Medical Oncology 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genoa, Italy.
Melanoma, Sarcoma & Rare Tumors Division, European Institute of Oncology (IEO), Milan, Italy.
BMC Cancer. 2021 Apr 17;21(1):425. doi: 10.1186/s12885-021-08165-0.
Treatment beyond progression with immunotherapy may be appropriate in selected patients based on the potential for late responses. The aim of this systematic review was to explore the impact of treatment beyond progression in patients receiving an anti-PD-1/PD-L1 based regimen for an advanced solid tumor.
A systematic literature search was performed to identify prospective clinical trials reporting data on overall response rate by immune-related criteria and/or the number of patients treated beyond conventional criteria-defined PD and/or the number of patients achieving a clinical benefit after an initial PD with regimens including an anti-PD-1/PD-L1 agent which received the FDA approval for the treatment of an advanced solid tumor.
254 (4.6%) responses after an initial RECIST-defined progressive disease were observed among 5588 patients, based on 35 trials included in our analysis reporting this information. The overall rate of patients receiving treatment beyond progressive disease was 30.2%, based on data on 5334 patients enrolled in 36 trials, and the rate of patients who achieved an unconventional response among those treated beyond progressive disease was 19.7% (based on 25 trials for a total of 853 patients).
The results of our systematic review support the clinical relevance of unconventional responses to anti-PD-1/PD-L1-based regimens; however, most publications provided only partial information regarding immune-related clinical activity, or did not provide any information at all, highlighting the need of a more comprehensive report of such data in trials investigating immunotherapy for the treatment of patients with advanced tumors.
基于潜在的晚期反应，对于某些患者，免疫治疗进展后继续治疗可能是合适的。本系统综述的目的是探讨在接受抗 PD-1/PD-L1 方案治疗晚期实体瘤的患者中，进展后治疗的影响。
进行了系统文献检索，以确定报告根据免疫相关标准和/或超出常规标准定义的 PD 治疗的患者数量和/或在初始 PD 后实现临床获益的患者数量的前瞻性临床试验数据，这些试验包括抗 PD-1/PD-L1 药物，该药物已获得 FDA 批准用于治疗晚期实体瘤。
根据我们分析中报告此信息的 35 项试验，在 5588 名患者中观察到 254 例（4.6%）初始 RECIST 定义进展后疾病的缓解。基于在 36 项试验中招募的 5334 名患者的数据，超过进展后疾病接受治疗的患者总体比例为 30.2%，而在超过进展后疾病接受治疗的患者中实现非常规缓解的比例为 19.7%（基于 25 项试验共 853 名患者）。
我们的系统综述结果支持抗 PD-1/PD-L1 方案非常规缓解的临床相关性；然而，大多数出版物仅提供了关于免疫相关临床活性的部分信息，或者根本没有提供任何信息，突出了在研究免疫治疗治疗晚期肿瘤患者的试验中更全面报告此类数据的必要性。
