Zhou Meng, Zhang Chunhui, Nie Jianhua, Sun Yajuan, Xu Ye, Wu Fangfang, Huang Yuhong, Li Shun, Wang Yuan, Zhou Yang, Zheng Tongsen
Department of Gastrointestinal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Department of Radiology, Harbin Medical University Cancer Hospital, Harbin, China.
Front Oncol. 2021 Dec 9;11:764189. doi: 10.3389/fonc.2021.764189. eCollection 2021.
Precise evaluation of the efficacy of immunotherapy is critical in the effective management and treatment of advanced hepatocellular carcinoma (HCC). Therefore, the purpose of this study was to compare the response assessments achieved by different criteria and to evaluate the correlation between survival outcome and response assessment in HCC treated with programmed cell death protein 1 (PD-1) inhibitor.
Fifty patients with advanced HCC treated with first-line PD-1 inhibitor with baseline and follow-up CT images were analyzed. The patients were categorized into responders and nonresponders according to the criteria.
When the response assessments between RECIST 1.1 and mRECIST were compared, no statistically significant differences were observed. Overall response rate was 16% by RECIST 1.1 and iRECIST and was 24% by mRECIST. According to RECIST 1.1 and mRECIST, overall survival (OS) and progression-free survival (PFS) were not statistically different between the complete response (CR) and partial response (PR) groups and the stable disease (SD) and progressive disease (PD) groups. The OS and PFS were significantly different between responders and nonresponders according to mRECIST. The Cohen's Kappa for RECIST 1.1, iRECIST, and mRECIST was 0.534, 0.438, and 0.363, respectively.
The mRECIST criteria have a powerful ability to discriminate between responders and nonresponders and demonstrated significantly longer OS and PFS in responders than in nonresponders. However, mRECIST needs to be further improved in order for it to be widely used in the clinical evaluation of immunotherapy in HCC.
准确评估免疫疗法的疗效对于晚期肝细胞癌（HCC）的有效管理和治疗至关重要。因此，本研究的目的是比较不同标准所达成的疗效评估，并评估程序性细胞死亡蛋白1（PD - 1）抑制剂治疗的HCC患者生存结局与疗效评估之间的相关性。
分析了50例接受一线PD - 1抑制剂治疗且有基线和随访CT图像的晚期HCC患者。根据标准将患者分为反应者和无反应者。
比较RECIST 1.1和mRECIST的疗效评估时，未观察到统计学上的显著差异。根据RECIST 1.1和iRECIST，总体缓解率为16%，根据mRECIST为24%。根据RECIST 1.1和mRECIST，完全缓解（CR）和部分缓解（PR）组与疾病稳定（SD）和疾病进展（PD）组之间的总生存期（OS）和无进展生存期（PFS）在统计学上无差异。根据mRECIST，反应者和无反应者之间的OS和PFS有显著差异。RECIST 1.1、iRECIST和mRECIST的 Cohen's Kappa分别为0.534、0.438和0.363。
mRECIST标准在区分反应者和无反应者方面具有强大能力，并且显示反应者的OS和PFS明显长于无反应者。然而，mRECIST需要进一步改进，以便在HCC免疫疗法的临床评估中广泛应用。
