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Background. Post-registration observational studies with switching therapy from the original drug to a biosimilar for non-medical indications allow us to assess the safety and effectiveness of this type of switching in real clinical practice. Aim. Evaluation of the safety and effectiveness of non-medical switching from the original drug Keytruda® to the biosimilar drug Pembroria® in patients with various oncological pathologies in real clinical practice (REFLECTION). Materials and methods. A retrospective analysis of data from electronic medical records from 21 medical institutions of the Russian Federation for the period 2020–2023 was carried out. Data were included from patients with cancer of various locations who received at least 2 injections of Keytruda® followed by switching to Pembroria® for non-medical indications (at least 2 injections). Primary criteria: incidence of immune-mediated adverse reactions (ImARs) of any severity. Secondary indicators: incidence of ImARs of various degrees of severity and infusion reactions, frequency of objective response rate (according to RECIST 1.1 criteria). Results. The analysis included data from 382 patients (male/female 200/182, median age 62 years) with NSCLC (24.1%), RCC (23.3%), melanoma (20.4%) and cancer of other localization. Patients received Keytruda® on 1st and 2nd lines (54.2 and 25.4% of patients, respectively), on 3 or 4 lines (14.1%), or as part of adjuvant therapy (6.3%). 50.5% of patients received pembrolizumab as monotherapy. The median number of administrations was 7.0 and 5.0 for Keytruda® and Pembroria®, respectively. ImARs were registered in 44 (11.5%) patients (60 ImARs), including 40 ImARs in 35 (9.2%) patients while using Keytruda® and 20 ImARs in 17 (2.4%) patients with Pembroria®. The most common ImARs were hypothyroidism, hyperthyroidism, and hepatitis; the frequency of these ImARs was higher with Keytruda® (EAER for hypothyroidism 0.00422 and 0.00144, for hepatitis – 0.00124 and 0.00096, respectively). All 5 reported cases of hyperthyroidism in patients on Keytruda® (EAER 0.00124), were resolved before switching to Pembroria®. No infusion-related reactions or deaths due to ImARs have been reported. The objective response rate was comparable – 104 (32.6%) and 90 (29.2%) patients оn Keytruda® and Pembroria® therapy, respectively. Most patients maintained disease control after switching to Pembroria® [progression was recorded in 29 (9.4%) patients after switching to a biosimilar]. Conclusion. The safety profiles of Keytruda® and Pembroria® were satisfactory and comparable in this study. Switching from therapy with Keytruda® to Pembroria® is not accompanied by an increase in the frequency or severity of ImARs. Switching from Keytruda® to Pembroria® maintains disease control in most patients.

Cholangiocarcinoma ranks second in the prevalence among primary malignant neoplasms of the liver. The paper discusses epidemiology, classification, risk factors of the disease, as well as the treatment approaches used all over the world, including surgical and interventional techniques, and drug therapy of the locally advanced and metastatic cholangiocarcinoma.

Gastric cancer remains one of the most common malignancies in Russia. Despite steady decrease of gastric cancer incidence it still reaches 24.65 per 100 000 population (crude rate) in 2019 with about 36 000 new cases annually. More than 29 000 people die of gastric cancer every year. High mortality rate is mostly caused by an extremely significant proportion of patients with metastatic disease which reached 40.1% in 2019. The majority of cases is related to Helicobacter pylori infection, salty diet, tobacco exposure as well as hereditary syndromes. Staging of locally advanced gastric cancer includes contrast-enhanced computed tomography of the thorax, abdomen and pelvis as well as diagnostic laparoscopy with peritoneal washings. In patients with inoperable or disseminated cancer of the stomach additional analysis for HER2, microsatellite instability and PD-L1 status is recommended. Endoscopic or laparoscopic resection remains the mainstay of treatment in patients with early cancer. Laparoscopic gastrectomy in patients with locally advanced cancer is reserved for high-volume centers with extensive experience with the procedure. Recently, perioperative cytotoxic therapy became the standard of treatment in patients with locally advanced gastric cancer. FLOT regimen is recommended while FOLFOX6 or XELOX are considered possible in the elderly or frail patients. Drug therapy includes standard doublet or triplet chemotherapy regimens for metastatic disease with trastuzumab for HER2(+++) patients. Patients with MSI-H tumors can be treated with pembrolizumab starting with 2nd line while nivolumab is reserved for the 3rd and further lines regardless of PD-L1 status. Importantly, this year guidelines include multimodal prehabilitation including physical exercise, nutritional support and psychological counselling as a possibility in all patients in need of surgery. Also standardized enhanced recovery protocols are recommended for usage during the perioperative period.

According to the official statistics, by the beginning of 2021, the overall number of registered HIV cases in Russia exceeded 1.1 million. For about 100 000 new HIV-infected patients have been registered annually in Russia recent years. Russia occupies one of the leading places in the incidence of HIV infection, and the growth rate of new HIV cases is not decreasing. HIV-infected patients have higher incidence of malignant neoplasms (MN) in comparison with the overall population and have the highest cancer mortality rates. The problem of HIV-associated malignancies is at the junction of two socially significant issues, and this situation especially taking into account in Russian Federation. The problems of diagnosis and treatment of MN are becoming topical, and it is extremely important to study HIV-associated malignancies epidemiology in the Russian Federation. This will help to create effective algorithms for organizing dispensary observation for HIV infected people, will help to early diagnosis of the disease, timely initiation of treatment and, as a result, will help to achieve the best oncological results.

HIV infection refers to socially significant diseases. As a result of the wide coverage of effective antiretroviral therapy for people living with HIV, the rates of AIDS-related mortality have significantly decreased. At the same time, there was a noticeable increase in morbidity and mortality from other non-AIDS-related diseases, not the last place in this list is occupied by malignant neoplasms. A decrease in the frequency of AIDS-associated tumors and an increase in the proportion of AIDS-unassociated tumors are significant changes in the structure of malignant neoplasms. There is a complex relationship between HIV-induced immune suppression, chronic antigenic stimulation and concomitant oncogenic viral infections, which increases the risk of developing malignant tumors in these patients. People living with HIV have higher rates of cancer mortality associated with both the lack of adequate antitumor therapy, complications of treatment, and the existence of a direct relationship between immunosuppression and tumor progression. This article analyzes the problems that arise in the treatment of oncological HIV-infected patients, and offers specific practical steps to solve complex interdisciplinary problems.

Prostate cancer (RPP) is a malignant neoplasm that arises from the epithelium of the prostate gland gland (PJ). Thethiology and pathogenesis of this disease remain poorly studied. Many studies are aimed at studying diet, food, hormonal impact, as well as infections in the etiology of the RLPG. The prevalence of RPL depends on ethnic and geographical features. The highest incidence of African Americans living in the United States (60% higher than that of white Americans), the least high - in the Chinese living in China [1]. In addition to racial features, the risk factors of the RPG are considering the genetic predisposition, the age of men and nutritional features. The probability of developing a PJ tumor in a man who has one of the closest relatives of the first degree of kinship (father or brother) sick of the RLPG, is 1.8 times higher than in the population. If two relatives were sick or more (father and brother or both brothers), the risk of RPG increases in 5.51 and 7.71 times, respectively [2, 3]. African Americans have an increased risk of identifying RPG, as well as a greater probability of detecting aggressive RPG [4]. Also, the risk of RLPG is rising in men who use a large amount of animal fats [5].

Relevance. Peripheral T-cell lymphomas (PTCL) comprise a heterogeneous group of aggressive lymphoproliferative malignancies that account for approximately 10% of adult non-Hodgkins lymphomas. Despite the variety of PTCL subtypes, CHOP-like regimens are the standard first-line therapy in most cases. At the same time, the level of complete remissions at the using these schemes is about 39%, the 2-year event-free survival rate does not exceed 45%. The possibilities of subsequent therapy of patients are very limited: the median overall survival after relapse is only 6.5 months. The most significant results were obtained only in patients with relapses of anaplastic large cell lymphoma after the use of the targeted drug brentuximab vedotin BV (conjugate of a CD30-directed monoclonal antibody and an antitumor agent). Given the favorable safety profile of this drug, a phase 3, double-blind, randomized study (ECHELON-2) was initiated and conducted comparing the efficacy and safety of the combination of BV with CHP (cyclophosphamide, doxorubicin, prednisolone) (BV+CHP) and standard CHOP regimen in previously untreated patients with CD30-positive PTCL. Aim. Discuss the entire spectrum of unmet medical needs in the treatment of patients with PTCL and adapt existing approaches taking into account new therapeutic options (results of the protocol ECHELON-2). Results. The advantages of the BV+CHP regimen in the treatment of previously untreated patients with CD30-positive PTCL were recognized as convincing. Given the lack of real therapeutic options, it is recommended to register in Russia a broad indication for BV: treatment of previously untreated CD30-expressing peripheral T-cell lymphomas (in combination with CHP). It was considered expedient to include the BV+CHP regimen in the updated Clinical Guidelines for the Treatment of Lymphoproliferative Diseases.

Multiple myeloma

Differentiated thyroid cancer

One of the integral components of modern large-scale research projects in the field of medicine are biobanks. The main objective of this infrastructure is the professional collection of biological samples that can be studied with respect to a wide range of molecular biological parameters and will not lose their information value over a long storage period. These samples are made informative not only by correctly conducted preanalytical preparation at the stage of taking samples and placing them in storage, but also by detailed information support (the so-called annotated samples). The sample annotation is the fully collected personal, clinical and laboratory data about a patient. An important point of the biobank infrastructure is compliance with regulatory legal acts and ethical standards, including the procedure for signing an informed consent by a patient about voluntary donation of biological samples and the use of personal data. All this ensures the implementation of the main objective of creating biobanks the wide and uninterrupted availability of collections of biological material for researchers and developers and compliance with specific scientific tasks. This review is devoted to biobanking issues, as well as to the description and analysis of the currently existing oncological biobank infrastructure, both globally and within the Russian Federation.

Azoximer bromide (AZB) was identified as an immunomodulator, and was initially developed and currently successfully indicated as one of several natural polyelectrolytes, a vaccine adjuvant, and an effective agent for the treatment of infectious and inflammatory diseases of viral, bacterial, and fungal origin. AZB has the potential to increase an individual’s resistance to local and general infection and is indicated for the treatment of viral infections, and has also demonstrated clinical efficacy in the treatment of a variety of secondary immunodeficiencies. However, AZB may offer long-term promise beyond use against infection. Multiple clinical trials and research studies in cancer patients have reported favourable outcomes with AZB as well as an optimal safety and tolerability profile. The findings raise the possibility of direct antitumor properties. This literature review analyses the novel mechanisms that mediate the AZB direct anticancer effects. Overall, the evidence suggests that AZB has the hallmark of an agent that could be used to support existing cancer treatments at different stages of disease.