Radical prostatectomy or watchful waiting in early prostate cancer.
Radical prostatectomy or watchful waiting in early prostate cancer.
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DOI：
10.1056/nejmoa1311593
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发表时间：
2014-03-06
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影响因子：
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通讯作者：
Johansson JE
中科院分区：
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作者：
Bill-Axelson A;Holmberg L;Garmo H;Rider JR;Taari K;Busch C;Nordling S;Häggman M;Andersson SO;Spångberg A;Andrén O;Palmgren J;Steineck G;Adami HO;Johansson JE
根治性前列腺癌切除术降低了局限性前列腺癌患者的死亡率；然而，关于长期受益的重要问题仍然存在。在和1999年之间，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癌切除术，并对他们进行跟踪观察，直到2012年底。斯堪的纳维亚前列腺癌小组第4号研究(SPCG-4)的主要终点是任何原因导致的死亡、前列腺癌死亡和转移风险。次要终点包括开始雄激素剥夺治疗。在23.2年的随访中，手术组的347名男性中有200人死亡，守望组的348名男性中有247人死亡。死亡病例中，手术组63例，守望组99例；相对危险度为0.56(95%可信区间为0.41~0.77；P=0.001)，绝对差异为11.0个百分点(95%可信区间为4.5%~17.5)。需要治疗才能防止1人死亡的人数是8人。根治性前列腺切除术组有1人在手术后死亡。在接受前列腺切除术的患者中使用雄激素剥夺治疗的患者较少(差异25.0个百分点；95%CI，17.7比32.3)。手术对前列腺癌死亡的益处在65岁以下的男性(相对风险为0.45)和患有中等风险前列腺癌的男性(相对风险为0.38)中最大。然而，根治性胸骨切除与老年男性转移风险的降低有关(相对风险，0.68；P=0.04)。延长的随访证实了根治性前列腺切除术后死亡率的大幅下降；当根据确诊年龄和肿瘤风险修改治疗时，防止一人死亡所需的治疗数量继续减少。在警惕等待组中，很大比例的长期幸存者不需要任何姑息治疗。(由瑞典癌症协会和其他机构资助。)
Radical prostatectomy reduces mortality among men with localized prostate cancer; however, important questions regarding long-term benefit remain. Between 1989 and 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012. The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) were death from any cause, death from prostate cancer, and the risk of metastases. Secondary end points included the initiation of androgen-deprivation therapy. During 23.2 years of follow-up, 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died. Of the deaths, 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer; the relative risk was 0.56 (95% confidence interval [CI], 0.41 to 0.77; P = 0.001), and the absolute difference was 11.0 percentage points (95% CI, 4.5 to 17.5). The number needed to treat to prevent one death was 8. One man died after surgery in the radical-prostatectomy group. Androgen-deprivation therapy was used in fewer patients who underwent prostatectomy (a difference of 25.0 percentage points; 95% CI, 17.7 to 32.3). The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age (relative risk, 0.45) and in those with intermediate-risk prostate cancer (relative risk, 0.38). However, radical pros-tatectomy was associated with a reduced risk of metastases among older men (relative risk, 0.68; P = 0.04). Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk. A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment. (Funded by the Swedish Cancer Society and others.)