Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
JAMA. 2010 Dec 1;304(21):2373-80. doi: 10.1001/jama.2010.1720.
In the United States, 192,000 men were diagnosed as having prostate cancer in 2009, the majority with low-risk, clinically localized disease. Treatment of these cancers is associated with substantial morbidity. Active surveillance is an alternative to initial treatment, but long-term outcomes and effect on quality of life have not been well characterized.
To examine the quality-of-life benefits and risks of active surveillance compared with initial treatment for men with low-risk, clinically localized prostate cancer.
Decision analysis using a simulation model was performed: men were treated at diagnosis with brachytherapy, intensity-modulated radiation therapy (IMRT), or radical prostatectomy or followed up by active surveillance (a strategy of close monitoring of newly diagnosed patients with serial prostate-specific antigen measurements, digital rectal examinations, and biopsies, with treatment at disease progression or patient choice). Probabilities and utilities were derived from previous studies and literature review. In the base case, the relative risk of prostate cancer-specific death for initial treatment vs active surveillance was assumed to be 0.83. Men incurred short- and long-term adverse effects of treatment.
Hypothetical cohorts of 65-year-old men newly diagnosed as having clinically localized, low-risk prostate cancer (prostate-specific antigen level <10 ng/mL, stage ≤T2a disease, and Gleason score ≤6).
Quality-adjusted life expectancy (QALE).
Active surveillance was associated with the greatest QALE (11.07 quality-adjusted life-years [QALYs]), followed by brachytherapy (10.57 QALYs), IMRT (10.51 QALYs), and radical prostatectomy (10.23 QALYs). Active surveillance remained associated with the highest QALE even if the relative risk of prostate cancer-specific death for initial treatment vs active surveillance was as low as 0.6. However, the QALE gains and the optimal strategy were highly dependent on individual preferences for living under active surveillance and for having been treated.
Under a wide range of assumptions, for a 65-year-old man, active surveillance is a reasonable approach to low-risk prostate cancer based on QALE compared with initial treatment. However, individual preferences play a central role in the decision whether to treat or to pursue active surveillance.
2009 年，美国有 19.2 万名男性被诊断患有前列腺癌，其中大多数为低危、临床局限性疾病。这些癌症的治疗与严重的发病率相关。主动监测是初始治疗的一种替代方法，但长期结果和对生活质量的影响尚未得到很好的描述。
研究与初始治疗相比，主动监测对低危、临床局限性前列腺癌男性的生活质量获益和风险。
使用模拟模型进行决策分析：男性在诊断时接受近距离放射治疗、调强放疗（IMRT）或根治性前列腺切除术治疗，或通过主动监测（对新诊断的患者进行连续前列腺特异性抗原检测、数字直肠检查和活检的密切监测策略，在疾病进展或患者选择时进行治疗）进行随访。概率和效用来自以前的研究和文献综述。在基本情况下，初始治疗与主动监测相比，前列腺癌特异性死亡的相对风险假设为 0.83。男性会发生治疗的短期和长期不良反应。
新诊断为临床局限性、低危前列腺癌（前列腺特异性抗原水平<10ng/mL，分期≤T2a 疾病，Gleason 评分≤6）的 65 岁男性假设队列。
质量调整生命期望（QALE）。
主动监测与最大 QALE（11.07 个质量调整生命年[QALYs]）相关，其次是近距离放射治疗（10.57 QALYs）、调强放疗（10.51 QALYs）和根治性前列腺切除术（10.23 QALYs）。即使初始治疗与主动监测相比，前列腺癌特异性死亡的相对风险低至 0.6，主动监测仍与最高 QALE 相关。然而，QALE 获益和最佳策略高度取决于个人对主动监测和治疗的偏好。
在广泛的假设下，对于 65 岁的男性，与初始治疗相比，基于 QALE，主动监测是治疗低危前列腺癌的合理方法。然而，个人偏好在是否治疗或选择主动监测的决策中起着核心作用。
