Radioembolization of the liver by 188Re albumin microspheres 20–40 μm (“HEPATOREN”): results of the first phase of the study
https://doi.org/10.18705/2782-3806-2023-3-5-74-81
EDN: BHTXAA
Abstract
Purpose. Description of the results of the phase I clinical study of albumin microspheres 20– 40 microns, labeled 188Re (Hepatoren). Materials and methods. From June 2022 to August 2023, 20 patients with inoperable liver tumors underwent radioembolization of the liver with 188Re albumin microspheres 20–40 μm at the A. F. Tsyba MRSC — a branch of the Federal State Budgetary Institution “NMIC of Radiology” of the Ministry of Health of the Russian Federation. Results. The technical success of the operation is 100 %. After the introduction of 99mTc-MAA and the implementation of the SPECT/CT scan of none of the patients revealed the accumulation of radiopharmaceuticals in the organs of the gastrointestinal tract; bypass surgery to the lungs ranged from 1 % to 4.5 %. Grade I hematological toxicity was observed in 15 (75 %) patients, grade II — in 3 (15 %) patients, grade III — in 2 (10 %) patients. All the studied patients had grade II hepatological toxicity. Good tolerability was observed in 10 (50 %) patients, satisfactory tolerability — in 7 (35 %) patients, unsatisfactory tolerability — in 3 (15 %) patients. There were no pronounced complications during the follow-up of patients of the first phase of the study. Conclusion. Our first experience of using domestic microspheres has demonstrated acceptable indicators of toxicity and tolerability, which allows us to continue working in this direction.
About the Authors
A. D. Kaprin
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Kaprin Andrey D., Doctor of Medical Sciences, Professor, Academician of the Russian Academy of Sciences, Director General of the National Medical Research Center for Radiology,
10, Marshala Zhukova str., Obninsk, 249031.
S. A. Ivanov
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Ivanov Sergey A., Doctor of Medical Sciences, Corresponding Member of the Russian Academy of Sciences, Director of the Tsyb Center,
10, Marshala Zhukova str., Obninsk, 249031.
P. V. Shegay
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Shegay Petr V., Candidate of Medical Sciences, Deputy General Director for Science of the National Medical Research Center for Radiology,
10, Marshala Zhukova str., Obninsk, 249031.
V. V. Kucherov
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Kucherov Valery V., Candidate of Medical Sciences, Head of the Department of Interventional Radiology,
10, Marshala Zhukova str., Obninsk, 249031.
A. P. Petrosyan
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Petrosyan Artur P., Candidate of Medical Sciences, doctor of the Department of Interventional Radiology,
10, Marshala Zhukova str., Obninsk, 249031.
V. P. Stepanenko
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Stepanenko Valery P., Doctor of Biological Sciences, Professor, Head of the Laboratory of Medical and Environmental Dosimetry and Radiation Safety,
10, Marshala Zhukova str., Obninsk, 249031.
V. K. Tischenko
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Tischenko Viktorya K., Doctor of Biological Sciences, Head of the Laboratory of Experimental Nuclear Medicine,
10, Marshala Zhukova str., Obninsk, 249031.
M. A. Sigov
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Sigov Mikhail A.,Head of the Radionuclide Diagnostics Department,
10, Marshala Zhukova str., Obninsk, 249031.
L. O. Petrov
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Petrov Leonid O., Candidate of Medical Sciences, Head of the Department of Radiation and Surgical Treatment of abdominal diseases,
10, Marshala Zhukova str., Obninsk, 249031.
A. T. Stehova
The Tsyb Medical Radiological Research Center — branch of the National Medical Research Radiological Center
Russian Federation
Russian Federation
Stehova Armina T., clinical resident,
10, Marshala Zhukova str., Obninsk, 249031.
References
1. Состояние онкологической помощи населению России в 2019 году. / Под ред. А. Д. Каприна, В. В. Старинского, Г. В. Петровой. М.: МНИОИ им. П. А. Герцена — филиал ФГБУ «НМИЦ радиологии» Минздрава России, 2020.
2. Гранов А.М., Давыдов М.И. (ред.). Интервенционная радиология в онкологии. СПб: Фолиант. 2013. 560 с.
3. Каприн А.Д., Иванов С.А., Кучеров В.В. и др. Радиоэмболизация печени: новая глава в отечественной онкологии. Российский журнал гастроэнтерологии, гепатологии, колопроктологии. 2019;29(5):7–12. https://doi.org/10.22416/1382-4376-2019-29-5-7-12
4. Таразов П.Г., Поликарпов А.А., Иванова А.А. Артериальная радиоэмболизация злокачественных опухолей печени стеклянными микросферами иттрия-90: первый опыт. Диагностическая и интервенционная радиология. 2014;8:59–66.
5. EASL-EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol 2018; 69 j 182–236.
6. Vogel A, Cervantes A, Chau I, et al. ESMO Guidelines Committee, Hepatocellular carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Annals of Oncology, Volume 29, Issue Supplement_4, October 2018, Pages iv238–iv255, https://doi.org/10.1093/annonc/mdy308.
7. NCCN Clinical Practice Guidelines in Oncology, Hepatobiliary Cancers. 2.2018. National Comprehensive Cancer Network. Fort Washington, PA [Update: Jun 2018; Accessed: Sep 2018.
8. Thomas MB, Jaffe D, Choti MM, et al. Hepatocellular carcinoma: consensus recommendations of the National Cancer Institute Clinical Trials Planning Meeting. J Clin Oncol. 2010; 28(25): 3994–4005.
9. Петриев В.М. Фармакокинетические свойства и дозиметрические характеристики радиофармпрепаратов на основе сывороточного альбумина человека. Обнинск. Дисс. докт. биол. наук. 2011.
10. Salem R, Thurston KG: Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol 2006, 17:1571–1593.
11. Powerski MJ, Scheurig-Munkler C, Banzer J, et al. Clinical practice in radioembolization of hepatic malignancies: a survey among interventional centres in Europe. Eur J Radiol. 2012;81(7):e804–11. https://doi.org/10.1016/j.ejrad.2012.04.004.
12. Степаненко В.Ф., Петриев В.М., Каприн А.Д. и др. Персонализированная дозиметрия внутреннего облучения опухолевых образований и органов риска пациентов: разработка и реализация методического базиса для дозиметрического обеспечения клинических исследований терапевтических радиофармпрепаратов // Радиация и риск (Бюллетень Национального радиационно-эпидемиологического регистра). 2023. Т. 32, № 1. С. 156–167. DOI 10.21870/0131-3878-2023-32-1-156-167. – EDN AWJWKU.
Review
For citations:
Kaprin A.D., Ivanov S.A., Shegay P.V., Kucherov V.V., Petrosyan A.P., Stepanenko V.P., Tischenko V.K., Sigov M.A., Petrov L.O., Stehova A.T. Radioembolization of the liver by 188Re albumin microspheres 20–40 μm (“HEPATOREN”): results of the first phase of the study. Russian Journal for Personalized Medicine. 2023;3(5):74-81. (In Russ.) https://doi.org/10.18705/2782-3806-2023-3-5-74-81. EDN: BHTXAA
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