目的分析初始不可切除肝细胞癌患者接受免疫联合靶向序贯外科根治性手术方案治疗的远期疗效。
方法前瞻性收集2018年12月至2023年8月于解放军总医院肝胆胰外科医学部接受免疫联合靶向序贯外科根治性手术治疗的初始不可切除肝细胞癌患者资料。最终入组100例患者，其中男性87例，女性13例，年龄24～73岁，中位数55岁。本研究为前瞻性队列研究。患者治疗前肿瘤分期采用中国肝癌分期(CNLC)。采用改良实体瘤临床疗效评价标准(mRECIST)评估免疫联合靶向转化治疗疗效，分析用药周期。术后病理分析肿瘤残留情况。Kaplan-Meier法计算生存率。
结果治疗前CNLC Ⅲa期46例(46.0%)，CNLC Ⅲb期40例(40.0%)，另有14例(14.0%)是CNLCⅠb、Ⅱa、Ⅱb期，因肿瘤破裂或剩余功能性肝体积不足而行免疫联合靶向转化治疗。100例患者接受了3～28个周期(中位数5个周期)免疫联合靶向转化治疗，转化成功后序贯外科根治性手术。根据mRECIST评估，肿瘤达到完全缓解14例(14.0%)、部分缓解63例(63.0%)、疾病稳定18例(18.0%)、疾病进展5例(5.0%)。手术切除肿瘤标本达到病理学完全缓解24例(24.0%)，病理残留肿瘤比例≤10%患者61例(61.0%)，病理残留肿瘤比例≤50%患者82例(82.0%)。100例患者1、3、5年累积生存率分别为98.0%、83.1%、74.5%，术后1、2、3年无复发生存率分别为67.5%、54.8%、49.6%。
结论免疫联合靶向序贯外科根治性手术方案给初始不可切除肝细胞癌患者带来显著的远期生存获益。
ObjectiveTo assess the long-term outcome of sequential radical surgery after immune combined with targeted therapy for patients with initially unresectable hepatocellular carcinoma (HCC).
MethodsClinical data of 100 patients with initially unresectable HCC undergoing sequential radical surgery after immune combined with targeted therapy at the Faculty of Hepato-Pancreato-Biliary Surgery of Chinese PLA General Hospital from December 2018 to August 2023 were prospectively collected, including 87 males and 13 females, with a median age of 55 (24-73) years. The pre-treatment tumor staging was determined using the China liver cancer staging (CNLC). The efficacy of immune combined with targeted therapy was accessed using the modified response evaluation criteria in solid tumor (mRECIST). The cycles of immune combined with targeted therapy were analyzed. The tumor residual of resected tissue was analyzed through a standard pathological protocol. The prognosis was analyzed using the Kaplan-Meier method.
ResultsUpon initial diagnosis, there were 46 cases (46.0%) staged CNLC-Ⅲa and 40 (40.0%) staged CNLC-Ⅲb. There were also 14 cases (14.0%) staged CNLC-Ⅰb, Ⅱa, and Ⅱb who underwent immune combined with targeted therapy due to rupture of tumor or insufficient liver remnant. All patients received a median of 5 (3-28) cycles of immune combined with targeted therapy and underwent radical surgery after successful conversion. According to mRECIST, 14 (14.0%) were determined as complete remission, 63 (63.0%) as partial remission, 18 (18.0%) as stable disease, and 5 (5.0%) as disease progression. Of 24 (24.0%) were defined as pathologically complete remission by postoperative pathology. Furthermore, pathological tumor residue was less than 10% in 61 (61.0%) cases and less than 50% in 82 (82.0%) cases. The 1, 3, and 5 year-overall survival rates of patients were 98.0%, 83.1%, and 74.5%, respectively. The 1, 2 and 3 year-recurrence-free survival rates were 67.5%, 54.8%, and 49.6%, respectively.
ConclusionSequential radical surgery after immune combined with targeted therapy benefits the long-term survival of patients with initially unresectable HCC.
李雪瑞,李俊锋,张雯雯,等. 免疫联合靶向序贯外科根治性手术方案治疗初始不可切除肝细胞癌的远期疗效[J]. 中华肝胆外科杂志,2024,30(01)：9-14.
DOI:10.3760/cma.j.cn113884-20231130-00147版权归中华医学会所有。
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李雪瑞：资料收集、数据整理和分析、文章撰写；李俊锋、张雯雯、王志军、胡丙洋、唐浩文、刘兵、万涛、刘哲、王湛博：资料收集、数据整理；卢实春：研究设计、研究指导、文章审阅和修改
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