替诺福韦与恩替卡韦对乙型肝炎相关肝细胞癌术后预后的影响：一项随机对照试验。
Tenofovir versus entecavir on the prognosis of hepatitis B-related hepatocellular carcinoma after surgical resection: a randomised controlled trial.
机构信息
Department of Thyroid and Parathyroid surgery, Laboratory of Thyroid and Parathyroid Disease.
Department of Liver Surgery and Liver Transplantation Center.
出版信息
Int J Surg. 2023 Oct 1;109(10):3032-3041. doi: 10.1097/JS9.0000000000000554.
BACKGROUND
Nucleot(s)ide analog treatment (entecavir (ETV) and tenofovir (TDF)) is reported to be associated with decreased tumor recurrence and death in hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) patients, yet further work is needed to evaluate the different efficacies of these two agents on the prognosis of early-stage HBV-related HCC patients after curative liver resection.
MATERIAL AND METHODS
From July 2017 to January 2019, 148 patients with HBV-related HCC who underwent curative liver resection were randomized to receive TDF ( n =74) or ETV ( n =74) therapy. The primary end point was tumor recurrence in the intention-to-treat population. Overall survival and tumor recurrence of patients were compared by multivariable-adjusted Cox regression and competing risk analyses.
RESULTS
During the follow-up with continued antiviral therapy, 37 (25.0%) patients developed tumor recurrence, and 16 (10.8%) patients died ( N =15) or received liver transplantation ( N =1). In the intention-to-treat cohort, the recurrence-free survival for the TDF group was significantly better than that for the ETV group ( P =0.026). In the multivariate analysis, the relative risks of recurrence and death/liver transplantation for ETV therapy were 3.056 (95% CI: 1.015-9.196; P =0.047) and 2.566 (95% CI: 1.264-5.228; P =0.009), respectively. Subgroup analysis of the PP population indicated a better overall survival and RFS of patients receiving TDF therapy ( P =0.048; hazard ratio (HR) =0.362; 95% CI: 0.132-0.993 and P =0.014; HR =0.458; 95% CI: 0.245-0.856). Additionally, TDF therapy was an independent protective factor against late tumor recurrence ( P =0.046; (HR)=0.432; 95% CI: 0.189-0.985) but not against early tumor recurrence ( P =0.109; HR =1.964; 95% CI: 0.858-4.494).
CONCLUSION
HBV-related HCC patients treated with consistent TDF therapy had a significantly lower risk of tumor recurrence than those treated with ETV after curative treatment.
背景
核苷（酸）类似物治疗（恩替卡韦（ETV）和替诺福韦（TDF））据报道可降低乙型肝炎病毒（HBV）相关肝细胞癌（HCC）患者的肿瘤复发和死亡风险，但仍需要进一步研究来评估这两种药物对接受根治性肝切除术后早期 HBV 相关 HCC 患者预后的不同疗效。
材料和方法
2017 年 7 月至 2019 年 1 月，148 例接受根治性肝切除术的 HBV 相关 HCC 患者被随机分为 TDF（n=74）或 ETV（n=74）治疗组。主要终点为意向治疗人群中的肿瘤复发。通过多变量调整 Cox 回归和竞争风险分析比较患者的总生存率和肿瘤复发率。
结果
在接受抗病毒治疗的随访期间，37 例（25.0%）患者发生肿瘤复发，16 例（10.8%）患者死亡（n=15）或接受肝移植（n=1）。在意向治疗队列中，TDF 组的无复发生存率明显优于 ETV 组（P=0.026）。多变量分析显示，ETV 治疗的复发和死亡/肝移植的相对风险分别为 3.056（95%CI：1.015-9.196；P=0.047）和 2.566（95%CI：1.264-5.228；P=0.009）。PP 人群的亚组分析表明，接受 TDF 治疗的患者总生存率和 RFS 更好（P=0.048；风险比（HR）=0.362；95%CI：0.132-0.993 和 P=0.014；HR=0.458；95%CI：0.245-0.856）。此外，TDF 治疗是晚期肿瘤复发的独立保护因素（P=0.046；（HR）=0.432；95%CI：0.189-0.985），但不是早期肿瘤复发的保护因素（P=0.109；HR=1.964；95%CI：0.858-4.494）。
结论
HBV 相关 HCC 患者接受一致的 TDF 治疗后，肿瘤复发的风险明显低于接受 ETV 治疗。
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