Zubek Valentina Bayer, Konski Andre
Aureon Laboratories, Inc., Yonkers, New York 10701, USA.
Mol Diagn Ther. 2009;13(1):31-47. doi: 10.1007/BF03256313.
Ideally, tests that predict the risk of cancer recurrence should be capable of guiding treatment decisions that are both therapeutically effective and cost effective. This paper evaluates the cost effectiveness of two tools that identify patients at high risk for biochemical (prostate-specific antigen) recurrence of prostate cancer after prostatectomy, the hypothesis being that accurate classification of high-risk patients will allow more appropriate use of secondary (adjuvant/salvage) treatment and may improve on current clinical practice. These risk-prediction tools are the Kattan postoperative nomogram, which uses clinicopathologic features, and the Prostate Px test, which employs additional morphometric and immunofluorescence features of the prostate specimen to predict risk of biochemical recurrence. These tools were trained on patients treated at the Memorial Sloan-Kettering Cancer Center (996 patients for the nomogram, 342 patients for the Prostate Px test).
The cost effectiveness of the Prostate Px test, the Kattan postoperative nomogram, and current clinical practice were compared using a decision analytic model. The modeled treatment for low-risk patients was watchful waiting. The modeled treatments for high-risk patients were local radiation, hormonal therapy, and watchful waiting. Costs, utilities, and transition probabilities were obtained from the literature. Costs and effects were discounted at 3% per year. The time span modeled was 10 years after prostatectomy. Monte Carlo simulation was performed to estimate cost and effectiveness; sensitivity analysis was performed to examine the impact of uncertainty in the parameter values.
The expected quality-adjusted life years (QALYs) for the Prostate Px test, nomogram, and current practice were 8.11, 7.39, and 6.47, respectively. The expected costs were $US17 549, $US14 162, and $US14 104, respectively. The incremental cost-effectiveness ratio of the Prostate Px was $US4704/QALY compared with the nomogram, and $US2100/QALY compared with current practice. The incremental cost-effectiveness ratio of the nomogram was $US63/QALY compared with current practice. These ratios are well below the common willingness-to-pay limit of $US50 000/QALY. Expected effectiveness was highest for the Prostate Px test, followed by the nomogram. Expected cost was slightly higher for Prostate Px than for either alternative; nevertheless, the Prostate Px was cost effective compared with both the nomogram and current practice. The nomogram was cost effective compared with current practice. The acceptable cost effectiveness of the Prostate Px test and the nomogram compared with current practice were not sensitive to changes in the values used to inform the model within clinically plausible ranges. The superior performance of both Prostate Px test and nomogram over current practice resulted from identifying high-risk patients likely to benefit from adjuvant treatment, while sparing the low-risk patients the added cost and toxicity of treatment.
Incorporation of risk-prediction tools in the initial management of patients after prostatectomy resulted in increased QALYs at an acceptable increase in cost relative to current practice.
理想情况下,能够预测癌症复发风险的检测应能够指导既有效又具成本效益的治疗决策。本文评估了两种用于识别前列腺切除术后前列腺癌生化(前列腺特异性抗原)复发高风险患者的工具的成本效益,其假设是对高风险患者进行准确分类将有助于更合理地使用二线(辅助/挽救)治疗,并可能改善当前临床实践。这些风险预测工具分别是利用临床病理特征的卡坦术后列线图,以及采用前列腺标本的额外形态测量和免疫荧光特征来预测生化复发风险的前列腺Px检测。这些工具是基于纪念斯隆凯特琳癌症中心接受治疗的患者进行训练的(列线图996例患者,前列腺Px检测342例患者)。
使用决策分析模型比较前列腺Px检测、卡坦术后列线图和当前临床实践的成本效益。低风险患者的模拟治疗方案是密切观察。高风险患者的模拟治疗方案是局部放疗、激素治疗和密切观察。成本、效用和转移概率均取自文献。成本和效果按每年3%进行贴现。模拟的时间跨度为前列腺切除术后10年。进行蒙特卡洛模拟以估计成本和效果;进行敏感性分析以检验参数值不确定性的影响。
前列腺Px检测、列线图和当前实践的预期质量调整生命年(QALY)分别为8.11、7.39和6.47。预期成本分别为17549美元、14162美元和14104美元。与列线图相比,前列腺Px检测的增量成本效益比为4704美元/QALY,与当前实践相比为2100美元/QALY。列线图与当前实践相比的增量成本效益比为63美元/QALY。这些比率远低于常见的每QALY支付意愿上限50000美元。前列腺Px检测的预期效果最高,其次是列线图。前列腺Px检测的预期成本略高于其他两种方案;然而,与列线图和当前实践相比,前列腺Px检测仍具有成本效益。列线图与当前实践相比具有成本效益。与当前实践相比,前列腺Px检测和列线图可接受的成本效益在临床合理范围内对用于模型的数据值变化不敏感。前列腺Px检测和列线图相对于当前实践的卓越表现源于识别出可能从辅助治疗中获益的高风险患者,同时使低风险患者免受治疗的额外成本和毒性。
在前列腺切除术后患者的初始管理中纳入风险预测工具,相对于当前实践,在成本可接受增加的情况下导致了QALY的增加。