直接作用抗病毒治疗与多中心北美队列研究中肝细胞癌的复发无关。
Direct-Acting Antiviral Therapy Not Associated With Recurrence of Hepatocellular Carcinoma in a Multicenter North American Cohort Study.
机构信息
Division of Digestive and Liver Disease, UT Southwestern Medical Center, Dallas, Texas.
Division of Digestive and Liver Disease, UT Southwestern Medical Center, Dallas, Texas.
出版信息
Gastroenterology. 2019 May;156(6):1683-1692.e1. doi: 10.1053/j.gastro.2019.01.027. Epub 2019 Jan 18.
BACKGROUND & AIMS: There is controversy over the effects of direct-acting antiviral (DAA) therapies for hepatitis C virus (HCV) infection on hepatocellular carcinoma (HCC) recurrence and tumor aggressiveness. We compared HCC recurrence patterns between DAA-treated and untreated HCV-infected patients who had achieved a complete response to HCC treatment in a North American cohort.
METHODS
We conducted a retrospective cohort study of patients with HCV-related HCC with a complete response to resection, local ablation, transarterial chemo- or radioembolization, or radiation therapy from January 2013 through December 2017 at 31 health systems throughout the United States and Canada. Cox regression was used to examine the association between DAA therapy and time to recurrence after a complete response, with DAA therapy analyzed as a time-varying exposure. We also estimated the association between DAA therapy and risk of early HCC recurrence (defined as 365 days after complete response).
RESULTS
Of 793 patients with HCV-associated HCC, 304 (38.3%) received DAA therapy and 489 (61.7%) were untreated. HCC recurred in 128 DAA-treated patients (42.1%; early recurrence in 52 patients) and 288 untreated patients (58.9%; early recurrence in 227 patients). DAA therapy was not associated with HCC recurrence (hazard ratio 0.90, 95% confidence interval 0.70-1.16) or early HCC recurrence (hazard ratio 0.96, 95% confidence interval 0.70-1.34) after we adjusted for study site, age, sex, Child-Pugh score, α-fetoprotein level, tumor burden, and HCC treatment modality. In DAA-treated and untreated patients, most recurrences were within the Milan criteria (74.2% vs 78.8%; P = .23). A larger proportion of DAA-treated than untreated patients received potentially curative HCC therapy for recurrent HCC (32.0% vs 24.6%) and achieved a complete or partial response (45.3% vs 41.0%) but this did not achieve statistical significance.
CONCLUSION
In a large cohort of North American patients with complete response to HCC treatment, DAA therapy was not associated with increased overall or early HCC recurrence. HCC recurrence patterns, including treatment response, were similar in DAA-treated and untreated patients.
背景与目的
直接作用抗病毒（DAA）疗法治疗丙型肝炎病毒（HCV）感染对肝细胞癌（HCC）复发和肿瘤侵袭性的影响存在争议。我们比较了在北美队列中，接受 DAA 治疗和未接受治疗的 HCV 感染患者在 HCC 治疗完全缓解后的 HCC 复发模式。
方法
我们对 2013 年 1 月至 2017 年 12 月期间，美国和加拿大 31 个卫生系统中接受过 HCC 切除术、局部消融术、经动脉化疗栓塞术或放射治疗的完全缓解的 HCV 相关 HCC 患者进行了一项回顾性队列研究。使用 Cox 回归分析 DAA 治疗与完全缓解后复发的时间之间的关联，DAA 治疗作为时变暴露进行分析。我们还估计了 DAA 治疗与 HCC 早期复发（定义为完全缓解后 365 天）之间的关联。
结果
在 793 例 HCV 相关 HCC 患者中，304 例（38.3%）接受了 DAA 治疗，489 例（61.7%）未接受治疗。128 例 DAA 治疗患者（42.1%；52 例早期复发）和 288 例未治疗患者（58.9%；227 例早期复发）发生 HCC 复发。在调整了研究地点、年龄、性别、Child-Pugh 评分、α-胎蛋白水平、肿瘤负担和 HCC 治疗方式后，DAA 治疗与 HCC 复发（风险比 0.90，95%置信区间 0.70-1.16）或 HCC 早期复发（风险比 0.96，95%置信区间 0.70-1.34）无关。在 DAA 治疗和未治疗的患者中，大多数复发均符合米兰标准（74.2% vs 78.8%；P=0.23）。与未治疗的患者相比，接受 DAA 治疗的患者接受潜在治愈性 HCC 治疗的比例更高（32.0% vs 24.6%），且获得完全或部分缓解的比例更高（45.3% vs 41.0%），但差异无统计学意义。
结论
在接受 HCC 治疗完全缓解的大型北美患者队列中，DAA 治疗与总体或 HCC 早期复发无关。DAA 治疗和未治疗的患者 HCC 复发模式（包括治疗反应）相似。
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