{"title":"在播散性肾细胞癌患者中首次使用 Pembroria® 药物的经验","authors":"I. M. Shevchuk, N. D. Movchan","doi":"10.17650/1726-9776-2023-19-4-44-51","DOIUrl":null,"url":null,"abstract":"Background. According to the clinical guidelines from the leading Russian and international societies, treatment of patients with metastatic renal cell carcinoma is based on combination use of immune and targeted drugs. In December of 2022, the first Russian analogue of immune-oncological drug pembrolizumab with trade name Pembroria® was registered in Russia.Aim. To evaluate safety of the biosimilar, as well as register its effectiveness in the form of objective response estimation in accordance with the RECIST v.1.1 (Response Evaluation Criteria in Solid Tumors version 1.1) criteria. The article presents the results of the first experience of using Pembroria® in real clinical practice. Two clinical observations are presented demonstrating effectiveness and safety of the biosimilar.Materials and methods. At the clinic of the N. Lopatkin Scientific Research Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiology Center, 21 patients with clear cell renal cell carcinoma who did not previously receive systemic antitumor treatment underwent immunotarget therapy with Pembroria® and a targeted agent: lenvatinib (20 mg/day orally) or axitinib (10 mg/day orally).Results. The analysis of effectiveness considering short follow-up periods was performed in 18 patients. Median follow-up period was 6 (2–13) months and objective response rate was 50 %, in 28 % of cases stable disease was observed. Survival rates were not evaluated due to short observation time.Conclusion. Use of Pembroria® medication in patients with metastatic renal cell carcinoma in real clinical practice showed high objective response rate with acceptable toxicity level. No new, previously not described adverse events were registered during Pembroria® administration.","PeriodicalId":216890,"journal":{"name":"Cancer Urology","volume":"323 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"First experience of using Pembroria® medication in patients with disseminated renal cell carcinoma\",\"authors\":\"I. M. Shevchuk, N. D. Movchan\",\"doi\":\"10.17650/1726-9776-2023-19-4-44-51\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background. According to the clinical guidelines from the leading Russian and international societies, treatment of patients with metastatic renal cell carcinoma is based on combination use of immune and targeted drugs. In December of 2022, the first Russian analogue of immune-oncological drug pembrolizumab with trade name Pembroria® was registered in Russia.Aim. To evaluate safety of the biosimilar, as well as register its effectiveness in the form of objective response estimation in accordance with the RECIST v.1.1 (Response Evaluation Criteria in Solid Tumors version 1.1) criteria. The article presents the results of the first experience of using Pembroria® in real clinical practice. Two clinical observations are presented demonstrating effectiveness and safety of the biosimilar.Materials and methods. At the clinic of the N. Lopatkin Scientific Research Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiology Center, 21 patients with clear cell renal cell carcinoma who did not previously receive systemic antitumor treatment underwent immunotarget therapy with Pembroria® and a targeted agent: lenvatinib (20 mg/day orally) or axitinib (10 mg/day orally).Results. The analysis of effectiveness considering short follow-up periods was performed in 18 patients. Median follow-up period was 6 (2–13) months and objective response rate was 50 %, in 28 % of cases stable disease was observed. Survival rates were not evaluated due to short observation time.Conclusion. Use of Pembroria® medication in patients with metastatic renal cell carcinoma in real clinical practice showed high objective response rate with acceptable toxicity level. No new, previously not described adverse events were registered during Pembroria® administration.\",\"PeriodicalId\":216890,\"journal\":{\"name\":\"Cancer Urology\",\"volume\":\"323 3\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-02-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Urology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.17650/1726-9776-2023-19-4-44-51\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Urology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17650/1726-9776-2023-19-4-44-51","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
背景。根据俄罗斯和国际主要学会的临床指南,转移性肾细胞癌患者的治疗以联合使用免疫药物和靶向药物为基础。2022 年 12 月,俄罗斯首个免疫肿瘤药物 pembrolizumab 类似物在俄罗斯注册,商品名为 Pembroria®。评估生物类似物的安全性,并根据 RECIST v.1.1(实体瘤反应评估标准 1.1 版)标准,以客观反应评估的形式登记其有效性。文章介绍了在实际临床实践中首次使用 Pembroria® 的结果。材料与方法。在N.洛帕特金泌尿学和介入放射学科学研究所(N. Lopatkin Scientific Research Institute of Urology and Interventional Radiology)--国家医学研究放射学中心分部的诊所,21名之前未接受过全身抗肿瘤治疗的透明细胞肾细胞癌患者接受了Pembroria®和一种靶向药物的免疫靶向治疗:来伐替尼(20毫克/天口服)或阿西替尼(10毫克/天口服)。考虑到随访时间较短,对18名患者进行了疗效分析。中位随访时间为6(2-13)个月,客观反应率为50%,28%的病例病情稳定。由于观察时间较短,未对存活率进行评估。在实际临床实践中,对转移性肾细胞癌患者使用 Pembroria® 药物治疗显示出较高的客观反应率和可接受的毒性水平。在服用 Pembroria® 期间,没有出现新的、以前未曾描述过的不良事件。
First experience of using Pembroria® medication in patients with disseminated renal cell carcinoma
Background. According to the clinical guidelines from the leading Russian and international societies, treatment of patients with metastatic renal cell carcinoma is based on combination use of immune and targeted drugs. In December of 2022, the first Russian analogue of immune-oncological drug pembrolizumab with trade name Pembroria® was registered in Russia.Aim. To evaluate safety of the biosimilar, as well as register its effectiveness in the form of objective response estimation in accordance with the RECIST v.1.1 (Response Evaluation Criteria in Solid Tumors version 1.1) criteria. The article presents the results of the first experience of using Pembroria® in real clinical practice. Two clinical observations are presented demonstrating effectiveness and safety of the biosimilar.Materials and methods. At the clinic of the N. Lopatkin Scientific Research Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiology Center, 21 patients with clear cell renal cell carcinoma who did not previously receive systemic antitumor treatment underwent immunotarget therapy with Pembroria® and a targeted agent: lenvatinib (20 mg/day orally) or axitinib (10 mg/day orally).Results. The analysis of effectiveness considering short follow-up periods was performed in 18 patients. Median follow-up period was 6 (2–13) months and objective response rate was 50 %, in 28 % of cases stable disease was observed. Survival rates were not evaluated due to short observation time.Conclusion. Use of Pembroria® medication in patients with metastatic renal cell carcinoma in real clinical practice showed high objective response rate with acceptable toxicity level. No new, previously not described adverse events were registered during Pembroria® administration.