Zhang Liying, Loblaw Andrew, Klotz Laurence
Division of Clinical Trials and Epidemiology, and Department of Radiation Oncology, and Division of Urology, Sunnybrook and Women's College Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
J Urol. 2006 Oct;176(4 Pt 1):1392-7; discussion 1397-8. doi: 10.1016/j.juro.2006.06.103.
Prostate specific antigen doubling time was used to stratify patients into groups at low and high risk for progression. The prostate specific antigen kinetics in these 2 groups were modeled.
In this prospective, single-arm cohort study patients with favorable clinical parameters (stage T1b-T2b N0M0, Gleason score 7 or less, prostate specific antigen 15 ng/ml or less) were conservatively treated with watchful waiting. Evolution of serial prostate specific antigen measurements over time was estimated from a general linear mixed model of the natural log of prostate specific antigen. The corresponding average and individual prostate specific antigen doubling times were also calculated.
Since November 1995 a total of 231 patients had at least 6 months of followup and at least 3 prostate specific antigen measurements. Based on prostate specific antigen doubling time and repeat biopsy, 93 patients fulfilled the criteria for high risk of disease progression and 138 were defined as low risk. Given the baseline status of these individuals, 2 reference average lines (high risk and low risk) were derived to model the evolution of prostate specific antigen levels and permit more rational decision making regarding the need for definitive intervention. The average prostate specific antigen doubling time was 2.97 years (95% CI 2.2-4.4) in patients allocated to the high risk group and 6.54 years (95% CI 4.8-12.3) in those at low risk.
By applying the dynamic prognostic rule in combination with serial biopsy, a rational decision for definitive intervention based on the risk of disease progression could be optimally recommended about 2.3 years after initiated surveillance.
采用前列腺特异性抗原倍增时间将患者分为进展风险低和高的组。对这两组的前列腺特异性抗原动力学进行建模。
在这项前瞻性单臂队列研究中，对具有良好临床参数（T1b - T2b期N0M0、Gleason评分7分及以下、前列腺特异性抗原15 ng/ml及以下）的患者进行密切观察的保守治疗。通过前列腺特异性抗原自然对数的一般线性混合模型估计随时间连续前列腺特异性抗原测量值的变化。还计算了相应的平均和个体前列腺特异性抗原倍增时间。
自1995年11月以来，共有231例患者接受了至少6个月的随访且至少进行了3次前列腺特异性抗原测量。根据前列腺特异性抗原倍增时间和重复活检，93例患者符合疾病进展高风险标准，138例被定义为低风险。根据这些个体的基线状态，得出2条参考平均线（高风险和低风险）以对前列腺特异性抗原水平的变化进行建模，并就明确干预的必要性做出更合理的决策。分配到高风险组的患者平均前列腺特异性抗原倍增时间为2.97年（95%置信区间2.2 - 4.4），低风险组为6.54年（95%置信区间4.8 - 12.3）。
通过将动态预后规则与连续活检相结合，在开始监测约2.3年后，可以根据疾病进展风险为明确干预做出最佳的合理推荐。
