Outcomes of patients with solid tumour malignancies treated with first-line immuno-oncology agents who do not meet eligibility criteria for clinical trials
Outcomes of patients with solid tumour malignancies treated with first-line immuno-oncology agents who do not meet eligibility criteria for clinical trials
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DOI：
10.1016/j.ejca.2021.04.004
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发表时间：
2021-05-08
影响因子：
8.4
通讯作者：
Heng, Daniel Y. C.
中科院分区：
文献类型：
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作者：
Gan, Chun L.;Stukalin, Igor;Heng, Daniel Y. C.
背景资料：基于免疫肿瘤学（IO）的治疗已基于随机临床试验获得批准，但这些试验中未代表相当大比例的真实患者。我们试图比较试验不合格与患者和方法：使用国际转移性肾细胞癌（RCC）数据库联盟和阿尔伯塔免疫治疗数据库，包括用基于1 L PD-（L）1抑制的治疗治疗的晚期RCC、非小细胞肺癌（NSCLC）或黑色素瘤患者。根据常用的排除标准回顾性确定试验合格性。研究结果包括总生存期（OS）、总缓解率（ORR）、治疗持续时间（TD）和下次治疗时间（TTNT）。根据预先选定的排除标准，不合格的主要原因是Karnofsky体力状态1（40%，395例中的158例），脑转移（32%，395例中的126例），血红蛋白< 9 g/dL（16%，395例中的63例）和估计的肾小球滤过率
Background: Immuno-oncology (IO)-based therapies have been approved based on randomised clinical trials, yet a significant proportion of real-world patients are not represented in these trials. We sought to compare the outcomes of trial-ineligible vs.-eligible patients with advanced solid tumours treated with first-line (1L) IO therapy.Patients and methods: Using the International Metastatic Renal Cell Carcinoma (RCC) Database Consortium and the Alberta Immunotherapy Database, patients with advanced RCC, non-small-cell lung cancer (NSCLC) or melanoma treated with 1L PD-(L)1 inhibition-based therapy were included. Trial eligibility was retrospectively determined as per commonly used exclusion criteria. The outcomes of interest were overall survival (OS), overall response rate (ORR), treatment duration (TD) and time to next treatment (TTNT).Results: A total of 395 of 1241 (32%) patients were deemed trial-ineligible. The main reasons for ineligibility based on preselected exclusion criteria were Karnofsky performance status 1 (40%, 158 of 395), brain metastases (32%, 126 of 395), haemoglobin < 9 g/dL (16%, 63 of 395) and estimated glomerular filtration rate