Department of Urology, University Hospital, Uppsala, Sweden.
N Engl J Med. 2011 May 5;364(18):1708-17. doi: 10.1056/NEJMoa1011967.
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.
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.
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).
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. (Funded by the Swedish Cancer Society and the National Institutes of Health.).
2008 年，我们报道了与观察等待相比，根治性前列腺切除术可降低前列腺癌死亡率。在随访增加 3 年后，我们现在报告了估计的 15 年结果。
1989 年 10 月至 1999 年 2 月，我们随机分配了 695 名早期前列腺癌患者接受观察等待或根治性前列腺切除术。通过对活检和根治性前列腺切除术标本进行组织病理学检查以及对死因进行盲法评估，随访至 2009 年 12 月结束。使用 Cox 比例风险模型估计相对风险和 95%置信区间。
在中位时间为 12.8 年期间，在根治性前列腺切除术组的 347 名男性中，有 166 名男性死亡，在观察等待组的 348 名男性中，有 201 名男性死亡（P=0.007）。在被分配手术的 55 名男性和被分配观察等待的 81 名男性中，有 55 名男性和 81 名男性死于前列腺癌。这导致 15 年时死于前列腺癌的累积发生率分别为 14.6%和 20.7%（差异为 6.1 个百分点；95%置信区间[CI]，0.2 至 12.0），手术的相对风险为 0.62（95%CI，0.44 至 0.87；P=0.01）。在 9 年随访前后均观察到生存获益，在低危前列腺癌患者中也观察到了生存获益，并且仅在 65 岁以下的男性中观察到了生存获益。为避免 1 人死亡，需要治疗的人数为 15 人，年龄小于 65 岁的男性为 7 人。接受根治性前列腺切除术的男性中，有包膜外肿瘤生长的患者死于前列腺癌的风险是没有包膜外肿瘤生长的患者的 7 倍（相对风险，6.9；95%CI，2.6 至 18.4）。
根治性前列腺切除术与降低前列腺癌死亡率有关。有包膜外肿瘤生长的男性可能受益于辅助局部或全身治疗。（由瑞典癌症协会和美国国立卫生研究院资助）。
