Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment.
Patient-Reported Outcomes 12 Years after Localized Prostate Cancer Treatment.
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DOI：
10.1056/evidoa2300018
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发表时间：
2023-04-01
期刊：
影响因子：
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通讯作者：
Neal, David E
中科院分区：
文献类型：
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作者：
Donovan, Jenny L;Hamdy, Freddie C;Neal, David E
背景：需要长期患者报告的结果来为局部前列腺癌的治疗决策提供信息。方法：在ProtecT（前列腺癌检测和治疗）试验中，对1643名随机分配的患者报告的结果进行评估，以评估前列腺切除术、新辅助雄激素剥夺放疗和主动监测对功能和生活质量的影响。本文的重点是使用混合效应线性和逻辑模型对7至12岁随机分配的参与者的结果进行研究。结果：大多数措施的有效率超过80%。在7至12岁的随机分组中，一般生活质量评分相似。在前列腺切除术组中，需要垫尿的尿漏发生率为18 - 24%，超过7 - 12年，而主动监测组为9 - 11%，放疗组为3 - 8%。在前列腺切除术组中，18%的患者报告在7年时勃起足以进行性交，而主动监测组为30%，放疗组为27%；到第12年，它们的效力都降低了。12年时，前列腺切除术组夜尿症（每晚至少排尿两次）发生率为34%，放疗组为48%，积极监测组为47%。到12年，放射治疗组12%的患者出现了粪便渗漏，而其他组为6%。积极监测组经历了与年龄相关的性功能和泌尿功能逐渐下降，除非他们改变管理方法，否则避免激进的治疗效果。结论：ProtecT为治疗的长期持续影响提供了强有力的证据。这些数据使新诊断为局限性前列腺癌的患者和他们的临床医生能够评估治疗的危害和益处之间的权衡，并做出更明智和谨慎的治疗决策。（由英国国家卫生与保健研究所卫生技术评估计划项目96/20/06和96/20/99资助；ISRCTN编号：ISRCTN20141297； ClinicalTrials.gov编号：NCT02044172。）
BACKGROUND: Long-term patient-reported outcomes are needed to inform treatment decisions for localized prostate cancer. METHODS: Patient-reported outcomes of 1643 randomly assigned participants in the ProtecT (Prostate Testing for Cancer and Treatment) trial were evaluated to assess the functional and quality-of-life impacts of prostatectomy, radiotherapy with neoadjuvant androgen deprivation, and active monitoring. This article focuses on the outcomes of the randomly assigned participants from 7 to 12 years using mixed effects linear and logistic models. RESULTS: Response rates exceeded 80% for most measures. Among the randomized groups over 7 to 12 years, generic quality-of-life scores were similar. Among those in the prostatectomy group, urinary leakage requiring pads occurred in 18 to 24% of patients over 7 to 12 years, compared with 9 to 11% in the active monitoring group and 3 to 8% in the radiotherapy group. In the prostatectomy group, 18% reported erections sufficient for intercourse at 7 years, compared with 30% in the active monitoring and 27% in the radiotherapy groups; all converged to low levels of potency by year 12. Nocturia (voiding at least twice per night) occurred in 34% in the prostatectomy group compared with 48% in the radiotherapy group and 47% in the active monitoring group at 12 years. Fecal leakage affected 12% in the radiotherapy group compared with 6% in the other groups by year 12. The active monitoring group experienced gradual age-related declines in sexual and urinary function, avoiding radical treatment effects unless they changed management. CONCLUSIONS: ProtecT provides robust evidence about continued impacts of treatments in the long term. These data allow patients newly diagnosed with localized prostate cancer and their clinicians to assess the trade-offs between treatment harms and benefits and enable better informed and prudent treatment decisions. (Funded by the UK National Institute for Health and Care Research Health Technology Assessment Programme projects 96/20/06 and 96/20/99; ISRCTN number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.)