METHODS: Sixty-two Japanese patients with non-metastatic castration-resistant prostate cancer treated with 240 mg/day of apalutamide were enrolled in the present study.
RESULTS: Twenty-four patients (38.7%) developed cutaneous adverse events. Multivariable logistic regression analysis of age, height, and body weight identified body weight as a significant predictive factor for the incidence of cutaneous adverse events (p=0.019). When the mean body weight of patients (63.80 kg) was set as the cut-off value, the Kaplan-Meier analysis revealed that the risk of cutaneous adverse events was significantly increased in those with a body weight <63.8 kg (p=0.003, the log-rank test). The analysis also showed that cutaneous adverse events developed within the first 6 months regardless of body weight.
CONCLUSIONS: A lower body weight is a significant risk factor for apalutamide-related cutaneous adverse events and their onset is within 6 months of initiation of therapy.
方法:本研究纳入了62例接受240mg/天阿帕鲁胺治疗的非转移性去势抵抗性前列腺癌日本患者。
结果:24例患者(38.7%)出现皮肤不良事件。年龄的多变量logistic回归分析,高度,和体重确定体重是皮肤不良事件发生率的显著预测因素(p=0.019).当患者的平均体重(63.80kg)设定为临界值时,Kaplan-Meier分析显示,体重<63.8kg的患者发生皮肤不良事件的风险显著增加(p=0.003,对数秩检验).分析还显示,与体重无关,皮肤不良事件在前6个月内发生。
结论:体重降低是阿帕鲁胺相关皮肤不良事件的重要危险因素,其发病时间在治疗开始后6个月内。