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免疫检查点抑制剂在老年癌症患者中的安全性和有效性:48 项真实世界研究的系统评价。

Safety and Effectiveness of Immune Checkpoint Inhibitors in Older Patients with Cancer: A Systematic Review of 48 Real-World Studies.

机构信息

Oncology Unit, Medical Sciences Department, ASST Bergamo Ovest, Piazzale Ospedale 1, 24047, Treviglio, BG, Italy.

Oncology Unit, Casa di cura Igea, Milan, Italy.

出版信息

Drugs Aging. 2021 Dec;38(12):1055-1065. doi: 10.1007/s40266-021-00899-7. Epub 2021 Oct 20.

DOI:10.1007/s40266-021-00899-7
PMID:34671933
Abstract

BACKGROUND

Over recent years, immune checkpoint inhibitors (ICIs) have changed the clinical management and prognosis for most cancers. However, data on older patients in clinical trials are scarce.

OBJECTIVE

We performed a systematic review and pooled analysis of real-life studies to explore the efficacy and toxicity of ICIs in unselected older individuals in multiple tumor settings treated outside of clinical trials.

PATIENTS AND METHODS

We searched articles, including prospective cohort studies, observational or retrospective series, or expanded access programs, published in English from 2010 to October 2020 in PubMed, MEDLINE, the Cochrane Library, and EMBASE. We excluded hematological malignancies.

RESULTS

Forty-eight studies met the predefined criteria and were eligible for inclusion in the systematic review. We included 5524 patients. The pooled median overall survival was 8.9 (95% CI 7.3-10.5) and 14.3 (95% CI 11.3-17) months for non-small cell lung cancer (NSCLC: n = 17 studies; 95% in pretreated setting) and melanoma, respectively (n = 3). Median progression-free survival was 3.2 (95% CI 2.7-3.8) and 7.9 (95% CI 6.05-9.78) months for NSCLC and melanoma cohorts. Pooled rates of Grade 1-5 hepatitis, pneumonitis, hypothyroidism, and diarrhea were 5.3% (95% CI 3.7-7.6), 6% (95% CI 3.8-9.4), 8.3% (95% CI 5.4-12.5) and 7.6% (95% CI 5.7-10), respectively.

CONCLUSIONS

Our findings suggest that ICIs could be safely administered in older individuals with comparable survival outcomes with respect to younger individuals. Future studies should include some form of geriatric assessment to improve patient stratification.

摘要

背景

近年来,免疫检查点抑制剂(ICIs)改变了大多数癌症的临床治疗和预后。然而,临床试验中关于老年患者的数据却很少。

目的

我们进行了系统回顾和汇总分析,以探索在临床试验之外的多种肿瘤环境中,未经选择的老年患者使用免疫检查点抑制剂的疗效和毒性。

患者和方法

我们检索了 2010 年至 2020 年 10 月在 PubMed、MEDLINE、Cochrane 图书馆和 EMBASE 发表的英文文章,包括前瞻性队列研究、观察性或回顾性系列研究或扩展准入计划。我们排除了血液恶性肿瘤。

结果

48 项研究符合预先设定的标准,有资格进行系统回顾。我们纳入了 5524 名患者。非小细胞肺癌(NSCLC:预处理组 n=17 项研究;95%置信区间 7.3-10.5)和黑色素瘤的中位总生存期分别为 8.9(95%置信区间 7.3-10.5)和 14.3(95%置信区间 11.3-17)个月(n=3)。中位无进展生存期分别为 NSCLC 和黑色素瘤队列的 3.2(95%置信区间 2.7-3.8)和 7.9(95%置信区间 6.05-9.78)个月。1-5 级肝炎、肺炎、甲状腺功能减退和腹泻的汇总发生率分别为 5.3%(95%置信区间 3.7-7.6)、6%(95%置信区间 3.8-9.4)、8.3%(95%置信区间 5.4-12.5)和 7.6%(95%置信区间 5.7-10)。

结论

我们的研究结果表明,免疫检查点抑制剂在老年患者中是安全的,且与年轻患者的生存结果相当。未来的研究应包括某种形式的老年评估,以改善患者分层。

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