PDF(Pubmed)
Abstract：
UNASSIGNED: Transcatheter arterial chemoembolisation (TACE) is recommended for patients with hepatocellular carcinoma devoid of macrovascular invasion or extrahepatic spread but not eligible for curative therapies. We compared the efficacy and safety of the combination of a single TACE and external conformal radiotherapy (CRT) vs. classical TACE.
UNASSIGNED: TACERTE was an open-labelled, randomised controlled trial with a 1:1 allocation rate to two or three TACE (arm A) or one TACE + CRT (arm B). Participants had a mean age of 70 years, and 86% were male. The aetiology was alcohol in 85%. The primary endpoint was liver progression-free survival (PFS) in the intention-to-treat population. The typical CRT schedule was 54 Gy in 18 sessions of 3 Gy.
UNASSIGNED: Of the 120 participants randomised, 64 were in arm A and 56 in arm B; 100 participants underwent the planned schedule and defined the \'per-protocol\' group. In intention-to-treat participants, the liver PFS at 12 and 18 months were 59% and 19% in arm A and 61% and 36% in arm B (hazard ratio [HR] 0.69; 95% CI 0.40-1.18; p = 0.17), respectively. In the per-protocol population, treated liver PFS tended to be better in arm B (HR 0.61; 95% CI 0.34-1.06; p = 0.081) than in arm A. Liver-related grade III-IV adverse events were more frequent in arm B than in arm A. Median overall survival reached 30 months (95% CI 23-35) in arm A and 22 months (95% CI 15.7-26.2) in arm B.
UNASSIGNED: Although TACE + CRT tended to improve local control, this first Western randomised controlled trial showed that the combined strategy failed to increase PFS or overall survival and led more frequently to liver-related adverse effects.
UNASSIGNED: Hepatocellular carcinoma is frequently treated by arterial embolisation of the tumour and more recently by external radiotherapy. We tried to determine whether combination of the two treatments (irradiation after embolisation) might produce interesting results. Our results in this prospective randomised study were not able to demonstrate a beneficial effect of combining embolisation and irradiation in these patients. On the contrary, we observed more adverse effects with the combined treatment.
UNASSIGNED: NCT01300143.
UNASSIGNED: TACERTE was an open-labelled, randomised controlled trial with a 1:1 allocation rate to two or three TACE (arm A) or one TACE + CRT (arm B). Participants had a mean age of 70 years, and 86% were male. The aetiology was alcohol in 85%. The primary endpoint was liver progression-free survival (PFS) in the intention-to-treat population. The typical CRT schedule was 54 Gy in 18 sessions of 3 Gy.
UNASSIGNED: Of the 120 participants randomised, 64 were in arm A and 56 in arm B; 100 participants underwent the planned schedule and defined the \'per-protocol\' group. In intention-to-treat participants, the liver PFS at 12 and 18 months were 59% and 19% in arm A and 61% and 36% in arm B (hazard ratio [HR] 0.69; 95% CI 0.40-1.18; p = 0.17), respectively. In the per-protocol population, treated liver PFS tended to be better in arm B (HR 0.61; 95% CI 0.34-1.06; p = 0.081) than in arm A. Liver-related grade III-IV adverse events were more frequent in arm B than in arm A. Median overall survival reached 30 months (95% CI 23-35) in arm A and 22 months (95% CI 15.7-26.2) in arm B.
UNASSIGNED: Although TACE + CRT tended to improve local control, this first Western randomised controlled trial showed that the combined strategy failed to increase PFS or overall survival and led more frequently to liver-related adverse effects.
UNASSIGNED: Hepatocellular carcinoma is frequently treated by arterial embolisation of the tumour and more recently by external radiotherapy. We tried to determine whether combination of the two treatments (irradiation after embolisation) might produce interesting results. Our results in this prospective randomised study were not able to demonstrate a beneficial effect of combining embolisation and irradiation in these patients. On the contrary, we observed more adverse effects with the combined treatment.
UNASSIGNED: NCT01300143.
摘要：
未经证实：对于没有大血管侵犯或肝外扩散但不适合治愈性治疗的肝细胞癌患者，建议使用经导管动脉化疗栓塞术（TACE）。我们比较了单一TACE和外部适形放疗（CRT）与联合治疗的疗效和安全性。经典的TACE。
未经批准：TACERTE是一种开放标签，随机对照试验1:1分配率为2或3次TACE(A组)或1次TACE+CRT(B组).参与者的平均年龄为70岁，86%是男性。病因为85％的酒精。主要终点是意向治疗人群的肝脏无进展生存期（PFS）。在18个3Gy的疗程中，典型的CRT时间表为54Gy。
未经评估：在随机分组的120名参与者中，64人在A组，56人在B组；100名参与者接受了计划的时间表，并定义了“按方案”组。在意向治疗参与者中，在12个月和18个月时，A组的肝脏PFS分别为59％和19％，B组的PFS分别为61％和36％（风险比[HR]0.69;95％CI0.40-1.18;p=0.17），分别。在符合协议的人群中，B组接受治疗的肝脏PFS往往优于A组(HR0.61;95%CI0.34-1.06;p=0.081)。B组的肝脏相关III-IV级不良事件发生率高于A组。A组的中位总生存期达到30个月(95%CI23-35),B组达到22个月(95%CI15.7-26.2)。这项首个Western随机对照试验表明,联合治疗方案未能提高PFS或总生存率,导致肝脏相关不良反应的发生率更高.
UASSIGNED：肝细胞癌经常通过肿瘤的动脉栓塞治疗，最近通过外部放疗治疗。我们试图确定两种治疗方法（栓塞后的照射）的组合是否会产生有趣的结果。我们在这项前瞻性随机研究中的结果无法证明栓塞和放疗对这些患者的有益作用。相反,我们观察到联合治疗的不良反应较多.
未经评估：NCT01300143。
未经批准：TACERTE是一种开放标签，随机对照试验1:1分配率为2或3次TACE(A组)或1次TACE+CRT(B组).参与者的平均年龄为70岁，86%是男性。病因为85％的酒精。主要终点是意向治疗人群的肝脏无进展生存期（PFS）。在18个3Gy的疗程中，典型的CRT时间表为54Gy。
未经评估：在随机分组的120名参与者中，64人在A组，56人在B组；100名参与者接受了计划的时间表，并定义了“按方案”组。在意向治疗参与者中，在12个月和18个月时，A组的肝脏PFS分别为59％和19％，B组的PFS分别为61％和36％（风险比[HR]0.69;95％CI0.40-1.18;p=0.17），分别。在符合协议的人群中，B组接受治疗的肝脏PFS往往优于A组(HR0.61;95%CI0.34-1.06;p=0.081)。B组的肝脏相关III-IV级不良事件发生率高于A组。A组的中位总生存期达到30个月(95%CI23-35),B组达到22个月(95%CI15.7-26.2)。这项首个Western随机对照试验表明,联合治疗方案未能提高PFS或总生存率,导致肝脏相关不良反应的发生率更高.
UASSIGNED：肝细胞癌经常通过肿瘤的动脉栓塞治疗，最近通过外部放疗治疗。我们试图确定两种治疗方法（栓塞后的照射）的组合是否会产生有趣的结果。我们在这项前瞻性随机研究中的结果无法证明栓塞和放疗对这些患者的有益作用。相反,我们观察到联合治疗的不良反应较多.
未经评估：NCT01300143。
