Department of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57 Urafune-cho, Minami-ku, Yokohama, 232-0024, Japan.
Department of Urology, Yokosuka Kyosai Hospital, Yonegahamadori, Yokosuka, Kanagawa, 238-8558, Japan.
Int J Clin Oncol. 2022 Oct;27(10):1632-1643. doi: 10.1007/s10147-022-02221-w. Epub 2022 Aug 10.
Patient-reported outcome (PRO) measures can provide valuable information in evaluating patients' health-related quality of life (HRQoL). Post hoc analysis of the AFTERCAB study was conducted to evaluate the HRQoL benefit of enzalutamide plus androgen deprivation therapy (ADT) compared to flutamide plus ADT for the treatment of patients with castration-resistant prostate cancer (CRPC) in Japan.
The open-label AFTERCAB study was conducted from November 2016 to March 2020 in Japanese men aged ≥ 20 years with asymptomatic or mildly symptomatic CRPC. Patients received enzalutamide plus ADT or flutamide plus ADT, respectively, as first-line alternative androgen therapy (AAT). HRQoL was analyzed through the Functional Assessment of Cancer Therapy-Prostate, EuroQoL 5-Dimension 5-Level instruments, Brief Pain Inventory-Short Form, and Brief Fatigue Inventory. The longitudinal changes in HRQoL, HRQoL deterioration based on minimally important difference (MID), and time to HRQoL deterioration were evaluated for first-line AAT.
Overall, HRQoL between the enzalutamide and flutamide groups was similar during first-line treatment. No statistically significant HRQoL difference in change from baseline to week 61 (least square mean difference; p value) was observed. Furthermore, proportions of pain progression, symptom worsening, and HRQoL deterioration based on MID, were not significantly different between groups.
The results were similar in all subscales of each PRO, demonstrating similar HRQoL deterioration based on MID criteria between the enzalutamide and flutamide groups.
患者报告的结局(PRO)测量可以为评估患者的健康相关生活质量(HRQoL)提供有价值的信息。对 AFTERCAB 研究进行了事后分析,以评估恩扎卢胺联合雄激素剥夺疗法(ADT)与氟他胺联合 ADT 治疗日本去势抵抗性前列腺癌(CRPC)患者的 HRQoL 获益。
开放标签的 AFTERCAB 研究于 2016 年 11 月至 2020 年 3 月在日本年龄≥20 岁的无症状或轻度症状 CRPC 男性中进行。患者分别接受恩扎卢胺联合 ADT 或氟他胺联合 ADT 作为一线替代雄激素治疗(AAT)。通过功能评估癌症治疗-前列腺、欧洲五维健康量表 5 级、简明疼痛量表和简明疲劳量表分析 HRQoL。评估了一线 AAT 的 HRQoL 纵向变化、基于最小有意义差异(MID)的 HRQoL 恶化以及 HRQoL 恶化的时间。
总体而言,一线治疗期间恩扎卢胺组和氟他胺组的 HRQoL 相似。从基线到第 61 周的变化(最小二乘均数差异;p 值)没有统计学意义的 HRQoL 差异。此外,基于 MID 的疼痛进展、症状恶化和 HRQoL 恶化的比例在组间没有显著差异。
在每个 PRO 的所有子量表中,结果均相似,表明恩扎卢胺组和氟他胺组基于 MID 标准的 HRQoL 恶化程度相似。