Radical prostatectomy versus observation for localized prostate cancer.
Radical prostatectomy versus observation for localized prostate cancer.
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DOI：
10.1056/nejmoa1113162
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发表时间：
2012-07-19
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影响因子：
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通讯作者：
Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group
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作者：
Wilt TJ;Brawer MK;Jones KM;Barry MJ;Aronson WJ;Fox S;Gingrich JR;Wei JT;Gilhooly P;Grob BM;Nsouli I;Iyer P;Cartagena R;Snider G;Roehrborn C;Sharifi R;Blank W;Pandya P;Andriole GL;Culkin D;Wheeler T;Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group
对于通过前列腺特异性抗原（PSA）检测发现的局限性前列腺癌患者，手术与观察的有效性尚不清楚。从1994年11月到2002年1月，我们随机分配了731名患有局限性前列腺癌的男性（平均年龄67岁，平均PSA值为7.8 ng/ml）接受根治性前列腺切除术或观察，并随访至2010年1月。主要结局是全因死亡率;次要结局是前列腺癌死亡率。在中位10.0年的随访期间，364名接受根治性前列腺切除术的男性中有171人（47.0%）死亡，而367名接受观察的男性中有183人（49.9%）死亡（风险比，0.88; 95%置信区间[CI]，0.71至1.08; P = 0.22;绝对风险降低，2.9个百分点）。在接受根治性前列腺切除术的男性中，21例（5.8%）死于前列腺癌或治疗，而接受观察的男性中有31例（8.4%）死亡（风险比，0.63; 95%CI，0.36 - 1.09; P = 0.09;绝对风险降低，2.6个百分点）。治疗对全因死亡率和前列腺癌死亡率的影响并不因年龄、种族、共存疾病、自我报告的体力状态或肿瘤的组织学特征而异。根治性前列腺切除术与PSA值大于10 ng/ml的男性（相互作用P = 0.04）以及可能与中危或高危肿瘤患者（相互作用P = 0.07）的全因死亡率降低相关。21.4%的男性在术后30天内发生不良事件，包括1例死亡。在PSA检测早期发现的局限性前列腺癌患者中，根治性前列腺切除术并没有显著降低全因或前列腺癌死亡率，与观察相比，通过至少12年的随访。绝对差异小于3个百分点。（由退伍军人事务部合作研究计划和其他部门资助; PIVOT ClinicalTrials.gov编号，NCT 00007644。
The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known. From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality. During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P = 0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P = 0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P = 0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P = 0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death. Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.)