Adverse events reporting in phase 3 oncology clinical trials of checkpoint inhibitors: A systematic review

被引：1

作者：

Barhli, Aline ^{[1
]}

Joulia, Marie-Liesse ^{[1
]}

Tournigand, Christophe ^{[1
,2
]}

Kempf, Emmanuelle ^{[1
,2
]}

机构：

[1] Hop Henri Mondor, AP HP, Serv Oncol Med, 52 Ave Marechal de Lattre de Tassigny, F-94000 Creteil, France

[2] Univ Paris Est Creteil, INSERM, IMRB, F-94010 Creteil, France

来源：

CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY | 2021年 / 157卷

关键词：

Quality reporting; Immune toxicity; Adverse event; Immune checkpoint inhibitors; Systematic review; COMMON TERMINOLOGY CRITERIA; TOXICITIES; BLOCKADE; NIVOLUMAB; PATIENT;

D O I：

10.1016/j.critrevonc.2020.103162

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Introduction: This study aimed at exploring adverse events (AEs) reporting in cancer trials involving immune checkpoint inhibitors (ICIs). Method: A systematic review on how ICIs phase 3 trials follow TRIO and 2004 CONSORT harms extension recommendations referring to toxicity was performed by two independent reviewers. Results: Among 46 trials included, 74 % did not present separately grade 3 and grade 4 AEs. Timing of onset and duration were reported in 30 % and 28 %, respectively. AEs occurring in <10 % of patients were only reported in 35 % of studies. Patient-related outcomes (PROs) were analyzed in only 17 % of reports. Eight articles qualified the toxicity profile as "manageable", "tolerable", "well tolerated" or "favorable" despite reporting a rate of grade 3-4 greater than 33 %. Conclusion: Reporting toxicity results is crucial. However, toxicity reporting is highly incomplete in clinical trials. Guidelines, new metrics and incorporation of PROs are needed for a comprehensive knowledge of toxicity profile.

引用

页数：7

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