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Article Dans Une Revue Critical Reviews in Oncology/Hematology Année : 2021

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

Aline Barhli
Marie-Liesse Joulia
  • Fonction : Auteur
Christophe Tournigand
  • Fonction : Auteur

Résumé

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.
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hal-03560258 , version 1 (15-12-2022)

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Paternité - Pas d'utilisation commerciale

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Aline Barhli, Marie-Liesse Joulia, Christophe Tournigand, Emmanuelle Kempf. Adverse events reporting in phase 3 oncology clinical trials of checkpoint inhibitors: A systematic review. Critical Reviews in Oncology/Hematology, 2021, 157, pp.103162 -. ⟨10.1016/j.critrevonc.2020.103162⟩. ⟨hal-03560258⟩
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