Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer
Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer
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DOI：
10.1056/nejmoa1011967
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发表时间：
2011-05-05
影响因子：
158.5
通讯作者：
Johansson, Jan-Erik
中科院分区：
文献类型：
--
作者：
Bill-Axelson, Anna;Holmberg, Lars;Johansson, Jan-Erik
背景2008年，我们报道了根治性前列腺切除术，与观察等待相比，降低了前列腺癌的死亡率。经过额外的3年的后续行动，我们现在报告估计15年的results.METHODS从1989年10月至1999年2月，我们随机分配695名男性早期前列腺癌的观察等待或根治性前列腺切除术。随访至2009年12月完成，对活检和根治性乳腺切除术标本进行组织病理学审查，并对死亡原因进行盲法评价。相对风险，95%的置信区间，估计与使用一个考克斯比例风险model.Results在中位数为12.8年，166的347名男子在根治性切除术组和201的348名在观察等待组死亡（P=0.007）。在55名男性被分配到手术组和81名男性被分配到观察等待组的情况下，死亡是由于前列腺癌。结果显示，15年时前列腺癌的累积死亡率分别为14.6%和20.7%（差异为6.1个百分点; 95%置信区间[CI]，0.2 - 12.0），手术的相对风险为0.62（95% CI，0.44 - 0.87; P=0.01）。随访9年前后的生存获益相似，在低风险前列腺癌男性中也观察到，仅限于65岁以下的男性。为避免一例死亡而需要治疗的人数为15人，65岁以下男性为7人。在接受根治性前列腺切除术的男性中，囊外肿瘤生长的患者死于前列腺癌的风险是无囊外肿瘤生长的男性的7倍（相对风险，6.9; 95%CI，2.6至18.4）。囊外肿瘤生长的男性可能受益于辅助局部或全身治疗。
BACKGROUND In 2008, we reported that radical prostatectomy, as compared with watchful waiting, reduces the rate of death from prostate cancer. After an additional 3 years of follow-up, we now report estimated 15-year results.METHODS From October 1989 through February 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy. Follow-up was complete through December 2009, with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death. Relative risks, with 95% confidence intervals, were estimated with the use of a Cox proportional-hazards model.RESULTS During a median of 12.8 years, 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died (P=0.007). In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting, death was due to prostate cancer. This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6% and 20.7%, respectively (a difference of 6.1 percentage points; 95% confidence interval [CI], 0.2 to 12.0), and a relative risk with surgery of 0.62 (95% CI, 0.44 to 0.87; P=0.01). The survival benefit was similar before and after 9 years of follow-up, was observed also among men with low-risk prostate cancer, and was confined to men younger than 65 years of age. The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age. Among men who underwent radical prostatectomy, those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth (relative risk, 6.9; 95% CI, 2.6 to 18.4).CONCLUSIONS Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer. Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment.