Gonzalo Sapisochin, Wei Chen Lee, Dong Jin Joo, Jae-Won Joh, Koichiro Hata, Arvinder Singh Soin, Uday Kiran Veldandi, Shuhei Kaneko, Matthias Meier, Denise Leclair, Gangadhar Sunkara, Long Bin Jeng
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Data were collected retrospectively (end of core to the start of follow-up study), and prospectively (during the 3-year follow-up study). RESULTS Of 117 LDLTRs with HCC at LT in the core H2307 study (EVR+rTAC, N=56; sTAC, N=61), 86 patients (EVR+rTAC, N=41; sTAC, N=45) entered the follow-up study. Overall HCC recurrence was lower but statistically non-significant in the EVR+rTAC group (3.6% vs 11.5% in sTAC; P=0.136) at 5 years after LT. There was no graft loss or chronic rejection. Acute rejection and death were comparable between treatment groups. Higher mean estimated glomerular filtration rate in the EVR+rTAC group (76.8 vs 65.8 mL/min/1.73 m² in sTAC) was maintained up to 5 years. Reported adverse events were numerically lower in the EVR+rTAC group (41.0% vs 53.5% sTAC) but not statistically significant. CONCLUSIONS Although statistically not significant, early EVR initiation reduced HCC recurrence, with comparable efficacy and safety, and better long-term renal function, than that of sTAC treatment.</p>","PeriodicalId":7935,"journal":{"name":"Annals of Transplantation","volume":"27 ","pages":"e937988"},"PeriodicalIF":1.1000,"publicationDate":"2022-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9f/ed/anntransplant-27-e937988.PMC9700399.pdf","citationCount":"1","resultStr":"{\"title\":\"Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipients with Hepatocellular Carcinoma.\",\"authors\":\"Gonzalo Sapisochin, Wei Chen Lee, Dong Jin Joo, Jae-Won Joh, Koichiro Hata, Arvinder Singh Soin, Uday Kiran Veldandi, Shuhei Kaneko, Matthias Meier, Denise Leclair, Gangadhar Sunkara, Long Bin Jeng\",\"doi\":\"10.12659/AOT.937988\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>BACKGROUND The study objective was to evaluate the effect of everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared with a standard TAC (sTAC) regimen on hepatocellular carcinoma (HCC) recurrence in de novo living-donor liver transplantation recipients (LDLTRs) with primary HCC at liver transplantation through 5 years after transplantation. MATERIAL AND METHODS In this multicenter, non-interventional study, LDLTRs with primary HCC, who were previously randomized to either everolimus plus reduced tacrolimus (EVR+rTAC) or standard tacrolimus (sTAC), and who completed the 2-year core H2307 study, were followed up. Data were collected retrospectively (end of core to the start of follow-up study), and prospectively (during the 3-year follow-up study). RESULTS Of 117 LDLTRs with HCC at LT in the core H2307 study (EVR+rTAC, N=56; sTAC, N=61), 86 patients (EVR+rTAC, N=41; sTAC, N=45) entered the follow-up study. Overall HCC recurrence was lower but statistically non-significant in the EVR+rTAC group (3.6% vs 11.5% in sTAC; P=0.136) at 5 years after LT. There was no graft loss or chronic rejection. Acute rejection and death were comparable between treatment groups. Higher mean estimated glomerular filtration rate in the EVR+rTAC group (76.8 vs 65.8 mL/min/1.73 m² in sTAC) was maintained up to 5 years. Reported adverse events were numerically lower in the EVR+rTAC group (41.0% vs 53.5% sTAC) but not statistically significant. 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引用次数: 1
摘要
本研究的目的是评估依维莫司(EVR)联合还原性他克莫司(rTAC)与标准TAC (sTAC)方案对肝移植后5年内原发性肝癌的新生活体肝移植受者(ldlts)肝细胞癌(HCC)复发的影响。材料和方法在这项多中心、非介入研究中,对先前随机分配到依维莫司加减量他克莫司(EVR+rTAC)或标准他克莫司(sTAC)的原发性HCC ldltr患者进行随访,这些患者完成了为期2年的核心H2307研究。回顾性(研究结束至随访研究开始)和前瞻性(3年随访研究期间)收集数据。结果核心H2307研究中有117例ldltr合并肝细胞癌(EVR+rTAC, N=56;sTAC, N=61), 86例(EVR+rTAC, N=41;sTAC, N=45)进入随访研究。EVR+rTAC组总体HCC复发率较低,但无统计学意义(3.6% vs 11.5%;P=0.136)。移植后5年无移植物丢失或慢性排斥反应。急性排斥反应和死亡在治疗组之间具有可比性。EVR+rTAC组较高的平均肾小球滤过率(76.8 vs 65.8 mL/min/1.73 m²)维持了5年。EVR+rTAC组报告的不良事件数量较低(41.0% vs 53.5% sTAC),但无统计学意义。结论:与sTAC治疗相比,早期EVR治疗可减少HCC复发,且疗效和安全性相当,且长期肾功能更好。
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipients with Hepatocellular Carcinoma.
BACKGROUND The study objective was to evaluate the effect of everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared with a standard TAC (sTAC) regimen on hepatocellular carcinoma (HCC) recurrence in de novo living-donor liver transplantation recipients (LDLTRs) with primary HCC at liver transplantation through 5 years after transplantation. MATERIAL AND METHODS In this multicenter, non-interventional study, LDLTRs with primary HCC, who were previously randomized to either everolimus plus reduced tacrolimus (EVR+rTAC) or standard tacrolimus (sTAC), and who completed the 2-year core H2307 study, were followed up. Data were collected retrospectively (end of core to the start of follow-up study), and prospectively (during the 3-year follow-up study). RESULTS Of 117 LDLTRs with HCC at LT in the core H2307 study (EVR+rTAC, N=56; sTAC, N=61), 86 patients (EVR+rTAC, N=41; sTAC, N=45) entered the follow-up study. Overall HCC recurrence was lower but statistically non-significant in the EVR+rTAC group (3.6% vs 11.5% in sTAC; P=0.136) at 5 years after LT. There was no graft loss or chronic rejection. Acute rejection and death were comparable between treatment groups. Higher mean estimated glomerular filtration rate in the EVR+rTAC group (76.8 vs 65.8 mL/min/1.73 m² in sTAC) was maintained up to 5 years. Reported adverse events were numerically lower in the EVR+rTAC group (41.0% vs 53.5% sTAC) but not statistically significant. CONCLUSIONS Although statistically not significant, early EVR initiation reduced HCC recurrence, with comparable efficacy and safety, and better long-term renal function, than that of sTAC treatment.
期刊介绍:
Annals of Transplantation is one of the fast-developing journals open to all scientists and fields of transplant medicine and related research. The journal is published quarterly and provides extensive coverage of the most important advances in transplantation.
Using an electronic on-line submission and peer review tracking system, Annals of Transplantation is committed to rapid review and publication. The average time to first decision is around 3-4 weeks. Time to publication of accepted manuscripts continues to be shortened, with the Editorial team committed to a goal of 3 months from acceptance to publication.
Expert reseachers and clinicians from around the world contribute original Articles, Review Papers, Case Reports and Special Reports in every pertinent specialty, providing a lot of arguments for discussion of exciting developments and controversies in the field.