RE-CIST 1.1 与 mRECIST 用于评估肝细胞癌患者分子靶向治疗的肿瘤反应和疾病结局：系统评价和荟萃分析。

RECIST 1.1 versus mRECIST for assessment of tumour response to molecular targeted therapies and disease outcomes in patients with hepatocellular carcinoma: a systematic review and meta-analysis.

机构信息

Department of Gastroenterology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.

Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.

出版信息

BMJ Open. 2022 Jun 1;12(6):e052294. doi: 10.1136/bmjopen-2021-052294.

OBJECTIVES

Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) and modified RECIST (mRECIST) are commonly used to assess tumour response. Which one is better to evaluate efficacy after molecular targeted therapies in hepatocellular carcinoma (HCC) patients is still controversial. A systemic review was performed to compare the objective response rate (ORR) and disease control rate (DCR) and a meta-analysis was conducted to compare the correlation between objective response and overall survival (OS).

DESIGN

Systematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation approach.

DATA SOURCES

EMBASE, PubMed, Web of Science and Cochrane Library were searched through 31 December 2021.

ELIGIBILITY CRITERIA

We included studies assessing the efficacy of molecular targeted therapy for HCC according to both RECIST 1.1 and mRECIST.

DATA EXTRACTION AND SYNTHESIS

Two investigators extracted data independently. The consistency between RECIST 1.1 vs mRECIST is measured by the k coefficient. HRs with corresponding 95% CIs were used for meta-analysis.

RESULTS

23 studies comprising 2574 patients were included in systematic review. The ORR according to mRECIST is higher than RECIST1.1 (15.9% vs 7.8%, p<0.001). The DCR is similar (68.4% vs 67.2%, p=0.5). The agreement of tumour response is moderate for objective response (k=0.499) and perfect for progressive disease (k=0.901), calculated from 8 studies including 372 patients. OS was significantly longer in response group than non-response group according to mRECIST (HR 0.56, 95% CI 0.41 to 0.78, p0.0004) calculated from 7 studies including 566 patients, however, the RECIST1.1 could not distinguish the OS well (HR 0.68, 95% CI 0.44 to 1.05, p=0.08). Subgroup analusis by type of treatment was conducted.

CONCLUSIONS

mRECIST may be more accurate than RECIST 1.1 in assessing ORR after molecular targeted therapies in HCC patients and can better assess the prognosis. However, the performance of both criteria in assessing disease progression is identical.

PROSPERO REGISTRATION NUMBER

CRD42020200895.

ETHICS APPROVAL

Ethics approval is not required in this meta-analysis.

目的

实体瘤反应评价标准 1.1 版（RECIST 1.1）和改良 RECIST（mRECIST）常用于评估肿瘤反应。在肝细胞癌（HCC）患者中，哪种方法更适合评估分子靶向治疗后的疗效仍存在争议。本系统评价旨在比较客观缓解率（ORR）和疾病控制率（DCR），并进行荟萃分析以比较客观缓解与总生存期（OS）之间的相关性。

设计

采用推荐评估、制定和评估分级系统进行系统评价和荟萃分析。

数据来源

通过 2021 年 12 月 31 日检索 EMBASE、PubMed、Web of Science 和 Cochrane Library 进行荟萃分析。

纳入标准

我们纳入了根据 RECIST 1.1 和 mRECIST 评估分子靶向治疗 HCC 疗效的研究。

数据提取和综合

两位研究者独立提取数据。RECIST 1.1 与 mRECIST 的一致性通过 k 系数进行测量。使用具有相应 95%置信区间的 HR 进行荟萃分析。

结果

系统评价共纳入 23 项研究，共计 2574 例患者。mRECIST 下的 ORR 高于 RECIST1.1（15.9% vs. 7.8%，p<0.001）。DCR 相似（68.4% vs. 67.2%，p=0.5）。8 项研究共 372 例患者的肿瘤反应的一致性为中度（k=0.499），进展性疾病的一致性为完美（k=0.901）。7 项研究共 566 例患者的 mRECIST 计算 OS 结果显示，缓解组的 OS 明显长于非缓解组（HR 0.56，95% CI 0.41 至 0.78，p0.0004），而 RECIST1.1 不能很好地区分 OS（HR 0.68，95% CI 0.44 至 1.05，p=0.08）。按治疗类型进行亚组分析。

结论

mRECIST 可能比 RECIST 1.1 更能准确评估 HCC 患者分子靶向治疗后的 ORR，并能更好地评估预后。然而，这两种标准在评估疾病进展方面的表现是相同的。

前瞻性注册

CRD42020200895。

伦理批准

本荟萃分析不需要伦理批准。