of 380 patients were randomized into the study. The proportions of patients achieving tpCR (95 % CI) were not statistically different between the treatment groups (p=0.6521, Cochran–Mantel–Haenszel method). The risk difference (95 % CI) for achieving tpCR between the groups was within the pre-defined equivalence boundaries, demonstrating equivalent efficacy of BCD-178 and RP. The treatment groups were comparable in terms of safety profile, including the incidence of adverse reactions (ARs). The most common (≥10 % of patients) ARs were diarrhea and anemia. The pharmacokinetics and immunogenicity of the drugs were comparable.

Conclusions. The study demonstrated comparability between BCD-178 and RP in terms of efficacy, safety, pharmacokinetics, and immunogenicity when used in the neoadjuvant treatment of patients with HER2-positive ER/PR-negative breast cancer.

Introduction. Advances in molecular biology and biotechnology have enhanced the understanding of triple-negative breast cancer (TNBC) biology and facilitated the identification of patient subgroups that may potentially benefit from novel therapeutic approaches.

Objective. The aim of this study is to evaluate the efficacy of the combination of atezolizumab and nab-paclitaxel in patients with locallyadvanced/metastatic TNBC in real-world clinical practice in the Russian Federation.

Methods. This retrospective multicenter study included 65 patients with metastatic TNBC who received the atezolizumab and nab-paclitaxel in the second line of treatment and patients with early progression following neoadjuvant/adjuvant chemotherapy (≤12 months, primary resistance population) from October 2019 to September 2023 in routine clinical practice.

Results. At the median follow-up of 11.5 months the median progression-free survival (mPFS) was 11.43 months (95 % CI, 6.59–16.28) in the ITT population. There was only factor associated with worsened mPFS – recurrence-free interval of ≤12 months following anthracycline/taxane-based neoadjuvant/adjuvant chemotherapy. mPFS was 15.8 months for primary metastatic or anthracycline/taxane-sensitive TNBC vs. 6.4 months for primary resistance population (OR 0.52, 95 % CI 0.54–0.97; p=0.03). A trend towards improved PFS was observed in the BRCA1/2 wt subgroup and patients with objective response. The mPFS for BRCA1/2 wt patients was 13.9 months vs. 5.6 months for BRCA1/2 mut patients (p=0.14). mPFS in patients with an objective response was 21.9 months vs 13.9 months in those without an objective response (p=0.63).

Conclusions. This analysis represents the first multicenter study evaluating the efficacy of the combination of atezolizumab and nab-paclitaxel in real-world clinical practice in Russian population. The combination allows for an objective response rate of 20 % and mPFS of 11.43 months for patients as in the second line of treatment as with primary resistance.

Background. Small cell lung cancer (SCLC) is one of the most aggressive forms of lung tumors. Currently, there are ongoing discussions about the role of surgery in the treatment of patients with SCLC.

The purpose of the study: does surgery improve prognosis in patients with small-cell lung cancer (SCLC)?

Methods. The material for the study was 7549 patients with lung cancer diagnosed in Ugra from 2002 to 2022. 71 SCLC with stage I to III undergoing surgical resection were enrolled. Lobectomy was performed in 49 patients, pneumonectomy in 22. Systematic nodal dissection (SND) was performed in 59 patients (83.1 %).

Results. In stage I, the ten-year overall survival rate was 65.8 %, in stage II – 33.2 %, in stage III – 14.4 % (p=0,001). Remote results of surgical treatment of SCLC had a significant dependence on the state of regional lymph nodes: with N 0, the 10-year OS was 53.1 %, with N 1 the 10-year OS was 30.6 %, with N 2–15.1 % (p=0,003). Ten-year OS with SND was significantly exceeded other dissections on the lymphatic collector to 42.0 %, while with sampling nodal dissection the 10-year OS was only 20.0 % (p=0,028).

Conclusion. Good remote results in patients with stage I and II SCLC indicate the need to include surgery in the complex treatment of patients with SCLC. The optimal volume of surgery is lobectomy with systematic nodal dissection. Surgery can be performed in patients with stage IIIA and IIIB SCLC in case of tumor regression after induction chemoor chemoradiotherapy, as well as in case of life-threatening complications. Prospective studies are required to determine the indications for surgery in this cohort of patients.

The rarity of occurrence, difficulties in diagnosing and staging peritoneal mesothelioma have a significant impact on the formation of a consensus in the treatment of this disease. Pemetrexed remains the drug of choice for both systemic and intraperitoneal chemotherapy for peritoneal mesothelimoma. This article briefly presents the most interesting information on the treatment of peritoneal mesothelioma, presented at the IMIG2023 conference in France.

Relevance. Today, one of the promising areas of personalized oncology in the treatment of malignant neoplasms is targeted and immunotherapy. However, despite its effectiveness, dermatological adverse events are observed while taking these drugs. In severe cases, skin toxicity can lead to poor adherence to treatment and discontinuation of basic therapy, affecting survival and quality of life.

The aim of the study. Assessment of the impact of remote monitoring on the results of correction of skin toxicity, quality of life and 2-year progressionfree survival in cancer patients receiving EGFR inhibitors and immunotherapy.

Materials and methods. The study included 220 patients aged 18–70 years with manifestations of skin toxicity on the background of targeted and immune therapy, divided into 2 equivalent groups. The main group of patients received support therapy as part of remote monitoring using the Healthy Skin patient support program, the comparison group consisted of patients receiving outpatient consultations.

Results. The results of the multifactorial analysis confirm the statistically significant influence of the group and the number of consultations on the improvement of the 2-year progression-free survival rate by an average of 12 weeks in the online follow-up group compared with traditional outpatient consultations, as well as a decrease in the BSA, pruritus and DIC indices (with a 95 % probability) in the study group. After 4 weeks, an improvement in the pruritus index was recorded in 85.5 % of patients and no deterioration in the first group compared to the second, where deterioration in the index was detected in 31.8 % of patients. A close correlation was also established between the severity of skin toxicity and its negative impact on the quality of life of oncology patients, which is confirmed by the data from the DLQI and SF-12 questionnaires. The developed method made it possible to quickly achieve a stable condition of the skin without episodes of aggravation, which made it possible to continue anticancer therapy in full without interruptions and cancellations against the background of preserved quality of life, compared with the second group, where cases of interruption/cancellation of therapy were due to aggravation of skin toxicity.

Conclusion. Most modern cancer treatment methods are accompanied by adverse events, often affecting the skin. Correction of skin toxicity is a priority for oncology patients, as it is a complex interdisciplinary problem. Remote monitoring is an effective clinical tool, representing an accessible form of communication between the doctor and the patient, facilitating timely control of skin toxicity. The introduction of telemedicine technologies can minimize severe forms of skin toxicity, maintain a decent level of quality of life and reduce the incidence of interruption or termination of therapy, increasing survival of cancer patients.

Introduction. Pheochromocytoma (PC) and paraganglioma (PG) are neuroendocrine neoplasms and are characterized by a high frequency of somatostatin receptor (SSTR) expression. The efficacy of somatostatin analogues in PC/PG remains poorly studied, despite the lack of evidence base, these drugs are included in the international NCCN recommendations. The aim of this study was to investigate the effectiveness of somatostatin analogues in the treatment of PC/PG.

Materials and methods. This retrospective single-center study included patients older than 18 years with positive expression of SSTR 2A и/или SSTR 5 or with accumulation of 68Ga-DOTATATE who received somatostatin analogs (octreotide-depo or lanreotide) at the first line of treatment for metastatic PC/PG from April 2020 to September 2023.

Results. The study included 8 patients, 6 male (75 %) and 2 female (25 %). All patients had positive SSTR 2A expression and accumulation on 68Ga-DOTATATE PET. Half patients (N=4, 50 %) had pheochromocytoma and half (N=4, 50 %) paraganglioma. SDHB mutation was detected in 1 (12.5 %) patient. Four patients (50 %) had disease progression on follow-up before starting therapy with somatostatin analogues. No objective response was achieved (0 %). However, all patients had disease control ≥ 6 months. Two (33.3 %) of 6 had a ≥ 50 % decrease in metanephrine/ normetanephrine secretion. Median PFS was 21.57 months. (95 % Confidence Interval 14.95–28.19).

Conclusion. Based on our findings, we recommend considering somatostatin analogs as a first-line treatment option for patients with indolent disease course and low tumor burden who demonstrate progression during active surveillance. The impact of long-acting somatostatin analogs on catecholamine secretion warrants further investigation in a prospective cohort.

Triple negative breast cancer (TNBC) accounts for about 15 % of all diagnosed breast cancer cases and is an extremely aggressive disease with a high incidence of recurrence and metastases. Due to the molecular and biological features of this type of tumor, the currently available therapeutic options for the treatment of patients with advanced disease are extremely limited and include mainly the use of chemotherapy – classical cytostatic drugs. In recent years, great efforts of the scientific oncology community have been focused on the identification of specific targets for TNBC, which has additionally brought immuno-oncology drugs, PARP inhibitors and antibody-drug conjugates to the clinicians’ arsenal. Thanks to significant advances in the field of molecular genetics, it has been established that in triple negative subtype of breast cancer in almost 20 % of cases the presence of germinal mutations in BRCA1/2 genes is noted, therefore, testing patients for the presence of these aberrations is now an obligatory stage of diagnosis, starting from the earliest stages of the cancer process. Despite the fact that metastatic TNBC is generally considered an incurable disease, there are single reports in the literature describing cases of achieving a complete clinical response during drug treatment. Unfortunately, due to the rarity of such cases, the further management of patients remains largely uncertain. In this case report, we demonstrate our own positive experience with the PARP inhibitor talazoparib as maintenance therapy in a patient with advanced triple-negative breast cancer and a mutation in the BRCA gene after achieving a complete clinical response to 1 line of platinumcontaining therapy. This observation adds to the existing data and emphasizes the need for PARP inhibitors in the treatment of TNBC, and confirms the importance of further research in molecular genetics to develop more effective treatment approaches.

Small-cell laryngeal carcinoma is a rare and highly aggressive tumor with significant potential for metastasis. Given its biological characteristics, this disease should be considered as disseminated at the stage of primary diagnosis. Currently, about 700 cases of neuroendocrine neoplasms of the larynx have been described in the literature. According to the largest study involving 436 patients, chemoradiotherapy is one of the most effective treatment methods, which leads to an increase in progression-free time compared to other methods. This article presents a clinical case of treatment of a patient with small cell neuroendocrine laryngeal cancer with damage to regional lymph nodes who received chemoradiotherapy in combination with chemotherapy according to the CAV scheme, with the maximum effect of treatment in the form of complete regression.

The condition of the lymph nodes is a mandatory prognostic sign and criterion for adjuvant therapy for malignant neoplasms (MN). While micrometastases have been found to correlate with prognosis in a number of cancers using ultrastaging techniques and are part of the standard treatment for patients with hematologic malignancies, controversy remains in the case of cervical cancer and endometrium cancer. The purpose of this review is the novelty of sentinel lymph node (SLN) ultrastaging in guiding treatment decisions and reducing the risk of regional recurrence.

The article conducts research on increasing the economic efficiency of oncomammoscreening and monitoring the results of breast cancer diagnostics (BC) using artificial intelligence (AI) technologies in Russia. The relevance of breast cancer screening is noted, scientific approaches to screening problems that exist in the context of healthcare financing are analyzed, and the processes of using AI in Russia and the global medical community are flaring up.

Objective: to increase the economic efficiency of screening and diagnostic X-ray mammography (X-ray mammography) programs by introducing AI as a physician’s assistant in analyzing the results of medical examinations with budgetary financing of state healthcare institutions in the Sverdlovsk region.

Research objectives. 1. To identify key issues that reduce the effectiveness of oncomammoscreening. 2. To analyze the effectiveness of automated detection systems for pathological formations in the mammary gland using AI. 3. To justify ways to increase the economic effect by introducing an intelligent physician assistant in screening and diagnostic X-ray mammography. 4. To determine the areas of growth in the profitability of mammography as a medical service within the framework of budget financing. 5. To propose options for solving the problem of personnel shortage of radiologists in state healthcare institutions of the Sverdlovsk region.

Introduction. Over the past ten years, the incidence and mortality rates of endometrial cancer in Russia have remained quite high. Chemotherapy shows limited effectiveness in the case of recurrence, necessitating the search for new treatment methods, such as immune-targeted therapy. The combination of pembrolizumab and lenvatinib has demonstrated significant improvements in survival rates, changing the treatment standards for patients with recurrent uterine cancer.

Objective. To evaluate the efficacy and safety of the combination of lenvatinib + pembrolizumab in patients with recurrent endometrial cancer, analyze our own experience with this therapy, and compare it with international data.

Materials and Methods. The study included 39 cases of the combination of pembrolizumab + lenvatinib administered to patients with recurrent endometrial cancer. Patients with ECOG status 0–1 and microsatellite stable tumors were included.

Results. Treatment with the combination of pembrolizumab and lenvatinib achieved control over the tumor process in 95 % of patients. The most common side effects were arterial hypertension and hand-foot syndrome; however, through dose adjustments and symptomatic therapy, it was possible to manage these adverse events effectively.

Chemotherapy is an integral part of drug treatment of patients with metastatic breast cancer (mBC), regardless of the biological subtype of the tumor, and the availability of a large number of effective drug treatment options can significantly increase life expectancy. Intensive neoadjuvant and adjuvant chemo ± targeted therapy, as well as pretreatment for the metastatic form of the disease, can significantly reduce the effectiveness of subsequent lines of chemotherapy, which complicates the choice of treatment options. That is why the results of modern observational studies of real clinical practice are of exceptional value. Ixabepilone is a semi-synthetic analogue of epothilone B, used for locally advanced or metastatic breast cancer when previous therapy is ineffective.

The purpose of this study is to evaluate the efficacy and tolerability of ixabepilone alone and in combination with chemoor target drugs in real clinical practice in the Russian Federation.

Methods. A multicenter, non-interventional, retrospective study of ixabepilone therapy in routine clinical practice in patients with locally advanced or metastatic breast cancer with ineffectiveness of previous therapy NIRMA (CLO1418141) included 101 patients who received ixabepilone as monotherapy and in various combinations in the 1st and subsequent lines of therapy from 01.01.2021 to 31.12.2023 in 15 oncological institutions of the Russian Federation.

Results. The median of previous therapy lines for metastatic disease was 3. Ixabepilone therapy was administered alone (n=58), in combination with capecitabine (n=30), or in combination with trastuzumab (n=13). The median PFS was 5.77 months. [95 % CI 5.31–6.07] The objective response rate was 35.64 % (36/101), including 1 complete and 35 partial responses. Disease control rate in intensively pre-treated patients with mBC reached 84.16 % (84/101). Adverse events (AE) of any severity were recorded in 25.74 % of cases. The main adverse events with ixabepilone were neutropenia and peripheral polyneuropathy. In no case did toxicity lead to early discontinuation of treatment or death. In patients with mBC progression after anthracyclines and taxanes, the combination of ixabepilone with capecitabine or ixabepilone with trastuzumab demonstrates extremely high disease control rates in modern Real Clinical Practice (RCP). Ixabepilone monotherapy is an option of choice in patients with breast cancer progression after anthracyclines, taxanes and capecitabine.