More thoughts on the reporting of adverse events in cancer clinical trials. Clinical Oncology

摘要

To the Editor: In an article in the August 20,2006, issue of the Journal of Clinical Oncology, Scharf and Colevas1 described the variability in the reporting of adverse events (AEs) in phase II trials. In the accompanying editorial, Anderson2 deplored the "inconsistent and incomplete characterization and reporting of high-grade AEs." Scharf and Colevas do not distinguish between hematologic and nonhema-tologic AEs. My research has led me to pay considerable attention to AE reporting, and one of the areas in which AEs are reported especially inconsistently is hematologic toxicity. For example, in the same period covered by Scharf and Colevas's series, two randomized studies published in the same year in this very journal reported on the doxorubicin-cydophosphamide regimen; one reported an incidence of grade 3/4 neutropenia of 6.3%,3 the other reported an incidence of 88%.