治疗前列腺癌筛查男性患者的副作用所带来的过度负担。哥德堡随机人群前列腺癌筛查试验。

The excess burden of side-effects from treatment in men allocated to screening for prostate cancer. The Göteborg randomised population-based prostate cancer screening trial.

机构信息

Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Göteborg, Bruna Straåket 11B, Göteborg, Sweden.

出版信息

Eur J Cancer. 2011 Mar;47(4):545-53. doi: 10.1016/j.ejca.2010.10.016. Epub 2010 Nov 17.

DOI:10.1016/j.ejca.2010.10.016

PMID:21087857

Abstract

BACKGROUND

The number of men needed to treat to prevent one death is rather high in prostate cancer screening. How this affects the burden of treatment-related side-effects is unclear. The aim of this study was to evaluate the treatment related morbidity following radical prostatectomy in men participating in the Göteborg randomised population-based prostate cancer screening trial.

METHODS

In 1995, 20,000 men aged 50-64 years were randomly allocated (1:1) to biennial PSA-screening or to a control group not invited. A subset of prostate cancer patients undergoing radical prostatectomy between 2001 and 2008 responded to questionnaires preoperatively and at 18 months postoperatively. The primary endpoint was patient-reported frequencies of erectile dysfunction as measured by the validated International Index of Erectile Function-5 questionnaire and urinary incontinence as assessed by use of pads. Analyses were made according to intention to screen.

FINDINGS

After 14 years of follow-up, a total of 1849 men were detected with prostate cancer (1138 screened versus 711 controls, excluding 7 cancers detected at autopsy in the control group). Overall, 1047 received treatment with curative intent and radical prostatectomy was performed in 829 cases (79.2%). In this study, 294 of these men participated (205 screened and 89 controls). Of preoperatively potent men 79.1% (91/115) in the screening-group and 90.7% (49/54) in the control-group became impotent or sexually inactive 18 months postoperatively, whereas 14.3% (29/203) of screened men and 20.5% (18/88) of controls were considered postoperatively incontinent (regular use of pads). Extrapolated data yields that 120/10,000 more men become impotent and 25/10,000 more men will have the need of pads among men invited to regular PSA screening. The 'cost' per life saved at the same follow-up of screening is four men impotent and less than one man incontinent.

INTERPRETATION

Despite the relatively high risk of erectile dysfunction and incontinence following radical prostatectomy for prostate cancer, the excess burden of permanent side-effects after population-based screening can be regarded as relatively low, when related to the number of men saved from prostate cancer death. These data can be useful when calculating the harms and benefits of screening. However, the outcome on a population-level may differ from the benefit for the individual.

摘要

背景

在前列腺癌筛查中，需要治疗的男性人数相当多，才能预防一例死亡。这对治疗相关副作用的负担影响尚不清楚。本研究的目的是评估参加哥德堡随机人群前列腺癌筛查试验的男性接受根治性前列腺切除术的治疗相关发病率。

方法

1995 年，20000 名 50-64 岁的男性被随机分配（1:1）接受每两年一次的 PSA 筛查或不邀请参加对照组。2001 年至 2008 年间接受根治性前列腺切除术的前列腺癌患者亚组在术前和术后 18 个月时回答了问卷。主要终点是通过经过验证的国际勃起功能指数-5 问卷测量的患者报告的勃起功能障碍频率和使用尿垫评估的尿失禁。分析根据筛查意向进行。

结果

随访 14 年后，共检测出 1849 例前列腺癌（筛查组 1138 例，对照组 711 例，对照组中排除 7 例尸检发现的癌症）。总体而言，有 1047 例患者接受了治愈性治疗，其中 829 例接受了根治性前列腺切除术。在这项研究中，这些男性中有 294 名参加了研究（筛查组 205 名，对照组 89 名）。在筛查组中，术前有勃起功能的男性中，79.1%（115 例中的 91 例）和对照组中 90.7%（54 例中的 49 例）在术后 18 个月时出现勃起功能障碍或无法进行性行为，而 14.3%（203 例中的 29 例）的筛查男性和 20.5%（88 例中的 18 例）的对照组男性被认为术后尿失禁（定期使用尿垫）。推断数据表明，在接受定期 PSA 筛查的男性中，每 10000 人中会有 120 人出现勃起功能障碍，每 10000 人中会有 25 人出现尿垫需要。在相同的随访中，筛查的“收益”是每挽救一名死于前列腺癌的男性，就有 4 名男性出现勃起功能障碍和不到 1 名男性出现尿失禁。