PDF(Pubmed)
Abstract：
UNASSIGNED: As the immune-related response evaluation criteria in solid tumors (irRECIST) by imaging greatly underestimated the objective response to immunotherapy, we established the response evaluation criteria in solid tumors based on tumor markers (RecistTM) to explore whether RecistTM can compensate for the deficiencies of the irRECIST criteria.
UNASSIGNED: This was an observational study, which consisted of two parts. The first part (Group A) was a retrospective study including the patients with malignant solid tumors. The second part (Group B) was a prospective study, which were EGFR-negative and ALK-negative patients with stage IIIB-IV non-small cell lung cancer receiving first-line treatment. From January 2017 to September 2020, one hundred and ten patients with a three-time increase in tumor markers receiving immunotherapy were recruited. The treatment response to immunotherapy was evaluated by irRECIST and RecistTM. Efficacy, overall survival (OS), first evaluation time and earliest response time under the different evaluation criteria were compared by statistics.
UNASSIGNED: The treatment response evaluated by the RecistTM criteria was not consistent with that evaluated by the irRECIST criteria (Kappa = 0.386, p < 0.001). RecistTM had a higher completed response (CR) rate compared to irRECIST criteria (20.9% vs 1.8%, p < 0.001). The earliest response time under the RecistTM criteria was 3.42 weeks earlier than that under the irRECIST criteria (u = -5.233, p < 0.001). There were significant differences in median OS between tumor marker-related complete response (tmCR) and tumor marker-related partial response (tmPR), as well as between tmPR and tumor marker-related stable disease (tmSD) (χ2 = 15.572, p < 0.001; χ2 = 7.720, p = 0.005), but not between tmSD and tumor marker-related progressive disease (tmPD) (χ2 = 1.596, p = 0.206). When applying both criteria together, for patients with immune-related CR / immune-related PR (irCR/irPR) (n = 54) under irRECIST criteria, there was a significant difference in median OS between achieving tmCR (n = 22) and tmPR (n = 32) (χ2 = 14.011, p < 0.001). RecistTM criteria can predict 1-year and 2-year OS more accurately than irRECIST criteria (AUCs:0.862 vs 0.552, 0.649 vs 0.521, respectively;both p < 0.001). In RecistTM, 4 patients had been observed with pseudoprogression in tumor markers.
UNASSIGNED: The RecistTM criteria could effectively distinguish CR, PR, and SD, which may help resolve the shortcomings of the RECIST criteria in evaluating the treatment response to immunotherapy, especially in assessing whether patients can achieve deep or even complete response as soon as possible.
UNASSIGNED: This work was supported by the Key projects of Chongqing Health and Family Planning Commission (to Xueqin Yang, 2019ZDXM011).
UNASSIGNED: This was an observational study, which consisted of two parts. The first part (Group A) was a retrospective study including the patients with malignant solid tumors. The second part (Group B) was a prospective study, which were EGFR-negative and ALK-negative patients with stage IIIB-IV non-small cell lung cancer receiving first-line treatment. From January 2017 to September 2020, one hundred and ten patients with a three-time increase in tumor markers receiving immunotherapy were recruited. The treatment response to immunotherapy was evaluated by irRECIST and RecistTM. Efficacy, overall survival (OS), first evaluation time and earliest response time under the different evaluation criteria were compared by statistics.
UNASSIGNED: The treatment response evaluated by the RecistTM criteria was not consistent with that evaluated by the irRECIST criteria (Kappa = 0.386, p < 0.001). RecistTM had a higher completed response (CR) rate compared to irRECIST criteria (20.9% vs 1.8%, p < 0.001). The earliest response time under the RecistTM criteria was 3.42 weeks earlier than that under the irRECIST criteria (u = -5.233, p < 0.001). There were significant differences in median OS between tumor marker-related complete response (tmCR) and tumor marker-related partial response (tmPR), as well as between tmPR and tumor marker-related stable disease (tmSD) (χ2 = 15.572, p < 0.001; χ2 = 7.720, p = 0.005), but not between tmSD and tumor marker-related progressive disease (tmPD) (χ2 = 1.596, p = 0.206). When applying both criteria together, for patients with immune-related CR / immune-related PR (irCR/irPR) (n = 54) under irRECIST criteria, there was a significant difference in median OS between achieving tmCR (n = 22) and tmPR (n = 32) (χ2 = 14.011, p < 0.001). RecistTM criteria can predict 1-year and 2-year OS more accurately than irRECIST criteria (AUCs:0.862 vs 0.552, 0.649 vs 0.521, respectively;both p < 0.001). In RecistTM, 4 patients had been observed with pseudoprogression in tumor markers.
UNASSIGNED: The RecistTM criteria could effectively distinguish CR, PR, and SD, which may help resolve the shortcomings of the RECIST criteria in evaluating the treatment response to immunotherapy, especially in assessing whether patients can achieve deep or even complete response as soon as possible.
UNASSIGNED: This work was supported by the Key projects of Chongqing Health and Family Planning Commission (to Xueqin Yang, 2019ZDXM011).
摘要：
UASSIGNED：由于通过成像的实体瘤（irRECIST）的免疫相关反应评估标准大大低估了对免疫治疗的客观反应，我们建立了基于肿瘤标志物(RecistTM)的实体瘤应答评估标准,以探讨RecistTM是否可以弥补irRECIST标准的缺陷.
未经评估：这是一项观察性研究，它由两部分组成。第一部分（A组）是一项回顾性研究，包括恶性实体瘤患者。第二部分(B组)是一项前瞻性研究，EGFR阴性和ALK阴性的IIIB-IV期非小细胞肺癌患者接受一线治疗.从2017年1月到2020年9月，招募了一百一十名接受免疫治疗的肿瘤标志物增加三倍的患者。通过irRECIST和RecystTM评估对免疫疗法的治疗反应。功效,总生存期（OS），统计比较不同评价标准下的首次评价时间和最早响应时间。
UNASSIGNED：通过RecystTM标准评估的治疗反应与通过irRECIST标准评估的治疗反应不一致（Kappa=0.386，p<0.001）。与irRECIST标准相比，RecystTM的完成反应（CR）率更高（20.9％vs1.8％，p<0.001)。RecystTM标准下的最早响应时间比irRECIST标准下的早3.42周(u=-5.233,p<0.001)。肿瘤标志物相关完全应答(tmCR)和肿瘤标志物相关部分应答(tmPR)的中位OS差异显著,以及tmPR和肿瘤标志物相关的稳定疾病（tmSD）之间（χ2=15.572，p<0.001；χ2=7.720，p=0.005），但不在tmSD和肿瘤标志物相关进展性疾病（tmPD）之间（χ2=1.596，p=0.206）。当同时应用这两个标准时，对于根据irRECIST标准患有免疫相关CR/免疫相关PR（irCR/irPR）（n=54）的患者，达到tmCR（n=22）和tmPR（n=32）的中位OS差异有统计学意义（χ2=14.011，p<0.001）。RecystTM标准可以比irRECIST标准更准确地预测1年和2年OS(AUC:0.862vs0.552,0.649vs0.521;两者均p<0.001)。在RecistTM中,已观察到4例患者的肿瘤标志物出现假性进展。
未经评估：RecistTM标准可以有效区分CR，PR,SD,这可能有助于解决RECIST标准在评估免疫治疗反应方面的缺陷，特别是在评估患者是否可以尽快达到深度甚至完全的反应。
UNASSIGNED:这项工作得到了重庆市卫生和计划生育委员会重点项目的支持(杨雪琴,2019ZDXM011）。
未经评估：这是一项观察性研究，它由两部分组成。第一部分（A组）是一项回顾性研究，包括恶性实体瘤患者。第二部分(B组)是一项前瞻性研究，EGFR阴性和ALK阴性的IIIB-IV期非小细胞肺癌患者接受一线治疗.从2017年1月到2020年9月，招募了一百一十名接受免疫治疗的肿瘤标志物增加三倍的患者。通过irRECIST和RecystTM评估对免疫疗法的治疗反应。功效,总生存期（OS），统计比较不同评价标准下的首次评价时间和最早响应时间。
UNASSIGNED：通过RecystTM标准评估的治疗反应与通过irRECIST标准评估的治疗反应不一致（Kappa=0.386，p<0.001）。与irRECIST标准相比，RecystTM的完成反应（CR）率更高（20.9％vs1.8％，p<0.001)。RecystTM标准下的最早响应时间比irRECIST标准下的早3.42周(u=-5.233,p<0.001)。肿瘤标志物相关完全应答(tmCR)和肿瘤标志物相关部分应答(tmPR)的中位OS差异显著,以及tmPR和肿瘤标志物相关的稳定疾病（tmSD）之间（χ2=15.572，p<0.001；χ2=7.720，p=0.005），但不在tmSD和肿瘤标志物相关进展性疾病（tmPD）之间（χ2=1.596，p=0.206）。当同时应用这两个标准时，对于根据irRECIST标准患有免疫相关CR/免疫相关PR（irCR/irPR）（n=54）的患者，达到tmCR（n=22）和tmPR（n=32）的中位OS差异有统计学意义（χ2=14.011，p<0.001）。RecystTM标准可以比irRECIST标准更准确地预测1年和2年OS(AUC:0.862vs0.552,0.649vs0.521;两者均p<0.001)。在RecistTM中,已观察到4例患者的肿瘤标志物出现假性进展。
未经评估：RecistTM标准可以有效区分CR，PR,SD,这可能有助于解决RECIST标准在评估免疫治疗反应方面的缺陷，特别是在评估患者是否可以尽快达到深度甚至完全的反应。
UNASSIGNED:这项工作得到了重庆市卫生和计划生育委员会重点项目的支持(杨雪琴,2019ZDXM011）。
