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背景和目的射频消融术(RFA)是近年发展较快的肝癌治疗手段,有微创、操作简单、可反复治疗等特点。多项研究证明其对于小肝癌的疗效与手术切除相似,被认为是不能切除小肝癌的主要替代手段,甚至可作为小肝癌的一线治疗手段。经导管肝动脉栓塞化疗术(TACE)是中晚期肝癌的主要治疗手段。TACE联合射频消融,可治疗一些以前没有发现的微小病灶,并有利于日后射频治疗的施行。此外,射频消融术前行TACE治疗,可减少肝肿瘤的血流,从而减少射频消融过程中的热流失,增加消融范围;射频消融过程中产生的热量可以发挥TACE过程中注入化疗药物的疗效;可发现和控制肝肿瘤周围可能存在的微卫星灶,增强疗效。本研究是第一项研究RFA联合TACE的前瞻随机对照研究,目的在于比较射频消融术(RFA)联合或不联合经导管肝动脉栓塞化疗术(TACE)治疗肝细胞癌(HCC)的疗效。方法此项单中心随机对照临床试验在中山大学肿瘤医院完成。入选标准为:①年龄18~75岁;②HCC单个病灶≤7 cm,或3个及3个以下病灶,每个病灶≤3 cm;③影像学证据显示无大血管侵犯并且无肝外转移;④B超下可见病灶且病灶和腹壁之间有安全距离;⑤ECOG体力状态评分0;⑥之前未接受过HCC治疗;⑦Child-Pugh肝功能A或B级。自2006年10月至2009年6月,189例直径小于7 cm、符合入选标准的肝细胞癌患者完成对照试验。患者随机接受TACE结合RFA治疗(n=94)或单纯RFA治疗(n=95)。该项研究的主要终点为总体生存率,次要终点为无复发生存率,第三终点为不良事件。结果随访7至62个月期间,TACE-RFA组死亡34例,复发33例;RFA组死亡48例,复发52例。TACE-RFA组与RFA组患者1、3、4年总体生存率分别为92.6%、66.6%、61.8%以及85.3%、59%、45.0%,无复发生存率分别为79.4%、60.6%、54.8%以及66.7%、44.2%、38.9%。TACE-RFA组患者的总体生存率以及无复发生存率均优于RFA组患者(HR=0.525,95%CI:0.335~0.822,P=0.002;HR=0.575,95%CI:0.374~0.897,P=0.009)。研究中未出现相关死亡病例。Logistic回归分析显示,治疗分组、肿瘤大小以及肿瘤数量为患者总体生存率的显著预后因素,治疗分组与肿瘤数量为患者无复发生存率的显著预后因素。结论对于直径小于7 cm的HCC患者,接受TACE-RFA较单纯RFA治疗生存获益更显著。
Background and purpose Radiofrequency ablation (RFA) is a rapidly developing treatment of liver cancer in recent years. It has the characteristics of minimal invasion, simple operation and repeated treatment. A number of studies have shown that the curative effect of small hepatocellular carcinoma is similar to that of surgical resection, which is considered as the primary alternative method of not removing small hepatocellular carcinoma, even as first-line treatment of small hepatocellular carcinoma. Transcatheter hepatic arterial chemoembolization (TACE) is the main treatment of advanced liver cancer. TACE combined with radiofrequency ablation, which can treat some previously undiscovered micro-lesions, and is conducive to the implementation of radio frequency therapy in the future. In addition, radiofrequency ablation TACE before treatment can reduce the blood flow of liver tumors, thereby reducing the heat loss during radiofrequency ablation and increase the scope of ablation; radiofrequency ablation heat generated during TACE can play the role of chemotherapy drugs; Can detect and control the liver tumor may exist around the microsatellite, enhance the efficacy. This is the first prospective randomized controlled study of RFA combined with TACE to compare the efficacy of radiofrequency catheter ablation (RFA) with or without transcatheter hepatic arterial chemoembolization (TACE) in the treatment of hepatocellular carcinoma (HCC). Methods This single-center, randomized, controlled trial was completed at Sun Yat-sen University Cancer Hospital. The inclusion criteria were: ① age 18 to 75 years old; ② single lesion of HCC ≤ 7 cm, or less than 3 and less than 3 lesions, each lesion ≤ 3 cm; ③ imaging evidence of no major vascular invasion and no extrahepatic metastasis; ④ B Super-visible lesions and a safe distance between the lesion and the abdominal wall; ⑤ ECOG physical status score 0; ⑥ had not received HCC before treatment; ⑦Child-Pugh liver function A or B grade. From October 2006 to June 2009, 189 patients with hepatocellular carcinoma whose diameter was less than 7 cm met the inclusion criteria. Patients were randomized to receive either TACE combined with RFA (n = 94) or simple RFA (n = 95). The primary endpoint of the study was overall survival, the secondary endpoint was recurrence-free survival, and the third endpoint was an adverse event. Results During the follow-up period of 7 to 62 months, there were 34 deaths and 33 relapses in TACE-RFA group. There were 48 deaths and 52 relapses in RFA group. The overall survival rates at 1, 3 and 4 years in TACE-RFA group and RFA group were 92.6%, 66.6%, 61.8% and 85.3%, 59% and 45.0% respectively, and the recurrence-free survival rates were 79.4%, 60.6% and 54.8% % And 66.7%, 44.2%, 38.9%. The overall survival and recurrence-free survival of patients in the TACE-RFA group were better than those in the RFA group (HR = 0.525, 95% CI: 0.335-0.822, P = 0.002; HR = 0.575, 95% CI: 0.374-0.897, P = 0.009). No deaths were found in the study. Logistic regression analysis showed that the treatment grouping, tumor size, and tumor size were significant prognostic factors for overall patient survival, and treatment grouping and tumor size were significant prognostic factors for patients with no recurrence. Conclusions TACE-RFA is more effective than simple RFA for HCC patients less than 7 cm in diameter.