The prevalence of colon and rectal cancer (colorectal cancer), one of the most commonly diagnosed malignant neoplasms with a high risk of metastasis and death, has been increasing steadily in Russia and throughout the world. Despite advances in the early diagnosis of the disease, there has been a constant increase in the number of patients with bowel cancer by 2% and about 75,000 new cases reported annually in this country over the past ten years. More than 90% of patients are people aged over 50 years, but recent years have witnessed a steady increase in the incidence of the disease among young patients. BRAF-mutated CRC follows an especially aggressive clinical course.

Introduction. Biliary tract cancers (BTC) are aggressive malignancies with limited therapeutic options and poor overall survival. In recent years, the introduction of immunotherapy has shifted the treatment paradigm for BTC, particularly in combination with chemotherapy. This study presents a detailed analysis of current clinical data and evaluates the efficacy of chemoimmunotherapy in patients with unresectable and/or metastatic cholangiocarcinoma in routine clinical practice.

Aim. To assess the clinical outcomes of combined chemoimmunotherapy (GemCis + durvalumab/pembrolizumab) in patients with BTC in Russian clinical settings, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and toxicity profiles.

Materials and methods. This retrospective analysis included 23 patients with histologically confirmed cholangiocarcinoma treated between 2020 and 2024 at three centers of JSC “MEDSI Group”. The standard treatment regimen consisted of gemcitabine, cisplatin, and a PD-1/PD-L1 inhibitor followed by maintenance immunotherapy. Treatment efficacy was evaluated according to RECIST v1.1 criteria, and survival analysis was performed using the Kaplan–Meier method.

Results. The median PFS was 8.0 months (95% CI: 6.6–9.3), and the median OS was 14.0 months (95% CI: 8.4–19.5). The ORR was 25%, with five partial responses and no complete responses; the disease control rate was 68.5%. Grade 3–4 adverse events occurred in 39% of patients, including hematologic toxicity and rare immune-related adverse events.

Conclusion. The findings of this analysis support the real-world efficacy of chemoimmunotherapy and are consistent with data from large international trials. Incorporation of PD-1/PD-L1 inhibitors into first-line treatment regimens for BTC provides a clinically meaningful improvement in survival outcomes and disease control, particularly among patients demonstrating favorable responses to therapy.

Introduction. Predicting complete pathological response (pCR) after neoadjuvant chemo-immunotherapy (CIT) in resectable non-small cell lung cancer (NSCLC) is clinically important, but the diagnostic accuracy of positron emission tomography combined with computed tomography (PET/CT) for this purpose remains uncertain.

Aim. To evaluate whether PET/CT can reliably predict pCR in patients with resectable NSCLC following neoadjuvant CIT.

Materials and methods. 40 patients with resectable NSCLC stage II–IIIB were treated with neoadjuvant CIT. All patients were recruited for radical surgery for potentially resectable tumors, assessed after neoadjuvant therapy according to RECIST 1.1, PERCIST criteria. The resected tumor samples were morphologically evaluated to determine the response to neoadjuvant therapy.

Results. The best response, evaluated by the dynamics of the tumor process according to RECIST 1.1 and PERCIST criteria, in the form of complete tumor regression was achieved in 3 patients (7.5%). A partial response was achieved in 27 patients (67.5%). Stabilization of the tumor process occurred in 10 patients (25%). Thus, an objective response was achieved in 30 patients (75%) and a pCR in the examination of postoperative material was registered in 50% of cases. The obtained data on the complete clinical response of the tumor to treatment based on PET/CT results and the frequency of achieving a pCR coincided in only 10% of cases, indicating a low accuracy of PET/CT in predicting the pCR to treatment.

Conclusions. This study showed that the use of whole-body PET/CT to predict pCR in patients with resectable lung cancer after neoadjuvant CIT appears to be impractical.

Introduction. Uveal melanoma is a rare malignant neoplasm that develops from melanocytes of the choroid of the eyeball. It occupies a leading position in the structure of intraocular malignant neoplasms.

Aim. Тo analyze real-world clinical practice data on the use of nivolumab in combination with ipilimumab to treat patients with metastatic uveal melanoma.

Materials and methods. Fifteen patients with metastatic uveal melanoma received therapy with nivolumab and ipilimumab. The median age of patients was 53 years, the minimum age was 24 years, and the maximum was 71 years. The analysis included 9 (60%) men and 6 (40%) women. Evaluation of the functional status showed that 4 (26.7%) patients had ECOG 0 points, 6 (40%) – ECOG 1 and 5 (33.3%) – ECOG 2.

Results. The median relapse-free survival after enucleation of the eye was 61 months. Objective response to immunotherapy was achieved in 33.3% of patients, and the disease control rate was 86.6%. However, 4 (26.6%) patients discontinued therapy due to hepatotoxicity. The study noted that the median overall survival from the start of therapy with nivolumab in combination with ipilimumab reaches 8 months. It was found that the functional status of patients and the response to therapy are important predictors of survival, where patients with better indicators have a significantly higher life expectancy. Thus, patients with ECOG 0 show a median overall survival of 18 months.

Conclusion. Immune checkpoint inhibitors remain the mainstay of treatment for patients with metastatic uveal melanoma. Combined immunotherapy with nivolumab and ipilimumab can be considered as a possible treatment option for this category of patients in conditions of limited therapeutic options.

Hepatocellular carcinoma is the most common primary malignant neoplasm of the liver, accounting for more than 90% of cases. Before the introduction of targeted therapy, there were virtually no options for the treatment of unresectable HCC. Currently, sorafenib and lenvatinib are registered as first-line therapy for unresectable HCC. The introduction of the combination of atezolizumab and bevacizumab has significantly improved the results of HCC treatment. In the IMbrave 150 study, the median OS was 19.2 months in the atezolizumab and bevacizumab group and 13.4 months in the sorafenib group. The median progression-free survival was 6.9 and 4.3, respectively. The presented clinical observation describes a case of treatment of a patient with unresectable HCC, a large tumor burden and portal vein thrombosis. In the first line of therapy, we considered the combination of atezolizumab and bevacizumab. A rapid response to the therapy was obtained, a complete response was registered after 42 months of therapy with a combination of atezolizumab and bevacizumab. A minimum number of adverse events and satisfactory tolerability were noted. Currently, the patient continues therapy with this combination. Currently, an increasing number of patients receive therapy with atezolizumab and bevacizumab for a long time. Experience is accumulating in real clinical practice of monitoring patients who have been receiving a combination of immunooncologic and targeted drugs for a long time.

The article presents a clinical case of a patient with BRCA1-associated metastatic pancreatic cancer (mPC) who received first-line chemotherapy with mFOLFIRINOX followed by a transition to maintenance therapy with olaparib (300 mg 2 times a day). During the treatment, significant regression of the tumor and liver metastases, normalization of the CA-19-9 level (from 952 to 7 U/ml) were achieved. The patient underwent conditional radical surgery to remove the primary tumor, and olaparib therapy was continued. The clinical case illustrates the effectiveness of targeted therapy with PARP inhibitors in patients with BRCA1/2 mutations and emphasizes the importance of genetic testing in PCa and gives reason to think about the place of PARP inhibitors in adjuvant therapy. Nowadays olaparib is the standard of care for patients with gBRCA-mutated (including BRCA1) mPCa who have achieved disease control on first-line platinum-based chemotherapy. Long-term results are encouraging, demonstrating the potential for long-term disease control in a significant proportion of patients. Data on response to therapy and survival indicate a significant discrepancy in the effectiveness of treatment for patients with or without mutations. Thus, the median overall survival (OS) in BRCA-positive mPC without therapy is 8–12 months (which is comparable to sporadic mPC), and with chemotherapy (FOLFIRINOX/gemcitabine + cisplatin) it reaches 18–22 months. Maintenance therapy with olaparib after treatment with platinum drugs increases progression-free survival (PFS): 7.4 months versus 3.8 months without therapy. This indicates the high significance of BRCA1/2 testing in PC. The issue of surgical treatment of patients with mPCa who have responded positively to therapy remains highly controversial and requires further study. There is insufficient data on the adjuvant (after radical surgery) therapy regimen, but studies are underway (APOLLO, NCT04858334).

Introduction. Non-viral etiology of hepatocellular carcinoma (HCC) accounts for one third to one half of cases in European and American countries. In the 21st century, the role of non-alcoholic fatty liver disease is growing annually. Etiology affects the molecular genetic type of HCC, which is realized in the different effectiveness of targeted therapy and immunotherapy. Subgroup analysis of randomized trials confirms this fact. Studies of real clinical practice demonstrate similar or better treatment results with tyrosine kinase inhibitors in patients with non-viral etiology. Data on the effectiveness of HCC therapy of various etiologies in the Russian population are extremely limited and are of legitimate interest.

Aim. To study the long-term results of treatment of patients with non-viral HCC in routine practice.

Materials and methods. The retrospective study included patients over 18 years of age with a morphologically confirmed diagnosis of HCC established in 2021–2022, not subject to surgical or locoregional treatment due to its prevalence, without viral hepatitis, who received treatment with multikinase inhibitors at the Sverdlovsk Regional Oncology Dispensary. A total of 62 patients met the criteria: 32 received lenvatinib, 30 – sorafenib. HCC stage BCLC C was in 44 patients (71.0%), liver function according to Child–Pugh class B – in 10 (15.8%), AFP more than 400 ng/ml – in 17 (27.4

Results. First-line treatment was completed by 52 patients (83.9%), death was recorded in 40 patients (64.5%). The objective response rate was 25.8%, however, there were no complete responses, and all cases of response to treatment were partial – 16 out of 62 (25.8%). Stabilization was achieved in 39 patients (62.9%), and disease control was achieved in 55 patients (88.7%). Long-term disease control (more than 23 weeks) was 69.4% (in 43 patients). Disease progression at the first control (2–3 months after the start of treatment) was noted in 7 patients (11.3%). Second-line treatment was received by 18 out of 52 patients (34.6%). The median PFS was 10.5 months (95% CI 6.4–14.6), and the median OS was 20.5 months (95% CI 14.6 – n/a).

Conclusion. The obtained remote results of treatment of patients with non-viral HCC with tyrosine kinase inhibitors demonstrate the effectiveness and safety of the chosen approach. Further study of this group of patients is required not only in clinical practice, but also in prospective randomized trials.

The management of patients with metastatic melanoma remains a difficult clinical problem. Real-world practice of treating patients with encorafenib and binimetinib after progression on combination immunotherapy and combination targeted therapy demonstrates good tolerability and achievements in disease control, including the central nervous system. After progression on chemotherapy, combination targeted therapy, and combination immunotherapy, the patient developed extensive brain and spinal cord lesions and suffered from neurological symptoms (headache, neck pain, back pain, seizures). Rechallenge with BRAFi+MEKi inhibitors and switching to new generation drugs allowed us to achieve disease control, regression of neurological symptoms and a good quality of life for more than 12 months. This clinical case demonstrates the potential efficacy of rechallenge with combination targeted therapy and switching to newer class drugs, which helps achieve a long-term disease control and improve the patient’s quality of life. The article also provides a discussion of possible management strategies for patients who have progressed on currently available BRAFi + MEKi inhibitors.

Hormonal therapy is an effective treatment for luminal HER2-negative metastatic breast cancer (mBC). Aromatase inhibitors and fulvestrant are the mainstays of hormone therapy. Fulvestrant is both a competitive antagonist and a selective estrogen receptor degrader (SERD), this mechanism of action provides complete blocking of the estrogen signaling pathway. In the FALCON phase III study (n = 462), which included postmenopausal MBC patients who had not previously received any endocrine therapy, fulvestrant 500 mg was compared with the aromatase inhibitor anastrozole. Significant improvement in PFS was achieved with fulvestrant therapy compared to anastrozole: 16.6 months in the fulvestrant group versus 13.8 months with anastrozole [OR = 0.797; 95% CI 0.637–0.999; P = 0.0486]. A subgroup analysis showed that patients without visceral metastases can benefit most from taking fulvestrant. In all studies fulvestrant 500 mg has demonstrated a good toxicity profile, so it is being studied as a component of combined endocrine therapy. In the PALOMA-3 study the combination of fulvestrant with palbociclib (CDK4/6 inhibitor) demonstrated a median PFS 9.5 months, compared with monotherapy with fulvestrant – 4.6 months (HR = 0.46, p < 0.0001). In the MONALEESA-3 study, the median PFS in patients receiving ribociclib with fulvestrant was significantly higher compared to those taking placebo with fulvestrant: 20.5 months and 12.8 months, respectively (HR = 0.593; 95% CI: 0.480–0.732; p < 0.001). In the MONARCH-2 study the combination of fulvestrant and abemaciclib was studied in the second line of therapy, the median PFS was 16.4 months in the group of fulvestrant and abemaciclib, and 9.3 months in the group of fulvestrant and placebo (HR = 0.553; 95% CI 0.449–0.681; p < 0.0001). The SOLAR-1 study demonstrated the efficacy of the combination of fulvestrant + alpelisib (PI3K inhibitor) in luminal HER2-negative mBC associated with PIK3CA mutation in the first and second lines of therapy. The median PFS in the fulvestrant + alpelisib group was 11 months compared with 5.7 months in the fulvestrant group (HR = 0.65; 95% CI 0.50–0.85; p < 0.001). Based on clinical research data, the combination of aromatase inhibitors with CDK4/6 inhibitors is the optimal first-line treatment in patients with hormone-sensitive tumors, i.e. with progression more than 1 year after the end of adjuvant hormone therapy. While fulvestrant ± CDK4/6 inhibitors is used for disease progression on the background of adjuvant hormone therapy in the first line or as a second line for progression on aromatase inhibitor therapy for metastatic cancer. The combination fulvestrant + alpelisib is highly effective in the second-line treatment of luminal HER2negative breast cancer in the presence of a PIK3CA mutation.

Introduction. ABL tyrosine kinase inhibitors (TKIs) have significantly improved the treatment outcomes for patients with chronic myeloid leukemia (CML). Bosutinib is a second-generation TKI that has demonstrated high efficacy and safety in clinical trials in firstand subsequent-line therapy of CML.

Aim. To evaluate the long-term efficacy and safety of bosutinib in real-world clinical practice.

Materials and methods. In our retrospective study all patients in the first chronic phase of CML who had ever received bosutinib therapy as their first, second, or third TKI were included. Only 4 patients (2 men) aged from 30 to 41 years received bosutinib as first TKI. Bosutinib was administered as second or third TKI to 19 patients (12 men) with a median age of 50 (31–71) and 17 patients (8 men) with a median age of 49.8 (21–70), respectively. Most patients had a long history of CML and most of them were resistant to previous TKIs.

Results. All four patients who received bosutinib in the first-line achieved a complete hematological response (CHR), and three (75%) of them achieved a complete cytogenetic response (CCR) and a major molecular response (MMR). All 3 patients with MMR continued therapy for more than 16 years without significant adverse events. Among patients with bosutinib treatment after failure of imatinib or 2 TKIs, the CHR was achieved in most cases, and major cytogenetic response (MCR) was achieved in 7/19 (36.8%) and 6/17 (35.3%) cases. During the observation period, the median overall survival was not reached. There were few cases of bosutinib discontinuation due to drug intolerance. Long-term use of the drug did not lead to serious delayed side effects, including cardiovascular complications, associated with bosutinib therapy.

Conclusions. Thus, in our group of patients with long-term observation, bosutinib showed not only a high frequency of achieving an optimal response in all lines of therapy in CP CML, but also the absence of severe remote complications, both hematological and non-hematological.

significant decrease in the quality of life of patients, nutritional insufficiency, breaking of the chemotherapy therapy regimen. Nausea and vomiting worsen the result of chemotherapy and the prognosis of the disease. The oral combination of netupitant and palonosetron is a modern drug for the prevention of nausea and vomiting induced by chemotherapy. This combination includes a highly selective anatagonist of NK1-receptors netupitant at a dose of 300 mg and an antagonist of 5-HT3 receptors palonosetron at a dose of 0.5 mg.

Aim. To evaluate the antiemetic therapy regimen netupitant/palonosetron (NEPA, Akynzeo) + dexamethasone in breast cancer patients receiving AC chemotherapy (doxorubicin + cyclophosphamide) in real clinical practice.

Materials and methods. We conducted a single-center observational study. Patients with breast cancer receiving highly emetogenic chemotherapy (HEC) 4 cycles AC (doxorubicin 60 mg/m2 IV on the 1st day + cyclophosphamide 600 mg/ m2 IV on the 1st day once every 3 weeks or 2 weeks) as adjuvant or neoadjuvant therapy were included. All patients received netupitant/ palonosetron (NEPA, Akinzeo) + dexamethasone therapy. We evaluated complete response, absence of vomiting, absence of nausea, absence of significant nausea, and no use of rescue medication within 0-120 hours after chemotherapy after 1–4 treatment cycles. CINV was assessed using MASCC Antiemesis Tool. 52 patients were included.

Results. in the first cycle of therapy, a complete response (no vomiting and no use of rescue medication) was achieved in 100% of patients in the acute phase (0–24 hours), in 88.5% of patients in the delayed phase (24–120 hours), and in 88.5% of patients in the overall phase of therapy (0–120 hours). No patient developed vomiting during the 4 cycles. During  the  4  cycles, more  than  80%  of  patients  did  not  experience  nausea. Rescue  medication  was  required in 9.6% of patients during the 1st cycle, 11.5% of patients during the 2nd cycle, 15.3% of patients during the 3rd cycle, and 15.3% of patients during the 4th cycle. Constipation occurred in 7.7% of patients who received netupitant/palonosetron (NEPA, Akynzeo).

Conclusion. The combination of netupitant/palonosetron (NEPA, Akynzeo) for the prevention of CINV in patients with breast cancer receiving AC chemotherapy is effective and has a good safety profile in real-world clinical practice.

Introduction. This paper examines the treatment outcomes for patients with stage I and II non-small cell lung cancer (NSCLC) in real clinical practice. The frequency of molecular genetic testing of operated patients was determined, and long-term prognoses for the disease were determined depending on the volume of treatment.

Aim. To determine the effect of adding adjuvant treatment to radical surgery on the treatment outcomes in real clinical practice – overall and relapse-free survival. To determine the frequency and results of molecular genetic testing in patients with stage I–II NSCLC.

Materials and methods. The results were obtained during the study – clinical approbation of lung cancer (CARL-001). The study included 401 patients with stage I–IIB NSCLC. The study included 129 women and 272 men. The median age was 56 years. There were 272 patients with stage I disease, 129 with stage II. 83 patients received combined treatment, 318 patients received only surgical treatment. The median follow-up was 36 months.

Results. PD-L1 testing was performed in 31.7% of patients with stage II and in 14% of patients with stage I. The frequency of testing for mutations in the EGFR and ALK genes was 53.6% and 17.0% for stage II and 46% and 14.8% for stage I, respectively. Three-year overall survival of patients with stage IIA and adjuvant chemotherapy was higher compared to stage IIA patients who did not receive adjuvant treatment – 65% vs 69.24%. A similar indicator in patients with stage IIB also showed an advantage from adjuvant treatment 57.69% vs 72.86% in favor of those who received adjuvant. In patients with stage IIA and adjuvant therapy, 3-year relapse-free survival was 53.86% versus 50.0% without adjuvant. Among patients with stage IIB, the same parameter was 53.85% in the group without adjuvant versus 65.71% in the group that received adjuvant therapy.

Conclusions. Adjuvant polychemotherapy in patients with stage II disease has a positive effect on long-term treatment outcomes in the form of increased overall and relapse-free survival compared to patients with a similar stage of the disease without adjuvant treatment. Molecular genetic testing of patients with NSCLC allows us to identify the presence of activating mutations and PD-L1 expression, which is important information for planning further treatment tactics.

Introduction. Durvalumab is the first immunotherapy drug proven effective as consolidation therapy after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). The PACIFIC and PACIFIC-R trials confirmed significant survival benefits, but real-world data, including from Russian studies, show variability in outcomes.

Aim. To evaluate the effectiveness of durvalumab in real-world clinical practice in patients with stage IB-IIIC NSCLC after definitive CRT.

Materials and methods. A retrospective analysis of 81 patients (2021–2024) who received durvalumab after CRT (60 Gy ± 10%). Median age was 63 years; 78% were smokers. Histology: 75% squamous cell carcinoma, 23% adenocarcinoma. PD-L1 status: 22% ≥ 1%, 18% unknown. Progression-free survival (PFS) and overall survival (OS) were assessed using the Kaplan–Meier method.

Results. Median PFS was 14 months (95% CI: 12–22); OS at 28 months was 52%. Better PFS in squamous cell carcinoma (19 vs. 13 months in adenocarcinoma), but not statistically significant (p = 0.08). Significant PFS improvement in PD-L1+ (HR = 0.43; p = 0.025), but not OS (p = 0.053). Higher PFS in stages I–IIIA (22 vs. 12 months in IIIB-IV; p = 0.01), but no OS difference. Grade 3–4 adverse events in 15% (pneumonitis – 4.9%).

Conclusion. Durvalumab demonstrates clinically meaningful PFS improvement, especially in PD-L1+ patients and early-stage disease. However, its impact on OS requires further follow-up. Results align with PACIFIC but highlight the importance of individual factors (histology, PD-L1, stage).

Introduction. Despite the fact that several studies have found a correlation between the level of carcinoembryonic antigen (CEA) in the blood and the molecular subtypes of breast cancer (BC), there are limitations to using CEA as a cancer marker in the early stages of BC due to its lack of sensitivity. New approaches are needed to improve the methodology for using CEA in detecting BC.

Aim. To evaluate the effect of CEA on the production of cytokines by blood leukocytes in patients with BC with various molecular subtypes.

Materials and methods. Blood samples of 109 women with breast cancer aged 25–85 years were analyzed. Patients with breast cancer were divided into five subgroups according to the molecular subtype. Enzyme immunoassay was used to study spontaneous and CEA-induced cytokine production: IL-6, IL-8, IL-10, IL-18, IL-1β, IL-1Ra, TNF-α, IFN-γ, G-CSF, GM-CSF, VEGF and MCP-1. Results. In the luminal A subtype, there was a decrease in spontaneous and CEA-induced cytokine production compared to other molecular subtypes of breast cancer. When analyzing the ROC curves, it was found that exceeding the threshold values of the CEA influence index (II_CEA) on the production of TNF-α and G-CSF is characteristic of the luminal B HER2-negative subtype.
In the luminal B HER2 positive subtype, the following thresholds were exceeded: CEA of induced IL-6, IL-8, TNF-α and MCP-1 products; as well as II_CEA for IL-1Ra products. The HER2 positive subtype corresponded to exceeding the thresholds: spontaneous production of IL-8, G-CSF and MCP-1; CEA and II_CEA for GM-CSF products. The triple negative subtype was characterized by an increase in II_CEA thresholds for IL-8 products.

Conclusion. The determination of CEA-induced cytokine production by blood cells in patients with breast cancer makes it possible to identify molecular subtypes with an unfavorable outcome, in particular triple negative and HER2 positive subtypes even before surgery.

Introduction. According to foreign authors some laboratory markers and comorbidity are independent predictors of death in multiple myeloma (MM).

Aim. To identify risk factors associated with mortality in patients with MM.

Materials and methods. A retrospective analysis of 149 medical records of patients of the hematology department of the Regional Clinical Hospital with a diagnosis of multiple myeloma was carried out. The patients are divided into two groups depending on the clinical outcome: the 1^st  group includes 90 living patients; the 2^nd  group includes 59 patients whose death occurred in the hospital during the period from 2010–2019. Of the 149 patients: 87 women (58%), 62 men (42%). The mean age of the patients was 65.7 ± 8.7 years. The clinical, demographic and laboratory indicators of the groups were analyzed, and comorbidity was assessed using the Charlson index.

Results. In the 1^st  group of patients, there were 35 men (39%) and 55 women (61%). The ratio of men to women is 1:1.6. The mean age in this group is 67 ± 9.1 years. The 2^nd  group is represented by 27 (46%) men, 32 (54%) women. The mean age was 63.7 ± 7.6 years. In the 1^st  group of patients, all patients were diagnosed with stage III disease, with most patients in the subgroup associated with renal dysfunction (p = 0.002). Anaemia and markers of renal damage were more frequent in the group of deceased patients (p < 0.001, p = 0.002, respectively). Comparative analysis of laboratory indicators showed that in the haemogram of the group of living patients, the level of erythrocytes, haemoglobin, platelets was significantly higher than in group 2 (p < 0.05); the level of creatinine, urea was 1.8 times higher in the group of deceased patients than in the group of living patients (p < 0.05). Chronic heart failure was statistically significantly more common in the deceased group than in the living group (22% vs. 7.8%, p = 0.025). The incidence of pneumonia was higher in the deceased group than in the 1^st  group (p < 0.001).

Conclusion. Risk factors associated with mortality include manifestations of MM such as anaemia, thrombocytopenia, renal dysfunction and late diagnosis at stage III of the disease. Chronic heart failure, as a complication of cardiovascular disease, is a risk factor for adverse outcome. Comorbidity, infectious diseases (pneumonia) are associated with a worse prognosis, probably due to poorer tolerability of standard therapy.

Introduction. Access to modern methods of treatment and, consequently, innovative medicines, is one of the main indicators of the pharmaceutical industry development in the country and the healthcare system as a whole. The concept of “accessibility of medicines” can be considered in two aspects: physical and economic. Breast cancer confidently occupies the first place in the structure of oncological diseases among women. Since the beginning of 2023, doctors have identified 77 000 cases of breast cancer in Russia.

Aim. To assess the availability of innovative drugs used for the treatment of breast cancer on the Russian market.

Materials and methods. Data from open information sources were used as the analysis material: the IQVIA database; data on clinical trials in Europe and the USA; clinical guidelines of the Russian Federation. A search was also carried out in the scientific electronic libraries eLibrary and PubMed.

Results. From 2018 to 2023, the FDA approved 8 drugs and one diagnostic medicine for breast cancer. The European Agency has registered 6 medicines over the same 5-year period. In the Russian Federation, only three of these drugs have reached registration, and two more remain in Russian clinical trials with the status of “ongoing”.

Conclusions. Only one drug, Talazoparib (Talcenna, Pfizer), can be considered available to a Russian patient according to accepted criteria. Over the past 5 years, breast cancer therapy has focused on the new innovative drugs that have shown high efficacy in the treatment of severely treated patients or superior efficacy in comparison with established therapy algorithms.

Non-small cell lung cancer (NSCLC) is the second most common malignancy and the leading cause of cancer-related death worldwide. Platinum-based chemotherapy has been the standard of postsurgery care for early and locally advanced disease for many years, which only accounted for 4–5% increase in 5-year survival. Recent advances in biomarkers have altered the drug treatment paradigm for patients with NSCLC, first of all for advanced stages of disease. They were predictably integrated and successfully applied in the adjuvant settings, resulting in significant improvements in cancer care outcomes. Osimertinib was the first example of effective adjuvant targeted therapy in NSCLC for the treatment of tumours with epidermal growth factor receptor (EGFR) mutations, which updated the feasibility of using this strategy for other oncogenic drivers, in particular, ALK translocation. The Food and Drug Administration (FDA) approved alectinib as adjuvant treatment for anaplastic lymphoma kinase (ALK)-positive NSCLC on April 18, 2024. This approval was based on the results of the ALINA trial, which demonstrated that alectinib significantly prolonged a disease-free survival compared with the standard platinum-based chemotherapy. The clinical case described in the article demonstrates the experience of treating a 41-year-old woman with ALK-positive stage IIIA NSCLC, who started the postoperative therapy with alectinib after surgical treatment in November 2023.

Hepatocellular carcinoma (HCC) remains one of the leading causes of cancer mortality in the world, especially in regions with a high prevalence of viral hepatitis and cirrhosis of the liver. Systemic treatments remain the standard of treatment for common HCC. The most significant breakthrough was the appearance of a combination of the PD-L1 inhibitor Atezolizumab and the antiangiogenic drug Bevacizumab, which showed superiority over the tyrosine kinase inhibitor Sorafenib in key studies. A clinical case of treatment of a 61-year-old patient with advanced HCC on the background of cirrhosis of the liver of viral etiology, thrombosis of the portal vein and inferior vena cava with extrahepatic foci is presented. At the first stage, Atezolizumab and Bevacizumab were treated according to the first-line treatment protocol. Despite the development of immune-mediated toxic hepatitis and clinically significant bleeding, which required temporary discontinuation of treatment, repeated administration of the drugs led to a long-term stabilization of the process, confirmed by data from subsequent X-ray control studies. The case illustrates the effectiveness of a combination of immunotargeting therapy, including in patients with severe concomitant pathology, as well as the importance of a multidisciplinary approach and flexibility in correcting emerging complications.

Given the high prevalence and mortality from gastric cancer in the global population, interest in the treatment of this disease is growing. The standard treatment for locally advanced gastric cancer is a combined method that includes radical surgery with perioperative polychemotherapy. For gastric cancer with distant metastases and/or a peritoneal carcinomatosis index of more than 7, as well as for the locally advanced stage, polychemotherapy based on fluoropyrimidines (FP) (5-fluorouracil, capecitabine) is used, which are characterized by the frequent development of toxic reactions. Analysis of foreign literature data with presented clinical cases of FP toxicity demonstrated that characteristic adverse events when using FP are diarrhea, nausea/vomiting, mucositis, myelosuppression, neurotoxicity and palmar-plantar syndrome. Approximately 20–30% of patients receiving FP experience severe toxicity, which can lead to death in 1% of cases, with the main cause being a deficiency of the enzyme dihydropyrimidine dihydrogenase, Due to the lack of recommendations for testing mutations and polymorphisms in the DPYD gene for gastric cancer in the Russian Federation, information on the treatment of toxic post-chemotherapy phenomena in individual clinical cases is relevant. Of particular interest is the clinical observation of a forty-three-year-old patient with morphologically verified gastric adenocarcinoma, a peritoneal carcinomatosis index of 7 and the absence of other distant metastases. After three courses of chemotherapy with the inclusion of 5-fluorouracil and oxaliplatin, the patient developed severe hematological, gastrointestinal toxicity, polyneuropathy, and therefore, on a planned basis. A molecular genetic study was performed to determine the genotype of DPYD*2A/13 associated with a high risk of toxicity during chemotherapy. According to the results of the study, a germinal missense mutation NM_000110.4(DPYD): c.2194G>A (p.Val732Ile) was detected in the DPYD gene. The presented analysis of information from scientific sources and the data of our own clinical observation demonstrate the need to assess the status of the DPYD gene in patients subject to FP therapy. The issue of registering an antidote to 5-fluorouracil and capecitabine – uridine triacetate in the Russian Federation also remains open.

Non-small cell lung cancer (NSCLC) is a common type of malignant neoplasm that is the leading cause of cancer death worldwide. In the Russian Federation, according to statistical reports, there is also an increase in morbidity. Squamous cell histological variant of NSCLC is detected in 25–30% of lung cancer cases and belongs to unfavorable subtype. More than 10 years ago, chemotherapy was approved the treatment for metastatic squamous cell NSCLC only. In the era of checkpoint inhibitors, the number of treatment options for NSCLC has increased. The results of a double-blind, randomized, placebo-controlled phase III trial of KEYNOTE-407 showed undoubtedly better efficacy of the combination of pembrolizumab + chemotherapy compared with chemotherapy and placebo in patients with metastatic squamous cell carcinoma in terms of median progression-free survival –8.0 versus 5.1 months and median overall survival – 17.1 versus 11.6 months. This article presents a clinical observation efficacy combination of pembrolizumab and standard chemotherapy for the treatment of metastatic squamous cell NSCLC with high tumor burden. A significant reduction in disease symptoms and partial response were recorded after two courses of chemoimmunotherapy. Complete response achieved after four courses. Maintenance therapy with pembrolizumab was prescribed. According to the results of chest CT scans in March 2025, a complete response was maintained. Combination of pembrolizumab and chemotherapy in real clinical practice of therapy of a patient with a big tumor burden of squamous cell NSCLC demonstrates high efficacy in the treatment.

Introduction. MALT lymphoma is a rare histological type of malignant lung disease that develops from lymphoid tissue. This type of lymphoma belongs to the non-Hodgkin lymphomas. Given the lack of a standardized treatment protocol for patients with pulmonary MALT lymphoma, this study presents a case observation of the treatment of this disease. Each case observation is crucial for establishing a unified treatment strategy.

Aim. To demonstrate the effectiveness of comprehensive treatment in two patients with pulmonary MALT lymphoma.

Methods. This study presents two clinical cases of successful treatment of patients with MALT lymphoma at the regional clinical oncological dispensary in Ulyanovsk. The authors present their observations and describe the treatment regimens used. One patient underwent a tumor biopsy, which was inconclusive. Given the non-specific clinical presentation and the CT findings of a mass in the right lung with an undetermined histogenesis, as well as mediastinal involvement, surgical intervention was indicated for the morphological diagnosis of the lung mass. In both cases, targeted support with Rituximab was included in the treatment regimen. One case involved five courses of R-B therapy without progression, while in the other case, targeted therapy is planned as the next step after polychemotherapy.

Conclusions. MALT lymphoma is a rare nosological form. According to the authors, the most optimal treatment method is a combined approach, which includes surgical treatment, polychemotherapy, and subsequent targeted therapy.