Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs (VA) Health Care System, and Section of General Medicine, University of Minnesota School of Medicine, Minneapolis, USA.
N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.
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.).
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，手术与观察的疗效尚不清楚。
从 1994 年 11 月至 2002 年 1 月，我们将 731 例局限性前列腺癌患者（平均年龄 67 岁；中位 PSA 值 7.8ng/ml）随机分为根治性前列腺切除术或观察组，并随访至 2010 年 1 月。主要结局为全因死亡率；次要结局为前列腺癌死亡率。
中位随访 10.0 年期间，364 例接受根治性前列腺切除术的患者中有 171 例（47.0%）死亡，而 367 例接受观察的患者中有 183 例（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患者中，21 例（5.8%）死于前列腺癌或治疗，而接受观察的患者中 31 例（8.4%）死于前列腺癌或治疗（风险比，0.63；95%CI，0.36 至 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与年龄、种族、并存疾病、自我报告的功能状态或肿瘤的组织学特征无关。PSA 值大于 10ng/ml 的患者接受根治性前列腺切除术与全因死亡率降低相关（P=0.04 时交互作用），可能与中危或高危肿瘤患者相关（P=0.07 时交互作用）。术后 30 天内发生的不良事件发生在 21.4%的患者中，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，与观察相比，根治性前列腺切除术在至少 12 年的随访中并未显著降低全因死亡率或前列腺癌死亡率。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等资助；PIVOT ClinicalTrials.gov 编号，NCT00007644。）
