Umehara Kengo, Saito Yoshitaka, Takada Shinya, Yamagishi Kayo, Takada Norikata, Maruyama Satoru, Harabayashi Toru, Hashishita Hirokazu
Department of Pharmacy, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Department of Clinical Pharmaceutics & Therapeutics, Faculty of Pharmaceutical Sciences, Hokkaido University of Science, Sapporo, Japan;
In Vivo. 2025 Jan-Feb;39(1):459-466. doi: 10.21873/invivo.13849.
BACKGROUND/AIM: Apalutamide induces severe skin adverse events (sAEs) in 14.7% of Japanese patients, leading to treatment discontinuation. To maximize the management of sAEs in patients taking apalutamide for prostate cancer, we conducted pharmacist outpatient clinics for patients receiving apalutamide in the outpatient setting. During these sessions, patients were informed about skin care management, including the application of moisturizers to prevent sAEs. This study aimed to evaluate the usefulness of pharmacist-led outpatient services in managing sAEs.
Patients with castration-resistant prostate cancer without distant metastases or prostate cancer with distant metastases, receiving 240 mg apalutamide once daily, were divided into pharmacist intervention and nonintervention groups and retrospectively investigated. The primary endpoint was the incidence of all sAEs.
The incidence of sAEs of any grade was significantly lower in the intervention group (n=26) than in the nonintervention group (n=16) (30.8% vs. 68.8%, respectively, p=0.03), without a significant difference in the incidence of grade 3 or more sAEs (3.8% vs. 25.0%, respectively, p=0.05). At the pharmacist outpatient clinics, pharmacists gave 84 recommendations to urologists, with 98.8% of them reflected in prescriptions. The most frequently prescribed moisturizers were heparinoid oil-based creams, with a significantly higher prescription rate in the intervention compared to the nonintervention group (30.0 g/28 days vs. 0 g/28 days, p<0.01).
As far as we are aware, our study is the first to show that intervention by pharmacist outpatient clinics reduces apalutamide-induced sAEs. Pharmacist outpatient clinics can assist in the appropriate skin management of patients taking apalutamide.
背景/目的：阿帕鲁胺在14.7%的日本患者中会引发严重皮肤不良事件（sAE），导致治疗中断。为了最大限度地管理接受阿帕鲁胺治疗前列腺癌患者的sAE，我们为门诊接受阿帕鲁胺治疗的患者开设了药剂师门诊。在这些诊疗过程中，告知患者皮肤护理管理方法，包括使用保湿剂以预防sAE。本研究旨在评估药剂师主导的门诊服务在管理sAE方面的有效性。
将接受每日一次240 mg阿帕鲁胺治疗的去势抵抗性前列腺癌且无远处转移的患者或有远处转移的前列腺癌患者分为药剂师干预组和非干预组，并进行回顾性研究。主要终点是所有sAE的发生率。
干预组（n = 26）任何级别的sAE发生率均显著低于非干预组（n = 16）（分别为30.8%和68.8%，p = 0.03），3级及以上sAE的发生率无显著差异（分别为3.8%和25.0%，p = 0.05）。在药剂师门诊，药剂师向泌尿科医生提出了84条建议，其中98.8%被纳入处方。最常开具的保湿剂是类肝素油基乳膏，干预组的处方率显著高于非干预组（30.0 g/28天 vs. 0 g/28天，p<0.01）。
据我们所知，我们的研究首次表明药剂师门诊干预可降低阿帕鲁胺引起的sAE。药剂师门诊可协助对接受阿帕鲁胺治疗的患者进行适当的皮肤管理。
