{"title":"传统的还是药物洗脱珠?肝细胞癌化疗栓塞的随机对照研究:JIVROSG-1302。","authors":"Masafumi Ikeda, Yasuaki Arai, Yoshitaka Inaba, Toshihiro Tanaka, Shunsuke Sugawara, Yoshihisa Kodama, Takeshi Aramaki, Hiroshi Anai, Shinichi Morita, Yoshinori Tsukahara, Hiroshi Seki, Mikio Sato, Kenya Kamimura, Kimei Azama, Masakatsu Tsurusaki, Eiji Sugihara, Masaya Miyazaki, Tatsushi Kobayashi, Miyuki Sone","doi":"10.1159/000525500","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients with hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads (DEB-TACE) loaded with epirubicin or selective conventional TACE (cTACE) with epirubicin-ethiodized oil might be more effective for obtaining complete response(CR) in patients with HCC.</p><p><strong>Methods: </strong>Between March 2016 and May 2019, Child-Pugh class A or B patients with unresectable HCC who were scheduled to receive selective TACE were randomly assigned at a 1:1 ratio to the DEB-TACE arm or the cTACE arm. The primary endpoint was the CR rate at 3 months, as evaluated according to the modified Response Evaluation Criteria in Solid Tumors by an independent review committee, and the secondary endpoints were the CR rate at 1 month and incidences of adverse events.</p><p><strong>Results: </strong>A total of 200 patients (DEB-TACE, 99 patients; cTACE, 101 patients) were enrolled in the study. The CR rates at 3 months and 1 month were significantly higher in the cTACE arm (75.2%, 84.2%) as compared with the DEB-TACE arm (27.6%, 35.7%). However, the frequencies of adverse events of any grade, including pyrexia (DEB-TACE vs. cTACE, 19.4% vs. 45.5%, <i>p</i> = 0.0001), fatigue (5.1% vs. 15.8%, <i>p</i> = 0.0194), malaise (11.1% vs. 25.7%, <i>p</i> = 0.0103), appetite loss (12.1% vs. 28.7%, <i>p</i> = 0.0048), abdominal pain (12.1% vs. 23.8%, <i>p</i> = 0.0423), increased serum bilirubin (22.2% vs. 48.5%, <i>p</i> = 0.0002), hypoalbuminemia (43.4% vs. 60.3%, <i>p</i> = 0.0154), increased serum aspartate aminotransferase (35.7% vs. 81.2%, <i>p</i> < 0.0001), and increased serum alanine aminotransferase (35.7% vs. 77.2%, <i>p</i> < 0.0001), were also significantly higher in the cTACE arm than in the DEB-TACE arm.</p><p><strong>Conclusions: </strong>Selective cTACE appeared to have higher CR rates for local tumor control as compared to selective DEB-TACE for HCC. However, the frequency of postembolization syndrome was also significantly higher in the cTACE group than in the DEB-TACE group. Thus, to achieve CR, cTACE may be selected over DEB-TACE in patients who can be expected to tolerate postembolization syndrome.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"11 5","pages":"440-450"},"PeriodicalIF":11.6000,"publicationDate":"2022-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e1/0e/lic-0011-0440.PMC9485929.pdf","citationCount":"18","resultStr":"{\"title\":\"Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302.\",\"authors\":\"Masafumi Ikeda, Yasuaki Arai, Yoshitaka Inaba, Toshihiro Tanaka, Shunsuke Sugawara, Yoshihisa Kodama, Takeshi Aramaki, Hiroshi Anai, Shinichi Morita, Yoshinori Tsukahara, Hiroshi Seki, Mikio Sato, Kenya Kamimura, Kimei Azama, Masakatsu Tsurusaki, Eiji Sugihara, Masaya Miyazaki, Tatsushi Kobayashi, Miyuki Sone\",\"doi\":\"10.1159/000525500\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients with hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads (DEB-TACE) loaded with epirubicin or selective conventional TACE (cTACE) with epirubicin-ethiodized oil might be more effective for obtaining complete response(CR) in patients with HCC.</p><p><strong>Methods: </strong>Between March 2016 and May 2019, Child-Pugh class A or B patients with unresectable HCC who were scheduled to receive selective TACE were randomly assigned at a 1:1 ratio to the DEB-TACE arm or the cTACE arm. The primary endpoint was the CR rate at 3 months, as evaluated according to the modified Response Evaluation Criteria in Solid Tumors by an independent review committee, and the secondary endpoints were the CR rate at 1 month and incidences of adverse events.</p><p><strong>Results: </strong>A total of 200 patients (DEB-TACE, 99 patients; cTACE, 101 patients) were enrolled in the study. The CR rates at 3 months and 1 month were significantly higher in the cTACE arm (75.2%, 84.2%) as compared with the DEB-TACE arm (27.6%, 35.7%). However, the frequencies of adverse events of any grade, including pyrexia (DEB-TACE vs. cTACE, 19.4% vs. 45.5%, <i>p</i> = 0.0001), fatigue (5.1% vs. 15.8%, <i>p</i> = 0.0194), malaise (11.1% vs. 25.7%, <i>p</i> = 0.0103), appetite loss (12.1% vs. 28.7%, <i>p</i> = 0.0048), abdominal pain (12.1% vs. 23.8%, <i>p</i> = 0.0423), increased serum bilirubin (22.2% vs. 48.5%, <i>p</i> = 0.0002), hypoalbuminemia (43.4% vs. 60.3%, <i>p</i> = 0.0154), increased serum aspartate aminotransferase (35.7% vs. 81.2%, <i>p</i> < 0.0001), and increased serum alanine aminotransferase (35.7% vs. 77.2%, <i>p</i> < 0.0001), were also significantly higher in the cTACE arm than in the DEB-TACE arm.</p><p><strong>Conclusions: </strong>Selective cTACE appeared to have higher CR rates for local tumor control as compared to selective DEB-TACE for HCC. However, the frequency of postembolization syndrome was also significantly higher in the cTACE group than in the DEB-TACE group. Thus, to achieve CR, cTACE may be selected over DEB-TACE in patients who can be expected to tolerate postembolization syndrome.</p>\",\"PeriodicalId\":18156,\"journal\":{\"name\":\"Liver Cancer\",\"volume\":\"11 5\",\"pages\":\"440-450\"},\"PeriodicalIF\":11.6000,\"publicationDate\":\"2022-06-15\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e1/0e/lic-0011-0440.PMC9485929.pdf\",\"citationCount\":\"18\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Liver Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1159/000525500\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/9/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Liver Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000525500","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/9/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 18
摘要
导读:随着有效全身治疗的出现，经动脉化疗栓塞(TACE)被确立为一种高效的局部区域治疗方式，用于精心挑选的肝细胞癌(HCC)患者。这项随机对照试验的目的是阐明，在HCC患者中，是使用表柔比星药物洗脱珠(DEB-TACE)进行选择性TACE治疗，还是使用表柔比星乙化油进行选择性常规TACE治疗更有效。方法:2016年3月至2019年5月期间，Child-Pugh A级或B级不可切除HCC患者计划接受选择性TACE，按1:1的比例随机分配到DEB-TACE组或cace组。主要终点是3个月时的CR率，由独立审查委员会根据修订的实体瘤反应评价标准进行评估，次要终点是1个月时的CR率和不良事件的发生率。结果:共200例患者(DEB-TACE 99例;cTACE, 101例患者)纳入研究。3个月和1个月时，cTACE组的CR率(75.2%，84.2%)明显高于DEB-TACE组(27.6%，35.7%)。然而，任何级别的不良事件发生频率，包括发热(debtace vs. cTACE, 19.4% vs. 45.5%， p = 0.0001)、疲劳(5.1% vs. 15.8%， p = 0.0194)、不适(11.1% vs. 25.7%， p = 0.0103)、食欲减退(12.1% vs. 28.7%， p = 0.0048)、腹痛(12.1% vs. 23.8%， p = 0.0423)、血清胆红素升高(22.2% vs. 48.5%， p = 0.0002)、低白蛋白血症(43.4% vs. 60.3%， p = 0.0154)、血清天门氨酸转氨酶升高(35.7% vs. 81.2%， p < 0.0001)、血清丙氨酸转氨酶升高(35.7% vs 77.2%， p < 0.0001)， cace组也显著高于DEB-TACE组。结论:与选择性DEB-TACE治疗HCC相比，选择性cTACE在局部肿瘤控制方面具有更高的CR率。然而，栓塞后综合征的频率在cTACE组也明显高于DEB-TACE组。因此，为了达到CR，对于能够耐受栓塞后综合征的患者，可以选择cTACE而不是DEB-TACE。
Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302.
Introduction: With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients with hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads (DEB-TACE) loaded with epirubicin or selective conventional TACE (cTACE) with epirubicin-ethiodized oil might be more effective for obtaining complete response(CR) in patients with HCC.
Methods: Between March 2016 and May 2019, Child-Pugh class A or B patients with unresectable HCC who were scheduled to receive selective TACE were randomly assigned at a 1:1 ratio to the DEB-TACE arm or the cTACE arm. The primary endpoint was the CR rate at 3 months, as evaluated according to the modified Response Evaluation Criteria in Solid Tumors by an independent review committee, and the secondary endpoints were the CR rate at 1 month and incidences of adverse events.
Results: A total of 200 patients (DEB-TACE, 99 patients; cTACE, 101 patients) were enrolled in the study. The CR rates at 3 months and 1 month were significantly higher in the cTACE arm (75.2%, 84.2%) as compared with the DEB-TACE arm (27.6%, 35.7%). However, the frequencies of adverse events of any grade, including pyrexia (DEB-TACE vs. cTACE, 19.4% vs. 45.5%, p = 0.0001), fatigue (5.1% vs. 15.8%, p = 0.0194), malaise (11.1% vs. 25.7%, p = 0.0103), appetite loss (12.1% vs. 28.7%, p = 0.0048), abdominal pain (12.1% vs. 23.8%, p = 0.0423), increased serum bilirubin (22.2% vs. 48.5%, p = 0.0002), hypoalbuminemia (43.4% vs. 60.3%, p = 0.0154), increased serum aspartate aminotransferase (35.7% vs. 81.2%, p < 0.0001), and increased serum alanine aminotransferase (35.7% vs. 77.2%, p < 0.0001), were also significantly higher in the cTACE arm than in the DEB-TACE arm.
Conclusions: Selective cTACE appeared to have higher CR rates for local tumor control as compared to selective DEB-TACE for HCC. However, the frequency of postembolization syndrome was also significantly higher in the cTACE group than in the DEB-TACE group. Thus, to achieve CR, cTACE may be selected over DEB-TACE in patients who can be expected to tolerate postembolization syndrome.
期刊介绍：
Liver Cancer is a journal that serves the international community of researchers and clinicians by providing a platform for research results related to the causes, mechanisms, and therapy of liver cancer. It focuses on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy. The journal publishes clinical and translational research in the field of liver cancer in both humans and experimental models. It publishes original and review articles and has an Impact Factor of 13.8. The journal is indexed and abstracted in various platforms including PubMed, PubMed Central, Web of Science, Science Citation Index, Science Citation Index Expanded, Google Scholar, DOAJ, Chemical Abstracts Service, Scopus, Embase, Pathway Studio, and WorldCat.
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