Abdel-Rahman Omar
Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Immunotherapy. 2017 Sep;9(12):995-1004. doi: 10.2217/imt-2017-0074.
The use of immune checkpoint inhibitors in the treatment of solid tumors has been expanding recently. Standard response evaluation criteria are not well suited to evaluate the clinical benefit from these agents. To systematically review the incidence and characteristics of nonconventional patterns of benefit observed in solid tumors treated with immune checkpoint inhibitors.
MATERIALS & METHODS: MEDLINE and EMBASE databases have been searched. Moreover, reference lists of relevant articles were checked for cross-references.
Clinical studies evaluating PD-(L)1 inhibitors for the management of advanced solid tumors irrespective of the publication status or language. The review author extracted relevant data on the characteristics of participants and the outcomes of the different studies.
Nineteen prospective trials with 5404 participants were included. Among patients experiencing RECIST-defined progression and continued treatment beyond progression, rates of response beyond progression ranged from 4 to 10% (of the total number of included patients). These findings were similarly observed regardless of the PD-(L)1 inhibitor used, the disease treated, or the dose used indicating that these findings are part of the inherent characteristics of PD-(L)1 inhibitors for solid tumors. These findings need confirmation from the results of other prospective studies. Many additional ongoing trials were identified evaluating the use of PD-(L)1 inhibitors for the management of solid tumors.
Traditional RECIST criteria are not suited for proper assessment of response to PD-(L)1 inhibitors; and more tailored criteria (e.g. immune-related response criteria) should be employed for patients treated with PD-(L)1 inhibitors; moreover in patients with an evidence of disease progression on initial disease evaluation, treatment should not be stopped except after confirmation of progressive disease with a second evaluation at least 4 weeks later.
免疫检查点抑制剂在实体瘤治疗中的应用近来不断扩大。标准的疗效评估标准并不十分适合评估这些药物的临床获益。本研究旨在系统回顾在接受免疫检查点抑制剂治疗的实体瘤中观察到的非常规获益模式的发生率及特征。
检索了MEDLINE和EMBASE数据库。此外,还检查了相关文章的参考文献列表以获取交叉引用信息。
评估PD-(L)1抑制剂用于晚期实体瘤治疗的临床研究,无论其发表状态或语言。综述作者提取了关于参与者特征及不同研究结果的相关数据。
纳入了19项前瞻性试验,共5404名参与者。在经历了RECIST标准定义的疾病进展且进展后继续治疗的患者中,进展后缓解率为4%至10%(占纳入患者总数)。无论使用何种PD-(L)1抑制剂、治疗的疾病或使用的剂量,均观察到类似结果,这表明这些结果是PD-(L)1抑制剂治疗实体瘤固有特征的一部分。这些结果需要其他前瞻性研究结果的证实。还确定了许多正在进行的评估PD-(L)1抑制剂用于实体瘤治疗的试验。
传统的RECIST标准不适用于正确评估对PD-(L)1抑制剂的反应;对于接受PD-(L)1抑制剂治疗的患者,应采用更具针对性的标准(如免疫相关反应标准);此外,对于初始疾病评估显示有疾病进展证据的患者,除非至少4周后再次评估确认疾病进展否则不应停止治疗。