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Systemic Treatment of Advanced Unresectable Hepatocellular Carcinoma after First-Line Therapy: Expert Recommendations from Hong Kong, Singapore, and Taiwan. 晚期不可切除肝癌在一线治疗后的全身治疗:来自香港、新加坡和台湾的专家建议。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-17 eCollection Date: 2022-09-01 DOI: 10.1159/000525582
Thomas Yau, David Tai, Stephen Lam Chan, Yi-Hsiang Huang, Su Pin Choo, Chiun Hsu, Tan To Cheung, Shi-Ming Lin, Wei Peng Yong, Joycelyn Lee, Thomas Leung, Tracy Shum, Cynthia S Y Yeung, Anna Yin-Ping Tai, Ada Lai Yau Law, Ann-Lii Cheng, Li-Tzong Chen

Background: Asia has a high burden of hepatocellular carcinoma (HCC) due to the high rates of chronic hepatitis B infection and accounts for 70% of HCC cases globally. In the past 20 years, the systemic treatment landscape of advanced HCC has evolved substantially - from tyrosine kinase inhibitors to immune-oncology agents plus anti-vascular endothelial growth factor agents. The appropriate sequence of therapies has become critical in optimizing patient outcomes given the increase in systemic therapeutic options. This article evaluates the evidence and provides expert recommendations for the use of systemic therapies after first-line treatment in patients with advanced HCC.

Summary: Based on three virtual meetings held in early 2021, a team of 17 experts comprising oncologists, a hepatologist, and a hepatobiliary surgeon from Hong Kong, Singapore, and Taiwan reviewed available data about systemic treatments for HCC after first line and formulated 28 statements. These statements aimed to provide expert guidance on selecting first and subsequent lines of therapies as well as recommending therapies in special circumstances, such as poor liver function, posttransplantation, recent gastrointestinal bleeding, or autoimmune diseases. Data supporting the statements were drawn from clinical trials and real-world studies. The 28 statements were then evaluated anonymously using a 5-point Likert scale, and 24 reached consensus, predefined as achieving 75% agreement. Statements generated covered the selection of first-line systemic therapy, considerations and goals of second-line systemic therapies, treatment selection following first-line therapy, and treatment recommendations following first-line tyrosine kinase inhibitors, immune-oncology monotherapy, or immune-oncology combination therapy. The authors also shared expert opinion on the use of second-line systemic therapy in patients with liver dysfunction, liver transplantation, and recent gastrointestinal or autoimmune disease.

Key messages: These expert statements summarize the latest data and expert opinion on selecting systemic treatment following first-line therapy in patients with unresectable advanced or metastatic HCC.

背景:由于慢性乙型肝炎感染率高,亚洲的肝细胞癌(HCC)负担高,占全球HCC病例的70%。在过去的20年里,晚期HCC的全身治疗已经发生了巨大的变化——从酪氨酸激酶抑制剂到免疫肿瘤药物加上抗血管内皮生长因子药物。考虑到系统治疗选择的增加,适当的治疗顺序已成为优化患者预后的关键。本文评估了证据,并为晚期HCC患者在一线治疗后使用全身治疗提供了专家建议。摘要:基于2021年初举行的三次虚拟会议,由来自香港、新加坡和台湾的肿瘤学家、肝病学家和肝胆外科医生组成的17名专家组成的团队回顾了一线后肝细胞癌全身治疗的现有数据,并制定了28项声明。这些声明旨在为选择一线和后续治疗提供专家指导,以及在特殊情况下推荐治疗,如肝功能不良、移植后、近期胃肠道出血或自身免疫性疾病。支持这些说法的数据来自临床试验和现实世界的研究。然后使用5分李克特量表对28个陈述进行匿名评估,其中24个达成共识,预定义为达到75%的一致性。产生的陈述包括一线全身治疗的选择、二线全身治疗的考虑和目标、一线治疗后的治疗选择、一线酪氨酸激酶抑制剂、免疫肿瘤单一治疗或免疫肿瘤联合治疗后的治疗建议。作者还分享了对肝功能障碍、肝移植和近期胃肠道或自身免疫性疾病患者使用二线全身治疗的专家意见。关键信息:这些专家陈述总结了一线治疗后选择全身治疗的最新数据和专家意见。
{"title":"Systemic Treatment of Advanced Unresectable Hepatocellular Carcinoma after First-Line Therapy: Expert Recommendations from Hong Kong, Singapore, and Taiwan.","authors":"Thomas Yau,&nbsp;David Tai,&nbsp;Stephen Lam Chan,&nbsp;Yi-Hsiang Huang,&nbsp;Su Pin Choo,&nbsp;Chiun Hsu,&nbsp;Tan To Cheung,&nbsp;Shi-Ming Lin,&nbsp;Wei Peng Yong,&nbsp;Joycelyn Lee,&nbsp;Thomas Leung,&nbsp;Tracy Shum,&nbsp;Cynthia S Y Yeung,&nbsp;Anna Yin-Ping Tai,&nbsp;Ada Lai Yau Law,&nbsp;Ann-Lii Cheng,&nbsp;Li-Tzong Chen","doi":"10.1159/000525582","DOIUrl":"https://doi.org/10.1159/000525582","url":null,"abstract":"<p><strong>Background: </strong>Asia has a high burden of hepatocellular carcinoma (HCC) due to the high rates of chronic hepatitis B infection and accounts for 70% of HCC cases globally. In the past 20 years, the systemic treatment landscape of advanced HCC has evolved substantially - from tyrosine kinase inhibitors to immune-oncology agents plus anti-vascular endothelial growth factor agents. The appropriate sequence of therapies has become critical in optimizing patient outcomes given the increase in systemic therapeutic options. This article evaluates the evidence and provides expert recommendations for the use of systemic therapies after first-line treatment in patients with advanced HCC.</p><p><strong>Summary: </strong>Based on three virtual meetings held in early 2021, a team of 17 experts comprising oncologists, a hepatologist, and a hepatobiliary surgeon from Hong Kong, Singapore, and Taiwan reviewed available data about systemic treatments for HCC after first line and formulated 28 statements. These statements aimed to provide expert guidance on selecting first and subsequent lines of therapies as well as recommending therapies in special circumstances, such as poor liver function, posttransplantation, recent gastrointestinal bleeding, or autoimmune diseases. Data supporting the statements were drawn from clinical trials and real-world studies. The 28 statements were then evaluated anonymously using a 5-point Likert scale, and 24 reached consensus, predefined as achieving 75% agreement. Statements generated covered the selection of first-line systemic therapy, considerations and goals of second-line systemic therapies, treatment selection following first-line therapy, and treatment recommendations following first-line tyrosine kinase inhibitors, immune-oncology monotherapy, or immune-oncology combination therapy. The authors also shared expert opinion on the use of second-line systemic therapy in patients with liver dysfunction, liver transplantation, and recent gastrointestinal or autoimmune disease.</p><p><strong>Key messages: </strong>These expert statements summarize the latest data and expert opinion on selecting systemic treatment following first-line therapy in patients with unresectable advanced or metastatic HCC.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"11 5","pages":"426-439"},"PeriodicalIF":13.8,"publicationDate":"2022-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8a/55/lic-0011-0426.PMC9485972.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 9
Selective Internal Radiation Therapy with Yttrium-90 Resin Microspheres Followed by Gemcitabine plus Cisplatin for Unresectable Intrahepatic Cholangiocarcinoma: A Phase 2 Single-Arm Multicenter Clinical Trial. 选择性放射治疗后吉西他滨加顺铂治疗不可切除肝内胆管癌:一项2期单臂多中心临床试验
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-15 eCollection Date: 2022-09-01 DOI: 10.1159/000525489
Stephen Lam Chan, Chanisa Chotipanich, Su Pin Choo, Su Wen Kwang, Frankie Mo, Akeanong Worakitsitisatorn, David Tai, Raghav Sundar, David Chee Eng Ng, Kelvin Siu Hoong Loke, Leung Li, Kelvin Kwok Chai Ng, Yong Wei Peng, Simon Chun-Ho Yu

Introduction: This investigator-initiated clinical trial aims to study the efficacy and safety of administering selective internal radiation therapy with resin yttrium-90 microspheres (SIRT) followed by standard chemotherapy in unresectable intrahepatic cholangiocarcinoma (ICC).

Methods: A phase 2 single-arm multicenter study was conducted in patients with unresectable ICC (NCT02167711). SIRT was administered at dose of 120 Gy targeted at tumor followed by commencement of gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 on days one and eight of a 21-day cycle. The primary endpoint was overall survival (OS), and the secondary endpoints include progression-free survival (PFS), response rate according to Response Evaluation Criteria in solid tumors 1.1, toxicity, and time from SIRT to commencement of chemotherapy.

Results: Total 31 patients were screened and twenty-four were recruited. All patients completed SIRT and 16 of them underwent subsequent chemotherapy. The median cycle of chemotherapy was 5 (range: 1-8). The median OS was 13.6 months (95% CI: 5.4-21.6) for the intent-to-treat population. Among 16 patients undergoing chemotherapy, the median OS was 21.6 months (95% CI: 7.3-25.2) and the median PFS was 9 months (95% CI: 3.2-13.1). The response rate was 25% (95% CI: 3.8-46.2%), and the disease control rate was 75% (95% CI: 53.8-96.2%). No new safety signal was observed, with fewer than 10% of patients suffering from grade 3 or higher treatment-related adverse events. The median time from SIRT to chemotherapy was 29 (range: 7-42) days. Eight patients could not receive chemotherapy due to rapid progressive disease (n = 4), underlying treatment unrelated comorbidities (n = 2), and withdrawal of consent due to personal reasons (n = 2).

Conclusions: Treatment of SIRT followed by standard gemcitabine and cisplatin chemotherapy is feasible and effective for unresectable ICC. Further studies are required to study the optimal sequence of SIRT and chemotherapy.

本临床试验旨在研究树脂钇-90微球(SIRT)选择性内放射治疗后标准化疗对不可切除肝内胆管癌(ICC)的疗效和安全性。方法:在不可切除的ICC (NCT02167711)患者中进行了一项2期单臂多中心研究。SIRT以120 Gy的剂量靶向肿瘤,随后在21天周期的第1天和第8天开始使用吉西他滨1,000 mg/m2和顺铂25 mg/m2。主要终点是总生存期(OS),次要终点包括无进展生存期(PFS)、根据实体瘤反应评价标准1.1的反应率、毒性和从SIRT到开始化疗的时间。结果:共筛选31例患者,纳入24例。所有患者均完成了SIRT,其中16例接受了后续化疗。化疗周期中位数为5(范围:1-8)。意向治疗人群的中位OS为13.6个月(95% CI: 5.4-21.6)。在16例接受化疗的患者中,中位OS为21.6个月(95% CI: 7.3-25.2),中位PFS为9个月(95% CI: 3.2-13.1)。有效率为25% (95% CI: 3.8 ~ 46.2%),疾病控制率为75% (95% CI: 53.8 ~ 96.2%)。没有观察到新的安全性信号,只有不到10%的患者出现3级或更高级别的治疗相关不良事件。从SIRT到化疗的中位时间为29天(范围:7-42天)。8例患者因疾病进展迅速(n = 4),潜在治疗无关合并症(n = 2),以及个人原因撤回同意(n = 2)而无法接受化疗。结论:SIRT治疗后标准吉西他滨和顺铂化疗对不可切除的ICC是可行和有效的。SIRT与化疗的最佳顺序有待进一步研究。
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引用次数: 1
Exposure to Air Pollution and Survival in Follow-Up after Hepatocellular Carcinoma. 肝细胞癌术后随访中的空气污染暴露与存活率
IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-15 eCollection Date: 2022-09-01 DOI: 10.1159/000525346
Wei-Shan Chin, Shin-Chun Pan, Ching-Chun Huang, Pei-Jer Chen, Yue Leon Guo

Introduction: Air pollutants are classified as carcinogens by the International Agency for Research on Cancer. Long-term exposure to ambient particulate matter with an aerodiameter of 2.5 μm or lower (PM2.5) has been reported to be linked with increased mortality due to hepatocellular carcinoma (HCC). However, the effects of air pollutants other than PM2.5 on HCC-related mortality have not been fully investigated. Accordingly, we conducted this study to assess the effect of long-term exposure to air pollutants (PM2.5 and nitrogen dioxide [NO2]) on HCC-related mortality.

Method: In 2005, the Taiwan Liver Cancer Network (TLCN) was established by the National Research Program for Genomic Medicine to recruit liver cancer patients from 5 major medical centers in northern, central, and southern Taiwan. The TLCN had successfully recruited 9,344 patients by the end of 2018. In this study, we included 1,000 patients randomly sampled from the TLCN to assess the effect of exposure to air pollutants on HCC mortality after HCC diagnosis. Daily averages of PM2.5 and NO2 concentrations were retrieved from 77 air quality-monitoring stations and interpolated to the townships of patients' residences by using the Kriging method. The effect of air pollutants on HCC survival was assessed using a Cox proportional hazards model.

Results: A total of 940 patients were included in the analysis. After adjusting for potential confounders and mutually adjusting for co-pollutants, we observed that the hazards ratio (95% confidence interval) for HCC-related mortality for every 1-μg/m3 increase in PM2.5 concentration was 1.11 (1.08-1.14) and that for every 1-ppb increase in NO2 concentration was 1.08 (1.03-1.13).

Conclusion: Our study suggests that long-term exposure to PM2.5 and NO2 was associated with decreased survival time in patients with HCC in Taiwan.

导言:空气污染物被国际癌症研究机构列为致癌物质。据报道,长期暴露于空气直径为 2.5 μm 或更低的环境颗粒物(PM2.5)与肝细胞癌(HCC)死亡率的增加有关。然而,除 PM2.5 以外的其他空气污染物对 HCC 相关死亡率的影响尚未得到充分研究。因此,我们进行了这项研究,以评估长期暴露于空气污染物(PM2.5 和二氧化氮 [NO2])对 HCC 相关死亡率的影响:2005年,国家基因组医学研究计划(National Research Program for Genomic Medicine)建立了台湾肝癌网络(TLCN),从台湾北部、中部和南部的5个主要医疗中心招募肝癌患者。截至 2018 年底,TLCN 已成功招募 9344 名患者。在本研究中,我们纳入了从TLCN中随机抽样的1000名患者,以评估空气污染物暴露对HCC确诊后HCC死亡率的影响。研究人员从77个空气质量监测站获取了PM2.5和二氧化氮的日平均浓度,并使用克里格法将其内插于患者居住的乡镇。采用 Cox 比例危险模型评估了空气污染物对 HCC 存活率的影响:共有 940 名患者参与了分析。在对潜在的混杂因素进行调整并对共同污染物进行相互调整后,我们发现 PM2.5 浓度每增加 1μg/m3 HCC 相关死亡率的危险比(95% 置信区间)为 1.11(1.08-1.14),二氧化氮浓度每增加 1ppb HCC 相关死亡率的危险比为 1.08(1.03-1.13):我们的研究表明,长期暴露于PM2.5和二氧化氮与台湾HCC患者存活时间的缩短有关。
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引用次数: 0
Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302. 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。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-15 eCollection Date: 2022-09-01 DOI: 10.1159/000525500
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

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.

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。
{"title":"Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302.","authors":"Masafumi Ikeda,&nbsp;Yasuaki Arai,&nbsp;Yoshitaka Inaba,&nbsp;Toshihiro Tanaka,&nbsp;Shunsuke Sugawara,&nbsp;Yoshihisa Kodama,&nbsp;Takeshi Aramaki,&nbsp;Hiroshi Anai,&nbsp;Shinichi Morita,&nbsp;Yoshinori Tsukahara,&nbsp;Hiroshi Seki,&nbsp;Mikio Sato,&nbsp;Kenya Kamimura,&nbsp;Kimei Azama,&nbsp;Masakatsu Tsurusaki,&nbsp;Eiji Sugihara,&nbsp;Masaya Miyazaki,&nbsp;Tatsushi Kobayashi,&nbsp;Miyuki Sone","doi":"10.1159/000525500","DOIUrl":"https://doi.org/10.1159/000525500","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":13.8,"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":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 18
Systemic Treatments with Tyrosine Kinase Inhibitor and Platinum-Based Chemotherapy in Patients with Unresectable or Metastatic Hepatocholangiocarcinoma. 酪氨酸激酶抑制剂和铂基化疗对不可切除或转移性肝胆管癌患者的全身治疗
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-14 eCollection Date: 2022-09-01 DOI: 10.1159/000525488
Elia Gigante, Christian Hobeika, Brigitte Le Bail, Valérie Paradis, David Tougeron, Marie Lequoy, Mohamed Bouattour, Jean-Frederic Blanc, Nathalie Ganne-Carrié, Henri Tran, Clémence Hollande, Manon Allaire, Giuliana Amaddeo, Hélène Regnault, Paul Vigneron, Maxime Ronot, Laure Elkrief, Gontran Verset, Eric Trepo, Aziz Zaanan, Marianne Ziol, Massih Ningarhari, Julien Calderaro, Julien Edeline, Jean-Charles Nault

Backgrounds and aims: Even if no systemic treatment is currently validated for unresectable hepatocellular-cholangiocarcinoma (cHCC-CCA), tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy are frequently used in clinical practice. Our study aims to describe the effectiveness of first-line systemic treatments in patients with cHCC-CCA.

Patients and methods: Patients with histological diagnosis of unresectable or metastatic cHCC-CCA confirmed by a centralized review (WHO classification 2019) and who received systemic treatment from 2009 to 2020 were included retrospectively in 11 centers. The outcomes of patients with cHCC-CCA were compared with patients with hepatocellular carcinoma (HCC) treated by sorafenib (n = 117) and with intrahepatic cholangiocarcinoma (iCCA, n = 94) treated mainly by platinum-based chemotherapy using a frailty Cox model. The efficacy of TKIs and platinum-based chemotherapies in patients with cHCC-CCA was assessed using a doubly robust estimator.

Results: A total of 83 patients with cHCC-CCA were included and were predominantly male (72%) with underlying cirrhosis (55%). 67% of patients had extrahepatic metastases and 31% macrovascular tumor invasion. cHCC-CCAs were more often developed on cirrhosis (55.4%) than iCCA (26.6%) but less frequently than HCC (80.2%) (p < 0.001). Both HCC (36.8% and cHCC-CCA (66.2%) had less frequent extrahepatic metastases than iCCA (81%) (p < 0.001). Unadjusted overall survival (OS) was better in iCCA (13 months) compared to cHCC-CCA (12 months) and HCC (11 months) (p = 0.130). In multivariable analysis, after adjustment by a Cox frailty model, patients with cHCC-CCA had the same survival as HCC and iCCA (HR = 0.67, 95% CI: 0.37-1.22, p = 0.189 and HR = 0.66, 95% CI: 0.43-1.02, p = 0.064, respectively). ALBI score (HR = 2.15; 95% CI: 1.23-3.76; p = 0.009), ascites (HR = 3.45, 95% CI: 1.31-9.03, p = 0.013), and tobacco use (HR = 2.29, 95% CI: 1.08-4.87, p = 0.032) were independently associated with OS in patients with cHCC-CCA. Among patients with cHCC-CCA, 25 patients treated with TKI were compared with 54 patients who received platinum-based chemotherapies. Patients treated with TKI had a median OS of 8.3 months compared to 11.9 months for patients treated with platinum-based chemotherapy (p = 0.86). After a robust doubly adjustment on tumor number and size, vascular invasion, ALBI, MELD, and cirrhosis, the type of treatment did not impact OS (HR = 0.92, 95% CI: 0.27-3.15, p = 0.88) or progression-free survival (HR = 1.24, 95% CI: 0.44-3.49, p = 0.67).

Conclusions: First-line systemic treatments with TKIs or platinum-based chemotherapies have similar efficacy in patients with unresectable/metastatic cHCC-CCA. The ALBI score predicts OS.

背景和目的:即使目前没有针对不可切除的肝细胞胆管癌(cHCC-CCA)的全身治疗,酪氨酸激酶抑制剂(TKIs)和铂基化疗在临床实践中经常使用。我们的研究旨在描述一线全身治疗对cHCC-CCA患者的有效性。患者和方法:回顾性纳入2009年至2020年接受全身治疗的11个中心的组织学诊断为不可切除或转移性cHCC-CCA (WHO分类2019)的患者。采用脆性Cox模型,将cHCC-CCA患者的预后与接受索拉非尼治疗的肝细胞癌(HCC)患者(n = 117)和主要接受铂类化疗的肝内胆管癌(iCCA, n = 94)患者进行比较。TKIs和铂类化疗对cHCC-CCA患者的疗效采用双稳健估计器进行评估。结果:共纳入83例cHCC-CCA患者,主要为男性(72%),伴有肝硬化(55%)。67%的患者有肝外转移,31%的患者有大血管肿瘤浸润。chcc - cca发生于肝硬化的发生率(55.4%)高于iCCA(26.6%),但低于HCC (80.2%) (p < 0.001)。HCC(36.8%)和cHCC-CCA(66.2%)的肝外转移发生率均低于iCCA (81%) (p < 0.001)。与cHCC-CCA(12个月)和HCC(11个月)相比,iCCA的未调整总生存期(OS)(13个月)更好(p = 0.130)。在多变量分析中,经Cox脆弱性模型调整后,cHCC-CCA患者与HCC和iCCA患者的生存期相同(HR = 0.67, 95% CI: 0.37-1.22, p = 0.189; HR = 0.66, 95% CI: 0.43-1.02, p = 0.064)。ALBI评分(HR = 2.15;95% ci: 1.23-3.76;p = 0.009)、腹水(HR = 3.45, 95% CI: 1.31-9.03, p = 0.013)和吸烟(HR = 2.29, 95% CI: 1.08-4.87, p = 0.032)与cHCC-CCA患者的OS独立相关。在cHCC-CCA患者中,25例患者接受TKI治疗,54例患者接受铂类化疗。接受TKI治疗的患者中位OS为8.3个月,而接受铂类化疗的患者中位OS为11.9个月(p = 0.86)。在对肿瘤数量和大小、血管侵犯、ALBI、MELD和肝硬化进行了强有力的双重调整后,治疗类型没有影响OS (HR = 0.92, 95% CI: 0.27-3.15, p = 0.88)或无进展生存期(HR = 1.24, 95% CI: 0.44-3.49, p = 0.67)。结论:一线全身治疗TKIs或铂基化疗对不可切除/转移性cHCC-CCA患者的疗效相似。ALBI评分预测OS。
{"title":"Systemic Treatments with Tyrosine Kinase Inhibitor and Platinum-Based Chemotherapy in Patients with Unresectable or Metastatic Hepatocholangiocarcinoma.","authors":"Elia Gigante,&nbsp;Christian Hobeika,&nbsp;Brigitte Le Bail,&nbsp;Valérie Paradis,&nbsp;David Tougeron,&nbsp;Marie Lequoy,&nbsp;Mohamed Bouattour,&nbsp;Jean-Frederic Blanc,&nbsp;Nathalie Ganne-Carrié,&nbsp;Henri Tran,&nbsp;Clémence Hollande,&nbsp;Manon Allaire,&nbsp;Giuliana Amaddeo,&nbsp;Hélène Regnault,&nbsp;Paul Vigneron,&nbsp;Maxime Ronot,&nbsp;Laure Elkrief,&nbsp;Gontran Verset,&nbsp;Eric Trepo,&nbsp;Aziz Zaanan,&nbsp;Marianne Ziol,&nbsp;Massih Ningarhari,&nbsp;Julien Calderaro,&nbsp;Julien Edeline,&nbsp;Jean-Charles Nault","doi":"10.1159/000525488","DOIUrl":"https://doi.org/10.1159/000525488","url":null,"abstract":"<p><strong>Backgrounds and aims: </strong>Even if no systemic treatment is currently validated for unresectable hepatocellular-cholangiocarcinoma (cHCC-CCA), tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy are frequently used in clinical practice. Our study aims to describe the effectiveness of first-line systemic treatments in patients with cHCC-CCA.</p><p><strong>Patients and methods: </strong>Patients with histological diagnosis of unresectable or metastatic cHCC-CCA confirmed by a centralized review (WHO classification 2019) and who received systemic treatment from 2009 to 2020 were included retrospectively in 11 centers. The outcomes of patients with cHCC-CCA were compared with patients with hepatocellular carcinoma (HCC) treated by sorafenib (<i>n</i> = 117) and with intrahepatic cholangiocarcinoma (iCCA, <i>n</i> = 94) treated mainly by platinum-based chemotherapy using a frailty Cox model. The efficacy of TKIs and platinum-based chemotherapies in patients with cHCC-CCA was assessed using a doubly robust estimator.</p><p><strong>Results: </strong>A total of 83 patients with cHCC-CCA were included and were predominantly male (72%) with underlying cirrhosis (55%). 67% of patients had extrahepatic metastases and 31% macrovascular tumor invasion. cHCC-CCAs were more often developed on cirrhosis (55.4%) than iCCA (26.6%) but less frequently than HCC (80.2%) (<i>p</i> < 0.001). Both HCC (36.8% and cHCC-CCA (66.2%) had less frequent extrahepatic metastases than iCCA (81%) (<i>p</i> < 0.001). Unadjusted overall survival (OS) was better in iCCA (13 months) compared to cHCC-CCA (12 months) and HCC (11 months) (<i>p</i> = 0.130). In multivariable analysis, after adjustment by a Cox frailty model, patients with cHCC-CCA had the same survival as HCC and iCCA (HR = 0.67, 95% CI: 0.37-1.22, <i>p</i> = 0.189 and HR = 0.66, 95% CI: 0.43-1.02, <i>p</i> = 0.064, respectively). ALBI score (HR = 2.15; 95% CI: 1.23-3.76; <i>p</i> = 0.009), ascites (HR = 3.45, 95% CI: 1.31-9.03, <i>p</i> = 0.013), and tobacco use (HR = 2.29, 95% CI: 1.08-4.87, <i>p</i> = 0.032) were independently associated with OS in patients with cHCC-CCA. Among patients with cHCC-CCA, 25 patients treated with TKI were compared with 54 patients who received platinum-based chemotherapies. Patients treated with TKI had a median OS of 8.3 months compared to 11.9 months for patients treated with platinum-based chemotherapy (<i>p</i> = 0.86). After a robust doubly adjustment on tumor number and size, vascular invasion, ALBI, MELD, and cirrhosis, the type of treatment did not impact OS (HR = 0.92, 95% CI: 0.27-3.15, <i>p</i> = 0.88) or progression-free survival (HR = 1.24, 95% CI: 0.44-3.49, <i>p</i> = 0.67).</p><p><strong>Conclusions: </strong>First-line systemic treatments with TKIs or platinum-based chemotherapies have similar efficacy in patients with unresectable/metastatic cHCC-CCA. The ALBI score predicts OS.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"11 5","pages":"460-473"},"PeriodicalIF":13.8,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ac/9b/lic-0011-0460.PMC9485952.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
Front & Back Matter 正面和背面
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-01 DOI: 10.1159/000525471
{"title":"Front & Back Matter","authors":"","doi":"10.1159/000525471","DOIUrl":"https://doi.org/10.1159/000525471","url":null,"abstract":"","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"28 1","pages":""},"PeriodicalIF":13.8,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81202324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
APPLE News 苹果公司的新闻
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-06-01 DOI: 10.1159/000525224
{"title":"APPLE News","authors":"","doi":"10.1159/000525224","DOIUrl":"https://doi.org/10.1159/000525224","url":null,"abstract":"","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"48 1","pages":"281 - 281"},"PeriodicalIF":13.8,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79929000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Regarding "Postresection Period-Specific Hazard of Recurrence as a Framework for Surveillance Strategy in Patients with Hepatocellular Carcinoma: A Multicenter Outcome Study". 关于“肝细胞癌患者术后特定时期复发风险作为监测策略框架:一项多中心结果研究”。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-05-13 eCollection Date: 2022-09-01 DOI: 10.1159/000525065
Hiroshi Imamura, Kiyoshi Hasegawa, Yuji Soejima, Akio Saiura
We added a comment to the the article by Kim et al.. We first described how the hazard function and commonly used survival function act complementary, although these two functions are mathematically equivalent.Then, we pointed out two notable findings of the present article: 1) a recurrence by metastasis is presumed to occurred constantly at an annualized incidence of 4%-10% until 6 postoperative years; and 2) the annualized recurrence rates between the 5th and 10th postoperative years were between 3%-10% in cirrhotic patients and this figure was comparable to or even lower than the reported annual incidence of HCC in cirrhotic patients (up to 8%). We also pointed out three issues to be paid attention for: 1) the authors amalgamated patients with HBV- and HCV-related HCC together when calculating the hazard function, although the background liver of HCV-related HCC is hypothesized to have a higher carcinogenetic activity than that of HBV-related HCC, at least during the era before the advent of direct-acting antivirals; 2) the authors would have obtained interesting results had they evaluated the risk factors for late-phase recurrence exclusively in patients with HBV infection, including HBV-specific covariates into the analysis; and 3) many investigators may confuse a pathogenic factor with its surrogate marker when interpreting the significance of fibrosis in studies investigating risk factors leading to HCC development.
{"title":"Regarding \"Postresection Period-Specific Hazard of Recurrence as a Framework for Surveillance Strategy in Patients with Hepatocellular Carcinoma: A Multicenter Outcome Study\".","authors":"Hiroshi Imamura,&nbsp;Kiyoshi Hasegawa,&nbsp;Yuji Soejima,&nbsp;Akio Saiura","doi":"10.1159/000525065","DOIUrl":"https://doi.org/10.1159/000525065","url":null,"abstract":"We added a comment to the the article by Kim et al.. \u0000 We first described how the hazard function and commonly used survival function act complementary, although these two functions are mathematically equivalent.\u0000Then, we pointed out two notable findings of the present article: 1) a recurrence by metastasis is presumed to occurred constantly at an annualized incidence of 4%-10% until 6 postoperative years; and 2) the annualized recurrence rates between the 5th and 10th postoperative years were between 3%-10% in cirrhotic patients and this figure was comparable to or even lower than the reported annual incidence of HCC in cirrhotic patients (up to 8%).\u0000 We also pointed out three issues to be paid attention for: 1) the authors amalgamated patients with HBV- and HCV-related HCC together when calculating the hazard function, although the background liver of HCV-related HCC is hypothesized to have a higher carcinogenetic activity than that of HBV-related HCC, at least during the era before the advent of direct-acting antivirals; 2) the authors would have obtained interesting results had they evaluated the risk factors for late-phase recurrence exclusively in patients with HBV infection, including HBV-specific covariates into the analysis; and 3) many investigators may confuse a pathogenic factor with its surrogate marker when interpreting the significance of fibrosis in studies investigating risk factors leading to HCC development.","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"11 5","pages":"483-486"},"PeriodicalIF":13.8,"publicationDate":"2022-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/55/1a/lic-0011-0483.PMC9485984.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Combination Immunotherapy with Anti-PD-1/PD-L1 Antibody plus Anti-VEGF Antibody May Promote Cytotoxic T Lymphocyte Infiltration in Hepatocellular Carcinoma, Including in the Noninflamed Subclass. 抗pd -1/PD-L1抗体加抗vegf抗体联合免疫治疗可促进肝癌细胞毒性T淋巴细胞浸润,包括非炎症亚类。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-05-10 eCollection Date: 2022-06-01 DOI: 10.1159/000524977
Masatoshi Kudo
NA
{"title":"Combination Immunotherapy with Anti-PD-1/PD-L1 Antibody plus Anti-VEGF Antibody May Promote Cytotoxic T Lymphocyte Infiltration in Hepatocellular Carcinoma, Including in the Noninflamed Subclass.","authors":"Masatoshi Kudo","doi":"10.1159/000524977","DOIUrl":"https://doi.org/10.1159/000524977","url":null,"abstract":"<jats:p>NA</jats:p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"11 3","pages":"185-191"},"PeriodicalIF":13.8,"publicationDate":"2022-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9218634/pdf/lic-0011-0185.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40616546","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 7
Clinical Practice Guidelines for Hepatic Arterial Infusion Chemotherapy with a Port System Proposed by the Japanese Society of Interventional Radiology and Japanese Society of Implantable Port Assisted Treatment. 日本介入放射学会和日本植入式端口辅助治疗学会提出的《使用端口系统进行肝动脉输注化疗的临床实践指南》。
IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-05-05 eCollection Date: 2022-09-01 DOI: 10.1159/000524893
Kazuomi Ueshima, Atsushi Komemushi, Takeshi Aramaki, Hideki Iwamoto, Shuntaro Obi, Yozo Sato, Toshihiro Tanaka, Kiyoshi Matsueda, Michihisa Moriguchi, Hiroya Saito, Miyuki Sone, Takuji Yamagami, Yoshitaka Inaba, Masatoshi Kudo, Yasuaki Arai

Hepatocellular carcinoma is one of the leading causes of cancer-related death both in Japan and globally. In the advanced stage, hepatic arterial infusion chemotherapy (HAIC) is one of the most commonly used treatment options for liver cancer in Japan, and implantation of a catheter system (called a port system) in the body is a treatment method that has evolved mainly in Japan. The Guideline Committee of the Japanese Society of Interventional Radiology and the Japanese Society of Implantable Port Assisted Treatment jointly published clinical practice guidelines for HAIC with a port system to ensure its appropriate and safe performance in Japanese in 2018. We have written an updated English version of the guidelines with the aim of making this treatment widely known to experts globally. In this article, the evidence, method, indication, treatment regimen, and maintenance of the system are summarized.

肝细胞癌是日本和全球癌症相关死亡的主要原因之一。在晚期阶段,肝动脉灌注化疗(HAIC)是日本最常用的肝癌治疗方法之一,在体内植入导管系统(称为端口系统)是主要在日本发展起来的一种治疗方法。日本介入放射学会指南委员会和日本植入式端口辅助治疗学会于2018年联合发布了带端口系统的HAIC临床实践指南,以确保其在日本的适当和安全实施。我们撰写了该指南的最新英文版,旨在让全球专家广泛了解这种治疗方法。本文对该系统的证据、方法、适应症、治疗方案和维护进行了总结。
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引用次数: 0
期刊
Liver Cancer
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