Вопросы гематологии/онкологии и иммунопатологии в педиатрии. 2020; 19: 20-31
Фармакокинетика 13-цис-Ретиноевой кислоты у пациентов с нейробластомой группы высокого риска
https://doi.org/10.24287/1726-1708-2020-19-4-20-31Аннотация
13-цис-Ретиноевая кислота (13-цис-РК) является дифференцировочным агентом для клеток нейробластомы (НБ) и входит в состав постконсолидационной терапии пациентов группы высокого риска. Эффективность данного терапевтического подхода в настоящее время продолжает изучаться. В исследовании фармакокинетики методом высокоэффективной жидкостной хроматографии с ультрафиолетовым детектором в зависимости от способа приема 13-цис-РК (целые капсулы или извлечение препарата из капсул) включены 26 пациентов с НБ группы высокого риска, получавших лечение в ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава России. Данное исследование одобрено независимым этическим комитетом и утверждено решением ученого совета ФГБУ «НМИЦ ДГОИ им. Дмитрия Рогачева» Минздрава России. Исследование показало, что терапевтической концентрации > 2 мкмоль/л при приеме 13-цис-РК в дозе 160 мг/м2 удалось достичь в обеих группах независимо от способа приема препарата. Однако содержание в плазме крови 13-цис-РК на 4 ч после введения на 14-й день терапии было выше в группе пациентов, принимавших целую капсулу (4,1 ± 1,8 мкмоль/л), чем в группе больных, которым для приема необходимо было вскрытие капсулы (1,9 ± 1,5 мкмоль/л) (р = 0,022). Внедрение в клиническую практику терапевтического мониторинга уровня 13-цис-РК в плазме крови у детей с НБ группы высокого риска с оценкой пиковой концентрации и коррекции дозы в последующих курсах может быть важным компонентом оптимизации постконсолидационной терапии, направленным на улучшение выживаемости.
Список литературы
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5. Matthay K.K., Reynolds C.P., Seeger R.C., Shimada H., Adkins E.S., Haas-Kogan D., et al. Long-term results for children with high-risk neuroblastoma treated on a randomized trial of myeloablative therapy followed by 13-cis-retinoic acid: a Children’s Oncology Group study. J Clin Oncol 2009; 27 (7):1007–13. DOI: 10.1200/JCO.2007.13.8925
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13. Villablanca J.G., Khan A.A., Avramis V.I., Seeger R.C., Matthay K.K., Ramsay N.K., et al. Phase I trial of 13-cis-retinoic acid in children with neuroblastoma following bone marrow transplantation. J Clin Oncol 1995; 13 (4): 894–901.
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22. Peinemann F., van Dalen E.C., Enk H., Berthold F. Retinoic acid postconsolidation therapy for high-risk neuroblastoma patients treated with autologous haematopoietic stem cell transplantation. Cochrane Database Syst Rev 2017; 2017 (8): CD010685.
23. ClinicalTrials.gov Oral Liquid 13-cis-retinoic Acid(13-CRA) (My-CRA). Identifier: NCT03291080 2017-2020.
24. Singh A., Ruan Y., Tippett T., Narendran A. Targeted inhibition of MEK1 by cobimetinib leads to differentiation and apoptosis in neuroblastoma cells. J Exp Clin Cancer Res 2015; 34: 104.
25. Zhang L., Scorsone K., Woodfield S.E., Zage P.E. Sensitivity of neuroblastoma to the novel kinase inhibitor cabozantinib is mediated by ERK inhibition. Cancer Chemother Pharmacol 2015; 76 (5): 977–87.
Pediatric Hematology/Oncology and Immunopathology. 2020; 19: 20-31
Pharmacokinetics of 13-cis-Retinoic acid in high-risk neuroblastoma patients
https://doi.org/10.24287/1726-1708-2020-19-4-20-31Abstract
13-cis-Retinoic acid is a differentiation agent for neuroblastoma cells and is a part of post-consolidation therapy for high-risk patients. The effectiveness of this therapeutic approach is currently under study. 26 patients with high-risk neuroblastoma treated at Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology were included in the study of 13-cis-Retinoic acid pharmacokinetics by high-performance liquid chromatography assay with ultraviolet detector depending on the method of administration of drug (swallowed capsules or opened capsules before administration). This study is supported by the Independent Ethics Committee and approved by the Academic Council of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology. The current study showed that the therapeutic concentration of > 2 μM when taking 13-cis-Retinoic acid at a dose of 160 mg/m2/day was achieved in two groups, regardless of the method of drug administration. However, plasma concentrations of 13-cis-Retinoic acid at 4 hours after administration on the 14th day of therapy were higher in the group of patients who swallowed the capsules (4.1 ± 1.8 μM), compared to those who could not do it (1.9 ± 1.5 μM) (p = 0.022). The introduction into the clinical practice of therapeutic drug monitoring of 13-cis-retinoic acid in high-risk neuroblastoma patients with an assessment of peak concentration and dose adjustment of the following courses may be an important point in the attempt to optimize postconsolidation therapy and improve prognosis.
References
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2. D’Angio G.J., Evans A.E., Koop C.E. Special pattern of widespread neuroblastoma with a favourable prognosis. Lancet 1971; 1 (7708): 1046–9.
3. Diede S.J. Spontaneous regression of metastatic cancer: learning from neuroblastoma. Nat Rev Cancer 2014; 14 (2): 71–2.
4. Reynolds C.P. Detection and treatment of minimal residual disease in high-risk neuroblastoma. Pediatr Transplant 2004; 8 (5): 56–66.
5. Matthay K.K., Reynolds C.P., Seeger R.C., Shimada H., Adkins E.S., Haas-Kogan D., et al. Long-term results for children with high-risk neuroblastoma treated on a randomized trial of myeloablative therapy followed by 13-cis-retinoic acid: a Children’s Oncology Group study. J Clin Oncol 2009; 27 (7):1007–13. DOI: 10.1200/JCO.2007.13.8925
6. Veal G.J., Errington J., Redfern C.P., Pearson A.D., Boddy A.V. Influence of isomerisation on the growth inhibitory effects and cellular activity of 13-cis and all-trans retinoic acid in neuroblastoma cells. Biochem Pharmacol 2002; 63 (2): 207–15.
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8. Veal G.J., Errington J., Rowbotham S.E., Illingworth N.A., Malik G., Cole M., et al. Adaptive dosing approaches to the individualization of 13-cis-retinoic acid (isotretinoin) treatment for children with high-risk neuroblastoma. Clin Cancer Res 2013; 19 (2): 469–79.
9. Brodeur G.M., Seeger R.C., Barrett A., Berthold F., Castleberry R.P., D'Angio G., et al. International criteria for diagnosis, staging, and response to treatment in patients with neuroblastoma. J Clin Oncol 1988; 6 (12): 1874–81.
10. Brodeur G.M., Pritchard J., Berthold F., Carlsen N.L., Castel V., Castelberry R.P., et al. Revisions of the international criteria for neuroblastoma diagnosis, staging and response to treatment. J Clin Oncol 1993; 11 (8): 1466–77.
11. Thorsten S., Barbara H., Schulte J.H., Deubzer H., Hundsdoerfer P., von Schweinitz D., et al. 2017 GPOH Guidelines for Diagnosis and Treatment of Patients with Neuroblastic Tumors. Klin Padiatr 2017; 229 (3): 147–67.
12. Sidell H. Retinoic acid-induced growth inhibition and morphologic differentiation of human neuroblastoma cells in vitro. J Natl Cancer Inst 1982; 68 (4): 589–96.
13. Villablanca J.G., Khan A.A., Avramis V.I., Seeger R.C., Matthay K.K., Ramsay N.K., et al. Phase I trial of 13-cis-retinoic acid in children with neuroblastoma following bone marrow transplantation. J Clin Oncol 1995; 13 (4): 894–901.
14. Kohler J.A, Imeson J., Ellershaw C., Lie S.O. A randomized trial of 13-cis retinoic acid in children with advanced neuroblastoma after high dose therapy. Br J Cancer 2000; 83 (9): 1124–7.
15. Li C., Einhorn P.A., Reynolds C.P. Expression of retinoic acid receptors alpha, beta, and gamma in human neuroblastoma cell lines. Prog Clin Biol Res 1994; 385 (1): 221–7.
16. Reynolds C.P., Kane D.J., Einhorn P.A., Matthay K.K., Crouse V.L., Wilbur J.R., et al. Response of neuroblastoma to retinoic acid in vitro and in vivo. Prog Clin Biol Res 1991; 366 (1): 203–11.
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20. Cho H., Yang S., Sonawane P., Yu A.L., Park J.R., Kreisman S., et al. Pharmacokinetics of 13-cis-retinoic acid in COG phase III neuroblastoma studies. Proceedings of Advances in Neuroblastoma Research Congress. Cairns, Australia; 2016. R. 217.
21. Cash T., Alazraki A., Qayed M., Katzenstein H.M. Prolonged Isotretinoin in Ultra High-Risk Neuroblastoma. J Pediatr Hematol Oncol 2017; 39 (1): 33–5.
22. Peinemann F., van Dalen E.C., Enk H., Berthold F. Retinoic acid postconsolidation therapy for high-risk neuroblastoma patients treated with autologous haematopoietic stem cell transplantation. Cochrane Database Syst Rev 2017; 2017 (8): CD010685.
23. ClinicalTrials.gov Oral Liquid 13-cis-retinoic Acid(13-CRA) (My-CRA). Identifier: NCT03291080 2017-2020.
24. Singh A., Ruan Y., Tippett T., Narendran A. Targeted inhibition of MEK1 by cobimetinib leads to differentiation and apoptosis in neuroblastoma cells. J Exp Clin Cancer Res 2015; 34: 104.
25. Zhang L., Scorsone K., Woodfield S.E., Zage P.E. Sensitivity of neuroblastoma to the novel kinase inhibitor cabozantinib is mediated by ERK inhibition. Cancer Chemother Pharmacol 2015; 76 (5): 977–87.
