Background. The long-acting granulocyte colony-stimulating factor (G-CSF) pegfilgrastim has proven to be an effective option for primary febrile neutropenia (FN) prophylaxis. Its efficacy has been demonstrated across a wide range of malignancies, chemotherapy regimens, and varying baseline risks of FN. Prophylactic use of G-CSF reduces not only the risk of developing FN but also the risk of early death, including infection-related mortality. Currently, available literature lacks information on the real-world clinical practice of using pegfilgrastim in patients with lymphomas receiving intensive chemotherapy for remission induction prior to high-dose therapy with autologous hematopoietic stem cell transplantation, including data on the pharmacoeconomic aspects of these prophylactic measures. Aim. Based on real-world clinical practice data, to evaluate the clinical and economic consequences of G-CSF use in lymphoma patients undergoing high-dose polychemotherapy (PCT) prior to autologous hematopoietic stem cell transplantation. Materials and methods. The study included 104 patients with lymphoma who received short-acting G-CSF filgrastim (n=30) or long-acting empegfilgrastim (n=74) at the Department of Hematology and Bone Marrow Transplantation Pirogov National Medical and Surgical Center. Based on real-world clinical practice data, the effectiveness of FN prophylaxis was assessed, including the incidence of FN, length of hospital stay, and impact on intervals between PCT cycles. Budget impact analysis was performed for a population of 100 patients, considering only costs for drug therapy with comparator agents and costs for treating FN episodes. Results. Compared with filgrastim, empegfilgrastim use reduced the proportion of PCT cycles leading to FN from 16 to 1% (p0.001) and the proportion of patients experiencing an FN episode from 23 to 3% (p0.001). Budget impact analysis for a population of 100 patients showed that direct medical costs with filgrastim therapy were 0.6 million RUB (5%) higher, totaling 13.6 million RUB, compared to 13.0 million RUB with empegfilgrastim therapy. In the cost structure, when using empegfilgrastim, the main expenses were for FN prophylaxis, accounting for 95% (12.5 million RUB), whereas with filgrastim therapy, the main costs (67%, 9.17 million RUB) were for treating FN episodes that occurred, with prophylaxis costs accounting for only 32%. Although the cost of a single empegfilgrastim administration is higher than that of filgrastim (41.5 thousand RUB versus 14.9 thousand RUB for 5.5 days of therapy), subsequent costs for treating FN episodes offset the expected savings. Conclusion. Primary neutropenia prophylaxis with empegfilgrastim allows for a statistically significant reduction in adverse events without increasing healthcare system costs and therefore can be recommended for widespread use.
This article examines contemporary treatment strategies for advanced non-small cell lung cancer (NSCLC) with a BRAF gene mutation, which is observed in approximately 5% of NSCLC patients. The significance of molecular genetic testing to detect the BRAF V600E mutation in all patients diagnosed with advanced NSCLC is underscored. The article describes the principles guiding the selection of treatment regimens for NSCLC with BRAF V600E mutation, highlighting the need to use targeted therapies in the first line due to their association with the highest objective response rates and survival outcomes. Various factors should be considered when selecting the first-line regimen, including the Eastern Cooperative Oncology Group (ECOG) performance status, the presence of intracranial metastases, concurrent medical conditions, and the patient’s tolerance to antitumor therapy. Detailed results from a phase II PHAROS clinical study evaluating the efficacy and safety of encorafenib in combination with binimetinib in patients with metastatic NSCLC exhibiting the BRAF V600E mutation are presented. This study reported the most favorable overall survival to date in treatment-naive patients with BRAF V600E-mutated metastatic NSCLC, with an overall survival of 47.6 months, surpassing that achieved with other systemic therapies. Hence, the implementation of molecular genetic testing to identify driver mutations prior to initiating treatment, alongside first-line targeted therapy, is a critical factor in improving survival rates for patients with advanced NSCLC and the BRAF V600E mutation.
Background. This article presents a thorough medical and legal examination of the principle of "discretion" in the surgical management of malignancies. The significance of this study arises from the mandatory implementation of clinical guidelines effective January 1, 2022, in accordance with Article 37 of Federal Law No. 323-ФЗ. This legislation has notably restricted the scope for individualized medical decision-making. At the same time, the complete algorithmization of surgical oncology remains fundamentally impossible due to the unique features of each clinical case. The authors interpret medical discretion as a specific form of administrative discretion – a legally conferred right enabling physicians to make informed and independent decisions based on clinical circumstances, evidence-based data, and the overarching principle of safeguarding the patient's health. Aim. To provide a comprehensive medical and legal analysis of the "discretion" principle within the surgical phase of cancer treatment, including examining its legal boundaries, its relationship with clinical guidelines, and the notion of informed voluntary consent, as well as an assessment of relevant law enforcement practices. Materials and methods. The study used system analysis, formal legal analysis, comparative law, and content analysis of judicial rulings. A total of 87 judicial decisions about civil cases from 2018 to 2025, relevant regulatory frameworks, and clinical guidelines issued by the Ministry of Health of Russia, the Association of Oncologists of Russia, the Russian Society of Clinical Oncology (RUSSCO), as well as NCCN and ESMO guidelines, along with the 8th edition of the TNM classification of malignant tumors, were reviewed. Results. The findings indicate that discrepancies in clinical and pathomorphological staging, which may reach up to 23.9% in colorectal cancer, render intraoperative approach adjustments a necessary practice. Analysis of specific court cases revealed that the legitimacy of extending the surgical intervention is evaluated not by the outcome but by the appropriateness of the surgeon's actions at the time they were performed, based on the intrinsic connection between surgical practices and pathological morphology, thereby facilitating a clear distinction in responsibility between surgery and pathology teams. Particular importance is attached to informed voluntary consent; it is the substance and completeness of this consent – rather than the mere availability of the document itself – that serves as the decisive mechanism for risk allocation. Conclusion. The authors establish criteria for the legality of extending the surgical intervention and advocate for enhancements to clinical guidelines, the format of informed voluntary consent, surgical protocols, the introduction of a standard for the "reasonable surgeon," and the legislative endorsement of the concept of "reasonable medical risk."
Background. Small cell lung cancer (SCLC) accounts for about 15% of all lung cancer cases. It is characterized by aggressive progression, high proliferative capacity, and early hematogenous and lymphogenous dissemination. Although there is a significant baseline sensitivity to first-line chemotherapy, the majority of patients experience disease progression within 6 to 12 months following treatment initiation, with a median overall survival of approximately 12 months. Aim. To evaluate the efficacy and safety of first-line therapy utilizing atezolizumab combined with carboplatin or cisplatin and etoposide in patients diagnosed with SCLC in a real-world context. Materials and methods. This retrospective and prospective observational study included 157 patients (119 males and 38 females) aged 32 to 84 years. Compromised performance status (ECOG 2–3) at baseline was observed in 54 patients (34.4%). Results. The median progression-free survival in patients with SCLC undergoing first-line therapy was 6.18 months (95% confidence interval [CI] 5.69-6.90), while the median overall survival was 10.55 months (95% CI 8.12-13.02). An objective response was recorded in 82 patients (52.3%). Grade 3–4 immune-related adverse events were documented in only 5.1% of the patient population. Conclusion. The combination of atezolizumab with platinum-based chemotherapy and etoposide as a first-line treatment for SCLC demonstrates high efficacy and an acceptable safety profile in real-world clinical settings.
Mutations in the BRCA1/2 genes are oncogenic, since their carriers are associated with an increased risk of developing malignant neoplasms of the mammary glands, ovaries, fallopian tubes, peritoneum, as well as breast cancer in men and, less often, pancreatic cancer. When oncogenic mutations are detected, the information obtained should be used in the formulation of personal recommendations on possible effective lifestyle measures and modifications to reduce the predicted cancer risks. The article contains data from the European Society of Medical Oncology (ESMO), including an indication of the strength of the recommended measures. To manage these risks, timely risk-reducing salpingo-oovarectomy, risk-reducing mastectomy, as well as annual selective screening of diseases of the mammary glands, ovaries and, if indicated, other organs are recommended, informing the patient about the risks at the time of treatment and personalized strategies aimed at reducing them.
