Paolo Bossi1, Laura Botta2, Paolo Bironzo3, Cristina Sonetto3, Gianna Musettini4, Andrea Sbrana4, Valerio Di Giannantonio5, Laura D Locati5, Massimo Di Maio6, Andrea Antonuzzo4. 1. Medical Oncology Unit, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, ASST Spedali Civili and University of Brescia, Italy. 2. Department of Epidemiological and Molecular Medicine Research, Evaluative Epidemiology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Italy. 3. AOU S Luigi Gonzaga, Orbassano, Turin & Department of Oncology, University of Turin, Turin, Italy. 4. Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 5. Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. 6. Ordine Mauriziano Hospital, Turin & Department of Oncology, University of Turin, Turin, Italy.
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.
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.