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目的:以实体肿瘤疗效评价标准(RECIST)为基准,比较血清中甲胎蛋白(AFP)变化和改良RECIST(mRE-CIST)在评价索拉非尼治疗晚期肝癌后疗效及预测预后价值。方法:规定不易进行手术治疗的晚期肝癌患者AFP基线水平>20ng/mL,且经8周索拉非尼治疗后AFP下降率>20%为AFP响应组;反之为非响应组。所有患者同时接受RECIST和mRECIST评价,且基于成像结果分为进展型疾病或疾病控制型(包括全部、部分响应型和病情稳定型)。各分组间使用Kaplan-Meier乘积极限法估计生存率,Log-rank检验比较总生存时间(OS)和疾病进展时间(TTP)。结果:符合条件的42例患者被纳入AFP响应分组评价,其中38例同时收集完整RECIST和mRECIST评价数据。15例AFP响应组患者与27例AFP非响应组患者的总生存时间比较,差异有统计学意义,P=0.019;肿瘤进展时间比较,差异亦有统计学意义,P=0.018。AFP响应组与RECIST疾病控制型生存率危险比(HR)分别为0.090(P=0.030)和0.164(P=0.011);AFP响应组和mRECIST疾病控制型HR分别为0.055(P=0.022)和0.033(P=0.021);而RECIST与mRE-CIST疾病控制型之间比较,差异无统计学意义。结论:采用AFP变化和mRECIST评估肝细胞癌索拉非尼治疗后效果及预测预后是较RECIST评价标准更合理的方法。
OBJECTIVE: To compare the changes of serum alpha-fetoprotein (AFP) and modified RECIST (mRE-CIST) in the evaluation of the efficacy and predictive value of sorafenib in the treatment of advanced hepatocellular carcinoma using solid tumor efficacy evaluation criteria (RECIST) as a benchmark. Methods: The baseline AFP level in patients with advanced hepatocellular carcinoma who were not susceptible to surgical treatment was >20 ng/mL, and after 8 weeks of sorafenib treatment, the AFP reduction rate was >20% in the AFP response group, and vice versa in the non-response group. All patients received both RECIST and mRECIST evaluations, and were classified as either progressive or disease-controlled (including all, partially responsive, and stable disease) based on imaging results. Kaplan-Meier multiplicative positive limit method was used to estimate survival among groups, and Log-rank test was used to compare overall survival time (OS) and disease progression time (TTP). RESULTS: Forty-two eligible patients were included in the evaluation of AFP response group, of which 38 patients were simultaneously collected complete RECIST and mRECIST evaluation data. The overall survival time of 15 patients with AFP response group and 27 patients with AFP non-response group had statistically significant differences (P=0.019). The difference in tumor progression time was also statistically significant (P=0.018). The hazard ratio (HR) for AFP response group and RECIST disease control was 0.090 (P=0.030) and 0.164 (P=0.011), respectively; the AFP response group and mRECIST disease control HR were 0.055 (P=0.022) and 0.033, respectively. (P=0.021); There was no statistically significant difference between RECIST and mRE-CIST disease control types. Conclusions: The use of AFP changes and mRECIST to evaluate the efficacy and prognosis of sorafenib treatment of hepatocellular carcinoma is a more reasonable method than RECIST criteria.