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.

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

Bironzo P.;Sonetto C.;Di Maio M.
Co-last
;
2019-01-01

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.
2019
15
21
2543
2553
http://www.futuremedicine.com/loi/fon
immunotherapy; Systematic Review; targeted treatments; toxicities; Antineoplastic Combined Chemotherapy Protocols; Clinical Trials as Topic; Humans; Immunotherapy; Molecular Targeted Therapy; Neoplasms; Treatment Outcome
Bossi P.; Botta L.; Bironzo P.; Sonetto C.; Musettini G.; Sbrana A.; Di Giannantonio V.; Locati L.D.; Di Maio M.; Antonuzzo A.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1729972
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