![]() However, because the PRO-CTCAE analysis was prespecified in the approved protocol, we conducted the analysis. The study protocol for the trial was amended, with the dose reduced to 3 mg/kg, but the trial was terminated early for an unfavorable risk:benefit ratio. ![]() Ipilimumab 10 mg/kg was initially used but resulted in a higher-than-expected irAE rate in the first six patients. This study aimed to evaluate whether the addition of PRO-CTCAE to standard care during oncology clinical trials can lead to a more comprehensive understanding of patients’ experience of irAEs. ![]() A customized survey of 14 questions covering the previous 7 days was incorporated into each clinic visit. The PRO-CTCAE items chosen represented the symptoms and related severities most often associated with ICI treatment. HSPC may have immunologic differences compared with castration-resistant prostate cancer, providing a therapeutic opportunity for ICI in this earlier disease setting. ![]() To address this, we incorporated selected items from the NCI’s PRO-CTCAE into a phase II clinical trial ( Identifier: NCT02020070) evaluating the efficacy and safety of ipilimumab, a humanized monoclonal antibody directed to the cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) in combination with standard androgen deprivation therapy (ADT) in patients with hormone-sensitive prostate cancer (HSPC). Limited data are available about the benefit of using PRO-CTCAE to monitor irAEs resulting from treatment with ICIs in clinical trials. ![]()
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