PD-1抑制剂预防肝细胞癌消融术后复发的临床研究OACSTPCD
Efficacy of PD-1 inhibitors in preventing recurrence of hepatocellular carcinoma after local ablation
目的 探讨程序性细胞死亡受体-1(PD-1)抑制剂用于肝细胞癌(HCC)消融术后预防复发的有效性和安全性.方法 前瞻性选择2021年1月至2023年3月在首都医科大学附属北京佑安医院行肝动脉栓塞(TAE)序贯局部消融术(微波消融或射频消融)治疗后达到完全消融的HCC患者63例,根据患者意愿将患者非随机分配至试验组(n=31)或对照组(n=32),试验组术后接受PD-1抑制剂辅助治疗(卡瑞利珠单抗治疗200 mg,每3周1次)),对照组无辅助治疗.Kaplan-Meier法绘制累计复发率曲线,Log-rank检验比较两组生存率差异;Cox回归分析得出影响HCC患者局部消融术后无复发生存期(RFS)的独立危险因素.结果 两组治疗后随访2～15个月,中位随访8个月.试验组复发率明显低于对照组(41.94%vs 68.75%,χ2=4.59,P=0.03).试验组中1～2级免疫相关不良事件发生率为92.59%(25/27),≥3级为7.41%.肿瘤最大径(HR=0.49,95%CI 0.25-0.98,P<0.05)与抗PD-1辅助治疗(HR=0.41,95%CI 0.20-0.85,P<0.05)是HCC患者消融术后RFS的独立影响因素(P<0.05).结论 本研究的短期结果表明,PD-1抑制剂用于HCC根治性消融术后的肿瘤预防复发安全、有效.
Objective To explore the efficacy and safety of programmed cell death protein-1(PD-1)inhibitors as adjunctive therapy for recurrence of hepatocellular carcinoma(HCC)after local ablation.Methods A total of 63 HCC patients who received sequential therapy of transcatheter arterial embolization(TAE)combined with local ablation(microwave ablation or radiofrequency ablation),and achieved complete ablation,in Beijing Youan Hospital from Jan.2021 to Mar.2023,were prospectively selected.According to the patient's wishes,the 63 patients were assigned to either the experimental group(n=31)or the control group(n=32).Patients in the experimental group received adjuvant treatment of PD-1 inhibitor(Camrelizumab,200 mg,once every 3 weeks)after local ablation,while patients in the control group received no adjuvant treatment.The accumulated recurrence rate curve was performed by Kaplan-Meier method,and the difference of survival rates between the two groups was compared by Log-rank test.Cox regression analysis was used for univariate and multivariate analysis of risk factors of relapse free survival(RFS)in patients with HCC after local ablation.Results After a median follow-up of 8 months,the recurrence rate in the experimental group was significantly lower than that in the control group(41.94%vs 68.75%,χ2=4.59,P=0.03).The incidence rate of immune related adverse events in the experimental group was 92.59%for grade 1-2,and 7.41%for grade≥3.Tumor diameter(HR=0.49,95%CI 0.25-0.98,P<0.05)and anti PD-1 adjuvant therapy(HR=0.41,95%CI 0.20-0.85,P<0.05)were independent influencing factors for the RFS of HCC patients after local ablation(P<0.05).Conclusion This short-term study shows that djuvant therapy of PD-1 inhibitors is safe and effective in preventing recurrence of HCC after local ablation.
张洪海;袁春旺;生守鹏;张永宏;孙玉
首都医科大学附属北京佑安医院 肝病与肿瘤介入治疗中心,北京 100069
临床医学
肝细胞癌程序性细胞死亡受体-1抑制剂微波消融射频消融肝癌复发无复发生存期
hepatocellular carcinomaprogrammed cell death protein-1 inhibitorsmicrowave ablationradiofrequency ablationrecurrence of hepatocellular carcinomarelapse free survival
《肝胆胰外科杂志》 2024 (004)
193-197,204 / 6
北京市属医院科研培育计划(PX2022067).
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