Keyword: Safety
4 results found.
Congress Abstract
Oncology, Nuclear Medicine and Transplantology, 2(3, Suppl. 1), 2026, onmt_A31, https://doi.org/10.63946/onmt/19332
ABSTRACT:
Introduction: The problem of developing effective and safe pharmacological agents for the prevention and treatment of acute and late complications of radiation therapy for malignant neoplasms is highly relevant for the entire global community. Currently, various modalities of radiation therapy are used in the treatment of 50–70% of patients with oncological diseases. At the same time, despite continuous improvement of medical radiological devices and methods of planning radiation exposure, a significant proportion of patients (from 10–20% to 40–60%, depending on localization) receiving radiotherapy develop acute or late complications caused by radiation-induced damage to normal, non-malignant tissues.
At the A.F. Tsyb Medical Radiological Research Center, an innovative agent for the prevention of radiotherapy complications has been developed – a unique radioprotector T1082, capable of selectively protecting healthy tissues without reducing the efficacy of radiation therapy for solid tumors. Its high efficacy has been demonstrated with both parenteral and oral administration in small and large laboratory animals using models of acute and late radiation injuries and in experimental radiation therapy of tumors.
It has been shown that T1082, when administered as a single oral dose at safe doses of 180–220 mg/kg (constituting 1/13–1/10 of LD10), provides pronounced (DRF – 1.6–1.9) prevention of bone marrow and intestinal acute radiation sickness in mice and rats under total-body gamma irradiation, without being inferior in efficacy to the best known radioprotectors. Moreover, the radioprotective effect of T1082 is systemic in nature, which allows it to also effectively (DRF – 1.4–1.7) counteract the development of and mitigate the course of acute and late local radiation injuries to normal somatic tissues, as demonstrated in models of radiation skin burn, radiation mucositis, and radiation pneumofibrosis.
At the same time, in malignant tissues of solid neoplasms, the radioprotective effect of T1082 is practically not realized: in models of radiotherapy of transplantable solid tumors of animals of various histogenesis and organ specificity, T1082, when administered as a single oral dose at 1/13–1/10 of LD10, reliably protected irradiated normal tissues but did not attenuate the antitumor effects of gamma and β radiation against experimental solid neoplasms.
Thus, the results of preclinical studies demonstrate the efficacy and safety of the developed agent and create the conditions for the development and introduction into clinical practice of an innovative domestic medicinal product capable of qualitatively limiting the toxicity of existing methods of radiation therapy for solid tumors and, overall, improving the efficacy and quality of treatment of oncological diseases.
At the A.F. Tsyb Medical Radiological Research Center, an innovative agent for the prevention of radiotherapy complications has been developed – a unique radioprotector T1082, capable of selectively protecting healthy tissues without reducing the efficacy of radiation therapy for solid tumors. Its high efficacy has been demonstrated with both parenteral and oral administration in small and large laboratory animals using models of acute and late radiation injuries and in experimental radiation therapy of tumors.
It has been shown that T1082, when administered as a single oral dose at safe doses of 180–220 mg/kg (constituting 1/13–1/10 of LD10), provides pronounced (DRF – 1.6–1.9) prevention of bone marrow and intestinal acute radiation sickness in mice and rats under total-body gamma irradiation, without being inferior in efficacy to the best known radioprotectors. Moreover, the radioprotective effect of T1082 is systemic in nature, which allows it to also effectively (DRF – 1.4–1.7) counteract the development of and mitigate the course of acute and late local radiation injuries to normal somatic tissues, as demonstrated in models of radiation skin burn, radiation mucositis, and radiation pneumofibrosis.
At the same time, in malignant tissues of solid neoplasms, the radioprotective effect of T1082 is practically not realized: in models of radiotherapy of transplantable solid tumors of animals of various histogenesis and organ specificity, T1082, when administered as a single oral dose at 1/13–1/10 of LD10, reliably protected irradiated normal tissues but did not attenuate the antitumor effects of gamma and β radiation against experimental solid neoplasms.
Thus, the results of preclinical studies demonstrate the efficacy and safety of the developed agent and create the conditions for the development and introduction into clinical practice of an innovative domestic medicinal product capable of qualitatively limiting the toxicity of existing methods of radiation therapy for solid tumors and, overall, improving the efficacy and quality of treatment of oncological diseases.
Congress Abstract
Oncology, Nuclear Medicine and Transplantology, 2(3, Suppl. 1), 2026, onmt_A34, https://doi.org/10.63946/onmt/19314
ABSTRACT:
Background: Internal quality control is an essential component of healthcare management aimed at ensuring compliance with established standards, identifying and eliminating deficiencies, improving clinical processes, and enhancing patient safety.
Objective: To evaluate the main activities and outcomes of the Medical Quality Control Service at the State Enterprise on the Right of Economic Management “Multidisciplinary Medical Center” of the Akimat of Astana.
Materials and Methods: The activities of the Quality Control Service in 2024–2025 were analyzed. Key areas included preparation for national accreditation, updating standard operating procedures, internal audits of medical records and clinical processes, identification of deficiencies, and analysis of complications and mortality.
Results: In 2024–2025, the Center successfully completed national accreditation. In 2025, more than 3,000 inpatient medical records and 1,500 day-care records were audited. Clinical processes in surgical and chemotherapy departments were regularly monitored. More than 40 mortality case reviews and 14 meetings of the Medical Quality Control Committee were conducted. Identified deficiencies were analyzed, followed by the development of corrective measures.
Conclusions: Systematic internal audits, process standardization, and analysis of healthcare deficiencies are important tools for quality assurance. The Quality Control Service contributes to identifying areas for improvement, implementing corrective measures, and maintaining compliance with established healthcare quality standards.
Objective: To evaluate the main activities and outcomes of the Medical Quality Control Service at the State Enterprise on the Right of Economic Management “Multidisciplinary Medical Center” of the Akimat of Astana.
Materials and Methods: The activities of the Quality Control Service in 2024–2025 were analyzed. Key areas included preparation for national accreditation, updating standard operating procedures, internal audits of medical records and clinical processes, identification of deficiencies, and analysis of complications and mortality.
Results: In 2024–2025, the Center successfully completed national accreditation. In 2025, more than 3,000 inpatient medical records and 1,500 day-care records were audited. Clinical processes in surgical and chemotherapy departments were regularly monitored. More than 40 mortality case reviews and 14 meetings of the Medical Quality Control Committee were conducted. Identified deficiencies were analyzed, followed by the development of corrective measures.
Conclusions: Systematic internal audits, process standardization, and analysis of healthcare deficiencies are important tools for quality assurance. The Quality Control Service contributes to identifying areas for improvement, implementing corrective measures, and maintaining compliance with established healthcare quality standards.
Original Article
Oncology, Nuclear Medicine and Transplantology, 2(2), 2026, onmt018, https://doi.org/10.63946/onmt/18529
ABSTRACT:
Type 2 diabetes mellitus is associated with an increased risk of several malignancies, prompting interest in the potential oncologic effects of antidiabetic therapies, particularly metformin. This study evaluated cancer-related adverse event reporting associated with metformin compared with other antidiabetic agents using real-world pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS) between Q1 2023 and Q4 2024. A disproportionality analysis was conducted on over 3.2 million reports, including 66,187 metformin cases and 55,257 comparator cases comprising GLP-1 receptor agonists, SGLT2 inhibitors, sulfonylureas, and insulin. Reporting odds ratios (ROR), proportional reporting ratios (PRR), information components (IC), and chi-squared tests were applied across twelve pre-specified cancer types.
Metformin was associated with significantly lower reporting of hepatocellular carcinoma (ROR 0.377, 95% CI 0.181–0.782) and pancreatic carcinoma (ROR 0.669, 95% CI 0.493–0.908). In contrast, increased reporting signals were observed for prostate cancer (ROR 2.065, 95% CI 1.435–2.972), leukaemia (ROR 2.388, 95% CI 1.155–4.939), and breast cancer (ROR 1.404, 95% CI 1.023–1.926). Drug-specific comparisons indicated relatively lower overall cancer reporting for metformin compared with sitagliptin and empagliflozin, but higher reporting compared with insulin. Temporal analyses demonstrated variability in reporting patterns across study quarters.
These findings represent disproportionality signals reflecting reporting associations rather than causal effects and may be influenced by reporting bias, residual confounding, and differences in healthcare utilization. Overall, the results suggest a heterogeneous, cancer-type-specific reporting profile for metformin and highlight the value of pharmacovigilance analyses in generating real-world safety signals. Further confirmation in prospective and mechanistic studies is required.
Metformin was associated with significantly lower reporting of hepatocellular carcinoma (ROR 0.377, 95% CI 0.181–0.782) and pancreatic carcinoma (ROR 0.669, 95% CI 0.493–0.908). In contrast, increased reporting signals were observed for prostate cancer (ROR 2.065, 95% CI 1.435–2.972), leukaemia (ROR 2.388, 95% CI 1.155–4.939), and breast cancer (ROR 1.404, 95% CI 1.023–1.926). Drug-specific comparisons indicated relatively lower overall cancer reporting for metformin compared with sitagliptin and empagliflozin, but higher reporting compared with insulin. Temporal analyses demonstrated variability in reporting patterns across study quarters.
These findings represent disproportionality signals reflecting reporting associations rather than causal effects and may be influenced by reporting bias, residual confounding, and differences in healthcare utilization. Overall, the results suggest a heterogeneous, cancer-type-specific reporting profile for metformin and highlight the value of pharmacovigilance analyses in generating real-world safety signals. Further confirmation in prospective and mechanistic studies is required.
Review Article
Oncology, Nuclear Medicine and Transplantology, 1(2), 2025, onmt010, https://doi.org/10.63946/onmt/17526
ABSTRACT:
Pathogen-reduction technologies (PRTs) methods for platelet and plasma are increasingly being relied on to inactivate a broad spectrum of pathogens to ensure safety in transfusion. However, there is continuing debate about the impact of such technology on clinical effectiveness, bleeding outcomes, and transfusion-related adverse events.
Objective: This systematic review evaluated the clinical effectiveness and safety of PRT-treated platelets and plasma using studies published between 2015 and 2025.
Methods: Following PRISMA 2020 guidelines, major databases including PubMed, Scopus, Embase, Web of Science, and Google Scholar were searched for studies published between 2015 and 2025. Eligible studies included human studies, platelet and/or plasma products that have been treated with specific PRT technology. A total of 1256 records were identified. Findings were synthesized narratively and presented descriptively.
Results: Fifteen qualifying studies utilizing pathogen-reduced platelets and plasma from various areas were included. In randomized trials, platelets treated with PRT consistently exhibited decreased CCI at both 1 hour and 24 hours compared to conventional platelets, with certain studies indicating greater platelet use. Even though the platelet increments were lower, most trials did not report any significant rise in WHO grade ≥2 clinical bleeding, and the hemostatic efficacy was still satisfactory. Safety outcomes were relatively good: datasets showed that transfusion-reaction rates were low (<1%) and major adverse events were not so common. PRT systems showed strong pathogen-inactivation abilities, including the ability to effectively inactivate clinically important viruses such as hepatitis viruses, dengue, and Japanese encephalitis virus. Different technologies had different results, and UVC-based systems sometimes showed smaller increases after transfusions.
Conclusion: Platelets and plasma treated with PRT are still clinically useful and very safe. They also greatly lower the risk of infections that can be spread by transfusions. Even though there are fewer laboratory increments and more platelet use, these changes don't seem to affect clinical hemostasis. Strengthening implementation methods, inventory planning, and hemovigilance systems alongside continuing evaluation of performance will enable safer transfusion procedures and safeguard vulnerable patient groups globally.
Objective: This systematic review evaluated the clinical effectiveness and safety of PRT-treated platelets and plasma using studies published between 2015 and 2025.
Methods: Following PRISMA 2020 guidelines, major databases including PubMed, Scopus, Embase, Web of Science, and Google Scholar were searched for studies published between 2015 and 2025. Eligible studies included human studies, platelet and/or plasma products that have been treated with specific PRT technology. A total of 1256 records were identified. Findings were synthesized narratively and presented descriptively.
Results: Fifteen qualifying studies utilizing pathogen-reduced platelets and plasma from various areas were included. In randomized trials, platelets treated with PRT consistently exhibited decreased CCI at both 1 hour and 24 hours compared to conventional platelets, with certain studies indicating greater platelet use. Even though the platelet increments were lower, most trials did not report any significant rise in WHO grade ≥2 clinical bleeding, and the hemostatic efficacy was still satisfactory. Safety outcomes were relatively good: datasets showed that transfusion-reaction rates were low (<1%) and major adverse events were not so common. PRT systems showed strong pathogen-inactivation abilities, including the ability to effectively inactivate clinically important viruses such as hepatitis viruses, dengue, and Japanese encephalitis virus. Different technologies had different results, and UVC-based systems sometimes showed smaller increases after transfusions.
Conclusion: Platelets and plasma treated with PRT are still clinically useful and very safe. They also greatly lower the risk of infections that can be spread by transfusions. Even though there are fewer laboratory increments and more platelet use, these changes don't seem to affect clinical hemostasis. Strengthening implementation methods, inventory planning, and hemovigilance systems alongside continuing evaluation of performance will enable safer transfusion procedures and safeguard vulnerable patient groups globally.