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Фосапрепитант: современные возможности предупреждения тошноты и рвоты, индуцированных химиотерапией
Фосапрепитант: современные возможности предупреждения тошноты и рвоты, индуцированных химиотерапией
Огнерубов Н.А. Фосапрепитант: современные возможности предупреждения тошноты и рвоты, индуцированных химиотерапией. Современная Онкология. 2022;24(4):477–486.
DOI: 10.26442/18151434.2022.4.202019
© ООО «КОНСИЛИУМ МЕДИКУМ», 2022 г.
DOI: 10.26442/18151434.2022.4.202019
© ООО «КОНСИЛИУМ МЕДИКУМ», 2022 г.
________________________________________________
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Аннотация
Актуальность. Среди современных методов лечения злокачественных опухолей химиотерапия (ХТ) занимает лидирующее положение. Тошнота и рвота, индуцированные ХТ, наблюдаются у 30–90% пациентов на протяжении 0–120 ч после применения умеренно и высокоэметогенной ХТ. Их наличие может весьма серьезно повлиять на качество лечения, повседневную жизнедеятельность и приверженность лечению, что снижает эффективность терапии и продолжительность жизни.
Материалы и методы. Автор приводит результаты систематического обзора научных статей, включая клинические исследования, посвященные эффективности применения антагониста рецепторов нейрокинина-1 фосапрепитанта для предотвращения тошноты и рвоты, индуцированных ХТ. Исследовались данные из базы PubMed.
Результаты. Предупреждение и лечение тошноты и рвоты, ассоциированных с ХТ, представляет жизненно важную проблему, и ее следует рассматривать как необходимый этап при применении специальных методов лечения, включая симптоматическую терапию. С этой целью международные организации рекомендуют применять тройную комбинацию с включением антагонистов рецепторов нейрокинина-1, серотониновых 5-гидрокситриптамин-3-рецепторов и дексаметазона. Согласно полученным данным эффективность фосапрепитанта доказана в острой, отсроченной и общей фазах в ряде крупных, хорошо спланированных исследований – препарат позволяет снизить частоту нежелательных явлений в 2,7–4,4 раза по сравнению с апрепитантом.
Заключение. Фосапрепитант является антагонистом рецепторов нейрокинина-1, при внутривенном введении он быстро превращается в апрепитант. Применение его в составе триплета с антагонистами серотониновых 5-гидрокситриптамин-3-рецепторов и дексаметазоном у пациентов, получающих умеренно и высокоэметогенную ХТ, позволяет достичь большей частоты полных ответов при контроле тошноты и рвоты. В целом фосапрепитант хорошо переносится.
Ключевые слова: фосапрепитант, антагонисты рецепторов нейрокинина-1, химиотерапия, тошнота, рвота
Materials and methods. The author provides the results of a systematic review of research papers, including clinical studies, on the efficacy of the neurokinin-1 receptor antagonist fosaprepitant to prevent CT-induced nausea and vomiting. Data from the PubMed database were reviewed.
Results. The prevention and treatment of CT-associated nausea and vomiting are vital during special therapy, including symptomatic therapy. International organizations recommend using a triple combination with antagonists of neurokinin-1 and 5-hydroxytryptamine-3 receptors and dexamethasone. According to the data obtained, the efficacy of fosaprepitant has been proven in delayed and general phases in several large, well-planned studies; the drug reduces the incidence of adverse events by 2.7–4.4 times compared with aprepitant.
Conclusion. Fosaprepitant is an antagonist of neurokinin-1 receptors; when administered intravenously, it rapidly converts into aprepitant. When used as part of a triple combination with 5-hydroxytryptamine-3 receptor antagonists and dexamethasone in patients receiving moderate and highly emetogenic CT leads to a higher rate of complete response when controlling nausea and vomiting. In general, fosaprepitant is well tolerated.
Keywords: fosaprepitant, neurokinin-1 receptor antagonists, chemotherapy, nausea, vomiting
Материалы и методы. Автор приводит результаты систематического обзора научных статей, включая клинические исследования, посвященные эффективности применения антагониста рецепторов нейрокинина-1 фосапрепитанта для предотвращения тошноты и рвоты, индуцированных ХТ. Исследовались данные из базы PubMed.
Результаты. Предупреждение и лечение тошноты и рвоты, ассоциированных с ХТ, представляет жизненно важную проблему, и ее следует рассматривать как необходимый этап при применении специальных методов лечения, включая симптоматическую терапию. С этой целью международные организации рекомендуют применять тройную комбинацию с включением антагонистов рецепторов нейрокинина-1, серотониновых 5-гидрокситриптамин-3-рецепторов и дексаметазона. Согласно полученным данным эффективность фосапрепитанта доказана в острой, отсроченной и общей фазах в ряде крупных, хорошо спланированных исследований – препарат позволяет снизить частоту нежелательных явлений в 2,7–4,4 раза по сравнению с апрепитантом.
Заключение. Фосапрепитант является антагонистом рецепторов нейрокинина-1, при внутривенном введении он быстро превращается в апрепитант. Применение его в составе триплета с антагонистами серотониновых 5-гидрокситриптамин-3-рецепторов и дексаметазоном у пациентов, получающих умеренно и высокоэметогенную ХТ, позволяет достичь большей частоты полных ответов при контроле тошноты и рвоты. В целом фосапрепитант хорошо переносится.
Ключевые слова: фосапрепитант, антагонисты рецепторов нейрокинина-1, химиотерапия, тошнота, рвота
________________________________________________
Materials and methods. The author provides the results of a systematic review of research papers, including clinical studies, on the efficacy of the neurokinin-1 receptor antagonist fosaprepitant to prevent CT-induced nausea and vomiting. Data from the PubMed database were reviewed.
Results. The prevention and treatment of CT-associated nausea and vomiting are vital during special therapy, including symptomatic therapy. International organizations recommend using a triple combination with antagonists of neurokinin-1 and 5-hydroxytryptamine-3 receptors and dexamethasone. According to the data obtained, the efficacy of fosaprepitant has been proven in delayed and general phases in several large, well-planned studies; the drug reduces the incidence of adverse events by 2.7–4.4 times compared with aprepitant.
Conclusion. Fosaprepitant is an antagonist of neurokinin-1 receptors; when administered intravenously, it rapidly converts into aprepitant. When used as part of a triple combination with 5-hydroxytryptamine-3 receptor antagonists and dexamethasone in patients receiving moderate and highly emetogenic CT leads to a higher rate of complete response when controlling nausea and vomiting. In general, fosaprepitant is well tolerated.
Keywords: fosaprepitant, neurokinin-1 receptor antagonists, chemotherapy, nausea, vomiting
Полный текст
Список литературы
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3. Bloechl-Daum B, Deuson RR, Mavros P. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472-8. DOI:10.1200/JCO.2006.05.6382
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5. Hesketh PJ, Bohlke K, Lyman GH, et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol. 2016;34(4):381-6. DOI:10.1200/JCO.2015.64.3635
6. Warr DG, Grunberg SM, Gralla RJ, et al. The oral NK(1) antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: Pooled data from 2 randomised, double-blind, placebo controlled trials. Eur J Cancer. 2005;41(9):1278-85. DOI:10.1016/j.ejca.2005.01.024
7. Tsuji D, Suzuki K, Kawasaki Y, et al. Risk factors associated with chemotherapy-induced nausea and vomiting in the triplet antiemetic regimen including palonosetron or granisetron for cisplatin-based chemotherapy: analysis of a randomized, double-blind controlled trial. Support Care Cancer. 2019;27(3):1139‑47. DOI:10.1007/s00520-018-4403-y
8. Mosa ASM, Hossain AM, Lavoie BJ, Yoo I. Patient-related risk factors for chemotherapy-induced nausea and vomiting: a systematic review. Front Pharmacol. 2020;11:329. DOI:10.3389/fphar.2020.00329
9. Navari RM, Schwartzberg LS. Evolving role of neurokinin 1-receptor antagonists for chemotherapy-induced nausea and vomiting. Onco Targets Ther. 2018;11:6459-78. DOI:10.2147/OTT.S158570
10. Kreys ED, Kim TY, Delgado A, Koeller JM. Impact of cancer supportive care pathways compliance on emergency department visits and hospitalizations. J Oncol Pract. 2014;10(3):168-73. DOI:10.1200/JOP.2014.001376
11. Dranitsaris G, Molassiotis A, Clemons M, et al. The development of a prediction tool to identify cancer patients at high risk for chemotherapy-induced nausea and vomiting. Ann Oncol. 2017;28(6):1260-7. DOI:10.1093/annonc/mdx100
12. Rojas C, Raje M, Tsukamoto T, Slusher BS. Molecular mechanisms of 5-HT(3) and NK(1) receptor antagonists in prevention of emesis. Eur J Pharmacol. 2014;722:26-37. DOI:10.1016/j.ejphar.2013.08.049
13. Aogi K, Takeuchi H, Saeki T, et al. Optimizing antiemetic treatment for chemotherapy-induced nausea and vomiting in Japan: Update summary of the 2015 Japan Society of Clinical Oncology Clinical Practice Guidelines for Antiemesis. Int J Clin Oncol. 2021;26(1):1-17. DOI:10.1007/s10147-020-01818-3
14. Piechotta V, Adams A, Haque M, et al. Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis. Cochrane Database Syst Rev. 2021;11(11):CD012775. DOI:10.1002/14651858.CD012775.pub2
15. Kraut L, Fauser AA. Anti-emetics for cancer chemotherapy-induced emesis: Potential of alternative delivery systems. Drugs. 2001;61(11):1553-62.
DOI:10.2165/00003495-200161110-00003
16. Jordan K, Gralla R, Jahn F, Molassiotis A. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014;722:197-202. DOI:10.1016/j.ejphar.2013.09.073
17. Soukop M. Management of cyclophosphamide-induced emesis over repeat courses. Oncology. 1996;53(Suppl. 1):39-45. DOI:10.1159/000227639
18. Gralla RJ, Osoba D, Kris MG, et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol. 1999;17(9):2971-94. DOI:10.1200/JCO.1999.17.9.2971
19. Roscoe JA, Morrow GR, Hickok JT, Stern RM. Nausea and vomiting remain a significant clinical problem: Trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices. J Pain Symptom Manage. 2000;20(2):113-21. DOI:10.1016/s0885-3924(00)00159-7
20. Nakamura M, Ishiguro A, Muranaka T, et al. A prospective observational study on effect of short-term periodic steroid premedication on bone metabolism in gastrointestinal cancer (ESPRESSO-01). Oncologist. 2017;22(5):592-600. DOI:10.1634/theoncologist.2016-0308
21. Celio L, Bonizzoni E, Zattarin E, et al. Impact of dexamethasonesparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomized evidence. BMC Cancer. 2019;19(1):1268. DOI:10.1186/s12885-019-6454-y
22. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. J Clin Oncol. 2020;38(24):2782-97. DOI:10.1200/JCO.20.01296
23. Watanabe D, Iihara H, Fujii H, et al. One-Day Versus Three-Day Dexamethasone with NK1RA for Patients Receiving Carboplatin and Moderate Emetogenic Chemotherapy: A Network Meta-analysis. Oncologist. 2022;27(6):e524-32. DOI:10.1093/oncolo/oyac060
24. Di Maio M, Baratelli C, Bironzo P, et al. Efficacy of neurokinin-1 receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based chemotherapy: a systematic review and meta-analysis. Crit Rev Oncol Hematol. 2018;124:21-8. DOI:10.1016/j.critrevonc.2018.02.001
25. Wang DS, Hu MT, Wang ZQ, et al. Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(4):e215250. DOI:10.1001/jamanetworkopen.2021.5250
26. Kim JE, Jang JS, Kim JW, et al. Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Support Care Cancer. 2017;25(3):801-9. DOI:10.1007/s00520-016-3463-0
27. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Antiemesis, Version 2. 2020. Available at: https://www.nccn.org. Accessed: 20.10.2020.
28. Javid H, Afshari AR, Avval FZ, et al. Aprepitant Promotes Caspase-Dependent Apoptotic Cell Death and G2/M Arrest through PI3K/Akt/NF-κB Axis in Cancer Stem-Like Esophageal Squamous Cell Carcinoma Spheres. BioMed Res Int. 2021;2021:8808214. DOI:10.1155/2021/8808214
29. The National Comprehensive Cancer Network: NCCN clinical practice guidelines in oncology: Antiemesis, Version 1. 2021. Available at: https://www.nccn.org. Accessed: 20.07.2022.
30. Roila F, Molassiotis A, Herrstedt J, et al; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016;27(Suppl. 5):v119-33. DOI:10.1093/annonc/mdw270
31. Rapoport BL, Jordan K, Boice JA, et al. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010;18(4):423-31. DOI:10.1007/s00520-009-0680-9
32. Bošnjak SM, Gralla RJ, Schwartzberg L. Prevention of chemotherapy-induced nausea: the role of neurokinin-1 (NK1) receptor antagonists. Support Care Cancer. 2017;25(5):1661-71. DOI:10.1007/s00520-017-3585-z
33. Colon-Gonzalez F, Kraft WK. Pharmacokinetic evaluation of fosaprepitant dimeglumine. Expert Opin Drug Metab Toxicol. 2010;6(10):1277-86. DOI:10.1517/17425255.2010.513970
34. Van Laere K, De Hoon J, Bormans G, et al. Equivalent dynamic human brain NK1-receptor occupancy following single-dose i.v. fosaprepitant vs. oral aprepitant as assessed by PET imaging. Clin Pharmacol Ther. 2012;92(2):243-50. DOI:10.1038/clpt.2012.62
35. Boccia R, Geller RB, Clendeninn N, Ottoboni T. Hypersensitivity and infusion-site adverse events with intravenous fosaprepitant after anthracycline-containing chemotherapy: a retrospective study. Future Oncol. 2019;15(3):297‑303. DOI:10.2217/fon-2018-0662
36. Dranitsaris G, Moezi M, Dobson K, et al. A real-world study to evaluate the safety and efficacy of three injectable neurokinin-1 receptor antagonist formulations for the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Support Care Cancer. 2022;30(8):6649-58. DOI:10.1007/s00520-022-07082-7
37. Sugawara S, Inui N, Kanehara M, et al. Multicenter, placebo-controlled, double-blind, randomized study of fosnetupitant in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. Cancer. 2019;125(22):4076-83. DOI:10.1002/cncr.32429
38. Weinstein C, Jordan K, Green SA, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016;27:172-8. DOI:10.1093/annonc/mdv482
39. National Comprehensive Cancer Network. Antiemesis: NCCN clinical practice guidelines in oncology, Version 2. 2016. Available at: http://www.nccn.org. Accessed: 8.07.2016.
40. Saito H, Yoshizawa H, Yoshimori K, et al. Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Ann Oncol. 2013;24(4):1067-73. DOI:10.1093/annonc/mds541
41. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis, Version 3. 2018. Available at: www.nccn.org/patients. Accessed: 11.06.2018.
42. Grunberg S, Chua D, Maru A, et al. Single-Dose Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Cisplatin Therapy: Randomized, Double-Blind Study Protocol–EASE. J Clin Oncol. 2011;29(11):1495-501. DOI:10.1200/JCO.2010.31.7859
43. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011;29(31):4189-98. DOI:10.1200/JCO.2010.34.4614
44. Weinstein C, Jordan K, Green S, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type. BMC Cancer. 2020;20(1):918. DOI:10.1186/s12885-020-07259-5
45. Yang LQ, Sun XC, Qin SK, et al. Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study. Eur J Cancer Care (Engl). 2017;26(6):e12668. DOI:10.1111/ecc.12668
46. Gao A, Guan S, Sun Y, et al. Prolonged usage of fosaprepitant for prevention of delayed CINV in patients receiving highly emetogenic chemotherapy. Preprint. 2022. DOI:10.21203/rs.3.rs-1737681/v1
47. Lupin receives U.S. FDA approval for fosaprepitant for injection. September 6, 2019. Available at: https://www.lupin.com/lupin-receives-u-s-fda-approval-for-fosaprepitant-for-injection/ Accessed: 27.08.2021.
48. Novadoz Pharmaceuticals/MSN Labs receives FDA clearance for fosaprepitant and decitabine the company’s first generic specialty injectable products. September 5, 2019. Available at: https://www.prnewswire.com/news-releases/novadoz-pharmaceuticalsmsn-labs-receives-fda-clearance-for-.... Accessed: 27.08.2021.
49. Craver C, Gayle J, Balu S, Buchner D. Clinical and economic burden of chemotherapy-induced nausea and vomiting among patients with cancer in a hospital outpatient setting in the United States. J Med Econ. 2011;14(1):87-98. DOI:10.3111/13696998.2010.547237
50. Burke TA, Wisniewski T, Ernst FR. Resource utilization and costs associated with chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy administered in the US outpatient hospital setting. Support Care Cancer. 2011;19(1):131-40. DOI:10.1007/s00520-009-0797-x
51. Xu X, Bao Y, Xu K, et al. Economic Value of Fosaprepitant-Containing Regimen in the Prevention of Chemotherapy-Induced Nausea and Vomiting in China: Cost-Effectiveness and Budget Impact Analysis. Front Public Health. 2022;10:913129. DOI:10.3389/fpubh.2022.913129
2. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Antiemesis. Version 2.2019. Available at: https://www.nccn.org. Accessed: 15.07.2022.
3. Bloechl-Daum B, Deuson RR, Mavros P. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472-8. DOI:10.1200/JCO.2006.05.6382
4. Zhang B, Li XL. Adherence to clinical guidelines for prophylaxis of chemotherapy induced nausea and vomiting. Chin Hosp Pharm J. 2018;38(12):1325-9 (in Chinese). DOI:10.13286/j.cnki.chinhosppharmacyj.2018.12.19
5. Hesketh PJ, Bohlke K, Lyman GH, et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol. 2016;34(4):381-6. DOI:10.1200/JCO.2015.64.3635
6. Warr DG, Grunberg SM, Gralla RJ, et al. The oral NK(1) antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: Pooled data from 2 randomised, double-blind, placebo controlled trials. Eur J Cancer. 2005;41(9):1278-85. DOI:10.1016/j.ejca.2005.01.024
7. Tsuji D, Suzuki K, Kawasaki Y, et al. Risk factors associated with chemotherapy-induced nausea and vomiting in the triplet antiemetic regimen including palonosetron or granisetron for cisplatin-based chemotherapy: analysis of a randomized, double-blind controlled trial. Support Care Cancer. 2019;27(3):1139‑47. DOI:10.1007/s00520-018-4403-y
8. Mosa ASM, Hossain AM, Lavoie BJ, Yoo I. Patient-related risk factors for chemotherapy-induced nausea and vomiting: a systematic review. Front Pharmacol. 2020;11:329. DOI:10.3389/fphar.2020.00329
9. Navari RM, Schwartzberg LS. Evolving role of neurokinin 1-receptor antagonists for chemotherapy-induced nausea and vomiting. Onco Targets Ther. 2018;11:6459-78. DOI:10.2147/OTT.S158570
10. Kreys ED, Kim TY, Delgado A, Koeller JM. Impact of cancer supportive care pathways compliance on emergency department visits and hospitalizations. J Oncol Pract. 2014;10(3):168-73. DOI:10.1200/JOP.2014.001376
11. Dranitsaris G, Molassiotis A, Clemons M, et al. The development of a prediction tool to identify cancer patients at high risk for chemotherapy-induced nausea and vomiting. Ann Oncol. 2017;28(6):1260-7. DOI:10.1093/annonc/mdx100
12. Rojas C, Raje M, Tsukamoto T, Slusher BS. Molecular mechanisms of 5-HT(3) and NK(1) receptor antagonists in prevention of emesis. Eur J Pharmacol. 2014;722:26-37. DOI:10.1016/j.ejphar.2013.08.049
13. Aogi K, Takeuchi H, Saeki T, et al. Optimizing antiemetic treatment for chemotherapy-induced nausea and vomiting in Japan: Update summary of the 2015 Japan Society of Clinical Oncology Clinical Practice Guidelines for Antiemesis. Int J Clin Oncol. 2021;26(1):1-17. DOI:10.1007/s10147-020-01818-3
14. Piechotta V, Adams A, Haque M, et al. Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis. Cochrane Database Syst Rev. 2021;11(11):CD012775. DOI:10.1002/14651858.CD012775.pub2
15. Kraut L, Fauser AA. Anti-emetics for cancer chemotherapy-induced emesis: Potential of alternative delivery systems. Drugs. 2001;61(11):1553-62.
DOI:10.2165/00003495-200161110-00003
16. Jordan K, Gralla R, Jahn F, Molassiotis A. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014;722:197-202. DOI:10.1016/j.ejphar.2013.09.073
17. Soukop M. Management of cyclophosphamide-induced emesis over repeat courses. Oncology. 1996;53(Suppl. 1):39-45. DOI:10.1159/000227639
18. Gralla RJ, Osoba D, Kris MG, et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol. 1999;17(9):2971-94. DOI:10.1200/JCO.1999.17.9.2971
19. Roscoe JA, Morrow GR, Hickok JT, Stern RM. Nausea and vomiting remain a significant clinical problem: Trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices. J Pain Symptom Manage. 2000;20(2):113-21. DOI:10.1016/s0885-3924(00)00159-7
20. Nakamura M, Ishiguro A, Muranaka T, et al. A prospective observational study on effect of short-term periodic steroid premedication on bone metabolism in gastrointestinal cancer (ESPRESSO-01). Oncologist. 2017;22(5):592-600. DOI:10.1634/theoncologist.2016-0308
21. Celio L, Bonizzoni E, Zattarin E, et al. Impact of dexamethasonesparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomized evidence. BMC Cancer. 2019;19(1):1268. DOI:10.1186/s12885-019-6454-y
22. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. J Clin Oncol. 2020;38(24):2782-97. DOI:10.1200/JCO.20.01296
23. Watanabe D, Iihara H, Fujii H, et al. One-Day Versus Three-Day Dexamethasone with NK1RA for Patients Receiving Carboplatin and Moderate Emetogenic Chemotherapy: A Network Meta-analysis. Oncologist. 2022;27(6):e524-32. DOI:10.1093/oncolo/oyac060
24. Di Maio M, Baratelli C, Bironzo P, et al. Efficacy of neurokinin-1 receptor antagonists in the prevention of chemotherapy-induced nausea and vomiting in patients receiving carboplatin-based chemotherapy: a systematic review and meta-analysis. Crit Rev Oncol Hematol. 2018;124:21-8. DOI:10.1016/j.critrevonc.2018.02.001
25. Wang DS, Hu MT, Wang ZQ, et al. Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial. JAMA Netw Open. 2021;4(4):e215250. DOI:10.1001/jamanetworkopen.2021.5250
26. Kim JE, Jang JS, Kim JW, et al. Efficacy and safety of aprepitant for the prevention of chemotherapy-induced nausea and vomiting during the first cycle of moderately emetogenic chemotherapy in Korean patients with a broad range of tumor types. Support Care Cancer. 2017;25(3):801-9. DOI:10.1007/s00520-016-3463-0
27. National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology. Antiemesis, Version 2. 2020. Available at: https://www.nccn.org. Accessed: 20.10.2020.
28. Javid H, Afshari AR, Avval FZ, et al. Aprepitant Promotes Caspase-Dependent Apoptotic Cell Death and G2/M Arrest through PI3K/Akt/NF-κB Axis in Cancer Stem-Like Esophageal Squamous Cell Carcinoma Spheres. BioMed Res Int. 2021;2021:8808214. DOI:10.1155/2021/8808214
29. The National Comprehensive Cancer Network: NCCN clinical practice guidelines in oncology: Antiemesis, Version 1. 2021. Available at: https://www.nccn.org. Accessed: 20.07.2022.
30. Roila F, Molassiotis A, Herrstedt J, et al; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016;27(Suppl. 5):v119-33. DOI:10.1093/annonc/mdw270
31. Rapoport BL, Jordan K, Boice JA, et al. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010;18(4):423-31. DOI:10.1007/s00520-009-0680-9
32. Bošnjak SM, Gralla RJ, Schwartzberg L. Prevention of chemotherapy-induced nausea: the role of neurokinin-1 (NK1) receptor antagonists. Support Care Cancer. 2017;25(5):1661-71. DOI:10.1007/s00520-017-3585-z
33. Colon-Gonzalez F, Kraft WK. Pharmacokinetic evaluation of fosaprepitant dimeglumine. Expert Opin Drug Metab Toxicol. 2010;6(10):1277-86. DOI:10.1517/17425255.2010.513970
34. Van Laere K, De Hoon J, Bormans G, et al. Equivalent dynamic human brain NK1-receptor occupancy following single-dose i.v. fosaprepitant vs. oral aprepitant as assessed by PET imaging. Clin Pharmacol Ther. 2012;92(2):243-50. DOI:10.1038/clpt.2012.62
35. Boccia R, Geller RB, Clendeninn N, Ottoboni T. Hypersensitivity and infusion-site adverse events with intravenous fosaprepitant after anthracycline-containing chemotherapy: a retrospective study. Future Oncol. 2019;15(3):297‑303. DOI:10.2217/fon-2018-0662
36. Dranitsaris G, Moezi M, Dobson K, et al. A real-world study to evaluate the safety and efficacy of three injectable neurokinin-1 receptor antagonist formulations for the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Support Care Cancer. 2022;30(8):6649-58. DOI:10.1007/s00520-022-07082-7
37. Sugawara S, Inui N, Kanehara M, et al. Multicenter, placebo-controlled, double-blind, randomized study of fosnetupitant in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. Cancer. 2019;125(22):4076-83. DOI:10.1002/cncr.32429
38. Weinstein C, Jordan K, Green SA, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016;27:172-8. DOI:10.1093/annonc/mdv482
39. National Comprehensive Cancer Network. Antiemesis: NCCN clinical practice guidelines in oncology, Version 2. 2016. Available at: http://www.nccn.org. Accessed: 8.07.2016.
40. Saito H, Yoshizawa H, Yoshimori K, et al. Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Ann Oncol. 2013;24(4):1067-73. DOI:10.1093/annonc/mds541
41. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis, Version 3. 2018. Available at: www.nccn.org/patients. Accessed: 11.06.2018.
42. Grunberg S, Chua D, Maru A, et al. Single-Dose Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Cisplatin Therapy: Randomized, Double-Blind Study Protocol–EASE. J Clin Oncol. 2011;29(11):1495-501. DOI:10.1200/JCO.2010.31.7859
43. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011;29(31):4189-98. DOI:10.1200/JCO.2010.34.4614
44. Weinstein C, Jordan K, Green S, et al. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type. BMC Cancer. 2020;20(1):918. DOI:10.1186/s12885-020-07259-5
45. Yang LQ, Sun XC, Qin SK, et al. Efficacy and safety of fosaprepitant in the prevention of nausea and vomiting following highly emetogenic chemotherapy in Chinese people: A randomized, double-blind, phase III study. Eur J Cancer Care (Engl). 2017;26(6):e12668. DOI:10.1111/ecc.12668
46. Gao A, Guan S, Sun Y, et al. Prolonged usage of fosaprepitant for prevention of delayed CINV in patients receiving highly emetogenic chemotherapy. Preprint. 2022. DOI:10.21203/rs.3.rs-1737681/v1
47. Lupin receives U.S. FDA approval for fosaprepitant for injection. September 6, 2019. Available at: https://www.lupin.com/lupin-receives-u-s-fda-approval-for-fosaprepitant-for-injection/ Accessed: 27.08.2021.
48. Novadoz Pharmaceuticals/MSN Labs receives FDA clearance for fosaprepitant and decitabine the company’s first generic specialty injectable products. September 5, 2019. Available at: https://www.prnewswire.com/news-releases/novadoz-pharmaceuticalsmsn-labs-receives-fda-clearance-for-.... Accessed: 27.08.2021.
49. Craver C, Gayle J, Balu S, Buchner D. Clinical and economic burden of chemotherapy-induced nausea and vomiting among patients with cancer in a hospital outpatient setting in the United States. J Med Econ. 2011;14(1):87-98. DOI:10.3111/13696998.2010.547237
50. Burke TA, Wisniewski T, Ernst FR. Resource utilization and costs associated with chemotherapy-induced nausea and vomiting (CINV) following highly or moderately emetogenic chemotherapy administered in the US outpatient hospital setting. Support Care Cancer. 2011;19(1):131-40. DOI:10.1007/s00520-009-0797-x
51. Xu X, Bao Y, Xu K, et al. Economic Value of Fosaprepitant-Containing Regimen in the Prevention of Chemotherapy-Induced Nausea and Vomiting in China: Cost-Effectiveness and Budget Impact Analysis. Front Public Health. 2022;10:913129. DOI:10.3389/fpubh.2022.913129
________________________________________________
2. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Antiemesis. Version 2.2019. Available at: https://www.nccn.org. Accessed: 15.07.2022.
3. Bloechl-Daum B, Deuson RR, Mavros P. Delayed nausea and vomiting continue to reduce patients' quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol. 2006;24(27):4472-8. DOI:10.1200/JCO.2006.05.6382
4. Zhang B, Li XL. Adherence to clinical guidelines for prophylaxis of chemotherapy induced nausea and vomiting. Chin Hosp Pharm J. 2018;38(12):1325-9 (in Chinese). DOI:10.13286/j.cnki.chinhosppharmacyj.2018.12.19
5. Hesketh PJ, Bohlke K, Lyman GH, et al. Antiemetics: American Society of Clinical Oncology Focused Guideline Update. J Clin Oncol. 2016;34(4):381-6. DOI:10.1200/JCO.2015.64.3635
6. Warr DG, Grunberg SM, Gralla RJ, et al. The oral NK(1) antagonist aprepitant for the prevention of acute and delayed chemotherapy-induced nausea and vomiting: Pooled data from 2 randomised, double-blind, placebo controlled trials. Eur J Cancer. 2005;41(9):1278-85. DOI:10.1016/j.ejca.2005.01.024
7. Tsuji D, Suzuki K, Kawasaki Y, et al. Risk factors associated with chemotherapy-induced nausea and vomiting in the triplet antiemetic regimen including palonosetron or granisetron for cisplatin-based chemotherapy: analysis of a randomized, double-blind controlled trial. Support Care Cancer. 2019;27(3):1139‑47. DOI:10.1007/s00520-018-4403-y
8. Mosa ASM, Hossain AM, Lavoie BJ, Yoo I. Patient-related risk factors for chemotherapy-induced nausea and vomiting: a systematic review. Front Pharmacol. 2020;11:329. DOI:10.3389/fphar.2020.00329
9. Navari RM, Schwartzberg LS. Evolving role of neurokinin 1-receptor antagonists for chemotherapy-induced nausea and vomiting. Onco Targets Ther. 2018;11:6459-78. DOI:10.2147/OTT.S158570
10. Kreys ED, Kim TY, Delgado A, Koeller JM. Impact of cancer supportive care pathways compliance on emergency department visits and hospitalizations. J Oncol Pract. 2014;10(3):168-73. DOI:10.1200/JOP.2014.001376
11. Dranitsaris G, Molassiotis A, Clemons M, et al. The development of a prediction tool to identify cancer patients at high risk for chemotherapy-induced nausea and vomiting. Ann Oncol. 2017;28(6):1260-7. DOI:10.1093/annonc/mdx100
12. Rojas C, Raje M, Tsukamoto T, Slusher BS. Molecular mechanisms of 5-HT(3) and NK(1) receptor antagonists in prevention of emesis. Eur J Pharmacol. 2014;722:26-37. DOI:10.1016/j.ejphar.2013.08.049
13. Aogi K, Takeuchi H, Saeki T, et al. Optimizing antiemetic treatment for chemotherapy-induced nausea and vomiting in Japan: Update summary of the 2015 Japan Society of Clinical Oncology Clinical Practice Guidelines for Antiemesis. Int J Clin Oncol. 2021;26(1):1-17. DOI:10.1007/s10147-020-01818-3
14. Piechotta V, Adams A, Haque M, et al. Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis. Cochrane Database Syst Rev. 2021;11(11):CD012775. DOI:10.1002/14651858.CD012775.pub2
15. Kraut L, Fauser AA. Anti-emetics for cancer chemotherapy-induced emesis: Potential of alternative delivery systems. Drugs. 2001;61(11):1553-62.
DOI:10.2165/00003495-200161110-00003
16. Jordan K, Gralla R, Jahn F, Molassiotis A. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014;722:197-202. DOI:10.1016/j.ejphar.2013.09.073
17. Soukop M. Management of cyclophosphamide-induced emesis over repeat courses. Oncology. 1996;53(Suppl. 1):39-45. DOI:10.1159/000227639
18. Gralla RJ, Osoba D, Kris MG, et al. Recommendations for the use of antiemetics: evidence-based, clinical practice guidelines. American Society of Clinical Oncology. J Clin Oncol. 1999;17(9):2971-94. DOI:10.1200/JCO.1999.17.9.2971
19. Roscoe JA, Morrow GR, Hickok JT, Stern RM. Nausea and vomiting remain a significant clinical problem: Trends over time in controlling chemotherapy-induced nausea and vomiting in 1413 patients treated in community clinical practices. J Pain Symptom Manage. 2000;20(2):113-21. DOI:10.1016/s0885-3924(00)00159-7
20. Nakamura M, Ishiguro A, Muranaka T, et al. A prospective observational study on effect of short-term periodic steroid premedication on bone metabolism in gastrointestinal cancer (ESPRESSO-01). Oncologist. 2017;22(5):592-600. DOI:10.1634/theoncologist.2016-0308
21. Celio L, Bonizzoni E, Zattarin E, et al. Impact of dexamethasonesparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomized evidence. BMC Cancer. 2019;19(1):1268. DOI:10.1186/s12885-019-6454-y
22. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO Guideline Update. J Clin Oncol. 2020;38(24):2782-97. DOI:10.1200/JCO.20.01296
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Авторы
Н.А. Огнерубов*
ФГБОУ ВО «Тамбовский государственный университет им. Г.Р. Державина», Тамбов, Россия
*ognerubov_n.a@mail.ru
Derzhavin Tambov State University, Tambov, Russia
*ognerubov_n.a@mail.ru
ФГБОУ ВО «Тамбовский государственный университет им. Г.Р. Державина», Тамбов, Россия
*ognerubov_n.a@mail.ru
________________________________________________
Derzhavin Tambov State University, Tambov, Russia
*ognerubov_n.a@mail.ru
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