Qing He, Yong-Song Guan, Oncology Department, West China Hospital of Sichuan University, Chengdu 610041, Sichuan Province, China.
World J Gastroenterol. 2013 Dec 21;19(47):9104-10. doi: 10.3748/wjg.v19.i47.9104.
To investigate the safety and effectiveness of combined (131)I-metuximab and transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC).
One hundred and eighty-five patients (159 men and 26 women) with advanced HCC were enrolled in this study from February 2009 to July 2011. There were 95 patients in the combined metuximab and TACE group, and 90 patients in the TACE only group. The patients were followed for 12 mo. Clinical symptoms, blood cell counts, Karnofsky Performance Score (KPS) evaluation and therapeutic effects according to the Response Evaluation Criteria in Solid Tumors were recorded and evaluated.
The 1-mo effective rates (complete response + partial response + stable disease) of the test group and control group were 71.23% and 38.89%, respectively (P < 0.001). The 6-, 9- and 12-mo survival rates were 86.42%, 74.07% and 60.49% for the test group and 60.0%, 42.22% and 34.44% for the control group (P < 0.001). The incidence of adverse events (gastrointestinal symptoms, fever and pain) and blood cell toxicity were significantly higher for the test group than for the control group (P < 0.001). No severe (131)I-metuximab-related complications were identified. With respect to efficacy, patients in the test group had greater improvement in tumor-related pain (P = 0.014) and increase in KPS (P < 0.001) than those in the control group.
Combination of (131)I-metuximab and TACE prolonged the survival time in patients with HCC compared with TACE alone. The combination treatment was safe and effective.
研究放射性碘标记美妥昔单抗联合肝动脉化疗栓塞（TACE）治疗肝细胞癌（HCC）的安全性和有效性。
本研究共纳入 2009 年 2 月至 2011 年 7 月期间 185 例晚期 HCC 患者（男 159 例，女 26 例），分为联合美妥昔单抗和 TACE 组（n=95）和单纯 TACE 组（n=90）。两组患者均随访 12 个月，记录并评价患者的临床症状、血细胞计数、卡氏功能状态评分（KPS）和实体瘤疗效评价标准（RECIST）评价的治疗效果。
试验组和对照组的 1 个月有效率（完全缓解+部分缓解+稳定疾病）分别为 71.23%和 38.89%（P<0.001）。试验组和对照组的 6、9 和 12 个月生存率分别为 86.42%、74.07%和 60.49%和 60.0%、42.22%和 34.44%（P<0.001）。试验组胃肠道症状、发热和疼痛等不良反应发生率和血细胞毒性明显高于对照组（P<0.001）。未发生严重的（131）I-美妥昔单抗相关并发症。在疗效方面，试验组患者的肿瘤相关疼痛改善（P=0.014）和 KPS 升高（P<0.001）均明显优于对照组。
与单纯 TACE 相比，放射性碘标记美妥昔单抗联合 TACE 可延长 HCC 患者的生存时间，且安全性和有效性良好。
