TACE

Tace
  • 文章类型: Journal Article
    本研究旨在探讨TACE联合Lenvatinib和PD-1阻滞治疗肝癌合并门静脉癌栓(PVTT)的疗效和安全性的可行性。
    在临床实践中接受TACE联合Lenvatinib和PD-1阻断作为一线治疗的HCC和PVTT患者。所有受试者定期随访以获得预后结果。收集并记录在联合治疗期间观察到的安全性概况。预后和基线特征的探索性分析采用Log秩检验,多因素分析采用Cox回归分析。
    本研究纳入了67例接受TACE联合Lenvatinib和PD-1阻断的PVTTHCC患者。治疗期间最佳治疗反应提示4例患者达到完全缓解,30例患者出现部分反应,25例患者病情稳定,5例患者有疾病进展,3例患者无疾病进展。该方案的客观缓解率为50.7%[95%置信区间(CI):38.2-63.2%],疾病控制率为88.1%(95%CI:77.8-94.7%)。67例接受TACE联合Lenvatinib和PD-1阻断的PVTTHCC患者的中位无进展生存期为9.3个月(95%CI:5.85-12.75),中位总生存期为24.4个月(95%CI:19.11~29.69).安全性概况强调,65例患者在治疗期间出现不良反应,无论级别如何(97.0%)。其中34例患者被视为≥3级不良反应(50.7%)。最常见的不良反应是高血压,疲劳,肝功能异常,恶心,呕吐,和腹泻。不良反应总体可接受且可控。
    TACE联合Lenvatinib和PD-1阻断作为PVTTHCC的一线治疗显示出潜在的可行性和令人鼓舞的临床结果,为HCC患者提供长期生存益处。这一结论应在前瞻性大规模临床试验中得到证实。
    UNASSIGNED: This study aimed to investigate the feasibility of the efficacy and safety of TACE combined with Lenvatinib and PD-1 blockade in HCC with portal vein tumor thrombus (PVTT).
    UNASSIGNED: Patients with HCC and PVTT who underwent TACE combined with Lenvatinib and PD-1 blockade as first-line therapy in clinical practice were retrospectively included. All subjects were followed-up regularly to obtain prognostic outcomes. The safety profile observed during the combination therapy was collected and documented. The Log rank test was used for exploratory analysis of prognosis and baseline characteristics and Cox regression analysis was used for multivariate analysis.
    UNASSIGNED: A total of 67 HCC patients with PVTT who received TACE combined with Lenvatinib and PD-1 blockade were included in this study. The best therapeutic response during treatment suggested that 4 patients achieved complete response, 30 patients showed partial response, 25 patients were stable disease, 5 patients had disease progression and 3 patients were not available. Objective response rate of this regimen was 50.7% [95% confidence interval (CI): 38.2-63.2%] and disease control rate was 88.1% (95% CI: 77.8-94.7%). The median progression-free survival of 67 HCC patients with PVTT who received TACE combined with Lenvatinib and PD-1 blockades was 9.3 months (95% CI: 5.85-12.75), and the median overall survival was 24.4 months (95% CI: 19.11-29.69). The safety profile highlighted that 65 patients experienced adverse reactions regardless of grade during treatment (97.0%), among whom 34 patients were deemed as grade ≥3 adverse reactions (50.7%). The most common adverse reactions were hypertension, fatigue, abnormal liver function, nausea, vomiting, and diarrhea. Overall adverse reactions were acceptable and controllable.
    UNASSIGNED: TACE combined with Lenvatinib and PD-1 blockades as first-line therapy for HCC with PVTT demonstrated potential feasibility and encouraging clinical outcomes, providing long-term survival benefits for HCC patients. This conclusion should be confirmed in prospective large-scale clinical trials.
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  • 文章类型: Journal Article
    背景:肝细胞癌(HCC)是癌症相关死亡率的主要原因,经肝动脉化疗栓塞术(TACE)是治疗中期HCC患者的既定技术。这项研究的目的是在澳大利亚环境中生成cTACE和DEB-TACE的准确成本计算数据,并评估其中一项程序是否具有良好的成本效益。
    方法:使用2018年1月至2022年12月在单个中心进行的所有TACE程序的数据进行成本研究。数据包括所有直接和间接成本,包括运营成本,工资,开销,病房费用,输血,病理学,药房和病房支持。通过将当地成本除以现有的质量调整寿命年(QALY)高质量数据来评估成本效益。
    结果:对44例患者进行了64次TACE治疗。平均年龄为66.5岁,91%为男性。对于整个TACE治疗方案,每位患者的总体总费用中位数为AUD$7380(范围AUD$3719-$20,258)。然而,39%的患者接受了一种以上的治疗,每个单独治疗的中位费用为AUD$5270(范围AUD$3533-$15,818)。cTACE(AUD$4978)和DEB-TACE(AUD$9202)之间的中位成本差异显着,P<0.001。在计算成本效益时,每次cTACE治疗的成本为每QALY2489澳元,而每个DEB-TACE的成本为每QALY3834澳元。DEB-TACE相对于cTACE的增量成本效益比(ICER)为每QALY获得10,560澳元。
    结论:在澳大利亚,cTACE和DEB-TACE都是低成本的治疗方法。然而,DEB-TACE提供的解决方案为每QALY获得10,560澳元的ICER,低于澳大利亚政府愿意支付的门槛,因此是一种更具成本效益的治疗方法。
    BACKGROUND: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality and transarterial chemoembolisation (TACE) is an established technique to treat patients with intermediate-stage HCC. The aim of this study was to generate accurate costing data on cTACE and DEB-TACE in an Australian setting and assess whether one of the procedures offers favourable cost-effectiveness.
    METHODS: Costing study using data from all TACE procedures performed at a single centre between January 2018 and December 2022. Data were included from all direct and indirect costs including operative costs, wages, overheads, ward costs, transfusion, pathology, pharmacy and ward support. Cost-effectiveness was assessed by dividing local costs by existing high-quality data on quality-adjusted life years (QALYs).
    RESULTS: 64 TACE treatments were performed on 44 patients. Mean age was 66.5 years and 91% were male. Overall median total cost per patient for the entire TACE treatment regime was AUD$7380 (range AUD$3719-$20,258). However, 39% of patients received more than one treatment, and the median cost per individual treatment was AUD$5270 (range AUD$3533-$15,818). The difference in median cost between cTACE (AUD$4978) and DEB-TACE (AUD$9202) was significant, P < 0.001. In calculating cost-effectiveness, each cTACE treatment cost AUD$2489 per QALY gained, while each DEB-TACE cost AUD$3834 per QALY gained. The incremental cost-effectiveness ratio (ICER) for DEB-TACE over cTACE was AUD$10,560 per QALY gained.
    CONCLUSIONS: Both cTACE and DEB-TACE are low-cost treatments in Australia. However, DEB-TACE offers a solution with an ICER of AUD$10,560 per QALY gained which is below the Australian government willingness to pay threshold and thus is a more cost-effective treatment.
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  • 文章类型: Journal Article
    背景:大多数肝细胞癌(HCC)患者的诊断发生在中晚期,有一些治愈性的治疗选择。因此,迫切需要发现针对这种致命恶性肿瘤的其他辅助疗法。本研究旨在评估姜黄素(C)的有效性,胡椒碱(P)和牛磺酸(T)组合作为血清IFN-γ水平的佐剂,经动脉化疗栓塞(TACE)治疗的HCC患者中单核白细胞(MNLs)的免疫表型和分子特征。
    方法:在用5g姜黄素胶囊治疗之前(基线对照样品)和之后,从20例TACE治疗的HCC患者中收集血清和MNLs,每天服用10mg胡椒碱和0.5mg牛磺酸,连续三个月。通过流式细胞术和实时定量PCR测定MNL的免疫表型和分子特征。分别。此外,通过ELISA定量血清IFN-γ水平。
    结果:接受CPT联合治疗后,与基线对照样品相比,患者血清中的IFN-γ水平显着增加。此外,与对照组相比,接受联合治疗组的MNL中PD-1表达水平下调.MNLs免疫表型分析显示CD4+CD25+细胞(调节性T淋巴细胞)显著下降。此外,临床病理特征显示CPT组合对天冬氨酸转氨酶(AST)有非常显著的影响,乳酸脱氢酶(LDH)和α-feto蛋白(AFP)水平。
    结论:本研究引入了一种有希望的辅助CPT联合治疗作为天然药物,以提高TACE治疗候选HCC患者的管理。
    BACKGROUND: Diagnosis of the majority of hepatocellular carcinoma (HCC) patients occurs at intermediate to advanced stages, with a few curative therapeutic options being available. It is therefore strongly urgent to discover additional adjuvant therapy for this lethal malignancy. This study aimed to assess the effectiveness of curcumin (C), piperine (P) and taurine (T) combination as adjuvant agents on serum levels of IFN-γ, immunophenotypic and molecular characterization of mononuclear leukocytes (MNLs) in HCC patients treated with Transarterial chemoembolization (TACE).
    METHODS: Serum and MNLs were collected from 20 TACE-treated HCC patients before (baseline-control samples) and after treatment with 5 g curcumin capsules , 10 mg piperine and 0.5 mg taurine taken daily for three consecutive months. Immunophenotypic and molecular characterization of MNLs were determined by flow cytometry and quantitative real time PCR, respectively. In addition, serum IFN-γ level was quantified by ELISA.
    RESULTS: After receiving treatment with CPT combination, there was a highly significant increase in IFN- γ levels in the sera of patients when compared to basal line control samples. Additionally, the group receiving combined therapy demonstrated a downregulation in the expression levels of PD-1, in MNLs as compared to controls. MNLs\' immunophenotyping revealed a significant decline in CD4+CD25+cells (regulatory T lymphocytes). Furthermore, clinicopathological characteristics revealed a highly significant impact of CPT combination on aspartate aminotransferase (AST), lactate dehydrogenase (LDH) and alpha feto protein (AFP) levels.
    CONCLUSIONS: This study introduces a promising adjuvant CPT combined treatment as natural agents to enhance the management of HCC patients who are candidates to TACE treatment.
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  • 文章类型: Multicenter Study
    乙型肝炎表面抗原(HBsAg)清除与改善长期预后和降低并发症风险相关。我们研究的目的是确定HBsAg水平在肝癌患者TACE和序贯消融的影响。此外,我们创建了一个列线图来预测局部治疗后HBsAg水平高(≥1000U/L)的HCC患者的预后。
    本研究回顾性评估了2014年1月至2021年12月在北京佑安医院和北京地坛医院行TACE联合消融的1008例HBV-HCC患者,其中HBsAg水平较低的患者334例,HBsAg水平较高的患者674例。高HBsAg组分为训练队列(N=385),内部验证队列(N=168),和外部验证队列(N=121)。收集患者的临床病理特征,并使用Lasso-Cox回归分析确定独立危险因素,以建立列线图.通过C指数评估列线图的性能,接收机工作特性(ROC)曲线,校正曲线,以及训练和验证队列中的决策曲线分析(DCA)曲线。根据列线图的风险评分将患者分为高风险和低风险组。
    PSM后,在低HBsAg水平和高HBsAg水平组中,mRFS为28.4个月(22.1-34.7个月)和21.9个月(18.5-25.4个月)(P<0.001)。列线图的内容包括年龄,BCLC阶段,肿瘤大小,球蛋白,GGT,和胆汁酸。C指数(0.682、0.666和0.740)和1-,3-,和5年的AUC培训,内部验证,和外部验证队列证明了对列线图的良好区分。校准曲线和DCA曲线表明准确性和净临床获益率。列线图能够根据复发风险将高HBsAg水平的患者分为低风险和高风险组。训练中两组间的RFS差异有统计学意义,内部验证,和外部验证队列(P<0.001)。
    高水平的HBsAg与肿瘤进展相关。在研究中开发和验证的列线图对高HBsAg水平的患者具有良好的预测能力。
    Hepatitis B surface antigen (HBsAg) clearance is associated with improved long-term outcomes and reduced risk of complications. The aim of our study was to identify the effects of levels of HBsAg in HCC patients undergoing TACE and sequential ablation. In addition, we created a nomogram to predict the prognosis of HCC patients with high levels of HBsAg (≥1000U/L) after local treatment.
    This study retrospectively evaluated 1008 HBV-HCC patients who underwent TACE combined with ablation at Beijing Youan Hospital and Beijing Ditan Hospital from January 2014 to December 2021, including 334 patients with low HBsAg levels and 674 patients with high HBsAg levels. The high HBsAg group was divided into the training cohort (N=385), internal validation cohort (N=168), and external validation cohort (N=121). The clinical and pathological features of patients were collected, and independent risk factors were identified using Lasso-Cox regression analysis for developing a nomogram. The performance of the nomogram was evaluated by C-index, receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA) curves in the training and validation cohorts. Patients were classified into high-risk and low-risk groups based on the risk scores of the nomogram.
    After PSM, mRFS was 28.4 months (22.1-34.7 months) and 21.9 months (18.5-25.4 months) in the low HBsAg level and high HBsAg level groups (P<0.001). The content of the nomogram includes age, BCLC stage, tumor size, globulin, GGT, and bile acids. The C-index (0.682, 0.666, and 0.740) and 1-, 3-, and 5-year AUCs of the training, internal validation, and external validation cohorts proved good discrimination of the nomogram. Calibration curves and DCA curves suggested accuracy and net clinical benefit rates. The nomogram enabled to classification of patients with high HBsAg levels into low-risk and high-risk groups according to the risk of recurrence. There was a statistically significant difference in RFS between the two groups in the training, internal validation, and external validation cohorts (P<0.001).
    High levels of HBsAg were associated with tumor progression. The nomogram developed and validated in the study had good predictive ability for patients with high HBsAg levels.
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  • 文章类型: Journal Article
    目的:探讨经肝动脉化疗栓塞术(TACE)联合免疫检查点抑制剂(ICIs)和酪氨酸激酶抑制剂(TKIs)治疗不可切除肝细胞癌(uHCC)的疗效和安全性。
    方法:456例HCC患者接受TACE联合ICIs和TKIs(联合组,n=139)或TACE单药治疗(单药治疗组,n=317)从2016年4月至2021年12月被纳入这项回顾性研究。我们采用倾向得分匹配(PSM),执行1:2最佳配对匹配,来平衡潜在的偏差。
    结果:截至2022年3月,匹配患者的平均随访时间为24.7个月(95%CI22.6-26.8)。匹配后,联合组实现了更长的OS和PFS(中位OS:21.9vs.16.3个月,P=0.022;PFS中位数:8.3vs.5.1个月,P<0.0001)优于TACE单药治疗组。联合组的客观缓解率(ORR)和疾病控制率(DCR)更好(ORR:52.5%vs.32.8%,P<0.001;DCR:82.7%vs.59.6%,P<0.001)。亚组分析显示,在第一次TACE手术后(TACE组之后)接受“TKIs+ICIs”的患者比第一次TACE手术前(TACE组之前)获得更长的OS(26.8vs.19.2个月,P=0.011)。不良事件与以前的TACE相关试验研究一致。
    结论:TACE加TKIs和ICIs似乎比TACE单一疗法在HCC患者中提供更长的PFS和OS。首次TACE手术后3个月内的“TKIs+ICIs”联合治疗可能是更好的用药策略。
    OBJECTIVE: To explore the efficacy and safety of Transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKIs) in patients with unresectable hepatocellular carcinoma (uHCC).
    METHODS: 456 patients with HCC receiving either TACE in combination with ICIs and TKIs (combination group, n = 139) or TACE monotherapy (monotherapy group, n = 317) were included from Apr 2016 to Dec 2021 in this retrospective study. We employed propensity score matching (PSM), performed 1:2 optimal pair matching, to balance potential bias.
    RESULTS: The mean follow-up time is 24.7 months (95% CI 22.6-26.8) for matched patients as of March 2022. After matching, the combination group achieved longer OS and PFS (median OS:21.9 vs. 16.3 months, P = 0.022; median PFS: 8.3 vs. 5.1 months, P < 0.0001) than TACE monotherapy group. The combination group had better objective response rate (ORR) and disease control rate (DCR) (ORR: 52.5% vs. 32.8%, P < 0.001; DCR: 82.7% vs. 59.6%, P < 0.001). Subgroup analysis showed that patients who received \"TKIs + ICIs\" after the first TACE procedure (after TACE group) achieved longer OS than those before the first TACE procedure (before TACE group) (26.8 vs. 19.2 months, P = 0.011). Adverse events were consistent with previous studies of TACE-related trials.
    CONCLUSIONS: TACE plus TKIs and ICIs appeared to deliver longer PFS and OS in HCC patients than TACE monotherapy. \"TKIs + ICIs\" co-treatment within 3 months after the first TACE procedure might be a better medication strategy.
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  • 文章类型: Multicenter Study
    目的:全身化疗(SYS)是不可切除的肝内胆管癌(ICC)的一线治疗方法。然而,SYS的生存优势仍然有限。这项研究比较了经肝动脉化疗栓塞(TACE)加SYS与单独SYS治疗的不可切除ICC患者的疗效和安全性。
    方法:多中心回顾性队列研究纳入年龄≥18岁且病理诊断为ICC的患者。患有无法测量的病变的患者,未接受SYS处理,Child-PughC级,东部肿瘤协作组表现状态得3分或更高,先前的肝切除术,不完整的医疗信息,或首次SYS治疗的终止被排除.数据收集主要来自医院系统,并通过随访获得患者的生存结局。使用Kaplan-Meier方法估计总生存期(OS),并使用对数秩检验进行比较。使用最近邻匹配算法以1:1的比率进行倾向评分匹配,以减少TACE加SYS和SYS单独组之间的选择偏差。Cox比例风险模型用于确定与OS相关的预后因素并估计其风险比。使用实体肿瘤标准中的修改的反应评估标准来评估肿瘤对治疗的反应。
    结果:在2016年6月至2023年2月之间,本研究纳入了来自三家医院的118名不可切除的ICC患者。其中,TACE加SYS组37例,SYS单独组81例。联合组的中位OS为11.3个月,比单独SYS组的6.4个月长(P=0.011)。联合组的客观反应率(ORR)和疾病控制率(DCR)比单独SYS组(ORR,48.65vs.6.17%,P<0.001;DCR,89.19vs.62.96%,P=0.004)。配对后每组16例,并且匹配的结果在OS和肿瘤反应方面保持一致。匹配后两组不良事件(AE)相似。
    结论:与单独的SYS相比,在改进操作系统方面,TACE加SYS的组合处理比单一SYS更有效,ORR,和DCR,AE没有任何显著增加。TACE加SYS可能是不可切除ICC患者的可行治疗选择。
    OBJECTIVE: Systemic chemotherapy (SYS) is the first-line treatment of unresectable intrahepatic cholangiocarcinoma (ICC). However, the survival benefit of SYS is still limited. This study compared the efficacy and safety of patients with unresectable ICC treated with transarterial chemoembolization (TACE) plus SYS to SYS alone.
    METHODS: The multicenter retrospective cohort study included patients aged ≥ 18 years old with pathologically diagnosed ICC. Patients with unmeasurable lesions, not receiving SYS treatment, Child-Pugh grade C, Eastern Cooperative Oncology Group performance status score of 3 or higher, prior liver resection, incomplete medical information, or discontinuation of the first SYS treatment were excluded. Data collection was mainly from the hospital system, and the survival outcome of patients was obtained through follow-up. Overall survival (OS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Propensity score matching at a 1:1 ratio using the nearest neighbor matching algorithm was performed to reduce selection bias between the TACE plus SYS and SYS alone groups. The Cox proportional hazards model was used to identify prognostic factors associated with OS and to estimate their hazard ratios. Modified Response Evaluation Criteria in Solid Tumors criteria were utilized to evaluate the response of tumors to therapy.
    RESULTS: Between June 2016 and February 2023, 118 unresectable ICC patients from three hospitals were included in this study. Of them, 37 were in the TACE plus SYS group and 81 were in the SYS alone group. The median OS in the combination group was 11.3 months, longer than the 6.4 months in the SYS alone group (P = 0.011). A greater objective response rate (ORR) and disease control rate (DCR) were observed in the combination group than in the SYS alone group (ORR, 48.65 vs. 6.17%, P < 0.001; DCR, 89.19 vs. 62.96%, P = 0.004). There were 16 patients in each group after matching, and the matched results remained consistent regarding OS and tumor response. Adverse events (AEs) were similar in the two groups after matching.
    CONCLUSIONS: Compared to SYS alone, the combination treatment of TACE plus SYS was more effective than SYS alone in improving OS, ORR, and DCR without any significant increase in AEs. TACE plus SYS may be a viable treatment option for patients with unresectable ICC.
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  • 文章类型: Journal Article
    背景:我们进行了荟萃分析和试验序贯分析(TSA),以比较以下肝细胞癌(HCC)患者治疗策略之间的疗效和不良事件(AE):TACE加酪氨酸激酶抑制剂(TKIs)和免疫检查点抑制剂(ICIs)(TACETI)与TACE加TKIs(TACET)。
    方法:我们系统地搜索了PubMed,WebofScience,Cochrane图书馆,和Embase用于比较TACE+T+I和TACE+T治疗BCLC中期或晚期HCC的研究。客观反应率(ORR),无进展生存期(PFS),总生存期(OS),和AE作为结果。我们使用基于异质性评估结果的固定或随机效应模型,并使用ReviewManager5.3和Stata16.0进行荟萃分析。然后我们执行了TSA。
    结果:这项研究共纳入了5项研究,共检查了425名患者。我们的荟萃分析显示,与TACE+T相比,TACE+T+I显著提高了ORR(风险比[RR]=1.53,95%置信区间[CI]=1.27-1.85,p<0.01),延长了中位PFS(平均差[MD]=4.51个月,95%CI=2.16-6.87,p<0.01)和中位OS(MD=5.75个月,95%CI=4.03-7.48,p<0.01)。TSA测试了这些结果是真实的,而不需要更大的信息大小。在AE中,与接受TACE+T治疗的患者相比,接受TACE+T+I治疗的患者更易发生高血压(RR=1.58,95%CI=1.05~2.40,p<0.05).然而,TSA建议需要更多病例来确认这一差异.关于其他AE,两组间无显著差异.
    结论:TACE+T+I对ORR有较好的疗效,PFS,和OS比TACE+T作为BCLCB期和C期HCC的治疗,不良事件没有明显增加。基于这些发现,精心设计,建议进行大型RCT。
    BACKGROUND: We conducted a meta-analysis and trial sequential analysis (TSA) to compare the therapeutic efficacy and adverse events (AEs) between the following treatment strategies for patients with hepatocellular carcinoma (HCC): TACE plus tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors (ICIs) (TACE + T + I) versus TACE plus TKIs (TACE + T).
    METHODS: We systematically searched PubMed, the Web of Science, the Cochrane Library, and Embase for studies comparing TACE + T + I and TACE + T for the treatment of BCLC intermediate- or advanced-stage HCC. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and AEs were included as outcomes. We used a fixed- or random-effects model based on the results of a heterogeneity evaluation and performed a meta-analysis using Review Manager 5.3 and Stata 16.0. We then carried out the TSA.
    RESULTS: Five studies examining a total of 425 patients were included in this study. Our meta-analysis revealed that, compared to TACE + T, TACE + T + I significantly improved the ORR (risk ratio [RR] = 1.53, 95% confidence interval [CI] = 1.27-1.85, p < 0.01) and extended both the median PFS (mean difference [MD] = 4.51 months, 95% CI = 2.16-6.87, p < 0.01) and median OS (MD = 5.75 months, 95% CI = 4.03-7.48, p < 0.01). These results were tested to be true by the TSA without requiring a larger information size. Among AEs, hypertension tended to occur more often in patients treated with TACE + T + I than in those treated with TACE + T (RR = 1.58, 95% CI = 1.05-2.40, p < 0.05). However, the TSA suggested that additional cases are necessary to confirm this difference. Regarding the other AEs, no significant differences were detected between the two groups.
    CONCLUSIONS: TACE + T + I showed better effects on the ORR, PFS, and OS than TACE + T as a treatment for BCLC stages B and C HCC, without an obvious increase in the AEs. Based on these findings, well-designed, large RCTs are suggested.
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  • 文章类型: Journal Article
    本研究旨在探讨经导管动脉化疗栓塞(TACE)联合阿帕替尼和卡姆瑞珠单抗治疗不可切除的晚期胃或胃食管交界处(G/GEJ)癌症的疗效和安全性。
    在这项研究中,我们评估了2018年8月至2021年12月接受TACE联合阿帕替尼和卡姆瑞珠单抗治疗的不可切除的晚期G/GEJ癌症患者的数据.在TACE之后,患者每3周静脉注射卡利珠单抗200mg,口服阿帕替尼250mg/天治疗.主要终点是总生存期(OS),次要终点是客观反应率(ORR),疾病控制率(DCR),和不良事件(AE)。
    本研究共纳入49例患者。中位随访时间为14.0个月,中位OS为20.0个月(95%CI=13.6-26.4)。2例(4.08%)完全缓解,28例(57.14%)部分缓解,18例(36.73%)病情稳定,1例患者(2.04%)出现疾病进展。ORR为61.22%,DCR为97.96%。多因素Cox回归分析显示,年龄(HR4.74,95%CI=1.674~13.440,P=0.003)和多远处转移(HR20.916,95%CI=4.094~106.808,P=0.001)是OS的独立危险因素。大多数不良事件被分类为1-2级,最常见的是RCCEP(69.39%)。3~4级不良事件5例(10.20%)。没有患者因不良事件而停止或减少治疗剂量,所有患者均接受对症治疗。
    TACE联合阿帕替尼和卡瑞珠单抗是不可切除的晚期G/GEJ癌症患者的安全有效的治疗选择,能显著改善患者的中位OS和ORR。不良事件(AE)是可以容忍和可控的。
    UNASSIGNED: This study aims to investigate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with Apatinib and Camrelizumab for treating unresectable advanced gastric or gastroesophageal junction (G/GEJ) cancer.
    UNASSIGNED: In this study, data of patients with unresectable advanced G/GEJ cancer who received TACE combined with Apatinib and Camrelizumab from August 2018 to December 2021 was evaluated. After TACE, patients were given intravenous Camrelizumab 200mg every three weeks and oral apatinib 250mg/day for treatment. The primary endpoint was overall survival (OS), and the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).
    UNASSIGNED: A total of 49 patients were enrolled in this study. The median follow-up time was 14.0 months, and the median OS was 20.0 months (95% CI = 13.6-26.4). Two patients (4.08%) achieved complete remission, 28 patients (57.14%) achieved partial remission, 18 patients (36.73%) had stable disease, and 1 patient (2.04%) had disease progression. The ORR was 61.22%, and the DCR was 97.96%. Multivariate Cox regression analysis indicated that age (HR 4.74, 95% CI = 1.674-13.440, P=0.003) and multiple distant metastases (HR 20.916, 95% CI = 4.094-106.808, P = 0.001) were independent risk factors for OS. Most AEs were classified as grade 1-2, the most common being RCCEP (69.39%). There were 5 cases of grade 3-4 adverse events (10.20%). No patients discontinued or reduced the treatment dose due to AEs, and all patients received symptomatic treatment.
    UNASSIGNED: TACE combined with Apatinib and Camrelizumab is a safe and effective therapeutic option for patients with unresectable advanced G/GEJ cancer, which can significantly improve the median OS and ORR of patients. And the adverse events (AEs) are tolerable and manageable.
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  • 文章类型: Journal Article
    TACE和有或没有靶向免疫治疗的TACE是中晚期HCC的关键综合疗法。然而,评估TACE和TACE联合全身治疗在HCC治疗中的应用需要合理和简洁的评分。
    将HCC患者分为两组:训练组(n=778)(接受TACE治疗)和验证组(n=333)。采用COX模型分析基线变量对总生存期的预测价值,和易于使用的ALR(AST和Lym-R)分数。使用X-Tile软件基于总生存时间(OS)确定AST和Lym-R的最佳截止值,并通过有限的三次样条方法进一步验证。同时,使用两个独立的有效组进一步验证了评分:TACE联合靶向治疗和TACE联合靶向联合免疫治疗.
    在多变量分析中,基线血清AST>57.1(p<0.001)和Lym-R≤21.7(p<0.001)为独立预后因素.TACE合并队列中0、1和2分患者的OS为28.1(95%CI24-33.8)个月,15个月(95%CI12.4-18.6),和7.4(95%CI5.7-9.1)个月,分别。基于ALR的时变ROC曲线显示,预测1年、-2年和3年OS的AUC值分别为0.698、0.718和0.636。这些结果在两个独立有效的TACE联合靶向治疗和TACE联合靶向联合免疫疗法中得到证实。我们建立了COX回归后的列线图来预测1-,2年和3年的生存时间。
    我们的研究证实,ALR评分可以预测TACE或TACE联合全身治疗的HCC的预后。
    UNASSIGNED: TACE and TACE with or without targeted immunotherapy are crucial comprehensive therapies for middle and advanced HCC. However, a reasonable and concise score is needed to evaluate TACE and TACE combined with systemic therapy in HCC treatment.
    UNASSIGNED: The HCC patients were grouped into two groups: training group (n = 778) (treated with TACE) and verification group (n = 333). The predictive value of baseline variables on overall survival was analyzed using COX model, and easy-to-use ALR (AST and Lym-R) scores. The best cut-off value of AST and Lym-R were determined using X-Tile software based on total survival time (OS) and further verified via a restricted three-spline method. Meanwhile, the score was further verified using two independent valid sets: TACE combined with targeted therapy and TACE with targeted combined immunotherapy.
    UNASSIGNED: In multivariate analysis, baseline serum AST>57.1 (p < 0.001) and Lym-R≤21.7 (p < 0.001) were identified as independent prognostic factors. The OS of patients in the TACE pooled cohort with 0, 1, and 2 scores were 28.1 (95% CI 24-33.8) months, 15 (95% CI 12.4-18.6) months, and 7.4 (95% CI 5.7-9.1) months, respectively. The time-varying ROC curve based on ALR showed that the AUC values for predicting 1, -2-and 3-year OS were 0.698, 0.718, and 0.636, respectively. These results are confirmed in two independent valid sets of TACE combined with targeted therapy and TACE with targeted combined immunotherapy. And we established a nomogram after COX regression to predict the 1 -, 2- and 3-year survival time.
    UNASSIGNED: Our study confirmed that ALR score can predict the prognosis of HCC treated with TACE or TACE combined with systemic therapy.
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  • 文章类型: Journal Article
    背景:中期肝细胞癌(HCC)患者的有效列线图可预测总生存期(OS)。本研究旨在探讨年龄-男性-白蛋白-胆红素-血小板(aMAP)评分在中期HCC患者预后中的作用,并开发基于aMAP评分的列线图来预测OS。方法:回顾性收集2007年1月至2012年5月中山大学肿瘤防治中心初诊中晚期肝癌患者的临床资料。通过多因素分析选择影响预后的独立危险因素。使用X-tile确定aMAP评分的最佳截止值。生存预后模型由列线图呈现。结果:对于875例中期肝癌患者,中位OS为22.2个月(95%CI19.6~25.1).根据X-tile图将患者分为三组(aMAP评分<49.42;49.42≤aMAP评分<56;aMAP评分≥56)。甲胎蛋白,乳酸脱氢酶,MAP得分,主要肿瘤直径,肝内病变的数量,治疗方案是影响预后的独立危险因素。在训练组中构建了C指数为0.70(95%CI:0.68-0.72)的预测模型,和它的1-,3-,和5年接受者工作曲线下的面积分别为:0.75,0.73和0.72。C指数的验证组为0.82。校准图显示实际和预测存活率之间的良好一致性。决策曲线分析表明该模型的临床实用性,这可以帮助临床医生指导临床决策。结论:aMAP评分是中晚期HCC的独立危险因素。基于aMAP得分的列线图具有良好的区分度,校准,和临床效用。
    Background: A less effective nomogram for patients with intermediate-stage hepatocellular carcinoma (HCC) to predict overall survival (OS) is available. This study aimed to investigate the role of age-male-albumin-bilirubin-platelet (aMAP) scores in the prognosis of patients with intermediate-stage HCC and develop an aMAP score-based nomogram to predict OS. Methods: Data on newly diagnosed intermediate-stage patients with HCC at Sun Yat-sen University Cancer Center between January 2007 and May 2012 were retrospectively collected. Independent risk factors affecting prognosis were selected by multivariate analyses. The optimal cut-off value for the aMAP score was determined using X-tile. The survival prognostic models were presented by the nomogram. Results: For the 875 patients with intermediate-stage HCC included, the median OS was 22.2 months (95% CI 19.6-25.1). Patients were classified into three groups by X-tile plots (aMAP score < 49.42; 49.42 ≤ aMAP score < 56; aMAP score ≥ 56). Alpha-fetoprotein, lactate dehydrogenase, aMAP score, diameter of main tumor, number of intrahepatic lesions, and treatment regimen were independent risk factors for prognosis. A predicted model was constructed with a C-index of 0.70 (95% CI: 0.68-0.72) in the training goup, and its 1-, 3-, and 5-year area under the receiver operating curve were: 0.75, 0.73, and 0.72. The validation group of the C-index is 0.82. Calibration graphs showed good consistency between the actual and predicted survival rates. The decision curve analysis suggested the clinical utility of the model, which may help clinicians guide clinical decision-making. Conclusion: The aMAP score was an independent risk factor for intermediate-stage HCC. The aMAP score-based nomogram has good discrimination, calibration, and clinical utility.
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