Buijs Manon, Vossen Josephina A, Frangakis Constantine, Hong Kelvin, Georgiades Christos S, Chen Yong, Liapi Eleni, Geschwind Jean-François H
Russell H. Morgan Department of Radiology and Radiological Sciences, Division of Vascular and Interventional Radiology, Johns Hopkins Hospital, 600 N Wolfe St, Blalock 545, Baltimore, MD 21287, USA.
Radiology. 2008 Oct;249(1):346-54. doi: 10.1148/radiol.2483071902.
To determine the toxicity profile of transarterial chemoembolization (TACE) at 6 months and 1 year after treatment in patients with hepatocellular carcinoma (HCC) in a standardized oncology protocol so that TACE could be compared with systemic chemotherapeutic regimens for liver cancer.
The study was authorized by the institutional review board. Between January 2002 and January 2007, 190 patients (155 men, 35 women; median age, 65 years; age range, 18-84 years) with HCC who underwent TACE treatment were identified from a prospectively collected database. Clinical records of complete blood cell counts and chemical profiles at baseline and at 6 and 12 months after treatment were studied retrospectively. Toxicity was graded according to the common terminology criteria for adverse events (CTCAE). A transition (survival) analysis perspective was used to estimate the distribution of toxicity grades. Patient survival from the first TACE session was calculated with Kaplan-Meier analysis.
Grade 3 or 4 toxicity 6 and 12 months, respectively, after treatment included leukocytopenia (7% and 19%); anemia (9% and 19%); thromobocytopenia (13% and 23%); prolonged activated partial thromboplastin time (8% and 18%); elevated aspartate aminotransferase (15% and 18%), alanine aminotransferase (10% and 18%), and alkaline phosphatase (8% and 18%) levels; hypoalbuminemia (10% and 19%); hyperbilirubinemia (10% and 22%); and alopecia (18%). The cumulative survival rate was 58% at 1 year, 39% at 2 years, and 29% at 3 years. These toxicity rates were considerably lower than those reported after treatment with currently used systemic chemotherapeutic agents.
Study results show that TACE has a favorable long-term toxicity profile in patients with HCC. Data clearly support the role of TACE in the treatment of patients with nonresectable HCC.
在标准化肿瘤学方案中,确定肝细胞癌(HCC)患者经动脉化疗栓塞术(TACE)治疗后6个月和1年时的毒性特征,以便将TACE与肝癌的全身化疗方案进行比较。
本研究经机构审查委员会批准。2002年1月至2007年1月期间,从一个前瞻性收集的数据库中识别出190例接受TACE治疗的HCC患者(155例男性,35例女性;中位年龄65岁;年龄范围18 - 84岁)。回顾性研究了基线时以及治疗后6个月和12个月时的全血细胞计数和化学指标的临床记录。毒性根据不良事件通用术语标准(CTCAE)进行分级。采用转换(生存)分析视角来估计毒性等级的分布。用Kaplan - Meier分析计算首次TACE治疗后患者的生存率。
治疗后6个月和12个月时3级或4级毒性分别包括白细胞减少(7%和19%);贫血(9%和19%);血小板减少(13%和23%);活化部分凝血活酶时间延长(8%和18%);天冬氨酸转氨酶水平升高(15%和18%)、丙氨酸转氨酶水平升高(10%和18%)以及碱性磷酸酶水平升高(8%和18%);低白蛋白血症(10%和19%);高胆红素血症(10%和22%);以及脱发(18%)。1年时累积生存率为58%,2年时为39%,3年时为29%。这些毒性发生率明显低于目前使用的全身化疗药物治疗后的报告发生率。
研究结果表明,TACE在HCC患者中具有良好的长期毒性特征。数据明确支持TACE在不可切除HCC患者治疗中的作用。