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前列腺癌主动监测与健康相关的生活质量:前瞻性试验芬兰部分的结果。

Prostate cancer active surveillance and health-related quality of life: results of the Finnish arm of the prospective trial.

机构信息

Department of Urology, University of Helsinki, Helsinki, Finland.

出版信息

BJU Int. 2012 Jun;109(11):1614-9. doi: 10.1111/j.1464-410X.2011.10677.x. Epub 2011 Nov 1.

Abstract

UNLABELLED

Study Type - Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Active surveillance is a management option in patients with localized prostate cancer. One concern is the possible psychological burden and quality-of-life effects caused by consciousness of living with untreated cancer. Previous studies have reported controversial results about the impact of active surveillance on patient's health-related quality of life. The data of the present study support the idea that patients with low-risk prostate cancer manage well on active surveillance and do not develop short-term mental or physical quality-of-life sequelae.

OBJECTIVE

To analyse longitudinal changes in general, mental and physical health-related quality of life (HRQL) and urinary and erectile function in patients with low-risk prostate cancer (PC) on active surveillance (AS).

PATIENTS AND METHODS

Patients comprised those (n= 124) enrolled in the Finnish arm of the Prostate Cancer Research International: Active Surveillance (PRIAS) study who were followed for at least 1 year (n= 80). All patients with PC received validated questionnaires at the start of surveillance and after 1 year of follow-up. General HRQL was assessed with the RAND 36-Item Health Survey (RAND-36), erectile function with the International Index of Erectile Function-5 (IIEF-5), and urinary symptoms with the International Prostate Symptom Score (IPSS) questionnaires. Results were also compared with an age-stratified general Finnish male population. A paired t-test served to compare results over time and a non-paired t-test or a corresponding non-parametric test, when applicable, served to compare the study group with the general population. Pearson and Spearman correlations were analysed between possible HRQL-affecting factors (demographic and clinical data) and HRQL data, followed by linear regression analysis to further evaluate any possible associations.

RESULTS

Of the 124 patients, 105 (85%) returned the baseline RAND-36 questionnaire, and 75 (94%) of the 80 patients answered both the baseline and follow-up questionnaires; 15 patients (12%) had discontinued AS, all for protocol-based reasons, none due to anxiety or distress. No differences existed in the HRQL main categories at the 1-year follow-up (mental and physical: P= 0.142 and P= 0.154, respectively). When all the eight dimensions were analysed separately, the physical role showed statistically significant improvement from a mean of 81 to a mean of 89 (P= 0.010). No clinically significant correlations appeared between HRQL and age, diagnostic prostate-specific antigen (PSA), free PSA or PSA change during follow-up at any of the time points; in regression analysis, HRQL was not predictable by any of the variables available at diagnosis or during follow-up. No statistically significant changes occurred in urinary function as analysed by the IPSS (P= 0.121) or in erectile function by the IIEF-5 questionnaire (P= 0.583).  Compared with an age-stratified Finnish general male population, patients with PC on AS had a significantly better general mental and physical HRQL at diagnosis and after 1 year of follow-up (P < 0.05).

CONCLUSIONS

Active surveillance does not provoke short-term quality-of-life disturbances as assessed by standardized RAND-36, IIEF-5 and IPSS questionnaires. None of the patients changed treatment due to anxiety. Unexpectedly, PC patients on AS had significantly better general mental and physical HRQL than did a general age-stratified Finnish male population.

摘要

背景

研究类型-治疗(病例系列)证据等级 4 已知的主题是什么?本研究有何补充?在局部前列腺癌患者中,主动监测是一种管理选择。一个担忧是,由于意识到未治疗的癌症而可能产生心理负担和生活质量影响。先前的研究报告了主动监测对患者健康相关生活质量影响的争议结果。本研究的数据支持这样一种观点,即低危前列腺癌患者在主动监测下管理良好,不会产生短期的精神或身体生活质量后遗症。

目的

分析低危前列腺癌(PC)患者接受主动监测(AS)时一般、心理和身体健康相关生活质量(HRQL)以及尿功能和勃起功能的纵向变化。

患者和方法

本研究纳入了芬兰前列腺癌研究国际:主动监测(PRIAS)研究的芬兰部分至少随访 1 年(n=80)的患者(n=124)。所有 PC 患者在开始监测时和随访 1 年后均接受了经过验证的问卷。一般 HRQL 采用 RAND 36 项健康调查(RAND-36)评估,勃起功能采用国际勃起功能指数-5(IIEF-5)评估,尿症状采用国际前列腺症状评分(IPSS)问卷评估。结果还与年龄分层的一般芬兰男性人群进行了比较。配对 t 检验用于比较随时间的变化,非配对 t 检验或相应的非参数检验(适用时)用于比较研究组与一般人群。对可能影响 HRQL 的因素(人口统计学和临床数据)与 HRQL 数据之间进行 Pearson 和 Spearman 相关性分析,然后进行线性回归分析,以进一步评估任何可能的关联。

结果

在 124 名患者中,有 105 名(85%)返回了基线 RAND-36 问卷,80 名患者中有 75 名(94%)回答了基线和随访问卷;15 名患者(12%)因协议原因停止了 AS,均无焦虑或痛苦。在 1 年随访时,HRQL 主要类别无差异(心理和身体:P=0.142 和 P=0.154)。当分别分析所有八个维度时,身体角色从平均 81 分显著改善至平均 89 分(P=0.010)。在任何时间点,HRQL 与年龄、诊断前列腺特异性抗原(PSA)、游离 PSA 或随访期间 PSA 变化之间均无临床显著相关性;在回归分析中,HRQL 不能由任何诊断或随访期间可用的变量预测。IPSS 分析的尿功能(P=0.121)或 IIEF-5 问卷的勃起功能(P=0.583)无统计学显著变化。与年龄分层的芬兰一般男性人群相比,接受 AS 的 PC 患者在诊断时和随访 1 年后具有明显更好的一般心理和身体 HRQL(P<0.05)。

结论

标准化 RAND-36、IIEF-5 和 IPSS 问卷评估表明,主动监测不会引起短期生活质量障碍。由于焦虑而改变治疗的患者无一例。出乎意料的是,接受 AS 的 PC 患者的一般心理和身体 HRQL 明显优于一般年龄分层的芬兰男性人群。

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