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质子束放疗与经动脉化疗栓塞治疗肝细胞癌的随机临床试验结果。

Proton beam radiotherapy versus transarterial chemoembolization for hepatocellular carcinoma: Results of a randomized clinical trial.

机构信息

Loma Linda University Medical Center, Radiation Medicine, Loma Linda, California, USA.

Loma Linda University Medical Center, Transplant Institute and Liver Center, Loma Linda, California, USA.

出版信息

Cancer. 2023 Nov 15;129(22):3554-3563. doi: 10.1002/cncr.34965. Epub 2023 Jul 28.

DOI:10.1002/cncr.34965
PMID:37503907
Abstract

BACKGROUND

This study compares survival rates, recurrence patterns, toxicity, and treatment cost in patients with hepatocellular carcinoma (HCC) treated with either transarterial chemoembolization (TACE) or proton beam radiotherapy (PBT).

METHODS

Subjects with untreated HCC meeting Milan or San Francisco transplant criteria were recruited. Subjects were randomized to receive PBT (n = 36) or TACE (n = 40). Proton therapy was administered in 15 fractions over 3 weeks to a total dose of 70.2 Gy. TACE was repeated until complete or maximal response. The primary outcome measure was overall survival (OS). Secondary end points were progression-free survival (PFS), local control (LC), toxicity, and cost.

RESULTS

Of the 76 randomized patients, 74 were assessed for outcome measures. The 2-year OS for PBT versus TACE was similar at 68%, 95% confidence interval (CI), 0.54-0.86, and 65%, 95% CI, 0.52-0.83 (p = .80), however, median PFS was improved for PBT versus TACE (not reached vs. 12 months, p = .002). LC was improved with PBT versus TACE (hazard ratio, 5.64; 95% CI, 1.78-17.9, p = .003). Days of posttreatment hospitalization were 24 for PBT and 166 for TACE (p < .001). Total mean cost per patient for treatment and posttreatment care revealed a 28% cost savings for PBT.

CONCLUSIONS

PBT and TACE yielded similar OS for treatment of HCC, but PFS and LC were improved with PBT compared to TACE. Patients treated with PBT required fewer courses of treatment, fewer posttreatment hospitalization days, and reduced cost of treatment compared to TACE. These data support the use of PBT as a viable treatment alternative to TACE for patients with HCC within transplant criteria.

摘要

背景

本研究比较了接受经动脉化疗栓塞术(TACE)或质子束放疗(PBT)治疗的肝细胞癌(HCC)患者的生存率、复发模式、毒性和治疗费用。

方法

招募符合米兰或旧金山移植标准的未经治疗的 HCC 患者。将患者随机分为 PBT 组(n=36)或 TACE 组(n=40)。质子治疗在 3 周内分 15 次进行,总剂量为 70.2Gy。TACE 重复至完全或最大反应。主要观察终点为总生存率(OS)。次要终点为无进展生存率(PFS)、局部控制率(LC)、毒性和成本。

结果

在 76 名随机患者中,74 名患者进行了结局评估。PBT 与 TACE 的 2 年 OS 相似,分别为 68%(95%CI,0.54-0.86)和 65%(95%CI,0.52-0.83)(p=0.80),但 PFS 改善为 PBT 优于 TACE(未达到 vs. 12 个月,p=0.002)。与 TACE 相比,PBT 的 LC 得到改善(风险比,5.64;95%CI,1.78-17.9,p=0.003)。PBT 的治疗后住院天数为 24 天,TACE 为 166 天(p<0.001)。每位患者的治疗和治疗后护理总平均费用显示 PBT 节省了 28%的费用。

结论

PBT 和 TACE 治疗 HCC 的 OS 相似,但与 TACE 相比,PFS 和 LC 得到改善。与 TACE 相比,接受 PBT 治疗的患者需要更少的治疗疗程、更少的治疗后住院天数和更低的治疗费用。这些数据支持将 PBT 作为符合移植标准的 HCC 患者的一种可行治疗选择。

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