新英格兰医学杂志爆料：长达20年的随访证实，这种癌症早期发现不需要治疗，切勿过度医疗！

《新英格兰医学杂志》2017年7月13日377:132-142

http://www.nejm.org/doi/full/10.1056/NEJMoa1615869?query=featured_home

对早期前列腺癌进行前列腺切除还是观察的对比随访

背景

以往我们发现，局限性前列腺癌进行手术的男性和仅仅观察随诊治疗者之间的死亡率并没有明显差异，但对非致命性健康影响和长期死亡率并无定论。

方法

自1994年11月至2002年1月，我们随机将731名局限性前列腺癌男性随机分组，一组进行根治性前列腺切除术，一组只观察。我们将主要终点全因死亡率和次要终点前列腺癌死亡率的随访延长至2014年8月。我们对截至到2010年1月（原计划随访）的疾病进展、所接受的治疗、患者报告结果进行了描述。

结果

在19.5年的随访期间（中位值，12.7年），手术组364名男性患者中223名（61.3%）死亡，观察组367名中245名（66.8%）死亡（风险绝对差值5.5个百分点，95%可信区间[CI]，-1.5至12.4；风险比，0.84，95%CI，0.70-1.01，P=0.06）。手术组有27名男性患者（7.4%）出现归因于前列腺癌或治疗引起的死亡，观察组有42名（11.4%）（风险绝对差值4.0个百分点，95%CI，-0.2至8.3；风险比，0.63，95%CI，0.39-1.02，P=0.06）。在中度风险的前列腺癌男性患者中，与观察组相比，手术可能与全因死亡率低相关（绝对差值，14.5个百分点，95%CI，2.8-25.6）；但在低危（绝对差值，0.7个百分点，95%CI，-10.5至11.8）或高危（绝对差值，2.3个百分点，95%CI，-11.5至16.1）患者中没有这种相关性（交互作用检验P=0.08）。手术组对肿瘤进展的治疗频次少于观察组（绝对差值，26.2个百分点，95%CI，19.0-32.9），主要是针对无症状进展、局部进展或生化（PSA）进展的治疗。手术组尿失禁、勃起和性功能障碍均多于长达10年的观察。肿瘤相关性或治疗相关性日常生活活动限制手术组重于长达2年的观察。

结论

局限性前列腺癌男性患者经过近20年的随访后发现，与观察相比，手术并未明显降低全因死亡率和前列腺癌死亡率，且与观察组相比，手术引起的不良事件更多，仅针对肿瘤进展的治疗频次减少，而这种针对肿瘤进展的治疗绝大多数是针对无症状进展、局部进展或生化进展。

南南和北北

Timothy J. Wilt, M.D., M.P.H., Karen M. Jones, M.S., Michael J. Barry, M.D., Gerald L. Andriole, M.D., Daniel Culkin, M.D., Thomas Wheeler, M.D., William J. Aronson, M.D., and Michael K. Brawer, M.D.

N Engl J Med 2017; 377:132-142July 13, 2017DOI: 10.1056/NEJMoa1615869

Background

We previously found no significant differences in mortality between men who underwent surgery for localized prostate cancer and those who were treated with observation only. Uncertainty persists regarding nonfatal health outcomes and long-term mortality.

Methods

From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer to radical prostatectomy or observation. We extended follow-up through August 2014 for our primary outcome, all-cause mortality, and the main secondary outcome, prostate-cancer mortality. We describe disease progression, treatments received, and patient-reported outcomes through January 2010 (original follow-up).

Results

During 19.5 years of follow-up (median, 12.7 years), death occurred in 223 of 364 men (61.3%) assigned to surgery and in 245 of 367 (66.8%) assigned to observation (absolute difference in risk, 5.5 percentage points; 95% confidence interval [CI], −1.5 to 12.4; hazard ratio, 0.84; 95% CI, 0.70 to 1.01; P=0.06). Death attributed to prostate cancer or treatment occurred in 27 men (7.4%) assigned to surgery and in 42 men (11.4%) assigned to observation (absolute difference in risk, 4.0 percentage points; 95% CI, −0.2 to 8.3; hazard ratio, 0.63; 95% CI, 0.39 to 1.02; P=0.06). Surgery may have been associated with lower all-cause mortality than observation among men with intermediate-risk disease (absolute difference, 14.5 percentage points; 95% CI, 2.8 to 25.6) but not among those with low-risk disease (absolute difference, 0.7 percentage points; 95% CI, −10.5 to 11.8) or high-risk disease (absolute difference, 2.3 percentage points; 95% CI, −11.5 to 16.1) (P=0.08 for interaction). Treatment for disease progression was less frequent with surgery than with observation (absolute difference, 26.2 percentage points; 95% CI, 19.0 to 32.9); treatment was primarily for asymptomatic, local, or biochemical (prostate-specific antigen) progression. Urinary incontinence and erectile and sexual dysfunction were each greater with surgery than with observation through 10 years. Disease-related or treatment-related limitations in activities of daily living were greater with surgery than with observation through 2 years.

Conclusions

After nearly 20 years of follow-up among men with localized prostate cancer, surgery was not associated with significantly lower all-cause or prostate-cancer mortality than observation. Surgery was associated with a higher frequency of adverse events than observation but a lower frequency of treatment for disease progression, mostly for asymptomatic, local, or biochemical progression. (Funded by the Department of Veterans Affairs and others; PIVOT ClinicalTrials.gov number, NCT00007644.)

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