Radical prostatectomy versus watchful waiting in localized prostate cancer:: the Scandinavian Prostate Cancer Group-4 randomized trial
Radical prostatectomy versus watchful waiting in localized prostate cancer:: the Scandinavian Prostate Cancer Group-4 randomized trial
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DOI：
10.1093/jnci/djn255
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发表时间：
2008-08-20
期刊：
影响因子：
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通讯作者：
Johansson, Jan-Erik
中科院分区：
文献类型：
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作者：
Bill-Axelson, Anna;Holmberg, Lars;Johansson, Jan-Erik
只有一项随机试验评估了根治性前列腺切除术对早期前列腺癌患者的益处。在2005年，我们报道了根治性前列腺切除术在平均8.2年的随访后，与观察等待相比，提高了前列腺癌的生存率。我们现在报告的结果后，3年多的follow-up.Methods从1989年10月1日至1999年2月28日，695名男性临床局限性前列腺癌被随机分配到根治性前列腺切除术（n = 347）或观察等待（n = 348）。随访完成至2006年12月31日，组织病理学审查和死亡原因的盲法评价。使用考克斯比例风险模型估计相对风险（RR）。结果在平均10.8年的随访期间（范围= 3周至17.2年），手术组有137名男性死亡，观察等待组有156名男性死亡（P= 0.09）。对于347名随机分配手术的男性中的47名（13.5%）和348名未随机分配手术的男性中的68名（19.5%），死亡是由于前列腺癌。在随访约10年后，前列腺癌死亡累积发生率的差异保持稳定。12年时，手术组和观察等待组分别有12.5%和17.9%死于前列腺癌（差异= 5.4%，95%可信区间[CI] = 0.2 - 11.1%），相对风险为0.65（95% CI = 0.45 - 0.94; P = 0.03）。随访10年后，远处转移累积发生率的差异并未增加。12年时，手术组中19.3%的男性和观察等待组中26%的男性被诊断为远处转移（差异= 6.7%，95% CI = 0.2至13.2%），相对风险为0.65（95% CI = 0.47至0.88; P = 0.006）。在接受根治性前列腺切除术的男性中，有囊外肿瘤生长者的前列腺癌死亡风险是无囊外肿瘤生长者的14倍（RR = 14.2，95%CI = 3.3 - 61.8; P
Background The benefit of radical prostatectomy in patients with early prostate cancer has been assessed in only one randomized trial. In 2005, we reported that radical prostatectomy improved prostate cancer survival compared with watchful waiting after a median of 8.2 years of follow-up. We now report results after 3 more years of follow-up.Methods From October 1, 1989, through February 28, 1999, 695 men with clinically localized prostate cancer were randomly assigned to radical prostatectomy (n = 347) or watchful waiting (n = 348). Follow-up was complete through December 31, 2006, with histopathologic review and blinded evaluation of causes of death. Relative risks (RRs) were estimated using the Cox proportional hazards model. Statistical tests were two-sided.Results During a median of 10.8 years of follow-up (range = 3 weeks to 17.2 years), 137 men in the surgery group and 156 in the watchful waiting group died (P=.09). For 47 of the 347 men (13.5%) who were randomly assigned to surgery and 68 of the 348 men (19.5%) who were not, death was due to prostate cancer. The difference in cumulative incidence of death due to prostate cancer remained stable after about 10 years of follow-up. At 12 years, 12.5% of the surgery group and 17.9% of the watchful waiting group had died of prostate cancer (difference = 5.4%, 95% confidence interval [CI] = 0.2 to 11.1%), for a relative risk of 0.65 (95% Cl = 0.45 to 0.94; P =.03). The difference in cumulative incidence of distant metastases did not increase beyond 10 years of follow-up. At 12 years, 19.3% of men in the surgery group and 26% of men in the watchful waiting group had been diagnosed with distant metastases (difference = 6.7%, 95% Cl = 0.2 to 13.2%), for a relative risk of 0.65 (95% Cl = 0.47 to 0,88; P =.006). Among men who underwent radical prostatectomy, those with extracapsular tumor growth had 14 times the risk of prostate cancer death as those without it (RR = 14.2, 95% Cl = 3.3 to 61.8; P