RECIST 1.1与Choi标准在舒尼替尼治疗胃肠胰神经内分泌肿瘤早期疗效评估的比较

摘要

目的 比较实体瘤疗效评价标准(response evaluation criteria in solid tumors version 1.1,RECIST 1.1)和Choi标准评估舒尼替尼对晚期胃肠胰神经内分泌肿瘤(gastroenteropancreatic neuroendocrine neoplasms,GEP-NENs)的早期疗效.方法 18例使用舒尼替尼治疗的晚期GEP-NENs患者.所有患者治疗前后均行CT检查.测量治疗前及治疗后2～3个月肿瘤大小及密度变化并根据两种评价标准分别评估肿瘤的早期应答.记录肿瘤进展时间(TTP)并用Kaplan Meier法比较各组间的TTP.结果 18例患者中,使用RECIST 1.1标准评价早期疗效时,4例(22％)为部分缓解(PR),9例(50％)为疾病稳定(SD),和5例(28％)出现疾病进展(PD),PR、SD和PD组的中位TTP分别为16.6、10.8和2.3个月.根据Choi标准,8例(44％)为PR,4例(22％)为SD,6例(33％)为PD,PR、SD和PD组的中位TTP分别为未达到10.8和2.3个月.根据RECIST 1.1标准,PR和PD组、SD和PD组的TTP有显著差异(分别为P=0.007和P＜0.001),但PR和SD组的TTP差异不具有统计学意义(P=0.131).根据Choi标准,PR组的TTP较SD组和PD组长,且差异具有统计学意义(P=0.026和P＜0.001),SD组的TTP显著长于PD组(P=0.006).结论 评估舒尼替尼对GEP-NENs的早期疗效时,使用Choi标准能够较RECIST 1.1标准识别出更多的缓解病例,且Choi标准的分组TTP具有统计学差异,较RECIST 1.1标准得到更为客观的评效结果.%Objective The aim of this study was to compare the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the Choi criteria for evaluating the early response of advanced gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) to sunitinib therapy.Methods 18 patients with pathologically proven advanced GEP-NENs treated with sunitinib were enrolled in the study.Pre-and post-treatment unenhanced and bi-phasic contrast-enhanced CT was performed on all patients.Changes in the target tumor size and density from pre-treatment to 1.4-3.1 months after treatment were measured for each patient.Tumor responses were identified using the RECIST 1.1 and Choi criteria.The time to tumor progression (TIP) for each patient was measured and compared between groups using the Kaplan-Meier method.Results The treatment responses using the RECIST 1.1 were partial response (PR) in 4/18 (22％),stable disease (SD) in 9/18 (50％),and progressive disease (PD) in 5/18 (28％).The median TTP of the PR group (16.6 months) was significantly longer (P=0.007) than that of the PD group (2.3 months) and not significantly longer (P=0.131) than that of the SD group (10.8 months).Using the Choi criteria,treatment responses were PR (8/18,44％),SD (4/18,22％),and PD (6/18,33％).According to Choi criteria,the median TTP of PR,SD and PD group were not reached,10.8 and 2.3 months,respectively.The median TTP of the PR group was not reached and significantly longer (P=0.026) than that of the SD (10.8 months) and PD groups (2.3 months,P＜0.001).Conclusion The Choi criteria appear to be more sensitive and precise than RECIST 1.1 for assessing the early response of advanced GEP-NENs to sunitinib therapy.