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• W2597937711 abstract "147 Background: ENZ is an androgen receptor inhibitor that improved survival in studies of men with mCRPC. Seizure is a risk of ENZ treatment, and patients (pts) with seizure risk factors were excluded in prior studies. In the TRUVEN report (data on file), pts with mCRPC and potential seizure risk factors, but no ENZ exposure, had a seizure rate of 2.8/100 pt-years. The UPWARD study assessed the seizure risk in ENZ-treated pts with mCRPC who had potential seizure risk factors. Methods: This was a global, multicenter, single-arm, open-label safety study. Enrolled pts had ≥ 1 baseline potential seizure risk factor, including medications lowering seizure threshold, stroke, or prior seizure history. Evaluable pts had ≥ 3 months (ms) of treatment with ENZ or ≥ 1 confirmed seizure in a 4-m treatment period. Exclusion criteria included seizure within the past 12 ms and receipt of anti-epileptic medication. Pts received ENZ (160 mg/day). The primary end point was the proportion of evaluable pts with ≥ 1 confirmed seizure during the 4-m treatment period. Results: A total of423 pts received ENZ; 366 were evaluable. Baseline seizure risk factors were medications lowering seizure threshold (n = 242), brain injury (n = 112), and cerebrovascular accident/transient ischemic attack history (n = 94). Four (1.1%) evaluable pts had ≥ 1 confirmed seizure within 4 ms of ENZ initiation. Four (1.1%) pts had a first seizure after 4 ms. The rate of confirmed seizure was 2.6/100 pt-years. 357 pts (84.4%) experienced ≥ 1 treatment-emergent adverse event (TEAE); 141 (33.3%) had ≥ 1 serious TEAE and 29 (6.9%) had ≥ 1 drug-related serious AE. 38 (9.0%) deaths were reported during treatment/within 30 days of discontinuation; four deaths were considered possibly drug related (cerebral hemorrhage, mCRPC progression, sudden cardiac death, and general deterioration). Conclusions: The incidence of confirmed seizures in the UPWARD study is similar to pts with mCRPC and similar risk factors but no ENZ exposure in the TRUVEN report. ENZ was generally well tolerated, and TEAE data are consistent with its known safety profile. These results suggest that ENZ did not increase the risk of seizures in the UPWARD study. Clinical trial information: NCT01977651." @default.
• W2597937711 created "2017-04-07" @default.
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• W2597937711 date "2017-02-20" @default.
• W2597937711 modified "2023-09-24" @default.
• W2597937711 title "Seizure rates in enzalutamide (ENZ)-treated men with metastatic castration-resistant prostate cancer (mCRPC) at increased risk of seizure: UPWARD study." @default.
• W2597937711 doi "https://doi.org/10.1200/jco.2017.35.6_suppl.147" @default.
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