根治性前列腺切除术与观察等待治疗局限性前列腺癌的比较。
Radical prostatectomy versus observation for localized prostate cancer.
机构信息
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.
出版信息
N Engl J Med. 2012 Jul 19;367(3):203-13. doi: 10.1056/NEJMoa1113162.
BACKGROUND
The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
背景
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。
方法
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。
结果
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。
结论
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。）
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