A prospective cohort study on the safety of checkpoint inhibitors in older cancer patients – the ELDERS study

ESMO Open

article

F. Gomes¹  P. Lorigan¹  S. Woolley⁴  P. Foden⁵  K. Burns⁴  J. Yorke²  F. Blackhall¹ 

[1] Medical Oncology Department, The Christie NHS Foundation Trust;Patient-Centred Research Centre, The Christie NHS Foundation Trust;Division of Medical Sciences, University of Manchester;Research & Innovation Department, The Christie NHS Foundation Trust;Data Analytics Department, The Christie NHS Foundation Trust;Division of Nursing, Midwifery and Social Work, University of Manchester

关键词: immunotherapy;    cancer;    toxicity;    elderly;    ELDERS;    G8;   

DOI  :  10.1016/j.esmoop.2020.100042

学科分类：社会科学、人文和艺术（综合）

来源: BMJ Publishing Group

【 摘 要 】

Objective Older cancer patients are underrepresented in the pivotal trials of checkpoint inhibitors (CPIs). This study aimed to investigate the impact of an ageing immune system on CPI-related toxicity and provide evidence for the role of geriatric assessments with CPI.Methods The ELDERS study is a prospective observational study with two cohorts: older (70+ years of age) and younger (<70 years of age). Patients with advanced/metastatic non-small-cell lung cancer or melanoma starting single-agent CPI were eligible. The older cohort was assessed for frailty with Geriatric-8 (G8) screening, which when positive (<15 points) was followed by a holistic set of geriatric assessments. Primary endpoint was the incidence of grade 3-5 immune-related adverse events (irAEs).Results One hundred and forty patients were enrolled with 43% being pretreated and pembrolizumab represented 92% of treatments on study. The older cohort had a significantly higher comorbidity burden (P < 0.001) and polypharmacy (P = 0.004). While 50% of older patients had a positive G8 screening, 60% on this frail subgroup had a performance status score of 0 or 1. There was no significant difference in the incidence of irAEs grade 3-5 between older and younger cohorts (18.6% versus 12.9%; odds ratio 1.55, confidence interval 95% 0.61-3.89; P = 0.353). Exposure to systemic steroids due to irAEs was numerically longer for older patients (22 versus 8 weeks; P = 0.208). A positive G8 screening predicted hospital admissions (P = 0.031) and risk of death (P = 0.01).Conclusions The use of CPI in older patients was not associated with more high-grade toxicity. The G8 screening identified a subgroup with higher risk of AEs and its implementation should be considered in the context of CPI.

【 授权许可】

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