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Front & Back Matter 正面和背面
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-12-01 DOI: 10.1159/000528495
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引用次数: 0
Atezolizumab plus Bevacizumab versus Sorafenib for Unresectable Hepatocellular Carcinoma: Results from Older Adults Enrolled in the IMbrave150 Randomized Clinical Trial. Atezolizumab联合贝伐单抗与索拉非尼治疗不可切除的肝细胞癌:来自参加IMbrave150随机临床试验的老年人的结果
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-12-01 DOI: 10.1159/000525671
Daneng Li, Han Chong Toh, Philippe Merle, Kaoru Tsuchiya, Sairy Hernandez, Wendy Verret, Alan Nicholas, Masatoshi Kudo

Introduction: The efficacy of systemic first-line treatments in older adults with unresectable hepatocellular carcinoma (HCC) has not been well-studied. We compared the safety and efficacy of atezolizumab plus bevacizumab versus sorafenib as a first-line treatment in younger versus older patients with unresectable HCC.

Methods: This global, phase 3, open-label, randomized clinical trial (IMbrave150) recruited patients aged ≥18 years with locally advanced metastatic or unresectable HCC, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and Child-Pugh class A liver function who had not previously received systemic therapy for liver cancer. Patients received either 1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks or 400 mg sorafenib orally twice daily until loss of clinical benefit or unacceptable toxicity. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary outcomes were the incidence of adverse events and time to deterioration of patient-reported outcomes (PROs). This subgroup analysis evaluated safety and efficacy endpoints in patients <65 years, ≥65 to <75 years, and ≥75 years.

Results: Of 501 patients, 165 patients were randomized to sorafenib and 336 were randomized to atezolizumab plus bevacizumab (175 patients <65 years; 106 patients ≥65 to <75 years; 55 patients ≥75 years). Across all age groups, patients receiving atezolizumab plus bevacizumab had longer median OS (<65: 18.0 vs. 12.2 months [HR, 0.57; 95% CI: 0.40-0.82]; ≥65 to <75: 19.4 vs. 14.9 months [HR, 0.80; 95% CI: 0.52-1.23]; ≥75: 24.0 vs. 18.0 months [HR, 0.72, 95% CI: 0.37-1.41]) and PFS than those receiving sorafenib. Time to deterioration for multiple PROs was delayed for patients receiving atezolizumab plus bevacizumab, including older adults. There were no clinically meaningful differences in toxicity between age groups.

Conclusion: Atezolizumab plus bevacizumab is safe and effective in adults <65, ≥65 to <75, and ≥75. Treatment was well-tolerated even in elderly patients.

老年人不可切除肝细胞癌(HCC)的系统性一线治疗的疗效尚未得到充分研究。我们比较了atezolizumab联合贝伐单抗与索拉非尼作为一线治疗年轻和老年不可切除HCC患者的安全性和有效性。方法:这项全球性的3期、开放标签、随机临床试验(IMbrave150)招募了年龄≥18岁的局部晚期转移性或不可切除的HCC患者,东部肿瘤合作组织(Eastern Cooperative Oncology Group)的表现状态评分为0或1,Child-Pugh A级肝功能,以前未接受过肝癌全身治疗。患者接受1200mg阿特唑单抗加15mg /kg贝伐单抗静脉注射,每3周一次,或400mg索拉非尼口服,每天两次,直到失去临床益处或不可接受的毒性。主要终点是总生存期(OS)和无进展生存期(PFS)。次要结局是不良事件的发生率和患者报告的结局(PROs)恶化的时间。该亚组分析评估了患者的安全性和有效性终点。结果:501例患者中,165例患者随机分配到索拉非尼组,336例患者随机分配到atezolizumab +贝伐单抗组(175例)。结论:atezolizumab +贝伐单抗在成人中是安全有效的
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引用次数: 6
Impact of Antibiotics Use on Cancer-Related and All-Cause Mortality among Patients Receiving Immunotherapy for Advanced Hepatocellular Carcinoma. 抗生素使用对接受免疫治疗的晚期肝癌患者癌症相关死亡率和全因死亡率的影响
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-12-01 DOI: 10.1159/000525028
Kong-Ying Lin, Shi-Chuan Tang, Cheng-Wu Zhang, Yong-Yi Zeng, Tian Yang
None
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引用次数: 1
Chinese Expert Consensus on Immunotherapy for Hepatocellular Carcinoma (2021 Edition). 中国肝癌免疫治疗专家共识(2021年版)。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-12-01 DOI: 10.1159/000526038
Yu Yang, Juxian Sun, Mengchao Wu, Wan Yee Lau, Shusen Zheng, Xue-Hao Wang, Xiaoping Chen, Jia Fan, Jiahong Dong, Jianqiang Cai, Minshan Chen, Yongjun Chen, Zhangjun Cheng, Chaoliu Dai, Jianzhen Shan, Cheng-You Du, Chihua Fang, Heping Hu, Zhili Ji, Weidong Jia, Gong Li, Jing Li, Jiangtao Li, Chang Liu, Fubao Liu, Yong Ma, Yilei Mao, Zuoxing Niu, Jie Shen, Jie Shi, Xuetao Shi, Wenjie Song, Hui-Chuan Sun, Guang Tan, Ran Tao, Xiaohu Wang, Tianfu Wen, Liqun Wu, Jinglin Xia, Bang-De Xiang, Maolin Yan, Mingang Ying, Ling Zhang, Xuewen Zhang, Zhao Chong Zeng, Yubao Zhang, Zhiwei Zhang, Jie Zhou, Cuncai Zhou, Jun Zhou, Ledu Zhou, Xinmin Zhou, Ji Zhu, Zhenyu Zhu, Qi Zhang, Qiu Li, Shuqun Cheng

Background: Hepatocellular carcinoma (HCC) is one of the most common malignancies in China. Most HCC patients are first diagnosed at an advanced stage, and systemic treatments are the mainstay of treatment.

Summary: In recent years, immune checkpoint inhibitors have made a breakthrough in the systemic treatment of middle-advanced HCC, breaking the single therapeutic pattern of molecular-targeted agents. To better guide the clinical treatment for effective and safe use of immunotherapeutic drugs, the Chinese Association of Liver Cancer and Chinese Medical Doctor Association has gathered multidisciplinary experts and scholars in relevant fields to formulate the "Chinese Clinical Expert Consensus on Immunotherapy for Hepatocellular Carcinoma (2021)" based on current clinical studies and clinical medication experience for reference in China.

Key messages: The consensus contained 17 recommendations, including the preferred regimen for first- and second-line immunotherapy, evaluation and monitoring before/during/after treatment, management of complications, precautions for special patients, and potential population for immunotherapy.

背景:肝细胞癌(HCC)是中国最常见的恶性肿瘤之一。大多数HCC患者在晚期才被诊断出来,全身治疗是治疗的主要手段。摘要:近年来,免疫检查点抑制剂在中晚期肝癌的全身治疗中取得突破,打破了分子靶向药物单一的治疗模式。为更好地指导临床治疗,有效、安全地使用免疫治疗药物,中国肝癌协会、中国医师协会联合相关领域多学科专家学者,根据目前的临床研究和国内临床用药经验,制定了《中国肝癌免疫治疗临床专家共识(2021)》,以供参考。关键信息:共识包含17项建议,包括一线和二线免疫治疗的首选方案,治疗前/治疗中/治疗后的评估和监测,并发症的处理,特殊患者的注意事项,以及免疫治疗的潜在人群。
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引用次数: 9
Hepatitis B Virus Treatment and Hepatocellular Carcinoma: Controversies and Approaches to Consensus. 乙型肝炎病毒治疗和肝细胞癌:争议和达成共识的途径。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-12-01 DOI: 10.1159/000525518
Soo Ki Kim, Takako Fujii, Soo Ryang Kim, Atsushi Nakai, Young-Suk Lim, Satoru Hagiwara, Masatoshi Kudo

Background: Long-term therapy with nucleos(t)ide analogs (NAs) such as entecavir (ETV) and tenofovir disoproxil fumarate (TDF) favorably affects the incidence of hepatocellular carcinoma (HCC) on the basis of data from randomized or matched control studies. Recent data suggest a lower HCC incidence after 5 years of ETV or TDF therapy in chronic hepatitis B (CHB) patients, especially those with baseline cirrhosis.

Summary: Three controversial issues remain to be resolved regarding hepatitis B virus (HBV) treatment and HCC. (1) The efficacy of antiviral treatment for the prevention of HCC is not established. The guidelines of the American Association for the Study of Liver Diseases (AASLD), the Asian Pacific Association for the Study of the Liver (APASL), and the European Association for the Study of the Liver (EASL) for the management of HBV infection state that antiviral treatment of HBV with interferon and NAs prevents the development of HCC. Among experts in CHB treatment, however, there is disagreement on the HCC prevention effects of antiviral treatment. (2) The rationale for antiviral management in patients with high HBV DNA and normal levels of alanine aminotransferase is unclear. The AASLD, EASL, and APASL guidelines do not recommend antiviral treatment for immune-tolerant CHB patients, and the terms and methods of treating such patients remain to be clarified. (3) The efficacy of first-line treatment with NAs, including ETV, TDF, and tenofovir alafenamide fumarate (TAF), to prevent HCC in CHB patients remains unknown. Several studies have produced controversial results regarding the effects of NAs on the risk and prevention of HCC. In the present review, we discuss these 3 issues, citing recent studies and clinical management guidelines from major international associations.

Key messages: Suggested approaches for reaching a consensus including applying the propensity score matching method, performing randomized controlled studies, and performing clinical studies with larger numbers of subjects and longer follow-up.

背景:根据随机或匹配对照研究的数据,长期使用核苷(t)类似物(NAs)如恩替卡韦(ETV)和富马酸替诺福韦二氧吡酯(TDF)治疗有利于影响肝细胞癌(HCC)的发病率。最近的数据显示,慢性乙型肝炎(CHB)患者,特别是基线肝硬化患者,在接受ETV或TDF治疗5年后,HCC发病率较低。总结:关于乙型肝炎病毒(HBV)治疗和HCC,仍有三个有争议的问题有待解决。(1)抗病毒治疗预防HCC的疗效尚未确定。美国肝病研究协会(AASLD)、亚太肝脏研究协会(APASL)和欧洲肝脏研究协会(EASL)的HBV感染管理指南指出,用干扰素和NAs进行HBV抗病毒治疗可预防HCC的发展。然而,在CHB治疗专家中,对抗病毒治疗的HCC预防效果存在分歧。(2)对高HBV DNA和正常丙氨酸转氨酶水平的患者进行抗病毒治疗的理由尚不清楚。AASLD、EASL和APASL指南不建议对免疫耐受型慢性乙型肝炎患者进行抗病毒治疗,治疗这类患者的术语和方法仍有待澄清。(3)一线NAs治疗,包括ETV、TDF和富马酸替诺福韦(tenofovir alafenamide fumarate, TAF)预防CHB患者HCC的疗效尚不清楚。关于NAs对HCC风险和预防的影响,一些研究产生了有争议的结果。在这篇综述中,我们讨论了这三个问题,引用了最近的研究和主要国际协会的临床管理指南。关键信息:建议达成共识的方法包括应用倾向评分匹配法,进行随机对照研究,以及进行大量受试者和较长随访时间的临床研究。
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引用次数: 5
Implications of the TACTICS Trial: Establishing the New Concept of Combination/Sequential Systemic Therapy and Transarterial Chemoembolization to Achieve Synergistic Effects. 战术试验的意义:建立联合/顺序全身治疗和经动脉化疗栓塞的新概念,以实现协同效应。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-12-01 DOI: 10.1159/000527404
Masatoshi Kudo
NA
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引用次数: 4
Outcomes of Salvage Surgery for Initially Unresectable Hepatocellular Carcinoma Converted by Transcatheter Arterial Chemoembolization Combined with Lenvatinib plus Anti-PD-1 Antibodies: A Multicenter Retrospective Study. 经导管动脉化疗栓塞联合乐伐替尼加抗PD-1抗体转化为最初无法切除的肝癌的挽救手术结果:一项多中心回顾性研究。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-11-30 eCollection Date: 2023-08-01 DOI: 10.1159/000528356
Jia-Yi Wu, Zhi-Bo Zhang, Jian-Yin Zhou, Jing-Peng Ke, Yan-Nan Bai, Yu-Feng Chen, Jun-Yi Wu, Song-Qiang Zhou, Shuang-Jia Wang, Zhen-Xin Zeng, Yi-Nan Li, Fu-Nan Qiu, Bin Li, Mao-Lin Yan

Introduction: The actual rate of conversion surgery and its prognostic advantages remain unclear. This study aimed to assess the outcomes of salvage surgery after conversion therapy with triple therapy (transcatheter arterial chemoembolization [TACE] combined with lenvatinib plus anti-PD-1 antibodies) in patients with initially unresectable hepatocellular carcinoma (uHCC).

Methods: Patients with initially uHCC who received at least one cycle of first-line triple therapy and salvage surgery at five major cancer centers in China were included. The primary endpoints were overall survival (OS) and recurrence-free survival (RFS) rates after salvage surgery. The secondary endpoints were perioperative complications, 90-day mortality, and pathological tumor response.

Results: Between June 2018 and December 2021, 70 patients diagnosed with uHCC who underwent triple therapy and salvage surgery were analyzed: 39 with Barcelona Clinic Liver Cancer (BCLC) stage C, 22 with BCLC stage B, and 9 with BCLC stage A disease. The median interval between the start of triple therapy and salvage surgery was 4.3 months (range, 1.7-14.2 months). Pathological complete response and major pathological response were observed in 29 (41.4%) and 59 (84.3%) patients, respectively. There were 2 cases of perioperative mortality (4.3%) and 5 cases of severe perioperative complications (7.1%). With a median follow-up of 12.9 months after surgery (range, 0.3-36.8 months), the median OS and RFS were not reached. The 1- and 2-year OS rates were 97.1% and 94.4%, respectively, and the corresponding RFS rates were 68.9% and 54.4%, respectively.

Conclusion: First-line combination of TACE, lenvatinib, and anti-PD-1 antibodies provides a better chance of conversion therapy in patients with initially uHCC. Furthermore, salvage surgery after conversion therapy is effective and safe and has the potential to provide excellent long-term survival benefits.

引言:转化手术的实际发生率及其预后优势尚不清楚。本研究旨在评估最初不可切除的肝细胞癌(uHCC)患者接受三重治疗(经导管动脉化疗栓塞[TACE]联合乐伐替尼加抗PD-1抗体)转换治疗后的挽救手术的结果中国的五个主要癌症中心也被包括在内。主要终点是挽救手术后的总生存率(OS)和无复发生存率(RFS)。次要终点是围手术期并发症、90天死亡率和病理性肿瘤反应。结果:在2018年6月至2021年12月期间,对70名接受三联治疗和挽救手术的uHCC患者进行了分析:39名患者为巴塞罗那临床癌症(BCLC)C期,22名患者为BCLC B期,9名为BCLC A期。从开始三联治疗到挽救手术的中位间隔为4.3个月(范围为1.7-14.2个月)。病理完全反应29例(41.4%),主要病理反应59例(84.3%)。有2例围手术期死亡率(4.3%)和5例严重围手术期并发症(7.1%)。术后中位随访12.9个月(范围为0.3-36.8个月),未达到中位OS和RFS。1年和2年OS率分别为97.1%和94.4%,相应的RFS率分别为68.9%和54.4%。结论:TACE、乐伐替尼和抗PD-1抗体的一线联合治疗为最初的uHCC患者提供了更好的转化治疗机会。此外,转换治疗后的挽救性手术是有效和安全的,有可能提供极好的长期生存益处。
{"title":"Outcomes of Salvage Surgery for Initially Unresectable Hepatocellular Carcinoma Converted by Transcatheter Arterial Chemoembolization Combined with Lenvatinib plus Anti-PD-1 Antibodies: A Multicenter Retrospective Study.","authors":"Jia-Yi Wu,&nbsp;Zhi-Bo Zhang,&nbsp;Jian-Yin Zhou,&nbsp;Jing-Peng Ke,&nbsp;Yan-Nan Bai,&nbsp;Yu-Feng Chen,&nbsp;Jun-Yi Wu,&nbsp;Song-Qiang Zhou,&nbsp;Shuang-Jia Wang,&nbsp;Zhen-Xin Zeng,&nbsp;Yi-Nan Li,&nbsp;Fu-Nan Qiu,&nbsp;Bin Li,&nbsp;Mao-Lin Yan","doi":"10.1159/000528356","DOIUrl":"https://doi.org/10.1159/000528356","url":null,"abstract":"<p><strong>Introduction: </strong>The actual rate of conversion surgery and its prognostic advantages remain unclear. This study aimed to assess the outcomes of salvage surgery after conversion therapy with triple therapy (transcatheter arterial chemoembolization [TACE] combined with lenvatinib plus anti-PD-1 antibodies) in patients with initially unresectable hepatocellular carcinoma (uHCC).</p><p><strong>Methods: </strong>Patients with initially uHCC who received at least one cycle of first-line triple therapy and salvage surgery at five major cancer centers in China were included. The primary endpoints were overall survival (OS) and recurrence-free survival (RFS) rates after salvage surgery. The secondary endpoints were perioperative complications, 90-day mortality, and pathological tumor response.</p><p><strong>Results: </strong>Between June 2018 and December 2021, 70 patients diagnosed with uHCC who underwent triple therapy and salvage surgery were analyzed: 39 with Barcelona Clinic Liver Cancer (BCLC) stage C, 22 with BCLC stage B, and 9 with BCLC stage A disease. The median interval between the start of triple therapy and salvage surgery was 4.3 months (range, 1.7-14.2 months). Pathological complete response and major pathological response were observed in 29 (41.4%) and 59 (84.3%) patients, respectively. There were 2 cases of perioperative mortality (4.3%) and 5 cases of severe perioperative complications (7.1%). With a median follow-up of 12.9 months after surgery (range, 0.3-36.8 months), the median OS and RFS were not reached. The 1- and 2-year OS rates were 97.1% and 94.4%, respectively, and the corresponding RFS rates were 68.9% and 54.4%, respectively.</p><p><strong>Conclusion: </strong>First-line combination of TACE, lenvatinib, and anti-PD-1 antibodies provides a better chance of conversion therapy in patients with initially uHCC. Furthermore, salvage surgery after conversion therapy is effective and safe and has the potential to provide excellent long-term survival benefits.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":"12 3","pages":"229-237"},"PeriodicalIF":13.8,"publicationDate":"2022-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ae/a5/lic-0012-0229.PMC10521320.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41165937","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: 4
IMbrave150: Efficacy and Safety of Atezolizumab plus Bevacizumab versus Sorafenib in Patients with Barcelona Clinic Liver Cancer Stage B Unresectable Hepatocellular Carcinoma: An Exploratory Analysis of the Phase III Study. IMbrave150:Atezolizumab联合贝伐单抗与索拉非尼治疗巴塞罗那临床癌症B期不可切除肝癌患者的疗效和安全性:III期研究的探索性分析。
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-11-28 eCollection Date: 2023-08-01 DOI: 10.1159/000528272
Masatoshi Kudo, Richard S Finn, Peter R Galle, Andrew X Zhu, Michel Ducreux, Ann-Lii Cheng, Masafumi Ikeda, Kaoru Tsuchiya, Ken-Ichi Aoki, Jing Jia, Riccardo Lencioni

Introduction: The phase III IMbrave150 study established atezolizumab + bevacizumab as standard of care in patients with unresectable hepatocellular carcinoma (HCC). This exploratory analysis reports efficacy and safety results in patients with baseline Barcelona Clinic Liver Cancer (BCLC) stage B disease.

Methods: Patients with systemic treatment-naive unresectable HCC and Child-Pugh class A liver function were randomized 2:1 to receive 1,200 mg of atezolizumab plus 15 mg/kg of bevacizumab or 400 mg of sorafenib. Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) per independent review facility (IRF)-assessed Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in the BCLC stage B subgroup. Patients in this analysis had BCLC stage B disease at baseline per electronic case report form. Secondary efficacy endpoints included the objective response rate (ORR) and change in the sum of longest diameters (SLD) of target lesions from baseline per IRF RECIST 1.1 and modified RECIST (mRECIST) for HCC.

Results: Of 501 enrolled patients, 74 (15%) had BCLC stage B disease at baseline (atezolizumab + bevacizumab, n = 49; sorafenib, n = 24). For this group, median follow-up was 19.7 months. A trend toward improved OS and PFS per IRF RECIST 1.1 was observed with atezolizumab + bevacizumab versus sorafenib (OS: hazard ratio [HR]: 0.63; 95% confidence interval [CI]: 0.29, 1.34; PFS: HR: 0.64; 95% CI: 0.36, 1.12). ORRs per IRF RECIST 1.1 and HCC mRECIST were 43% and 50% with atezolizumab + bevacizumab and 26% and 30% with sorafenib, respectively. Percentage change in SLD of target lesions from baseline per IRF RECIST 1.1 and HCC mRECIST showed durable responses with atezolizumab + bevacizumab treatment. Safety data were consistent with known profiles of atezolizumab and bevacizumab, as seen in the overall study population.

Discussion/conclusion: Efficacy benefits were observed with atezolizumab + bevacizumab in patients with baseline BCLC stage B disease, consistent with the intention-to-treat population.

引言:IMbrave150 III期研究确定atezolizumab+bevacizumab为不可切除肝细胞癌(HCC)患者的标准护理。这项探索性分析报告了基线巴塞罗那临床癌症(BCLC)B期疾病患者的疗效和安全性结果。方法:将系统治疗初期不可切除HCC和Child-Pugh A级肝功能的患者以2:1随机分组,接受1200 mg atezolizumab加15 mg/kg贝伐单抗或400 mg索拉非尼治疗。共同的主要终点是BCLC B期亚组中每个独立审查机构(IRF)评估的实体瘤反应评估标准(RECIST)1.1版的总生存期(OS)和无进展生存期(PFS)。根据电子病例报告表,该分析中的患者在基线时患有BCLC B期疾病。次要疗效终点包括根据IRF RECIST 1.1和改良RECIST(mRECIST)治疗HCC的客观有效率(ORR)和目标病变自基线以来最长直径之和(SLD)的变化。结果:在501名入选患者中,74人(15%)在基线时患有BCLC B期疾病(atezolizumab+bevacizumab,n=49;索拉非尼,n=24)。该组的中位随访时间为19.7个月。与索拉非尼相比,atezolizumab+bevacizumab在IRF RECIST 1.1中观察到OS和PFS改善的趋势(OS:危险比[HR]:0.63;95%置信区间[CI]:0.29,1.34;PFS:HR:0.64;95%CI:0.36,1.12)。根据IRF RECIST 1.1和HCC mRECIST,靶病变的SLD与基线相比的百分比变化显示,atezolizumab+贝伐单抗治疗具有持久的疗效。在整个研究人群中,安全性数据与atezolizumab和贝伐单抗的已知情况一致。讨论/结论:atezolizumab+bevacizumab在基线BCLC B期疾病患者中观察到疗效益处,与治疗人群的意向一致。
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引用次数: 7
Tumor Radiomic Features on Pretreatment MRI to Predict Response to Lenvatinib plus an Anti-PD-1 Antibody in Advanced Hepatocellular Carcinoma: A Multicenter Study. 多中心研究:治疗前核磁共振成像中的肿瘤放射学特征预测晚期肝细胞癌患者对伦伐替尼加抗PD-1抗体的反应
IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-11-28 eCollection Date: 2023-08-01 DOI: 10.1159/000528034
Bin Xu, San-Yuan Dong, Xue-Li Bai, Tian-Qiang Song, Bo-Heng Zhang, Le-Du Zhou, Yong-Jun Chen, Zhi-Ming Zeng, Kui Wang, Hai-Tao Zhao, Na Lu, Wei Zhang, Xu-Bin Li, Su-Su Zheng, Guo Long, Yu-Chen Yang, Hua-Sheng Huang, Lan-Qing Huang, Yun-Chao Wang, Fei Liang, Xiao-Dong Zhu, Cheng Huang, Ying-Hao Shen, Jian Zhou, Meng-Su Zeng, Jia Fan, Sheng-Xiang Rao, Hui-Chuan Sun

Introduction: Lenvatinib plus an anti-PD-1 antibody has shown promising antitumor effects in patients with advanced hepatocellular carcinoma (HCC), but with clinical benefit limited to a subset of patients. We developed and validated a radiomic-based model to predict objective response to this combination therapy in advanced HCC patients.

Methods: Patients (N = 170) who received first-line combination therapy with lenvatinib plus an anti-PD-1 antibody were retrospectively enrolled from 9 Chinese centers; 124 and 46 into the training and validation cohorts, respectively. Radiomic features were extracted from pretreatment contrast-enhanced MRI. After feature selection, clinicopathologic, radiomic, and clinicopathologic-radiomic models were built using a neural network. The performance of models, incremental predictive value of radiomic features compared with clinicopathologic features and relationship between radiomic features and survivals were assessed.

Results: The clinicopathologic model modestly predicted objective response with an AUC of 0.748 (95% CI: 0.656-0.840) and 0.702 (95% CI: 0.547-0.884) in the training and validation cohorts, respectively. The radiomic model predicted response with an AUC of 0.886 (95% CI: 0.815-0.957) and 0.820 (95% CI: 0.648-0.984), respectively, with good calibration and clinical utility. The incremental predictive value of radiomic features to clinicopathologic features was confirmed with a net reclassification index of 47.9% (p < 0.001) and 41.5% (p = 0.025) in the training and validation cohorts, respectively. Furthermore, radiomic features were associated with overall survival and progression-free survival both in the training and validation cohorts, but modified albumin-bilirubin grade and neutrophil-to-lymphocyte ratio were not.

Conclusion: Radiomic features extracted from pretreatment MRI can predict individualized objective response to combination therapy with lenvatinib plus an anti-PD-1 antibody in patients with unresectable or advanced HCC, provide incremental predictive value over clinicopathologic features, and are associated with overall survival and progression-free survival after initiation of this combination regimen.

简介在晚期肝细胞癌(HCC)患者中,伦伐替尼联合抗PD-1抗体显示出良好的抗肿瘤效果,但临床获益仅限于部分患者。我们开发并验证了一种基于放射学的模型,用于预测晚期肝细胞癌患者对这种联合疗法的客观反应:我们从中国的9个中心回顾性地招募了接受来伐替尼和抗PD-1抗体一线联合治疗的患者(170人),其中124人和46人分别进入训练组和验证组。从治疗前对比增强核磁共振成像中提取放射学特征。经过特征选择后,利用神经网络建立了临床病理学模型、放射学模型和临床病理学-放射学模型。对模型的性能、放射学特征与临床病理学特征相比的增量预测价值以及放射学特征与存活率之间的关系进行了评估:结果:临床病理模型可适度预测客观反应,训练组和验证组的AUC分别为0.748(95% CI:0.656-0.840)和0.702(95% CI:0.547-0.884)。放射学模型预测反应的AUC分别为0.886(95% CI:0.815-0.957)和0.820(95% CI:0.648-0.984),具有良好的校准性和临床实用性。放射学特征对临床病理学特征的增量预测价值得到了证实,在训练组和验证组中,净再分类指数分别为 47.9% (p < 0.001) 和 41.5% (p = 0.025)。此外,在训练组和验证组中,放射学特征与总生存期和无进展生存期相关,但改良白蛋白-胆红素分级和中性粒细胞-淋巴细胞比值与总生存期和无进展生存期无关:结论:从治疗前磁共振成像中提取的放射学特征可以预测不可切除或晚期HCC患者对来伐替尼加抗PD-1抗体联合治疗的个体化客观反应,比临床病理特征具有更高的预测价值,并且与联合治疗后的总生存期和无进展生存期相关。
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引用次数: 0
Front & Back Matter 正面和背面
IF 13.8 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Pub Date : 2022-09-01 DOI: 10.1159/000526882
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引用次数: 0
期刊
Liver Cancer
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