Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
J Hepatol. 2009 Dec;51(6):1030-6. doi: 10.1016/j.jhep.2009.09.004. Epub 2009 Oct 1.
BACKGROUND/AIMS: Transcatheter arterial chemoembolization (TACE) is a combination of transarterial infusion chemotherapy (TAI) and embolization, and has been widely used to treat patients with hepatocellular carcinoma (HCC). However, since the impact of adding embolization on the survival of patients treated with TAI had never been evaluated in a phase III study, we conducted a multi-center, open-label trial comparing TACE and TAI to assess the effect of adding embolization on survival.
Patients with newly diagnosed unresectable HCC were randomly assigned to either a TACE group or a TAI group. Zinostatin stimalamer was injected into the hepatic artery, together with gelatin sponge in the TACE group and without gelatin sponge in the TAI group. Treatment was repeated when follow-up computed tomography showed the appearance of new lesions in the liver or re-growth of previously treated tumors.
Seventy-nine patients were assigned to the TACE group, and 82 were assigned to the TAI group. The two groups were comparable with respect to their baseline characteristics. At the time of the analysis, 51 patients in the TACE group and 58 in the TAI group had died. The median overall survival time was 646 days in the TACE group and 679days in the TAI group (p=0.383).
The results of this study suggest that treatment intensification by adding embolization did not increase survival over TAI with zinostatin stimalamer alone in patients with HCC.
背景/目的：经导管动脉化疗栓塞术（TACE）是经动脉输注化疗（TAI）和栓塞的结合，已广泛用于治疗肝细胞癌（HCC）患者。然而，由于从未在 III 期研究中评估过添加栓塞对 TAI 治疗患者生存的影响，我们进行了一项多中心、开放标签试验，比较 TACE 和 TAI，以评估添加栓塞对生存的影响。
新诊断为不可切除的 HCC 患者被随机分配到 TACE 组或 TAI 组。在 TACE 组中向肝动脉内注射佐剂型司他汀，同时注射明胶海绵，而在 TAI 组中则不注射明胶海绵。当随访计算机断层扫描显示肝脏出现新病变或先前治疗的肿瘤重新生长时，再次进行治疗。
79 例患者被分配到 TACE 组，82 例患者被分配到 TAI 组。两组患者的基线特征具有可比性。在分析时，TACE 组有 51 例患者死亡，TAI 组有 58 例患者死亡。TACE 组的中位总生存时间为 646 天，TAI 组为 679 天（p=0.383）。
这项研究的结果表明，在 HCC 患者中，与单独使用佐剂型司他汀的 TAI 相比，通过添加栓塞来强化治疗并未增加生存时间。
