Abstract：
OBJECTIVE: Therapeutic strategies for prostate cancer are currently undergoing a paradigm shift due to the advent of next-generation androgen receptor inhibitors. Among these inhibitors, apalutamide is regarded as a key drug because of its effectiveness. However, risk factors for and the timing of the onset of apalutamide-related cutaneous adverse events remain unclear. Therefore, the present study investigated key risk factors for and timing of the onset of apalutamide-related cutaneous adverse events.
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.
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.
摘要：
目的：由于下一代雄激素受体抑制剂的出现，前列腺癌的治疗策略目前正在发生范式转变。在这些抑制剂中，阿帕鲁胺因其有效性而被认为是关键药物。然而,阿帕鲁胺相关皮肤不良事件的危险因素和发病时间尚不清楚.因此,本研究调查了阿帕鲁胺相关皮肤不良事件发生的关键危险因素和时间.
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。
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。
