Objective To evaluate the early effects of a tumor targeted agent M2ES in phase I trial in the patients with metastatic liver cancer using quantitative analysis of CEUS, and to investigate the correlation between response evaluation criteria in solid tumors (RECIST) and tumor perfusion parameters. Methods Fifteen patients with metastatic liver cancer were enrolled in this study. M2ES was administrated 15, 30, 45, 60 mg/mz once a week for three weeks, respectively. CEUS was performed before treatment and on the 2 nd, 7 th, 9 th, 14 th, 16 th, and 21 st days after treatment, quantitative analysis was performed using SonoTumor software. All patients were rated as responders or nonresponders according to RECIST. Results The percentage changes in several parameters including peak enhancement and wash-in area under curve revealed decrease at the 2 nd and the 9 th day, showing correlation with RECIST response (P<0. 05), but returned to the lever of pretherapy on the 7 th and 14 th days. Conclusion CEUS allows the early quantitative evaluation of tumor perfusion for M2ES in phase I trial of the patients with metastatic liver cancer.%目的 观察CEUS定量分析在肿瘤血管靶向药物M2ES Ⅰ期临床试验疗效评估中的应用价值,分析定量灌注参数与实体瘤疗效评价标准(RECIST标准)的相关性.方法 对15例肝转移癌患者,分别按不同给药剂量(15、30、45、60 mg/m2)每周给药1次,共3次.对每例患者于治疗前及给药后第2、7、9、14、16、21天分别行常规超声及CEUS检查.使用SonoTumor定量分析软件计算各功能参数.疗效评估采用RECIST标准.结果 与无效组比较,有效组CEUS定量分析的流入相曲线下面积及峰值强度在治疗后第2、9天明显减低(P＜0.05),但在第7、14天恢复至治疗前水平.结论 在肿瘤血管靶向药物Ⅰ期临床试验中,CEUS定量分析能够早期评价用药后肿瘤的血流灌注变化.
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