Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.
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DOI：
10.1056/nejmoa1606221
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发表时间：
2016-10-13
期刊：
影响因子：
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通讯作者：
ProtecT Study Group*
中科院分区：
文献类型：
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作者：
Donovan JL;Hamdy FC;Lane JA;Mason M;Metcalfe C;Walsh E;Blazeby JM;Peters TJ;Holding P;Bonnington S;Lennon T;Bradshaw L;Cooper D;Herbert P;Howson J;Jones A;Lyons N;Salter E;Thompson P;Tidball S;Blaikie J;Gray C;Bollina P;Catto J;Doble A;Doherty A;Gillatt D;Kockelbergh R;Kynaston H;Paul A;Powell P;Prescott S;Rosario DJ;Rowe E;Davis M;Turner EL;Martin RM;Neal DE;ProtecT Study Group*
缺乏关于患者报告的临床局限性前列腺癌治疗结果指标的可靠数据。我们研究了主动监测、根治性直肠癌切除术和激素根治性放疗对患者报告结局的影响。我们比较了前列腺癌症检测和治疗（ProtecT）试验中1643名男性的患者报告结果，这些男性在诊断前、随机分组后6个月和12个月以及此后每年完成问卷调查。患者完成了有效的措施，评估泌尿，肠道，性功能和生活质量，焦虑和抑郁，一般健康的具体影响。在5年时评估癌症相关生活质量。根据意向治疗原则分析完整的6年数据。在随访期间，大多数措施的问卷完成率高于85%。在三种治疗中，尿道切除术对性功能和泌尿系统的负面影响最大，尽管有一些恢复，但在整个试验过程中，尿道切除术组的这些结果仍然比其他组差。放疗对性功能的负面影响在6个月时最大，但随后性功能有所恢复，此后稳定;放疗对排尿功能影响不大。主动监测组的性功能和排尿功能逐渐下降。6个月时，放疗组的肠道功能比其他组更差，但随后有所恢复，只是血便频率增加;其他组的肠道功能没有变化。排尿和排尿在放疗组6个月时更差，但随后大部分恢复，12个月后与其他组相似。对生活质量的影响反映了报告的功能变化。各组之间在焦虑、抑郁或一般健康相关或癌症相关生活质量方面没有观察到显著差异。在对局限性前列腺癌治疗后患者报告结局的分析中，三组患者的严重程度、恢复模式以及泌尿、肠道和性功能下降和相关生活质量不同。（由英国资助。国家卫生研究所卫生技术评估计划; ProtecT当前对照试验编号，ISRCTN 20141297; ClinicalTrials.gov编号，NCT 02044172。）
Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297; ClinicalTrials.gov number, NCT02044172.)