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本文引用的文献

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Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial.regorafenib 用于索拉非尼治疗后进展的肝细胞癌患者(RESORCE):一项随机、双盲、安慰剂对照、3 期试验。
Lancet. 2017 Jan 7;389(10064):56-66. doi: 10.1016/S0140-6736(16)32453-9. Epub 2016 Dec 6.
2
Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial.索拉非尼辅助治疗肝细胞癌切除术后或消融后(STORM):一项 3 期、随机、双盲、安慰剂对照试验。
Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.
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Does race affect management and survival in hepatocellular carcinoma in the United States?在美国,种族会影响肝细胞癌的治疗及生存率吗?
Surgery. 2015 Nov;158(5):1244-51. doi: 10.1016/j.surg.2015.03.026. Epub 2015 May 6.
4
Sorafenib treatment in Child-Pugh A and B patients with advanced hepatocellular carcinoma: safety, efficacy and prognostic factors.索拉非尼治疗Child-Pugh A级和B级晚期肝细胞癌患者:安全性、疗效及预后因素
Invest New Drugs. 2015 Jun;33(3):729-39. doi: 10.1007/s10637-015-0237-3. Epub 2015 Apr 12.
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Safety and efficacy of sorafenib in patients with advanced hepatocellular carcinoma and Child-Pugh A or B cirrhosis.索拉非尼在晚期肝细胞癌合并Child-Pugh A或B级肝硬化患者中的安全性和疗效。
Oncol Lett. 2015 Apr;9(4):1628-1632. doi: 10.3892/ol.2015.2960. Epub 2015 Feb 12.
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Emerging trends in hepatocellular carcinoma: focus on diagnosis and therapeutics.肝细胞癌的新趋势:聚焦于诊断与治疗
Clin Med Insights Oncol. 2014 May 19;8:71-6. doi: 10.4137/CMO.S9926. eCollection 2014.
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Poor adherence to AASLD guidelines for chronic hepatitis B Management and treatment in a large academic medical center.在大型学术医疗中心,慢性乙型肝炎管理和治疗中对 AASLD 指南的依从性较差。
Am J Gastroenterol. 2014 Jun;109(6):867-75. doi: 10.1038/ajg.2014.72. Epub 2014 Apr 15.
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Racial disparity and their impact on hepatocellular cancer outcomes in inner-city New Orleans.美国新奥尔良市市中心的种族差异及其对肝细胞癌结果的影响。
Surgery. 2012 Oct;152(4):661-6; discussion 666-7. doi: 10.1016/j.surg.2012.07.008. Epub 2012 Aug 28.
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The use of single-agent sorafenib in the treatment of advanced hepatocellular carcinoma patients with underlying Child-Pugh B liver cirrhosis: a retrospective analysis of efficacy, safety, and survival benefits.索拉非尼单药治疗伴有基础 Child-Pugh B 级肝硬化的晚期肝细胞癌患者:疗效、安全性和生存获益的回顾性分析。
Cancer. 2012 Nov 1;118(21):5293-301. doi: 10.1002/cncr.27543. Epub 2012 Apr 19.
10
EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma.欧洲肝脏研究学会-欧洲肿瘤内科学会临床实践指南:肝细胞癌的管理
J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001.

索拉非尼在美国肿瘤学实践中用于治疗晚期肝细胞癌的应用情况。

Adoption of Sorafenib for the Treatment of Advanced-Stage Hepatocellular Carcinoma in Oncology Practices in the United States.

作者信息

Parsons Helen M, Chu Quyen, Karlitz Jordan J, Stevens Jennifer L, Harlan Linda C

机构信息

Division of Health Policy and Management, University of Minnesota, Minneapolis, MN.

LSU-Health Sciences Center-Shreveport, Shreveport, LA, USA.

出版信息

Liver Cancer. 2017 Jun;6(3):216-226. doi: 10.1159/000473862. Epub 2017 Apr 28.

DOI:10.1159/000473862
PMID:29234628
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5704716/
Abstract

BACKGROUND

The adoption of sorafenib into oncology practice as a first-line systemic treatment for advanced hepatocellular carcinoma (HCC) is not well understood. We examined sorafenib use since Food and Drug Administration (FDA) approval in 2007 and associated survival for individuals diagnosed with advanced HCC, conducting a population-based evaluation of treatment patterns and outcomes for this newly approved drug in the US over time.

METHODS

We identified individuals diagnosed with Barcelona Clinic Liver Cancer Stage C from the 2007 and 2012 National Cancer Institute Patterns of Care study. We examined trends in use as well as patient and clinical factors associated with receiving sorafenib using multivariate logistic regression analysis. We then evaluated the association between sorafenib use and overall hazard of death using multivariate Cox proportional hazards regression.

RESULTS

Among 550 individuals diagnosed with advanced HCC, we found no significant increase in the proportion of patients treated with sorafenib from 2007 to 2012 (26.3 vs. 30.4%). After adjusting for patient and clinical characteristics, non-Hispanic Blacks (compared to non-Hispanic Whites) and those with a lower Child-Pugh score remained more likely to receive sorafenib. Individuals receiving systemic chemotherapy only, radiation therapy only, or no treatment at all experienced a higher risk of death than those treated with sorafenib, while those receiving a transplant experienced a lower risk of death.

CONCLUSIONS

Sorafenib has not been widely adopted into oncology practice since FDA approval for advanced HCC. Few factors apart from Child-Pugh score and race/ethnicity predict sorafenib use in clinical practice, although sorafenib treatment is associated with a lower risk of death.

摘要

背景

索拉非尼作为晚期肝细胞癌(HCC)的一线全身治疗药物应用于肿瘤学实践的情况尚未得到充分了解。我们研究了自2007年美国食品药品监督管理局(FDA)批准索拉非尼以来其使用情况以及确诊为晚期HCC患者的相关生存率,对美国这种新批准药物的治疗模式和结果进行了基于人群的长期评估。

方法

我们从2007年和2012年美国国立癌症研究所的护理模式研究中确定了被诊断为巴塞罗那临床肝癌C期的患者。我们使用多因素逻辑回归分析研究了索拉非尼使用趋势以及与接受索拉非尼相关的患者和临床因素。然后,我们使用多因素Cox比例风险回归评估索拉非尼使用与总体死亡风险之间的关联。

结果

在550例确诊为晚期HCC的患者中,我们发现2007年至2012年接受索拉非尼治疗的患者比例没有显著增加(26.3%对30.4%)。在调整患者和临床特征后,非西班牙裔黑人(与非西班牙裔白人相比)以及Child-Pugh评分较低的患者接受索拉非尼治疗的可能性仍然更高。仅接受全身化疗、仅接受放射治疗或未接受任何治疗的患者死亡风险高于接受索拉非尼治疗的患者,而接受移植的患者死亡风险较低。

结论

自FDA批准用于晚期HCC以来,索拉非尼尚未广泛应用于肿瘤学实践。除了Child-Pugh评分和种族/民族外,很少有因素能预测索拉非尼在临床实践中的使用情况,尽管索拉非尼治疗与较低的死亡风险相关。