按体重计算的剂量可预测转移性阉割敏感性前列腺癌患者阿帕鲁胺相关皮疹的发生率和严重程度。

IF 2.3 3区医学 Q3 ONCOLOGY

Clinical genitourinary cancer Pub Date : 2024-10-28 DOI:10.1016/j.clgc.2024.102250

Kotaro Suzuki, Yusuke Shiraishi, Yasuyoshi Okamura, Yukari Bando, Takuto Hara, Keisuke Okada, Tomoaki Terakawa, Yoji Hyodo, Koji Chiba, Jun Teishima, Yuzo Nakano, Hideaki Miyake

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引用次数: 0

摘要

背景：阿帕鲁胺（APA）联合雄激素剥夺疗法治疗转移性阉割敏感性前列腺癌（mCSPC）的生存优势已在临床试验中得到证实，不分种族。然而，日本亚群中 APA 诱发皮疹的发生率高于全球人群。在本研究中，我们调查了按体重计算的 APA 剂量对皮疹发生率的预测价值：回顾性研究了2018年1月至2022年12月期间接受APA治疗的128例mCSPC患者。为确定最佳APA临界剂量，进行了接收者操作特征分析。除了比较APA诱发皮疹的情况外，还比较了倾向评分匹配后的无进展生存期（PFS）：结果：预测皮疹发生的最佳临界剂量为3.33 mg/kg。在APA诱发皮疹和因皮疹停用APA的时间上，我们的截断值对两组患者进行了明显的分层（分别为P = .005和P = .009）。接受≥3.33 mg/kg治疗的患者中，≥G3皮疹的发生率明显高于其他患者（6.5% vs. 19.7%，P = .037）。接受结论治疗的患者的 PFS 没有明显差异：我们的数据表明，单位体重的药物剂量可预测 APA 引起的皮疹的发生率和严重程度。需要进一步开展大规模前瞻性研究，以验证单位体重用药量的预测价值，并确定最佳临界值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Dose Per Body Weight Predicts Incidence and Severity of Apalutamide-Related Skin Rash in Metastatic Castration-Sensitive Prostate Cancer

Background

A survival advantage with apalutamide (APA) combined with androgen deprivation therapy for metastatic castration-sensitive prostate cancer (mCSPC) has been demonstrated in the clinical trial, irrespective of race. However, the incidence of APA-induced skin rash in the Japanese subpopulation is higher than that in the global population. In the present study, we investigated the predictive value of APA dose per body weight for the incidence of skin rash.

Methods

A total of 128 patients with mCSPC treated with APA between January 2018 and December 2022 were retrospectively reviewed. A receiver operating characteristic analysis was performed to identify the optimal APA cutoff dose. In addition to comparing the status of APA-induced skin rash, the progression-free survival (PFS) was compared after propensity score matching.

Results

The optimal cutoff dose predicting the occurrence of skin rash was 3.33 mg/kg. Our cutoff value significantly stratified the 2 groups in time to occurrence of APA-induced skin rash and discontinuation of APA due to skin rash (P = .005 and P = .009, respectively). The incidence of a ≥G3 skin rash in patients receiving ≥3.33 mg/kg was significantly higher than in others (6.5% vs. 19.7%, P = .037). There was no significant difference in the PFS between patients administered <3.33 mg/kg and those administered ≥3.33 mg/kg.

Conclusions

Our data suggest that the drug dosage per body weight may predict the incidence and severity of APA-induced skin rash. Further large-scale prospective studies are needed to validate the predictive value of drug dosage per body weight and identify the optimal cutoff value.

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来源期刊

Clinical genitourinary cancer 医学-泌尿学与肾脏学

CiteScore

5.20

自引率

6.20%

发文量

201

审稿时长

54 days

期刊介绍： Clinical Genitourinary Cancer is a peer-reviewed journal that publishes original articles describing various aspects of clinical and translational research in genitourinary cancers. Clinical Genitourinary Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of genitourinary cancers. The main emphasis is on recent scientific developments in all areas related to genitourinary malignancies. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.