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Real-World Evidence from a Nationwide Prospective Study of the Efficacy/Safety of Systemic Therapy for Unresectable Hepatocellular Carcinoma: First 1,000 Patients of the PRISM Study. 来自全国范围内不可切除肝细胞癌全身治疗有效性/安全性的前瞻性研究的真实证据:PRISM研究的前1000名患者
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-05-21 DOI: 10.1159/000552686
Masafumi Ikeda, Shinji Itoh, Daisuke Onozuka, Sadahisa Ogasawara, Tomokazu Kawaoka, Takashi Niizeki, Taro Yamashita, Yasuhito Tanaka, Tomoharu Yamada, Kazushi Numata, Ryosuke Tateishi, Tatsuya Yamashita, Takuji Okusaka, Junji Furuse, Masatoshi Kudo
{"title":"Real-World Evidence from a Nationwide Prospective Study of the Efficacy/Safety of Systemic Therapy for Unresectable Hepatocellular Carcinoma: First 1,000 Patients of the PRISM Study.","authors":"Masafumi Ikeda, Shinji Itoh, Daisuke Onozuka, Sadahisa Ogasawara, Tomokazu Kawaoka, Takashi Niizeki, Taro Yamashita, Yasuhito Tanaka, Tomoharu Yamada, Kazushi Numata, Ryosuke Tateishi, Tatsuya Yamashita, Takuji Okusaka, Junji Furuse, Masatoshi Kudo","doi":"10.1159/000552686","DOIUrl":"10.1159/000552686","url":null,"abstract":"<p><strong>Background: </strong>The PRISM study is a nationwide, multicenter, prospective observational study in Japan evaluating the real-world efficacy and safety of systemic therapies for unresectable hepatocellular carcinoma (HCC). HCC patients starting systemic therapy are prospectively enrolled, enabling assessment of outcomes and tolerability across treatment lines. By capturing all patients treated in routine practice, the study is expected to provide a clear picture of the actual treatment outcomes in Japan.</p><p><strong>Methods: </strong>We analyzed the first 1,000 patients enrolled between July 2020 and July 2022, focusing on outcomes of first-line therapy and subsequent patterns. Data on demographics, tumor stage, liver function, regimens, survival, and adverse events (AEs) were prospectively collected and centrally monitored. Survival was estimated by Kaplan-Meier method, and tumor responses were assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and modified RECIST (mRECIST).</p><p><strong>Results: </strong>Of 935 evaluable patients, 82.8% received atezolizumab + bevacizumab (Atezo+Bev) and 15.2% lenvatinib as first-line therapy. Median overall survival and progression-free survival were 21.8 and 7.7 months for Atezo+Bev, respectively, and 20.8 and 6.7 months for lenvatinib, with overall survival numerically longer than that reported in pivotal clinical trials, while progression-free survival remained comparable. Objective response rates were 29.6% (RECIST) and 35.0% (mRECIST) for Atezo+Bev, 24.6% and 35.2% for lenvatinib, and 0% and 6.3% for sorafenib by RECIST and mRECIST, respectively. Grade ≥3 treatment-related AEs occurred in 21.6% and 22.9%, with safety profiles consistent with prior reports. Approximately 50% of patients received second-line therapy, most often lenvatinib after Atezo+Bev and vice versa, with a median progression-free survival of ∼4 months; later-line regimens yielded even shorter benefit.</p><p><strong>Conclusion: </strong>The PRISM study confirms the real-world reproducibility of Atezo+Bev and lenvatinib in Japan, demonstrating their feasibility across diverse patient populations. Ongoing follow-up and subgroup analyses, particularly in special populations, are expected to help optimize long-term outcomes.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13423367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148630879","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
The China Paradox in LEAP-012 Trial. LEAP-012试验中的中国悖论。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-05-18 eCollection Date: 2026-06-01 DOI: 10.1159/000552537
Masatoshi Kudo
{"title":"The China Paradox in LEAP-012 Trial.","authors":"Masatoshi Kudo","doi":"10.1159/000552537","DOIUrl":"10.1159/000552537","url":null,"abstract":"","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":"329-336"},"PeriodicalIF":10.5,"publicationDate":"2026-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13241163/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199543","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
Methodological Concerns in "Prognostic Usefulness of Clinical Complete Response after PD-1 Inhibitor-Based Combination Therapy for Unresectable Hepatocellular Carcinoma". “基于PD-1抑制剂的联合治疗不可切除肝细胞癌后临床完全缓解的预后价值”的方法学关注。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-05-06 DOI: 10.1159/000551852
Shoujun Shen, Jiayan Chen, Bihua Yao
{"title":"Methodological Concerns in \"Prognostic Usefulness of Clinical Complete Response after PD-1 Inhibitor-Based Combination Therapy for Unresectable Hepatocellular Carcinoma\".","authors":"Shoujun Shen, Jiayan Chen, Bihua Yao","doi":"10.1159/000551852","DOIUrl":"10.1159/000551852","url":null,"abstract":"","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13368246/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148447790","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
Real-World Efficacy and Safety of TACE Combined with Lenvatinib and PD-1 Inhibitor in Conversion Therapy for Unresectable Hepatocellular Carcinoma (GUIDANCE007): A Multicenter Retrospective Study. TACE联合Lenvatinib和PD-1抑制剂用于不可切除肝细胞癌转换治疗的实际疗效和安全性(GUIDANCE007):一项多中心回顾性研究
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-05-06 DOI: 10.1159/000552409
Lin Ye, Guo-Xing Liu, Da-Long Yang, Fan-Jian Zeng, Jie Liu, Hong-Bing Yao, Jun-Liang Nong, Shao-Ping Liu, Ning Peng, Wen-Feng Li, Pei-Sheng Wu, Chuang Qin, Ze Su, Jun-Jie Ou, Xiao-Feng Dong, Yi-He Yan, Teng-Meng Zhong, Ming-Song Wu, Yao-Zhi Chen, Guo-Dong Wang, Mian-Jing Li, Xue-Yao Wang, Fu-Quan Yang, Shu-Chang Chen, Yong-Yu Yang, Kang Chen, Yong-Cheng Lai, Qing-Qing Pang, Xiu-Mei Liang, Xian-Shuang Mao, Yong-Rong Liang, Fu-Xin Li, Hao Shi, Ren-Jian Li, Bang-De Xiang, Liang Ma, Jian-Hong Zhong, Ya-Qun Yu
{"title":"Real-World Efficacy and Safety of TACE Combined with Lenvatinib and PD-1 Inhibitor in Conversion Therapy for Unresectable Hepatocellular Carcinoma (GUIDANCE007): A Multicenter Retrospective Study.","authors":"Lin Ye, Guo-Xing Liu, Da-Long Yang, Fan-Jian Zeng, Jie Liu, Hong-Bing Yao, Jun-Liang Nong, Shao-Ping Liu, Ning Peng, Wen-Feng Li, Pei-Sheng Wu, Chuang Qin, Ze Su, Jun-Jie Ou, Xiao-Feng Dong, Yi-He Yan, Teng-Meng Zhong, Ming-Song Wu, Yao-Zhi Chen, Guo-Dong Wang, Mian-Jing Li, Xue-Yao Wang, Fu-Quan Yang, Shu-Chang Chen, Yong-Yu Yang, Kang Chen, Yong-Cheng Lai, Qing-Qing Pang, Xiu-Mei Liang, Xian-Shuang Mao, Yong-Rong Liang, Fu-Xin Li, Hao Shi, Ren-Jian Li, Bang-De Xiang, Liang Ma, Jian-Hong Zhong, Ya-Qun Yu","doi":"10.1159/000552409","DOIUrl":"10.1159/000552409","url":null,"abstract":"<p><strong>Introduction: </strong>Transarterial chemoembolization (TACE) combined with lenvatinib has demonstrated efficacy for unresectable hepatocellular carcinoma (HCC). However, real-world evidence on the additional benefit of PD-1 inhibitors in conversion therapy remains limited. This study aimed to investigate the efficacy and safety of triple therapy (TACE, lenvatinib, and PD-1 inhibitors) versus dual therapy (TACE and lenvatinib) in conversion therapy for initially unresectable HCC.</p><p><strong>Methods: </strong>This multicenter study was conducted in 20 Chinese tertiary hospitals. Patients received either triple therapy (TLP group, <i>n</i> = 289) or dual therapy (TL group, <i>n</i> = 132). Inverse probability of treatment weighting (IPTW) was used to control for confounding. Multivariate models compared overall survival (OS) and progression-free survival (PFS).</p><p><strong>Results: </strong>From January 2019 to June 2023, 421 consecutive patients were enrolled. After IPTW adjustment, baseline characteristics were well balanced. The TLP group showed superior efficacy: objective response rate 55.1% versus 34.7% (<i>p</i> < 0.001), complete response rate 24.9% versus 14.9% (<i>p</i> = 0.010), and conversion surgery rate 35.5% versus 15.7% (<i>p</i> < 0.001). Median OS was prolonged (31.67 vs. 25.00 months; adjusted HR 0.60, 95% CI: 0.42-0.85, <i>p</i> = 0.001) and median PFS extended (16.47 vs. 12.00 months; adjusted HR 0.65, 95% CI: 0.47-0.93, <i>p</i> = 0.008). Sensitivity analyses including propensity score matching (HR 0.61), landmark analysis (HR 0.64), and time-varying covariate analysis (HR 0.58) confirmed the findings. E-value analysis (2.72) suggested unmeasured confounding alone is unlikely to explain the benefit. Treatment effects were consistent across subgroups. Grade 3-4 adverse events were similar (35.6% vs. 36.4%, <i>p</i> = 0.885), though immune-related adverse events were more frequent in the TLP group.</p><p><strong>Conclusions: </strong>Adding PD-1 inhibitors to TACE plus lenvatinib was associated with improved tumor response, prolonged survival, and higher conversion surgery rates, with an acceptable safety profile. Given the heterogeneity of PD-1 inhibitors and inherent limitations of retrospective design, these findings should be considered hypothesis generating and require verification in prospective randomized controlled trials.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13354299/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148422245","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
Addition of Intra-Arterial Therapy to Immunotherapy Improves Outcomes in Unresectable Hepatocellular Carcinoma: Taiwan Multicenter Cohort Study. 台湾多中心队列研究:动脉内治疗增加免疫治疗改善不可切除肝癌的预后。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-05-05 DOI: 10.1159/000552375
Teng-Yu Lee, Pei-Chang Lee, Ying-Chun Shen, Wei-Fan Hsu, Shiue-Wei Lai, Ching-Wei Chang, Yung-Yeh Su, Tung-Hung Su, Po-Ting Lin, Chia-Yen Dai, Ching-Sheng Hsu, San-Chi Chen, Kun-Ming Rau, I-Cheng Lee, Song-Ru Jhan, Tsung-Hao Liu, Hsueh-Chou Lai, Tsang-En Wang, Shi-Ming Lin, Po-Cheng Liang, Cheng-Hao Tseng, Pi-Yi Chang, Shu-Cheng Wu, Hung-Wei Wang, Shou-Wu Lee, Yi-Hsiang Huang
{"title":"Addition of Intra-Arterial Therapy to Immunotherapy Improves Outcomes in Unresectable Hepatocellular Carcinoma: Taiwan Multicenter Cohort Study.","authors":"Teng-Yu Lee, Pei-Chang Lee, Ying-Chun Shen, Wei-Fan Hsu, Shiue-Wei Lai, Ching-Wei Chang, Yung-Yeh Su, Tung-Hung Su, Po-Ting Lin, Chia-Yen Dai, Ching-Sheng Hsu, San-Chi Chen, Kun-Ming Rau, I-Cheng Lee, Song-Ru Jhan, Tsung-Hao Liu, Hsueh-Chou Lai, Tsang-En Wang, Shi-Ming Lin, Po-Cheng Liang, Cheng-Hao Tseng, Pi-Yi Chang, Shu-Cheng Wu, Hung-Wei Wang, Shou-Wu Lee, Yi-Hsiang Huang","doi":"10.1159/000552375","DOIUrl":"10.1159/000552375","url":null,"abstract":"<p><strong>Introduction: </strong>Evidence supporting the combination of immunotherapy with intra-arterial therapy (IAT) for unresectable hepatocellular carcinoma (HCC) remains limited. This study aimed to evaluate whether the addition of IAT to first-line immunotherapy improves survival outcomes.</p><p><strong>Methods: </strong>Using the Taiwan Liver Cancer Association (TLCA) Research Group database, we identified patients with unresectable HCC who initiated first-line immunotherapy between May 2017 and January 2024. Patients with Barcelona Clinic Liver Cancer (BCLC) stage A or D disease, prior liver transplantation, or follow-up of <6 weeks were excluded. Eligible patients received either IAT (transarterial chemoembolization, radioembolization, or hepatic arterial infusion chemotherapy) at the initiation of immunotherapy or immunotherapy alone. After 1:3 propensity score matching, 90 and 270 patients were included in the IAT and control groups, respectively. Overall survival (OS) was analyzed using adjusted hazard ratios (aHRs) in a time-dependent model.</p><p><strong>Results: </strong>The IAT group achieved a higher objective response rate (46.7% vs. 26.3%; <i>p</i> < 0.001) and a longer duration of response (median 19.0 [IQR: 9.7-36.6] vs. 11.0 [IQR: 8.4-23.1] weeks; <i>p</i> = 0.009) than the control group. IAT was independently associated with improved OS (aHR 0.53, 95% CI: 0.37-0.75; <i>p</i> < 0.001). Factors associated with worse OS included Child-Turcotte-Pugh class B (aHR 1.41, 95% CI: 1.01-1.97; <i>p</i> = 0.042), albumin-bilirubin grade >1 (aHR 1.58, 95% CI: 1.11-2.27; <i>p</i> = 0.012), tumor burden beyond the up-to-7 criteria (aHR 1.67, 95% CI: 1.02-2.74; <i>p</i> = 0.043), and portal vein invasion (aHR 1.67; 95% CI: 1.19-2.35; <i>p</i> = 0.003). Five-year OS was higher in the IAT group than in the control group (28.7% [95% CI: 17.8-46.2] vs. 16.4% [95% CI: 10.7-25.2]; <i>p</i> = 0.007). Landmark and subgroup analyses consistently supported the OS benefit of IAT.</p><p><strong>Conclusion: </strong>In unresectable HCC, the addition of IAT to first-line immunotherapy improves response rates, prolongs the duration of response, and enhances OS.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13345639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148412379","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
Transarterial Chemoembolization plus Systemic Therapy versus Transarterial Chemoembolization alone for Unresectable, Nonmetastatic Hepatocellular Carcinoma: Meta-Analysis and Trial Sequential Analysis from Randomized Controlled Trials. 经动脉化疗栓塞加全身治疗与单独经动脉化疗栓塞治疗不可切除的非转移性肝细胞癌:随机对照试验的荟萃分析和试验序列分析。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-04-30 DOI: 10.1159/000552229
Jiaxi Liu, Huan Zhai, Liqi Shang, Peng Wang, Jiaxuan Liu, Luke Wang, Qiwen You, Meiwen Qin, Yanan Ma, Haibo Shao
{"title":"Transarterial Chemoembolization plus Systemic Therapy versus Transarterial Chemoembolization alone for Unresectable, Nonmetastatic Hepatocellular Carcinoma: Meta-Analysis and Trial Sequential Analysis from Randomized Controlled Trials.","authors":"Jiaxi Liu, Huan Zhai, Liqi Shang, Peng Wang, Jiaxuan Liu, Luke Wang, Qiwen You, Meiwen Qin, Yanan Ma, Haibo Shao","doi":"10.1159/000552229","DOIUrl":"10.1159/000552229","url":null,"abstract":"<p><strong>Introduction: </strong>Transarterial chemoembolization (TACE) is the standard treatment for unresectable, nonmetastatic hepatocellular carcinoma (HCC). Although adding systemic therapies (TACE + S) is hypothesized to mitigate TACE-induced angiogenesis and enhance efficacy, the definitive clinical advantage of TACE + S over TACE monotherapy, particularly with respect to overall survival (OS), remains uncertain. We aimed to comprehensively evaluate the efficacy and safety of this combination using a rigorous meta-analysis and trial sequential analysis (TSA).</p><p><strong>Methods: </strong>We systematically searched major databases for randomized controlled trials (RCTs) comparing TACE + S versus TACE alone or TACE plus placebo in patients with unresectable HCC without macrovascular invasion or extrahepatic metastasis. The primary outcome was OS; secondary outcomes included progression-free survival, time to progression (TTP), objective response rate (ORR), and adverse events (AEs). TSA was employed to assess the statistical reliability of findings and the adequacy of the cumulative evidence across all outcomes.</p><p><strong>Results: </strong>A total of 10 RCTs comprising 2,296 patients were included. Compared with TACE alone/placebo, TACE + S demonstrated a statistically significant improvement in OS (hazard ratio [HR] = 0.83, 95% CI: 0.73-0.95, <i>p</i> = 0.008), with TSA confirming the statistical reliability of the evidence. TACE + S also significantly improved TTP based on mRECIST (HR = 0.63, 95% CI: 0.54-0.74, <i>p</i> < 0.001) and ORR by RECIST 1.1 (relative risk = 1.44, 95% CI: 1.22-1.70, <i>p</i> < 0.001). Subgroup analysis showed a more pronounced OS benefit in patients with HBV-related HCC (HR = 0.69, <i>p</i> = 0.009). However, the combination strategy was associated with a significantly higher incidence of both all-grade and grade ≥3 treatment-related AEs, though no treatment-related deaths were reported.</p><p><strong>Conclusion: </strong>In patients with unresectable, nonmetastatic HCC, the combination of TACE and systemic therapy provides superior OS, more favorable tumor control, and delayed disease progression compared with TACE monotherapy. These significant benefits are particularly pronounced in the HBV-associated HCC population. While the increased risk of AEs is notable, this approach remains a viable option, underscoring the necessity for careful patient selection and proactive management strategies.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13322702/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148368975","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
The 2024 International Liver Transplant Society and International Liver Cancer Association Consensus Recommendations for Liver Transplantation for Liver Cancer. 2024年国际肝移植协会和国际肝癌协会关于肝癌肝移植的共识建议。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-04-25 DOI: 10.1159/000550600
Sudha Kodali, Laura Kulik, Antonio D'Alessio, Eleonora De Martin, Abdul Rahman Hakeem, Monica Lewinska, Stacie Lindsey, Ken Liu, Zorana Maravic, Madhukar S Patel, David J Pinato, Ashwin Rammohan, Nicole Rich, Marco Sanduzzi Zamparelli, David W Victor, Carmen Vinaxia, Elizabeth W Brombosz, Augusto Villanueva, Tim Meyer, Nazia Selzner, R Mark Ghobrial, Mohamed Rela, Gonzalo Sapisochin
{"title":"The 2024 International Liver Transplant Society and International Liver Cancer Association Consensus Recommendations for Liver Transplantation for Liver Cancer.","authors":"Sudha Kodali, Laura Kulik, Antonio D'Alessio, Eleonora De Martin, Abdul Rahman Hakeem, Monica Lewinska, Stacie Lindsey, Ken Liu, Zorana Maravic, Madhukar S Patel, David J Pinato, Ashwin Rammohan, Nicole Rich, Marco Sanduzzi Zamparelli, David W Victor, Carmen Vinaxia, Elizabeth W Brombosz, Augusto Villanueva, Tim Meyer, Nazia Selzner, R Mark Ghobrial, Mohamed Rela, Gonzalo Sapisochin","doi":"10.1159/000550600","DOIUrl":"10.1159/000550600","url":null,"abstract":"<p><p>Liver transplantation (LT) provides the best long-term survival outcomes for patients with liver cancer. As a result, the field of transplant oncology has grown greatly over the past few decades, and many centers have expanded their criteria to allow increased access to LT for liver malignancies. Center-level guidelines and practices in transplant oncology significantly vary across the world, leading to debate regarding the best course of treatment for this patient population. An international consensus conference was convened by the International Liver Transplantation Society and the International Liver Cancer Association on February 1-2, 2024, in Valencia, Spain, to establish a more universal consensus regarding LT for oncologic indications. The conference followed the Delphi process, followed by external expert review. Consensus statements were accepted regarding patient assessment and waitlisting criteria, pretransplant treatment (including immunotherapy) and downstaging, living donor LT, post-LT patient management, and patient- and caregiver-related outcomes. The multidisciplinary participants in the consensus conference provided up-to-date recommendations regarding the selection and management of patients with liver cancer being considered for LT. Although participants deferred to center protocols in many cases, there was great interest in safely expanding access to LT for patients with larger tumor burden and biologically amenable lesions.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13271748/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148272308","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
An International Phase 4 Study of Lenvatinib and Sorafenib in Real-World Patients with Unresectable Hepatocellular Carcinoma: Final Analysis. Lenvatinib和Sorafenib在现实世界不可切除肝细胞癌患者中的国际4期研究:最终分析。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-04-24 DOI: 10.1159/000552115
Markus Peck-Radosavljevic, Akhmed Abdelgafur, Alessandro Granito, Antonio Gasbarrini, Yuk Ting Ma, Edward Mena, José Luis Lledó-Navarro, José Presa, Arndt Weinmann, Miriam T Levy, Adriano Pellicelli, Dirk-Thomas Waldschmidt, Henrik Toft Sørensen, Lipika Goyal, Min Ren, Hakim Saal, Chinyere E Okpara, Tim Meyer
{"title":"An International Phase 4 Study of Lenvatinib and Sorafenib in Real-World Patients with Unresectable Hepatocellular Carcinoma: Final Analysis.","authors":"Markus Peck-Radosavljevic, Akhmed Abdelgafur, Alessandro Granito, Antonio Gasbarrini, Yuk Ting Ma, Edward Mena, José Luis Lledó-Navarro, José Presa, Arndt Weinmann, Miriam T Levy, Adriano Pellicelli, Dirk-Thomas Waldschmidt, Henrik Toft Sørensen, Lipika Goyal, Min Ren, Hakim Saal, Chinyere E Okpara, Tim Meyer","doi":"10.1159/000552115","DOIUrl":"10.1159/000552115","url":null,"abstract":"<p><strong>Introduction: </strong>The phase 3 REFLECT trial demonstrated the efficacy and safety of lenvatinib versus sorafenib in the first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC). We report results from STELLAR, a non-interventional post-marketing study. The primary objectives were to characterize hepatotoxicity and overall safety of lenvatinib in patients from Western regions with uHCC.</p><p><strong>Methods: </strong>STELLAR was a prospective, open-label, observational, phase 4 study of patients treated with lenvatinib (<i>n</i> = 193). A cohort of sorafenib-treated patients (<i>n</i> = 123) was included as an internal reference group. The treating physician made the decision to treat patients with lenvatinib or sorafenib before enrollment. Study drugs were administered according to the Summary of Product Characteristics guidelines. Safety and efficacy evaluations were performed according to standard clinical practice at each site. The primary endpoint was safety. Secondary endpoints included treatment exposure and overall survival.</p><p><strong>Results: </strong>The median duration of treatment with lenvatinib or sorafenib was 6.5 months (range, 0.2-33.1 months) and 4.4 months (range, 0.5-30.7 months), respectively. Hepatotoxicity treatment-emergent adverse events (TEAEs) were observed in 26.9% of lenvatinib-treated patients and 33.3% of sorafenib-treated patients. The most frequently reported hepatotoxicity TEAEs were hepatic encephalopathy (7.8%; lenvatinib cohort) and ascites (11.4%; sorafenib cohort), respectively. Overall, 85.0% of lenvatinib-treated patients and 84.6% of sorafenib-treated patients experienced ≥1 TEAE. Median overall survival (95% CI) was 16.9 months (14.1-not estimable) in lenvatinib-treated patients.</p><p><strong>Conclusion: </strong>Our findings support the established safety and efficacy of lenvatinib in first-line patients with uHCC.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13200844/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148032031","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
Modality-Specific and Multilevel Barriers to Curative Treatment for Early-Stage Hepatocellular Carcinoma. 早期肝细胞癌治疗的模式特异性和多层障碍。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-04-16 DOI: 10.1159/000551705
Ashwini Arvind, Lisa Quirk, Sneha Deodhar, Samuel Phen, Gi Giamarqo, Emma Jones, Celina Li, Kishore Botla, Christina Zhu, Sanjeeva Kalva, Adam C Yopp, Madhukar S Patel, Amit G Singal, Nicole E Rich
{"title":"Modality-Specific and Multilevel Barriers to Curative Treatment for Early-Stage Hepatocellular Carcinoma.","authors":"Ashwini Arvind, Lisa Quirk, Sneha Deodhar, Samuel Phen, Gi Giamarqo, Emma Jones, Celina Li, Kishore Botla, Christina Zhu, Sanjeeva Kalva, Adam C Yopp, Madhukar S Patel, Amit G Singal, Nicole E Rich","doi":"10.1159/000551705","DOIUrl":"10.1159/000551705","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with early-stage hepatocellular carcinoma (HCC) are eligible for potentially curative treatments, yet these therapies are underused in clinical practice.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study of patients with treatment-naïve, early-stage HCC (within Milan criteria) seen between January 2010 and July 2021 at two US health systems. Barriers to curative treatment were identified through review of medical records. We used univariable and multivariable logistic regression to identify factors associated with curative treatment receipt.</p><p><strong>Results: </strong>Among 629 eligible patients with early-stage HCC (median age 60 years; 72.3% male), 396 (63.0%) received curative treatment. In multivariable analysis, evaluation at a tertiary care center was associated with higher odds of curative treatment (OR 2.95, 95% CI: 1.98-4.47). In contrast, having Medicaid (OR 0.27, 95% CI: 0.14-0.53), being enrolled in a county-based subsidy program (OR 0.31, 95% CI: 0.16-0.58), or being uninsured (OR 0.24, 95% CI: 0.11-0.50) were associated with lower odds of curative treatment compared to private insurance. Other factors inversely associated with curative treatment included multifocal disease (OR 0.49, 95% CI: 0.31-0.75), increasing tumor size (continuous: OR 0.73, 95% CI: 0.60-0.88), and worse liver function (Child-Pugh B vs. A: OR 0.27, 95% CI: 0.18-0.40; Child-Pugh C vs. A: OR 0.13, 95% CI: 0.07-0.24). Common barriers to liver transplantation included lack of insurance, medical comorbidities, and psychosocial challenges. Common barriers to resection and ablation included comorbidities and unfavorable tumor location, respectively.</p><p><strong>Conclusion: </strong>Underuse of curative treatment for early-stage HCC is mediated by tumor-specific, clinical, and system-level factors, underscoring a need for multilevel interventions to address identified barriers.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13290253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148317803","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
Survival Benefit of Combined Systemic and Locoregional Therapy in Hepatocellular Carcinoma with Portal Vein Tumor Thrombus: A Propensity Score-Matched Analysis. 肝细胞癌合并门静脉肿瘤血栓的全身和局部联合治疗的生存获益:倾向评分匹配分析。
IF 10.5 1区 医学
Liver Cancer Pub Date : 2026-04-16 DOI: 10.1159/000551935
Fan Gao, Chengxiang Guo, Yiwen Chen, Yinan Shen, Xiang Li, Xiaoyu Zhang, Shunliang Gao, Xueli Bai, Tingbo Liang
{"title":"Survival Benefit of Combined Systemic and Locoregional Therapy in Hepatocellular Carcinoma with Portal Vein Tumor Thrombus: A Propensity Score-Matched Analysis.","authors":"Fan Gao, Chengxiang Guo, Yiwen Chen, Yinan Shen, Xiang Li, Xiaoyu Zhang, Shunliang Gao, Xueli Bai, Tingbo Liang","doi":"10.1159/000551935","DOIUrl":"10.1159/000551935","url":null,"abstract":"<p><strong>Introduction: </strong>The prognosis of hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT) remains dismal. Although systemic therapy is the standard of care, its effectiveness is limited. This study aimed to compare the efficacy and safety of transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with systemic therapy versus systemic therapy alone in patients with HCC and PVTT.</p><p><strong>Methods: </strong>We retrospectively analyzed 478 patients newly diagnosed with HCC and PVTT between January 2021 and December 2024. Propensity score matching (PSM) was used to balance baseline characteristics. Outcomes compared between the combination therapy group (TACE/HAIC plus targeted therapy and immunotherapy, <i>n</i> = 374) and the systemic therapy group (<i>n</i> = 104) included overall survival (OS), progression-free survival (PFS), tumor response, and adverse events.</p><p><strong>Results: </strong>After PSM (184 vs. 102 patients), the combination therapy group showed significantly longer median OS (15.7 vs. 5.9 months; hazard ratio [HR] = 0.524, 95% confidence interval [CI]: 0.391-0.702; <i>p</i> < 0.001) and PFS (7.0 vs. 3.6 months, HR = 0.732, 95% CI: 0.558-0.959; <i>p</i> = 0.024). The disease control rate was also higher in the combination therapy group (43.5% vs. 27.5%, <i>p</i> = 0.007). Subgroup analyses revealed pronounced survival benefits in patients with Vp4 PVTT and those with Child-Pugh B liver function. Although adverse events were more frequent in the combination therapy group, the incidence of grade 3-4 toxicities was generally comparable between the two groups.</p><p><strong>Conclusion: </strong>In HCC patients with PVTT, combining TACE or HAIC with systemic therapy significantly improves survival outcomes compared to systemic therapy alone, with acceptable safety. This multimodal approach offers a promising treatment strategy, particularly for patients with advanced PVTT or impaired liver function.</p>","PeriodicalId":18156,"journal":{"name":"Liver Cancer","volume":" ","pages":""},"PeriodicalIF":10.5,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13271749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148272353","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
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