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本文引用的文献

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Efficacy, effectiveness, and comparative effectiveness in liver disease.肝病中的疗效、有效性及比较效果
Hepatology. 2010 Aug;52(2):403-7. doi: 10.1002/hep.23819.
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On the limitations of comparative effectiveness research.论比较效果研究的局限性。
Stat Med. 2010 Aug 30;29(19):1991-5; discussion 1996-7. doi: 10.1002/sim.3960.
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What is evidence?什么是证据?
Stat Med. 2010 Aug 30;29(19):1985-8; discussion 1996-7. doi: 10.1002/sim.3933.
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Hepatocellular carcinoma: consensus recommendations of the National Cancer Institute Clinical Trials Planning Meeting.肝细胞癌:美国国家癌症研究所临床试验计划会议的共识建议。
J Clin Oncol. 2010 Sep 1;28(25):3994-4005. doi: 10.1200/JCO.2010.28.7805. Epub 2010 Aug 2.
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Comparative effectiveness research: Policy context, methods development and research infrastructure.比较疗效研究:政策背景、方法发展与研究基础设施。
Stat Med. 2010 Aug 30;29(19):1963-76. doi: 10.1002/sim.3818.
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Chemoembolization for hepatocellular carcinoma: comprehensive imaging and survival analysis in a 172-patient cohort.肝癌的化疗栓塞治疗:172 例患者队列的综合影像学和生存分析。
Radiology. 2010 Jun;255(3):955-65. doi: 10.1148/radiol.10091473.
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Imaging response in the primary index lesion and clinical outcomes following transarterial locoregional therapy for hepatocellular carcinoma.经肝动脉区域性治疗原发性肝癌的影像反应与临床结果。
JAMA. 2010 Mar 17;303(11):1062-9. doi: 10.1001/jama.2010.262.
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Charting a path from comparative effectiveness funding to improved patient-centered health care.绘制一条从比较疗效研究资金到以患者为中心的医疗保健改善的路径。
JAMA. 2010 Mar 10;303(10):985-6. doi: 10.1001/jama.2010.259.
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A retrospective comparative analysis of the effect of Y90-radioembolization on the survival of patients with unresectable hepatocellular carcinoma.Y90放射性栓塞对不可切除肝细胞癌患者生存率影响的回顾性对比分析
Hepatogastroenterology. 2009 Nov-Dec;56(96):1683-8.
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Therapeutic equivalence in survival for hepatic arterial chemoembolization and yttrium 90 microsphere treatments in unresectable hepatocellular carcinoma: a two-cohort study.不可切除肝细胞癌的肝动脉化疗栓塞和钇 90 微球治疗的生存治疗等效性:一项两队列研究。
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与化疗栓塞相比,放射性栓塞可使肝癌患者的疾病进展时间延长且毒性降低。

Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma.

机构信息

Department of Radiology, Section of Interventional Radiology and Division of Interventional Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, USA.

出版信息

Gastroenterology. 2011 Feb;140(2):497-507.e2. doi: 10.1053/j.gastro.2010.10.049. Epub 2010 Oct 30.

DOI:10.1053/j.gastro.2010.10.049
PMID:21044630
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3129335/
Abstract

BACKGROUND & AIMS: Chemoembolization is one of several standards of care treatment for hepatocellular carcinoma (HCC). Radioembolization with Yttrium-90 microspheres is a novel, transarterial approach to radiation therapy. We performed a comparative effectiveness analysis of these therapies in patients with HCC.

METHODS

We collected data from 463 patients who were treated with transarterial locoregional therapies (chemoembolization or radioembolization) over a 9-year period. We excluded patients who were not appropriate for comparison and analyzed data from 245 (122 who received chemoembolization and 123 who received radioembolization). Patients were followed for signs of toxicity; all underwent imaging analysis at baseline and follow-up time points. Overall survival was the primary outcome measure. Secondary outcomes included safety, response rate, and time-to-progression. Uni- and multivariate analyses were performed.

RESULTS

Abdominal pain and increased transaminase activity were more frequent following chemoembolization (P < .05). There was a trend that patients treated with radioembolization had a higher response rate than with chemoembolization (49% vs 36%, respectively, P = .104). Although time-to-progression was longer following radioembolization than chemoembolization (13.3 months vs 8.4 months, respectively, P = .046), median survival times were not statistically different (20.5 months vs 17.4 months, respectively, P = .232). Among patients with intermediate-stage disease, survival was similar between groups that received chemoembolization (17.5 months) and radioembolization (17.2 months, P = .42).

CONCLUSIONS

Patients with HCC treated by chemoembolization or radioembolization with Yttrium-90 microspheres had similar survival times. Radioembolization resulted in longer time-to-progression and less toxicity than chemoembolization. Post hoc analyses of sample size indicated that a randomized study with > 1000 patients would be required to establish equivalence of survival times between patients treated with these two therapies.

摘要

背景与目的

化疗栓塞是治疗肝细胞癌 (HCC) 的几种标准治疗方法之一。钇-90 微球放射栓塞是一种新型的经动脉放射治疗方法。我们对这些治疗方法在 HCC 患者中的疗效进行了比较分析。

方法

我们收集了 463 例在 9 年内接受经动脉局部区域治疗(化疗栓塞或放射栓塞)的患者的数据。我们排除了不适合比较的患者,并对 245 例患者的数据进行了分析(化疗栓塞 122 例,放射栓塞 123 例)。患者随访观察毒性迹象;所有患者均在基线和随访时间点进行影像学分析。总生存期是主要观察终点。次要终点包括安全性、缓解率和无进展生存期。进行了单因素和多因素分析。

结果

化疗栓塞后更常出现腹痛和转氨酶活性升高(P <.05)。放射栓塞治疗的患者缓解率高于化疗栓塞(分别为 49%和 36%,P =.104),这一趋势具有统计学意义。虽然放射栓塞后无进展生存期长于化疗栓塞(分别为 13.3 个月和 8.4 个月,P =.046),但中位生存时间无统计学差异(分别为 20.5 个月和 17.4 个月,P =.232)。在中间期疾病患者中,接受化疗栓塞(17.5 个月)和放射栓塞(17.2 个月,P =.42)的两组患者生存时间相似。

结论

接受化疗栓塞或钇-90 微球放射栓塞治疗的 HCC 患者的生存时间相似。放射栓塞的无进展生存期长于化疗栓塞,毒性低于化疗栓塞。基于样本量的事后分析表明,需要进行超过 1000 例患者的随机研究,才能确定这两种治疗方法的患者生存时间是否等效。