RTI Health Solutions, Research Triangle Park, North Carolina.
Department of Industrial and Operations Engineering, University of Michigan, Ann Arbor, Michigan.
J Nucl Med. 2019 Dec;60(12):1705-1712. doi: 10.2967/jnumed.119.225771. Epub 2019 Jul 26.
The objective of this study was to evaluate the cost-effectiveness of F-choline PET/multiparametric MRI (mpMRI) versus mpMRI alone for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. A Markov model of prostate cancer onset and progression was used to estimate the health and economic consequences of F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 in men with elevated prostate-specific antigen levels. Multiple simultaneous hybrid F-choline PET/mpMRI strategies were evaluated using Likert or Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) scoring; the first was biopsy for Likert 5 mpMRI lesions or Likert 3-4 lesions with F-choline target-to-background ratios of greater than or equal to 1.58, and the second was biopsy for PI-RADSv2 5 mpMRI lesions or PI-RADSv2 3-4 mpMRI lesions with F-choline target-to-background ratios of greater than or equal to 1.58. These strategies were compared with universal standard biopsy, mpMRI alone with biopsy only for PI-RADSv2 3-5 lesions, and mpMRI alone with biopsy only for Likert 4-5 lesions. For each mpMRI strategy, either no biopsy or standard biopsy could be performed after negative mpMRI results were obtained. Deaths averted, quality-adjusted life years (QALYs), cost, and incremental cost-effectiveness ratios were estimated for each strategy. When the results of F-choline PET/mpMRI were negative, performing a standard biopsy was more expensive and had lower QALYs than performing no biopsy. The best screening strategy among those considered in this study performed hybrid F-choline PET/mpMRI with Likert scoring on men with elevated PSA, performed combined biopsy (targeted biopsy and standard 12-core biopsy) for men with positive imaging results, and no biopsy for men with negative imaging results ($22,706/QALY gained relative to mpMRI alone); this strategy reduced the number of biopsies by 35% in comparison to mpMRI alone. When the same policies were compared using PI-RADSv2 instead of Likert scoring, hybrid F-choline PET/mpMRI cost $46,867/QALY gained relative to mpMRI alone. In a threshold analysis, the best strategy among those considered remained cost-effective when the sensitivity and specificity of PET/mpMRI and combined biopsy (targeted biopsy and standard 12-core biopsy) were simultaneously reduced by 20 percentage points. F-choline PET/mpMRI for the detection of primary prostate cancer with a Gleason score of greater than or equal to 3 + 4 is cost-effective and can reduce the number of unneeded biopsies in comparison to mpMRI alone.
本研究旨在评估 F-胆碱 PET/多参数 MRI（mpMRI）在前列腺特异性抗原（PSA）水平升高的男性中，用于检测 Gleason 评分≥3+4 的原发性前列腺癌的成本效益，与单独进行 mpMRI 相比。采用前列腺癌发生和进展的 Markov 模型来估计 F-胆碱 PET/mpMRI 在 PSA 水平升高的男性中检测 Gleason 评分≥3+4 的原发性前列腺癌的健康和经济后果。使用 Likert 或前列腺成像报告和数据系统版本 2（PI-RADSv2）评分评估了多种同时的混合 F-胆碱 PET/mpMRI 策略；第一种策略是对 Likert 5 mpMRI 病变或 Likert 3-4 病变进行活检，F-胆碱的靶标与背景比大于或等于 1.58；第二种策略是对 PI-RADSv2 5 mpMRI 病变或 PI-RADSv2 3-4 mpMRI 病变进行活检，F-胆碱的靶标与背景比大于或等于 1.58。将这些策略与普遍标准活检、仅对 PI-RADSv2 3-5 病变进行 mpMRI 联合活检、仅对 Likert 4-5 病变进行 mpMRI 联合活检进行比较。对于每种 mpMRI 策略，如果 mpMRI 结果为阴性，可以进行标准活检或不进行活检。对于每种策略，估计了避免的死亡人数、质量调整生命年（QALYs）、成本和增量成本效益比。当 F-胆碱 PET/mpMRI 结果为阴性时，与不进行活检相比，进行标准活检的费用更高，且 QALYs 更低。在本研究中考虑的所有筛查策略中，最佳策略是对 PSA 升高的男性进行混合 F-胆碱 PET/mpMRI（采用 Likert 评分），对阳性影像学结果的男性进行联合活检（靶向活检和标准 12 针活检），对阴性影像学结果的男性不进行活检（与单独进行 mpMRI 相比，每获得一个质量调整生命年增加 22706 美元）；与单独进行 mpMRI 相比，该策略减少了 35%的活检次数。当使用 PI-RADSv2 而不是 Likert 评分进行比较时，与单独进行 mpMRI 相比，混合 F-胆碱 PET/mpMRI 的成本为每获得一个质量调整生命年增加 46867 美元。在阈值分析中，当 F-胆碱 PET/mpMRI 和联合活检（靶向活检和标准 12 针活检）的敏感性和特异性同时降低 20 个百分点时，所考虑的最佳策略仍然具有成本效益。F-胆碱 PET/mpMRI 用于检测 Gleason 评分≥3+4 的原发性前列腺癌具有成本效益，与单独进行 mpMRI 相比，可以减少不必要的活检数量。
