Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy

Paolo Bossi, Laura Botta, Paolo Bironzo, Cristina Sonetto, Gianna Musettini, Andrea Sbrana, Valerio Di Giannantonio, Laura D. Locati, Massimo Di Maio, Andrea Antonuzzo

Research output: Contribution to journalReview article

Abstract

Aim: Reporting toxicities of targeted therapies (TTs) and immunotherapy in oncology requires special attention. Materials & methods: We identified TTs and immunotherapies approved by the US FDA for solid malignancies in the adult population. Publications were reviewed according to a 24-point score based on the Consolidated Standards of Reporting Trials guidance. Results: We identified 81 trials (>45,000 patients). The experimental drug was studied as single agent in 51% of the cases; setting of disease was mainly (95%) advanced/metastatic. Lowest scores in adverse event (AE) description regarded: reporting recurrent/late toxicities and duration of the AEs (>90%), time of occurrence and indication of all-grade AEs (>75%). Conclusion: Suboptimal reporting of AEs in trials leading to approval of TTs and immunotherapy was shown. Improving AE descriptions should be a priority in ongoing trials.

Original languageEnglish
Pages (from-to)2543-2553
Number of pages11
JournalFuture Oncology
Volume15
Issue number21
DOIs
Publication statusPublished - Jul 2019

Keywords

  • immunotherapy
  • Systematic Review
  • targeted treatments
  • toxicities

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Bossi, P., Botta, L., Bironzo, P., Sonetto, C., Musettini, G., Sbrana, A., Di Giannantonio, V., Locati, L. D., Di Maio, M., & Antonuzzo, A. (2019). Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. Future Oncology, 15(21), 2543-2553. https://doi.org/10.2217/fon-2018-0772