Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Eur Urol. 2012 Aug;62(2):204-9. doi: 10.1016/j.eururo.2012.04.024. Epub 2012 Apr 19.
Although there is randomized evidence that radical prostatectomy improves survival, there are few data on how benefit varies by baseline risk.
We aimed to create a statistical model to calculate the decrease in risk of death associated with surgery for an individual patient, using stage, grade, prostate-specific antigen, and age as predictors.
DESIGN, SETTING, AND PARTICIPANTS: A total of 695 men with T1 or T2 prostate cancer participated in the Scandinavian Prostate Cancer Group 4 trial (SPCG-4).
Patients in SPCG-4 were randomized to radical prostatectomy or conservative management.
Competing risk models were created separately for the radical prostatectomy and the watchful waiting group, with the difference between model predictions constituting the estimated benefit for an individual patient.
Individualized predictions of surgery benefit varied widely depending on age and tumor characteristics. At 65 yr of age, the absolute 10-yr risk reduction in prostate cancer mortality attributable to radical prostatectomy ranged from 4.5% to 17.2% for low- versus high-risk patients. Little expected benefit was associated with surgery much beyond age 70. Only about a quarter of men had an individualized benefit within even 50% of the mean. A limitation is that estimates from SPCG-4 have to be applied cautiously to contemporary patients.
Our model suggests that it is hard to justify surgery in patients with Gleason 6, T1 disease or in those patients much above 70 yr of age. Conversely, surgery seems unequivocally of benefit for patients who have Gleason 8, or Gleason 7, stage T2. For patients with Gleason 6 T2 and Gleason 7 T1, treatment is more of a judgment call, depending on patient preference and other clinical findings, such as the number of positive biopsy cores and comorbidities.
尽管有随机对照试验证据表明根治性前列腺切除术可提高生存率，但关于基线风险差异的获益数据却很少。
我们旨在建立一个统计模型，使用分期、分级、前列腺特异性抗原和年龄作为预测因子，为个体患者计算手术相关死亡风险的降低。
设计、地点和参与者：共有 695 名 T1 或 T2 前列腺癌患者参加了北欧前列腺癌组 4 期试验（SPCG-4）。
SPCG-4 中的患者被随机分配至根治性前列腺切除术或保守治疗。
分别为根治性前列腺切除术组和观察等待组建立竞争风险模型，模型预测的差异构成了个体患者的估计获益。
根据年龄和肿瘤特征，手术获益的个体化预测差异很大。在 65 岁时，对于低危和高危患者，根治性前列腺切除术可使前列腺癌死亡率 10 年绝对风险降低 4.5%至 17.2%。年龄超过 70 岁的患者，手术获益很小。甚至只有大约四分之一的男性具有 50%以上的个体获益。该研究的局限性在于，SPCG-4 的估计值必须谨慎应用于当代患者。
我们的模型表明，对于 Gleason 评分 6、T1 期疾病或年龄在 70 岁以上的患者，手术难以证明是合理的。相反，对于 Gleason 评分 8、Gleason 评分 7、T2 期的患者，手术似乎明确获益。对于 Gleason 评分 6 T2 和 Gleason 评分 7 T1 的患者，治疗更具判断性，取决于患者的偏好和其他临床发现，如阳性活检核心的数量和合并症。
