Health-related Quality of Life Outcomes of Salvage Metastasis-directed Treatment Versus Elective Nodal Treatment for Oligorecurrent Nodal Prostate Cancer: A Secondary Analysis of the Phase 2, Open-label PEACE V–STORM Randomized Trial
Thomas Zilli, Shankar Siva, Sigmund Brabrand, Piet Dirix, Nick Liefhooghe, François-Xavier Otte, Alfonso Gomez-Iturriaga, Wouter Everaerts, Mohamed Shelan, Antonio Conde-Moreno, Fernando López Campos, Alexandros Papachristofilou, Matthias Guckenberger, Marta Scorsetti, Almudena Zapatero, Ana-Elena Villafranca Iturre, Clara Eito, Felipe Couñago, Paolo Muto, Wim Duthoy, Piet Ost
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引用次数: 0
Abstract
For prostate cancer patients with metachronous nodal oligorecurrences detected by positron emission tomography, the randomized phase 2 PEACE V–STORM trial (NCT03569241) demonstrated that, compared with metastasis-directed therapy (MDT), elective nodal pelvic radiotherapy (ENRT) in combination with 6 mo of androgen deprivation therapy (ADT) improved locoregional disease control and metastasis-free survival. In the 190 evaluable patients (MDT: 97 and ENRT: 93) of the 196 randomized in the study, health-related quality of life (HRQoL) was assessed by European Organization for Research and Treatment of Cancer QLQ-C-30 and QLQ-PR-25 questionnaires over a 4-yr period as a part of a statistically defined quality of life analysis. During a median follow-up of 50 mo (interquartile range 42–58), QLQ-C30 scores showed no significant differences between MDT and ENRT, except for worse physical functioning at month 24 in the ENRT group (mean decline −7.7 vs −1.3) and worse emotional functioning at month 12 in the MDT group (mean decline 5.8 vs −0.4, p = 0.034). No significant differences in QLQ-PR25 scores were observed, except slightly better bowel symptoms at 18 mo for ENRT, but with no difference before or after. The decline in sexual activity and increase in ADT-related symptoms during the first 6 mo were comparable between arms, returning to baseline by month 12. Consistent with physician-reported treatment-related adverse events, HRQoL analyses show no significant differences between ENRT and MDT.
对于正电子发射断层扫描检测到异时性淋巴结少复发的前列腺癌患者,随机2期PEACE V-STORM试验(NCT03569241)表明,与转移定向治疗(MDT)相比,选择性淋巴结盆腔放疗(ENRT)联合6个月的雄激素剥夺治疗(ADT)改善了局部疾病控制和无转移生存。在196名随机纳入研究的可评估患者中,有190名(MDT: 97名,ENRT: 93名)采用欧洲癌症研究与治疗组织QLQ-C-30和QLQ-PR-25问卷对健康相关生活质量(HRQoL)进行了为期4年的评估,作为统计定义的生活质量分析的一部分。在平均50个月的随访期间(四分位数范围42-58),MDT和ENRT之间的QLQ-C30评分没有显著差异,除了ENRT组在第24个月的身体功能恶化(平均下降-7.7 vs -1.3)和MDT组在第12个月的情绪功能恶化(平均下降5.8 vs -0.4, p = 0.034)。除了ENRT治疗18个月时肠道症状略有改善外,QLQ-PR25评分无显著差异,但前后无差异。在前6个月期间,两组间性活动的减少和adt相关症状的增加具有可比性,到第12个月时恢复到基线水平。与医生报告的治疗相关不良事件一致,HRQoL分析显示ENRT和MDT之间没有显着差异。
期刊介绍:
Journal Name: European Urology Oncology
Affiliation: Official Journal of the European Association of Urology
Focus:
First official publication of the EAU fully devoted to the study of genitourinary malignancies
Aims to deliver high-quality research
Content:
Includes original articles, opinion piece editorials, and invited reviews
Covers clinical, basic, and translational research
Publication Frequency: Six times a year in electronic format