ISSN (print): 1815-1434, ISSN (online): 1815-1442 Founder: Meditsinskie izdaniya Editor-in-Chief: Poddubnaya Irina Vladimirovna, Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor Frequency / Access: 4 issues per year / Open Included in: White List (4th level), Higher Attestation Commission List, RISC, Scopus
Authors who publish with this journal agree to the following terms: Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International Licensee (CC BY-NC-SA 4.0) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal. Authors are able to use published version of the work for educational and not-for-profit proposes (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access). All the Copyright statements for authors are present in the standart Publishing Agreement (Public Offer) to Publish an Article in an Academic Periodical 'JOURNAL OF MODERN ONCOLOGY'. READ the details online (tap to see in details) Publishing Agreement (Public Offer) to Publish an Article in an Academic Periodical 'JOURNAL OF MODERN ONCOLOGY' The editorial board of the JOURNAL OF MODERN ONCOLOGY (ISSN 1815-1434 (Print), ISSN 1815-1442 (Online), mass media registration certificate ПИ № ФС 77-63964 dated 18.12.2015, ЭЛ № ФС 77-69203 dated 24.03.2017) represented by editor-in-chief Irina V. Poddubnaya, acting under the Charter (hereinafter referred to as the Licensee), on one side, and the representative of the authors' team (hereinafter referred to as the Licensor), on the other side, hereinafter together referred to as Parties, have concluded this agreement (hereinafter referred to as Agreement) on publication of scientific work (hereinafter referred to as Work) in the JOURNAL OF MODERN ONCOLOGY (hereinafter referred to as the Journal) under the terms and conditions set forth below. General provisions This Agreement under clause 2 Art. 437 of the Civil Code of the Russian Federation is a public offer (hereinafter referred to as Offer), full and unconditional acceptance of which following Art. 438 of the Civil Code of the Russian Federation is deemed to be the submission by the Licensor of the Work by uploading it to the online electronic system for accepting manuscripts for review in the relevant section of the Journal's website on the information and telecommunication network Internet (hereinafter referred to as the Internet). Terms used in the Agreement Acceptance of the Offer is full and unconditional acceptance of the Offer on the terms and conditions specified in paragraph 4 of the Agreement (the Licensor accepts the Offer by sending an Application to the Licensee — uploading the Work and accompanying materials in the online electronic system of acceptance of articles for review in the relevant section of the Journal's website on the Internet). The Journal is a peer-reviewed scientific journal registered as a mass medium in the register of Roskomnadzor (the mass media registration certificate ПИ № ФС77-64546 dated 22.01.2016). The Application is an electronic application of the Licensor to the Licensee for publication of the Work in the Journal by uploading the Work and accompanying materials to the online electronic system of accepting manuscripts for review in the relevant section of the Journal's website on the Internet. The Licensor is an individual, a representative of the authors' group, by whose creative work the Work was created. The Licensee is the Editorial Board of the mass medium JOURNAL OF MODERN ONCOLOGY represented by the Editor-in-Chief. Metadata is information in Russian and English intended for inclusion in International Scientific Databases (ISDB), namely: the title of the Work; information about the authors (last name, first name, patronymic of the author (authors) in full, place of work of each author indicating his/her postal address, contact information (email), ISDB identifiers for each author; abstract; keywords; subject heading: UDC or other library and bibliographic classification and subject indexes; bibliographic list (references). Offer is this document (offer to the Licensor) to publish the Work by posting it on the Journal's website. Work is the result of fundamental and/or applied scientific research in the form of scientific material, review scientific material, scientific communication, bibliographic review on certain topics of scientific research, historical note on figures of Russian and foreign science, submitted by the Author for publication in the Journal. Publication is placement of an Article in the Journal. Article is a Work that has undergone the process of review and editorial processing. Parties are the Licensor and the Licensee. Requirements for manuscripts are the requirements for materials published in the Journal, available in the "Authors" section of the Journal's website on the Internet. Subject of the Agreement (Offer) Under this Agreement, the Licensor grants to the Licensee an exclusive license to use the Work, free of charge, within the limits and for the period specified in the Agreement. The Licensor warrants that it holds the exclusive copyright in the Work transferred to the Licensee. Rights and obligations of the Parties The Licensor grants c Licensee the following rights for the duration of the exclusive rights to the Work: the right to review and, if the manuscript of the Work is accepted, to make literary and scientific editing and proofreading; the right to reproduce the Work (to publish, make public, duplicate, replicate or otherwise reproduce the Work) without limitation of the number of copies (upon that each copy of the Work shall contain the name of the author of the Work); the right to distribute the Work by any means throughout the world; the right to post the Work in electronic format on the Journal's website; the right to translate the Work into any languages; the right of public disclosure; the right to use the metadata (title, author's (copyright holder's) name, abstracts, bibliographic materials, etc.) of the Works by disseminating and making available to the public, processing, and systematization, as well as inclusion in various databases and information systems on the Internet in the public domain; the right to assign, on contractual terms, some or all of the rights obtained hereunder to third parties without payment of remuneration to the Work. Other rights not expressly granted to the Licensee hereunder, including patent rights in any processes, methods, or techniques and the like described by the Licensor in the Work, as well as trademark rights, are reserved by the Licensor and other rights holders. The Licensee has the right to request, and the Licensor undertakes to provide, if necessary, source (raw) data as well as other information and documents required for an objective review of the manuscript of the Work and compliance with ethical standards of scientific and medical publications therein (e.g., copies of the ethics committee resolution, informed patient consent, etc.). The Licensee undertakes to observe the copyrights stipulated by the current legislation, the Licensor's rights, as well as to protect them and to take all possible measures to prevent infringement of copyrights by third parties. The territory in which the rights to the Works may be used is unlimited. The Licensor also grants the Licensee the right to store and process the following personal data without a time limit for all authors of the Work: name, patronymic, last name; date of birth; educational background; information on the place of work and the position held; information on the published works of literature, science and art; the international identification number ORCID and the data contained therein. Personal data are provided for their storage and processing in various databases and information systems, their inclusion in analytical and statistical reporting, the creation of a reasonable connection between the objects of science, literature, and art with personal data, etc. The Licensee has the right to transfer this data for processing and storage to third parties, provided that the Licensee notifies the third party of this fact and provides information about the third party (name and address) to the Licensor. Warranties and responsibilities of the Parties At the time of signing this Agreement, the Licensor warrants that it holds the exclusive copyright in the Work transferred to the Licensee and that at the time of granting the Licensee the right to the Work, it has not given any instructions that would conflict with the rights transferred to the Licensee under the Agreement. The Licensor warrants that this Work has not been previously contractually transferred to anyone for reproduction or other use. The Licensor warrants that the Work does not contain any copyrighted material of which it is not the copyright holder. If the Work incorporates copyrighted material owned by another person, the Licensor undertakes to obtain at its own cost and expense all necessary rights to use this material in the Work and to bear the property liability associated with the unauthorized use in the Work of copyrighted material belonging to other authors or other right holders. The Licensor agrees to indemnify the Licensee against all third-party claims caused by or arising out of any breach of the warranties and obligations stipulated above. The Licensor confirms that it has read and understood the instructions for authors and the publication ethics for authors and typical examples of violations (including plagiarism, multiple submissions, improper authorship, and other examples of violations). If any material in the Work is found which is not owned by the Licensor, or any other infringement in accordance with cl. 3.4. the Licensor may be denied placement of the Work. If the Work has already been published at the time such material or infringement is discovered, it may be revoked (retracted) or withdrawn entirely from the electronic version, in accordance with international and national guidelines and recommendations on publication ethics of scientific journals (including https://publicationethics.org and https://rasep.ru/sovet-po-etike/deklaratsiya). The Licensee is not account for the content of the Work. In the event of disputes concerning the rights to the work, the Licensor takes full responsibility for the settlement of these disputes and bears moral and financial responsibility. The Parties shall be liable, under the current legislation of the Russian Federation, for non-fulfillment or improper fulfillment of their obligations under this Agreement. The Party that improperly performs or fails to perform its obligations hereunder shall be obliged to reimburse losses incurred by the other Party, including lost profits. Acceptance of the Offer and conclusion of the Agreement Term of the Agreement This Agreement shall become effective on the date of its conclusion when the Licensor accepts the Offer by sending the Application to the Licensee and shall be valid for the duration of the exclusive rights to the Article. Acceptance of the Offer by the Licensor creates an Agreement concluded in writing (Articles 438 and 1286.1 of the Russian Federation Civil Code) on the Offer conditions. Procedure for amendment and termination of the Agreement The Licensee has the right to unilaterally change the terms of this Agreement by notifying the Licensor through the Journal's website or by sending a notice via e-mail to the e-mail address of the Licensor specified in the Application of the Licensor at least ten (10) calendar days prior to the effective date of the relevant changes. The amendments shall become effective on the date specified in the notice. In case the Licensor disagrees with the changes in the terms of this Agreement, the Licensor has the right to send the Licensee a written notice of withdrawal from this Agreement by uploading the notice to the online electronic system of accepting articles for review available in the relevant section of the Journal's website) or sending the notice to the official e-mail address of the Editorial Board on the Internet) This Agreement may be brought to an early termination: by mutual consent of the Parties at any time; on other grounds stipulated by this Agreement. The Licensor has the right to unilaterally withdraw from this Agreement by giving the Licensee a corresponding notice in writing not less than sixty (60) calendar days prior to the intended date of publication of the Work by the Licensor in the Journal. Termination of the Agreement for any reason shall not relieve the Parties from liability for breach of the terms and conditions of the Agreement arising during the term of its validity. Liability For non-fulfillment or improper fulfillment of their obligations under the Agreement the Parties shall be liable in accordance with the current legislation of the Russian Federation. All information provided by the Licensor must be accurate. The Licensor is responsible for the accuracy and completeness of the information transferred to the Licensee. When using inaccurate information received from the Licensor, the Licensee shall not be liable for any adverse consequences caused by its actions based on the provided inaccurate information. Concerning the content of the Article, the Licensor shall be solely responsible for compliance with the requirements of Russian legislation on advertising, protection of copyright and related rights, protection of trademarks and service marks, and protection of consumer rights. The Licensee shall not have any liability under the Agreement: for any actions resulting directly or indirectly from misconduct of the Licensor; for any losses of the Licensor regardless of whether the Licensee could have foreseen the possibility of such losses or not. The Licensee shall be exempt from liability for breach of the terms and conditions of the Agreement if such breach is caused by force majeure, including actions of public authorities (including the adoption of legal acts), fire, flood, earthquake, other natural disasters, power outage and/or computer network failures, strikes, civil unrest, riots, any other circumstances. Dispute settlement procedure Disputes and disagreements shall be resolved by the Parties by negotiations and in case of failure to reach an agreement following the current legislation of the Russian Federation. In case of unresolved disputes between the Parties, the disputes shall be resolved in the court according to the location of the Licensee following the current legislation of the Russian Federation. Other terms and conditions Any notifications, messages, requests, etc. (except for the documents to be sent in the form of original copies under the legislation of the Russian Federation) shall be deemed received by the Licensor if they have been transmitted (sent) by the Licensee via the Journal's website (including by publication), by fax, by e-mail specified in the Application and other communication channels. The Parties acknowledge the legal validity of notices, messages, requests, etc., transmitted (sent) in the abovementioned ways. In case of claims against the Licensee related to the infringement of exclusive copyright and other intellectual property rights of third parties in the creation of the Article or in connection with the conclusion of this Agreement, as well as in connection with the use of the Work by the Licensee in accordance with the Agreement, the Licensor shall be obliged: immediately upon receipt of the Licensee's notice, take measures to settle disputes with third parties, if necessary, enter into litigation on the side of the Licensee and take all actions in its power to exclude the Licensee from the list of defendants; reimburse to the Licensee the legal costs incurred, costs and losses caused by the application of measures of securing the claim and execution of a court decision, and amounts paid to a third party for violation of exclusive copyright and other intellectual property rights, as well as other losses incurred by the Licensee due to non-compliance with the guarantees provided by the Licensor under this Agreement. Registered office address and administrative details of the Licensee Editor-in-Chief, Journal of Modern Oncology Irina V. Poddubnaya Publisher: Consilium Medicum Address: Moscow, ul. Alabyan d. 13, k. 1, etazh 3, pom. XXVIIIA Taxpayer Identification Number (INN): 7714456747; Tax Registration Reason Code (KPP): 774301001; Primary State Registration Number (OGRN): 1197746753137; Russian Business and Organization Classification (OKPO): 42874998.
Evaluation of drug-drug interactions in patients receiving FOLFOX chemotherapy: A prospective study
Aim. To evaluate the frequency and clinical significance of drug-drug interactions (DDI) in patients receiving drug antitumor therapy using the Drugs® and Medscape® DDI calculators. Materials and methods. The study included 282 patients with a mean age of 65 years (36–84) who received FOLFOX chemotherapy, of whom 151 (53%) were males and 131 (47%) were females. At the start of the first course of chemotherapy, 214 (75%) patients were receiving concomitant therapy on a regular basis. Results. The odds of severe toxicity in patients receiving concomitant therapy were 2.720 times higher [95% confidence interval (CI) 1.025–7.218; p=0.038]. Patients with strong DDI were statistically significantly more likely to develop mucositis after the first course of drug antitumor therapy: 14 (38.9%) vs 36 (20.2%) according to Drugs®, p=0.041; 22 (33.3%) vs 28 (18.9%) according to Medscape®; p=0.036. Similar results were obtained in a subgroup of patients at risk of QT prolongation according to Drugs® – 10 (52.6%) vs 40 (20.5%); p<0.001. Patients taking calcium channel blockers were statistically significantly more likely to develop dose-limiting toxicity: 18 (40.9%) vs 52 (21.8%). The odds of dose-limiting toxicity were 2.476 times higher: 95% CI 1.261–4.864; p=0.007. Conclusion. The incidence of DDI in patients with gastrointestinal tumors receiving FOLFOX best supportive therapy can be as high as 90.2%, with one in three DDI classified as serious. Drugs® and Medscape® DDI services cover only 80% of concomitant medications and are not adapted to oncology, necessitating the development of more versatile approaches.
Copyright (c) 2025 Consilium Medicum https://creativecommons.org/licenses/by-nc-sa/4.0
Development of diabetes mellitus on the background of immunotherapy in patients with malignant neoplasms: A retrospective study
Background. Endocrinopathies are a subset of immune-related adverse events (irAEs) associated with immune checkpoint inhibitor (ICTI) immunotherapy, of which diabetes mellitus (irDM) is one of the most serious. Aim. To describe peculiarities of DM development against the background of immunotherapy in patients with malignant neoplasms on the example of a series of clinical cases. Materials and methods. Seven patients with melanoma, non-small-cell lung cancer and renal cancer aged 43 to 69 years, who developed DM against the background of immunotherapy (nivolumab, ipilimumab, pembrolizumab, atezolizumab both as monotherapy and combined treatment) were included in the retrospective study. Results. Partial response was observed in 1 patient, stabilization – in 6 patients. The median of time before the development of DM was 10.13 months. Complications of DM were observed in 4 patients, and other irAEs developed in 5 patients. Fatal outcome was observed in 2 patients, due to progression of the underlying disease (1 patient) and development of coma due to insulin-dependent DM (1 patient). Conclusion. IrDM is a rare but extremely serious complication of ICTI therapy that requires clear definition of diagnostic criteria. Identification of premorbid predictors of irDM may allow for targeted treatment trials and earlier detection of this complication of ICTI therapy.
Safety and toxicity of first-line combination therapy in patients with advanced renal cell carcinoma: A real-world retrospective study
Background. Preference regimens in line 1 therapy for advanced renal cell carcinoma (RCC) are combinations based on immuno-oncology (IO) drugs. The efficacy and safety of combination therapy have been demonstrated in large, randomized phase III clinical trials involving patients with satisfactory performance status and without severe organ dysfunction or comorbidities that could potentially impact treatment outcomes. The characteristics of patients receiving combination immunotherapy (IO-IO) or immunotargeted therapy with tyrosine kinase inhibitors (IO-TKIs) in real-world practice generally differ significantly from the profile of patients who meet the inclusion criteria for registration randomized clinical trials. The lack of comparative studies on IO-IO and IO-TKIs does not allow for a reasonable choice between these regimes in real-world practice, including from a safety perspective. Aim. Comparative assessment of safety and toxicity of first-line combination therapy in patients with advanced RCC treated with IO-IO or IO-TKIs in real-world practice. Materials and methods. A retrospective study conducted at the Moscow City Clinical Hospital named after S.S. Yudin from 07.07.2019 to 22.10.2024 included 194 patients ≥18 years old with verified advanced RCC who received first-line therapy with IO-IO [nivolumab with ipilimumab, 94 (48.5%) patients] or IO-TKIs [100 (51.5%) patients: pembrolizumab plus axitinib – 85 (43.7%), pembrolizumab plus lenvatinib – 10 (5.2%), nivolumab plus cabozantinib – 5 (2.6%)]. The median follow-up duration was 28.4 (1-63) months. In all patients during therapy, adverse events (AEs), dose reductions, interruptions in therapy, and discontinuations of therapy due to AEs were recorded. Results. No new safety signals emerged at a median duration of line 1 therapy of 11.1 (1.0-55.9) months. The incidence of any AE was 88.1%, including severe AEs in 42.3% of patients. The most common grade ≥3 AEs were hypertension (HTN) at 10.8%, transaminase increased at 10.8%, diarrhea at 7.2%, and creatinine increased at 5.2%. Risk factors for severe toxicity are baseline hypertension (p=0.001) and the neutrophil-to-lymphocyte ratio (NLR) ≥3 (p=0.012). IO-TKIs compared to IO-IO were associated with a higher incidence of severe AEs (p=0.008), as well as skin and mucosal AEs (p=0.042), gastrointestinal AEs (p=0.015), and hypertension (p<0.0001), but a lower incidence of nephrotoxicity (p=0.045). Conclusion. In real-world practice, in patients with advanced RCC treated with IO-IO and IO-TKIs as first-line therapy, the safety and toxicity of treatment regimens were comparable to the results of registration studies. IO-TKIs were associated with a higher incidence of severe AEs and certain types of AEs (skin, gastrointestinal, hypertension), but a lower incidence of nephrotoxicity compared to IO-IO.
Myelodysplastic syndrome during therapy with immune checkpoint inhibitors: A clinical case
Immune checkpoint inhibitors (ICIs) are widely used in the treatment of patients with solid tumors and lymphoproliferative diseases. However, these agents may cause immune-mediated adverse events, including the myelodysplastic syndrome (MDS) as a rare but serious hematologic side effect. The development of MDS during ICI therapy is usually associated with hyperactivation of the immune system, leading to autoimmune damage to the bone marrow. A clinical case of MDS (refractory anemia without sideroblasts) during ICI therapy is presented. In a 77-year-old patient with stage IV melanoma without a primary site, a persistent decrease in hemoglobin was noted during combination immunotherapy (ipilimumab 1 mg/kg + + nivolumab 3 mg/kg). During the examination, other causes of anemia were excluded – the most common being deficiencies of iron, vitamin B12, and folic acid. A negative Coombs test and normal levels of bilirubin and lactate dehydrogenase ruled out erythrocyte hemolysis. A decrease in the reticulocyte count and the appearance of a significant fraction of immature forms suggested bone marrow dysfunction. Prednisolone and erythropoietin therapy led to only a slight increase in hemoglobin levels, precluding continuation of ICI immunotherapy. Due to the lack of response to supportive therapy, the diagnostic evaluation was continued, and an iliac bone marrow biopsy was performed. The morphological study showed refractory anemia without sideroblasts, an MDS variant. Therefore, the anemia was due to a clonal erythropoietic disorder. This case highlights the need for a comprehensive anemia diagnosis in patients receiving ICIs. In the lack of a response to immunosuppression, after excluding other possible causes of anemia in cancer patients, clonal hematopoietic disorders, including MDS, should be considered. The concomitant MDS requires a multidisciplinary approach to balance the efficacy of cancer therapy with hematologic risks.
Following in the footsteps of ASCO-2025: TOP studies that will change the treatment strategy of advanced HR+ and HER2+ breast cancer. A review
This review summarizes the six most significant clinical studies on the treatment of advanced hormone-dependent and HER2-positive (HER2+) breast cancer (BC), presented at the ASCO congress in 2025. Among the new data on overcoming hormone resistance, the assessment of overall survival in patients with early relapses with a PIK3CA gene mutation in the INAVO120 study, the idea of a molecular navigation strategy for switching hormonal treatment when an ESR1 gene mutation appears in the randomized clinical trial SERENA-6, as well as a biomarker analysis of the trastuzumab deruxtecan effectiveness in advanced BC with HER2-low/ultralow expression in the randomized clinical trial DESTINY-Breast06 require special attention. For the treatment of patients with advanced HER2+ BC, an analysis of the efficacy and safety of the combination of trastuzumab deruxtecan with pertuzumab in the first line of treatment, the possibility of reintroducing trastuzumab deruxtecan in case of interstitial pneumonitis, as well as a new direction in the treatment of luminal HER2+ variant using the combination of CDK4/6 inhibitors with anti-HER2 therapy, are addressed.
Prospects for molecular profiling in bladder cancer stratification and treatment. A review
Modern trends in oncological care are based on the principles of precision medicine, which necessitates the identification of prognostic and predictive molecular genetic markers. The results of genomic profiling of bladder cancer (BC) represent a wide range of genes involved in carcinogenesis, but the functional significance and clinical potential of most of them have not been sufficiently studied. The aim of this study was to summarize modern scientific and practical data on the trends in precision medicine in the field of oncourology in BC. The materials for the study were domestic and foreign scientific databases, in particular the National Library of Medicine (http://www.ncbi.nlm.nih.gov/) using the electronic resource PubMed (https://pubmed.ncbi.nlm.nih.gov/), eLIBRARY.RU (https://www.elibrary.ru/) and Google Scholar (https://scholar.google.ru/schhp?hl=ru), when searching by keywords: BC, urothelial carcinoma, NGS, molecular profiling, genes, FGFR3, TERT, PIK3CA, TP53, mutations, expression. An analytical review concerning clinical, pathomorphological and molecular genetic data on the problems of diagnosis and treatment of BC included reports on preclinical experimental and clinical studies, meta-analyses, systematic reviews, cohort randomized studies for the period 2002–2025. A number of studies have demonstrated the association of molecular genetic changes in genes encoding receptor and intracellular kinases (FGFR2/3, PIK3CA etc.) with early stages of BC carcinogenesis, provided that the multifactorial prognostic significance is variable, taking into account the availability of modern molecular-targeted drugs. In particular, a pan-FGFR inhibitor, erdafitinib, which has demonstrated its effectiveness, is currently approved for the treatment of common forms of BC. Taking into account the pathogenetic mechanisms, an important further prospect for the use of receptor and intracellular kinase inhibitors in BC is the development and introduction into clinical practice of highly selective systemic and locally delivered forms with the possibility of their use in clinically heterogeneous groups of patients, including those with early stages of the disease. In turn, alterations in genes responsible for DNA repair (TP53, etc.) are associated with an aggressive course of the disease and a corresponding less favorable prognosis. In this direction, the key point of application of personalized therapy is the development and use of agents capable of modulating the activity of proteins of the reparation system at various stages of carcinogenesis. Thus, the mutational and functional status of genes involved in key oncogenic and reparation pathways in BC plays an important role in the context of developing a prognostic model, and also serves as a predictive target for therapeutic intervention.
Comparative analysis of reconstruction methods in patients with breast cancer using cell-based technologies
Introduction. Autologous adipose tissue transplantation (AATT) with platelet-rich plasma (PRP) is widely used in reconstructive and aesthetic breast surgery. However, differences in the methods of preparation of PRP and AATT, as well as in the approaches to the management of patients with breast cancer and without malignancies, require a comparative analysis to optimize clinical outcomes. Aim. To compare the surgical techniques and the results of PRP-assisted AATT in reconstructive and aesthetic breast surgery in three medical institutions in Russia and China. Materials and methods. Data from 84 patients in three centers were retrospectively analyzed: the Ruili Medical Cosmetic Hospital (RMCH, China, n=36), the Southeastern Hospital at Xiamen University (SEH, China, n=22), and the University Clinical Hospital No. 4 of the Sechenov University (UCH No. 4, Russia, n=26). Parameters of anesthesia, methods of harvesting and preparing AAT and PRP, the ratio of components, injection technique, and postoperative management were compared. Esthetic outcomes, graft survival, and complications were assessed. Results. In RMCH and SEH (aesthetic breast surgery), the volume of injected AAT was 150–250 mL per breast. The breast circumference increased by 3.19-6.28 cm after 6–12 months; 86–89% of patients achieved satisfactory results after 1–2 procedures. In UCH No. 4 (reconstruction after breast cancer), the volume of injected AAT was 50–100 mL per breast. The thickness of the subcutaneous fat layer increased by 1.4 cm (at 6 months) and 1.1 cm (at 12 months). Ten patients achieved the result after one procedure, while 16 required 2–3 lipofilling procedures. No complications were reported, and the graft survival rate did not correlate with the AAT volume. Conclusion. PRP-assisted AATT is effective and safe for aesthetic and reconstructive breast surgery. In patients with malignancies, a smaller volume of AAT and repeated procedures can provide correction of cicatricial defects and improve psychosocial status. Further research is needed to standardize the techniques.
Ultrasonic contrast enhancement and detection of sentinel lymph nodes in patients with breast cancer: A prospective single-center study
Background. For a personalized approach and the choice of treatment for patients with breast cancer (BC), the correct staging of the tumor process, including the assessment of the status of regional lymph nodes (LN), remains an important task. After the introduction of the sentinel lymph node (SLN) concept into clinical practice, it became possible to remove only one LN through which lymph drainage from the mammary gland occurs and to assess its status during urgent and planned histological examination. At the current stage of oncology and radiological diagnostic method development, SLNs are primarily detected using isotopic and fluorescent drugs. The most promising areas include the use of the SLN detection technique with an ultrasonic sulfur hexafluoride contrast medium. This technique is being gradually integrated into clinical practice due to its high diagnostic value; however, it is necessary to detail its diagnostic capabilities, develop utilization algorithms, and establish specific indications for its use. Aim. To study the possibilities of using an ultrasound contrast medium, sulfur hexafluoride, in the SLN detection, to identify the main enhancement patterns, and to determine the contrast uptake features of SLN with metastatic lesions in patients with BC. Materials and methods. The prospective study was conducted at the Department of Breast Pathology and the Imaging Department of the Kulakov National Medical Research Center for Obstetrics, Gynecology, and Perinatology from May to October 2024. This part of the study included 144 patients (91 with stage I surgery and 53 after neoadjuvant chemotherapy) with primary resectable stage I-IIIa BC (cT1-3N0-1M0), the average age was 52.4 years. The detection technique using ultrasonic imaging was performed with paraareolar and intradermal injections of the sulfur hexafluoride contrast medium on the affected side. Imaging with contrast enhancement was performed on the Mindray Resona 7 Diagnostic Ultrasound System (PRC) with contrast function. Results. The study detected SLN in 137 cases (out of 144), resulting in a detection rate of 95.1%. In most cases, 1 SLN was detected; in 24 (17.5%) patients, 2 SLNs were detected. In 7 (4.9%) cases, no SLN was detected (false negative results). There were 6 types (patterns) of contrast medium uptake: Type I (homogeneous, intensive), Type II (homogeneous, low-intensity), Type III (heterogeneous distribution of ultrasonic contrast medium with perfusion defects of <50% of the LN volume), Type IV (heterogeneous contrast enhancement with perfusion defects of >50% of the LN volume), Type V (annular), Type VI (contrast-enhanced lymphatic duct, without ultrasonic contrast medium uptake in the LN; LN structures are visualized in B mode). The most common patterns in metastatic disease were IV, V, and VI. Patterns I, II, and III were typical for LN with no signs of metastasis. Conclusion. Detection of SLN using ultrasound contrast-enhancement technique is an easily available and reproducible method in clinical practice in patients with BC, and the assessment of the intensity of the accumulation and distribution of contrast medium with ranking by selected patterns may indicate the presence of metastases in the LN.
Accuracy of endoscopic ultrasound in preoperative T and N staging of gastric cancer: results of single-center retrospective analysis
The optimal treatment strategy for patients with early and locally advanced forms of gastric cancer directly depends on the stage of TNM, which determines the importance of accurate preoperative staging. In accordance with international guidelines, the combination of gastroscopy and endoscopic ultrasound (EUS) is an integral part of the standard examination protocol. Aim. Assess the accuracy of EUS in assessing the T and N stage in gastric cancer. Materials and methods. Patients with gastric cancer who received surgical treatment without prior chemotherapy were included in the study. All patients were staged by gastroscopy with EUS and CT scan. Following radical gastric resection, the pathological T-stage (pT) and N-stage (pN) were compared with preoperative stage (uT-stage and uN-stage). Results. 174 patients were included in the study. The sensitivity of EUS ranged from 24 (for T4) to 63.9% (for T2). Specificity ranged from 65.9 (for T2) to 92.4% (for T4). Accuracy was 70.52, 65.32, 72.99 and 81.03% for T1, T2, T3 and T4 respectively. The T-stage was determined correctly in 66.7% of cases with T1a, in 50% of cases with T1b, in 32.9% of cases with T2, in 44.7% of cases with T3, and in 33.3% of cases with T4a. In patients with T2 tumors, where the greatest frequency of misstaging was observed, underestimation of the T-stage occurred in 30% of cases, overestimation – in 37.1% of cases. For N-staging, EUS has a sensitivity of 23.5%, specificity of 89.6% and an accuracy of 63.79%. Conclusion. EUS is mandatory part of the initial staging of patients with gastric cancer. For any T-stage, EUS often overestimated the stage rather than underestimated the true extent of tumor invasion. The accuracy of diagnosis is influenced by histological features of the tumor, such as the diffuse type and signet-ring cell carcinoma. Diagnostic value of EUS in N-staging is low.
Comparative efficacy and safety of prolgolimab + nurulimab and nivolumab + ipilimumab in the first-line therapy of metastatic or unresectable melanoma: A systematic review and matching-adjusted indirect comparison
Background. Metastatic and unresectable melanoma is considered as one of the most aggressive oncological diseases with a high mortality rate. In Russia, two first line immunotherapy combinations have been approved: nivolumab plus ipilimumab (NIVO+IPI) and prolgolimab plus nurulimab (PROLGO+NURU). Both regimens use dual immune checkpoint blockade targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). However, the lack of direct randomized comparisons between these regimens makes it difficult to choose the optimal first-line therapy. Aim. This analysis evaluated the relative efficacy and safety of PROLGO+NURU versus NIVO 1 mg/kg + IPI 3 mg/kg (NIVO 1 + IPI 3) and NIVO 3 mg/kg + IPI 1 mg/kg (NIVO 3 + IPI 1) in patients with metastatic and unresectable melanoma using matching-adjusted indirect comparisons (MAICs). Materials and methods. A systematic literature review was performed in Embase and PubMed databases. Three phase III randomized controlled trials (RCTs) were included: OCTAVA (PROLGO+NURU, n=135), CheckMate 067 (NIVO 1 mg/kg + IPI 3 mg/kg, n=314), and CheckMate 511 (two regimens: NIVO 1 mg/kg + IPI 3 mg/kg, n=178; NIVO 3 mg/kg + IPI 1 mg/kg, n=180). Individual patient data (IPD) on outcomes and baseline characteristics for PROLGO+NURU were obtained from the OCTAVA trial. For the NIVO + IPI arms, IPD on overall survival (OS) and progression-free survival (PFS) were reconstructed using Guyot’s algorithm from the published Kaplan–Meier curves, and aggregated baseline-characteristic data were extracted. Pairwise unanchored MAICs were performed, weighting on key prognostic factors and effect modifiers: baseline lactate dehydrogenase levels, TNM-defined presence of distant metastasis (M-stage), Eastern Cooperative Oncology Group (ECOG) performance status, BRAF-mutation status, PD-L1 expression <5%, age, and sum of longest diameters of target lesions. To address partial population non-overlap – specifically, the absence of mucosal melanoma and of asymptomatic central-nervous-system metastases (after local control) in OCTAVA – a simulation-based modelling was applied. Efficacy outcomes were analyzed with Cox proportional-hazards regression, and safety outcomes with logistic regression. Results. OS was statistically significantly higher in the PROLGO+NURU arm than in either NIVO 1 + IPI 3 or NIVO 3 + IPI 1 arms: hazard ratio (HR) 0.69 (95% CI 0.47–0.96; p=0.026) in the CheckMate 067 population, HR 0.64 (0.42–0.91; p=0.011) and HR 0.63 (0.41–0.89; p=0.008) – in the CheckMate 511 population versus NIVO 1 + IPI 3 and NIVO 3 + IPI 1 regimens, respectively. Differences in PFS were statistically insignificant. The PROLGO+NURU regimen also demonstrated a more favorable safety profile, with a lower incidence of treatment-related adverse events, including Grade 3–4 events and events led to treatment discontinuation. Conclusion. MAICs results showed that the PROLGO+NURU regimen achieved statistically significant superiority in OS compared with the approved NIVO+IPI regimens in Russia (as of 2025). The PROLGO+NURU combination also displayed a more favorable safety profile, with fewer treatment-related adverse events, including Grade 3–4 events and events led to treatment discontinuation. It should be emphasized that the comparison is indirect and the horizon of the comparison was limited (by about 50 months in CheckMate 511 population and 65 months in CheckMate 067 population). Consequently, the findings should be interpreted cautiously. Further updates incorporating data for the longer follow-up, including real-world data, are recommended.
Adjuvant targeted therapy in patients with skin melanoma: evidence from Russian real-world clinical practice (RATIONALE study)
Background. Adjuvant targeted therapy (ATT) with a combination of dabrafenib and trametinib after radical surgical treatment in patients with stage III skin melanoma (SM) with a BRAF V600 mutation reduces the risk of disease recurrence. The effectiveness of this approach has been demonstrated in randomized clinical trials, and also confirmed in several large non-Russian real-world (RW) studies. Aim. To evaluate, in RW settings, the effectiveness of ATT with a combination of dabrafenib and trametinib after definitive surgical treatment in patients with BRAF V600-positive SM in Russia. Materials and methods. The RATIONALE study is a prospective, non-interventional, multicenter RW study. The follow-up duration for the study was 1 year. Patients with SM older than 18 years who had previously started dabrafenib and trametinib therapy no more than 8 weeks prior to Visit 1 were included in the study. The paper presents results from the analysis of Cohort 1 only (patients who received dabrafenib and trametinib in the adjuvant setting). Results. The cohort included 214 patients with BRAF V600-mutated SM of stages IIIA–D and IV resectable. At the time of therapy initiation, the majority of patients were stage IIIc (54.7%) or IIIb (22.0%). The most common mutation – BRAF V600E – occurred in 66.3% of cases, while the second most common variant – BRAF V600 not otherwise specified – was detected in 31.3%. One-year overall survival for all included patients was 94%, one-year relapse-free survival was 84%, and one-year distant metastasis-free survival was 86%. No previously listed adverse events were reported. Adverse events led to therapy discontinuation in only 11.7% of cases. ATT did not reduce patients' quality of life. In the subgroup analysis, the effectiveness of the combination of dabrafenib and trametinib after removal of distant metastases (equivalent to stage IV resectable) was found, in particular, the one-year relapse-free survival rate was 83%, and the one-year overall survival rate was 100%, which is comparable to these indicators for stage IIIB-D (72–86 and 78–100%, respectively). Conclusion. The effectiveness and favorable safety profile of the combination of dabrafenib and trametinib in ATT after radical surgical treatment was confirmed in a population of Russian patients with SM in the RW settings.
Cabozantinib in the treatment of patients with advanced renal cell carcinoma: A review
The treatment strategy for patients with locally advanced and disseminated renal cell carcinoma (RCC) has undergone significant changes over the past 10 years. The emergence of effective antitumor immune response checkpoint inhibitors and high-affinity multikinase inhibitors of the second generation, the introduction of prognostic factors to personalize treatment, as well as the optimization of the sequence and combinations of drug regimens, have significantly increased the survival rates of patients with advanced RCC. Cabozantinib is one of the high-affinity multikinase inhibitors of the second generation with proven antitumor activity and safety in patients with advanced RCC. The results of registration studies contributed to the introduction of cabozantinib, both as monotherapy and in combination with nivolumab, into international and Russian clinical guidelines for the treatment of RCC patients across a wide range of indications. The launch of Cabozantinib-Promomed on the Russian market expands access to this treatment option for patients with RCC. The article presents the results of clinical studies of cabozantinib in patients with locally advanced and disseminated RCC, as well as bioequivalence studies of Cabozantinib.
New approaches in the treatment of aggressive subtypes of endometrial cancer and the prognostic role of HER2 status of the tumor: A systematic review
Background. Endometrial cancer (EC) remains one of the most pressing problems in gynecological oncology. Aggressive histological subtypes of EC (serous, clear cell, carcinosarcoma) are characterized by an insufficient response to standard therapy and a poor prognosis. The above subtypes have a high rate (up to 49%) of HER2 positivity and a strong association with the p53-aberrant molecular profile, which presents potential opportunities for targeted therapy. Aim. To review current data on approaches to the diagnosis of HER2 status, the effectiveness of anti-HER2 therapy, and the prognostic role of HER2 status of the tumor in aggressive subtypes of EC. Materials and methods. A systematic search of publications was conducted in the PubMed, MEDLINE, Cochrane Library, and Elibrary.ru databases for 2000–2024. Key words and their combinations were used: “endometrial cancer,” “serous carcinoma,” “carcinosarcoma,” “HER2,” “ERBB2,” “targeted therapy,” “trastuzumab,” “trastuzumab deruxtecan,” “disitamab vedotin,” “endometrial cancer,” “uterine serous carcinoma,” “carcinosarcoma,” “HER2-positive,” “targeted therapy.” The inclusion criteria were met by original studies, literature reviews, meta-analyses, and case reports on the prevalence of HER2 positivity, the efficacy of anti-HER2 therapy, and the prognostic role of HER2 status in aggressive histologic subtypes of EC. Excluded from the search were articles that have not been reviewed, as well as publications that do not report data on methods for determining HER2 status (immunohistochemistry, FISH method) or response to treatment. Results. Significant heterogeneity of HER2 expression was found with a maximum frequency in serous EC (49%) and carcinosarcoma (40%). HER2-positivity has been shown to be associated with a 45% reduction in overall survival (HR 2.1, 95% CI 1.4-3.2; p<0,001). Therapeutic studies have demonstrated the high efficacy of trastuzumab in combination with chemotherapy in the primary treatment of serous EC (median progression-free survival 17.9 months vs 9.3 months, HR 0.40; p=0.013). Trastuzumab deruxtecan showed significant activity even with expression of HER2 2+ (objective response rate 25-70% with of HER2 expression level 2+), with a median overall survival 26.0 months with HER2 expression 3+. The problems of standardization of HER2 testing and heterogeneity of expression are revealed. Conclusion. HER2-targeted therapy has become the new standard of treatment for aggressive subtypes of EC. The greatest effectiveness was achieved when using antibody conjugates with cytostatics, especially with HER2 overexpression. The development of unified HER2 testing standards, overcoming resistance, and optimizing combined modes are critically important areas. The perspectives are related to the adaptation of therapy to molecular subtypes and the identification of response predictors.
Real-world efficacy and safety of lenvatinib plus pembrolizumab in advanced renal cell carcinoma: Updated data from a Russian observational study
Background. A Russian phase IV observational study was initiated to evaluate the efficacy and safety of lenvatinib with pembrolizumab (Len-Pembro) in patients with advanced renal cell carcinoma (RCC) receiving therapy in real-world practice. This article is based on the results of the third analysis conducted with a median follow-up of 23.1 months and reflects data on the efficacy and safety of Len-Pembro in Russian patients. Aim. To evaluate the real-world efficacy and safety of Len-Pembro in patients with advanced RCC with a median follow-up increased to 23.1 months. The primary outcome of the study was progression-free survival (PFS), the secondary outcomes included overall survival (OS), progression-free survival on next-line therapy (PFS2), objective response rate (ORR), duration of response, as well as safety. Materials and methods. The study included data from 165 patients with verified advanced RCC who received Len-Pembro at 36 centers in the Russian Federation from February 05, 2018 to July 30, 2025. The median age was 60 (20–76) years, and 70.3% of the participants were male. Most patients (74.6%) presented with Karnofsky performance score of ≥80%, metachronous metastases (50.9%) of clear cell RCC (93.3%) in >1 organ (75.2%), and had not received any anticancer treatment (91.0%). The IMDC favorable prognosis group included 40 (24.2%), intermediate – 92 (55.8%), and unfavorable prognosis – 33 (20.0%) patients. The median follow-up reached 23.1 (0.5–72.9) months. A total of 110 (66.7%) patients completed Len-Pembro therapy, and 51 (30.9%) patients received next-line treatment. Results. Median PFS reached 25.8 (95% confidence interval – CI 17.0–34.5) months, 23-month PFS – 52.6%; median OS was 39.9 (95% CI 26.9–52.8) months, 23-month OS – 73.1%; median PFS2 was 33.2 (95% CI 23.4–41.1) months, 23-month PFS2 – 66.9%. The ORR was 49.1%, including 3.0% of complete responses, and the disease control rate was 89.1%. The median duration of response reached 29.7 (95% CI 24.9–34.6) months. The incidence of any adverse events (AEs) was 78.8%, severe AEs occurred in 29.1%, fatal AES – in 1.2%, immune-related AEs – 17.0%, severe immune-related AEs – 6.7%. Conclusion. In real-world practice, with increased follow-up duration, the values of PFS, OS, and PFS2 were comparable to those obtained in the registrational study, with a lower ORR and a satisfactory safety profile of the combination of Len-Pembro in advanced RCC.
Supportive care in oncology as a key to success. A review
The timely selection of appropriate supportive therapy for patients with malignancies is one of the priority tasks of the modern health care system due to the persistent high prevalence, the rapid expansion of antitumor drug therapies, and the increase in the life expectancy of patients. In addition to serious, potentially life-threatening complications, less severe adverse reactions (ADRs) often occur in patients during anticancer therapy, significantly reducing their quality of life. Optimal treatment outcomes, reducing the incidence of complications, and increasing treatment adherence can be achieved by integrating individualized supportive care regimens into a comprehensive management plan for patients with cancer. In real-world practice, oncologists often refer patients with complications to specialized professionals, even in cases where the ADRs do not require third-party consultation, which leads to unreasonable delays in the necessary therapy. To enhance the effectiveness of supportive therapy, it is essential to develop and implement precise clinical algorithms that govern the management of various complications. Our review presents a scheme for the routing of patients with cancer, illustrated by the management of gastrointestinal and hepatobiliary ADRs.
Common forms of basal cell carcinoma of the skin: The first experience with sonidegib in the B-SURE observational study in Russia
Background. Locally advanced (laBCC) and metastatic basal cell carcinoma of the skin (mBCC) have a poor prognosis. Hedgehog (Hh) pathway inhibitors, such as vismodegib and sonidegib, are highly effective in treatment of advanced forms of BCC. Aim. To evaluate the efficacy and safety of sonidegib in the investigator-initiated observational study B-SURE (Basal cell carcinoma – Sonidegib Use in Real-world Evidence) in patients with laBCC and mBCC in real-world clinical practice in the Russian Federation as first-line therapy (in patients with no history of treatment with Hh inhibitors), as well as in patients with a history of treatment with vismodegib (another Hh pathway inhibitor). Materials and methods. The study included 10 patients, 9 with laBCC and 1 with mBCC. Patients visited clinical center in accordance with routine clinical practice and underwent standard procedures and examinations in accordance with clinical guidelines and the physician’s decision. Visit intervals were 3–4 months. Data on patients’ use of sonidegib was collected during visits to the clinical site, and the efficacy of sonidegib therapy was assessed according to RECIST 1.1 criteria. The patients also completed the EORTC QLQ-C30, version 3, and the EQ-5D-5L, version 1.2, before starting sonidegib therapy and every 3 months thereafter during routine visits to clinic. Results. At the time of data analysis (September 2025), the efficacy of sonidegib therapy was evaluated in 9 patients, while tolerability and safety were evaluated in all 10 patients. Three patients had a history of vismodegib therapy, which was discontinued due to disease progression (n=1), intolerance (n=1), and intolerance with a complete clinical response (n=1). The median time from diagnosis to the development of laBCC and mBCC was 67.5 months. In patients with no prior vismodegib treatment, objective responses were observed in 4 of 7 patients (2 complete, 2 partial responses), yielding an objective response rate (ORR) of 57%. In patients with a history of vismodegib treatment, an objective response was reported in 1 of 3 (complete response in 1), yielding an ORR of 33.3%. The safety profile of sonidegib included adverse events (AEs) in 7 (70%) of 10 patients, mainly of Grade 1-2, which did not require a change in the dose regimen. Severe AEs (Grade 3-4) leading to discontinuation were reported in 1 patient (10%). It is noteworthy that in three patients with severe AEs during previous vismodegib therapy, sonidegib treatment was not associated with such complications, suggesting different safety profiles of these agents. Conclusion. For the first time, the efficacy of sonidegib, with an ORR of 57%, was demonstrated in a Russian population of Hh inhibitor-naive patients with laBCC and mBCC. Sonidegib demonstrated an acceptable safety profile, with a low discontinuation rate (10%) due to AEs. Particular attention should be given to the favorable tolerability of sonidegib in patients with a history of severe toxicity during vismodegib therapy, which expands the therapeutic options in case of intolerance to another Hh-inhibitor.
Laparoscopic heminephrectomy in renal cell carcinoma of the horseshoe kidney in a patient with end-stage renal disease with a transplanted kidney: A clinical case
The horseshoe kidney (HK) is the most common congenital anomaly of the urinary system, detected in 0.25% of the population. It combines several anatomical defects, including ectopia, malrotation, anomalies of the collecting system, and variations in the blood supply, which are associated with complications that can lead to end-stage renal disease (ESRD). The use of peritoneal dialysis and hemodialysis for this indication is a risk factor for renal cell carcinoma (RCC). HK is associated with various benign and malignant neoplasms. RCC and transitional cell carcinoma are the most common, accounting for 85% and 10% of all cases, respectively. According to the literature, renal transplant recipients are at an increased risk of RCC, predominantly involving their own kidneys. Additionally, kidney recipients who are on persistent immunosuppression are 4–15 times more likely to develop RCC. The article presents a unique case of surgical treatment of HK RCC in a 47-year-old patient who was treated for hypertension from the age of 20, and at the age of 36, he was diagnosed with HK according to ultrasound. At the age of 37, the patient developed ESRD. Peritoneal dialysis and hemodialysis were performed, followed by cadaveric kidney allotransplantation at the age of 42. The patient received continuous immunosuppression. After 5 years, gross hematuria appeared. When examined with native X-ray computed tomography and contrast-enhanced magnetic resonance imaging, a rounded mass with a clear, even outer contour, measuring up to 73×80 mm in size, and a heterogeneous structure without invasion into the fat tissue was visualized in the left half of the HK in the middle segment. Laparoscopic heminephrectomy was performed on the left. Histological examination showed papillary RCC, the resection margins were negative. Creatinine levels were stable. Diagnosis: Stage III renal cell carcinoma pT3aN0M0R0. The patient was assessed after 16 months; no evidence of recurrence was found. The case presented describes a rare case of HK RCC that developed after dialysis and kidney transplantation for ESRD. The patient successfully underwent laparoscopic heminephrectomy with a favorable outcome, with no signs of recurrence of the disease for 16 months. No such cases were reported in the literature.
In memory of Professor Evgeny Alexandrovich Osmanov
Erratum in "Results of lenvatinib as first-line targeted therapy for advanced hepatocellular cancer: A retrospective study" (DOI: 10.26442/18151434.2025.2.203293)
In the article «Results of lenvatinib as first-line targeted therapy for advanced hepatocellular cancer: A retrospective study», published in the Journal of Modern Oncology, Vol. 27, No. 2, 2025 (DOI: 10.26442/18151434.2025.2.203293), errors were made: the numerical data from Table 2 in four cells related to two columns (Median PFS and Median OS) were reversed. Data [12.7 (7.6-21.7)] were reversed with [6 (2.3-12.7)]; data [15.1 (3.9-43.8)] were reversed with [10.6 (1.8-16.1)].