Alberts Ian, Mingels Clemens, Zacho Helle D, Lanz Sabine, Schöder Heiko, Rominger Axel, Zwahlen Marcel, Afshar-Oromieh Ali
Department of Nuclear Medicine, Inselspital, Bern University Hospital, University of Bern, CH-3010, Bern, Switzerland.
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4252-4261. doi: 10.1007/s00259-021-05620-9. Epub 2021 Nov 13.
Amongst others, [Ga]Ga-PSMA-11 and [F]PSMA-1007 are available for the detection of recurrent prostate cancer (rPC). There are currently limited data comparing the performance of these two radioligands with respect to clinical outcomes or their cost efficacy, which this study aims to address.
Two hundred and forty-four patients undergoing PSMA PET/CT for rPC were retrospectively analysed for this study (one hundred and twenty two with each radiopharmaceutical) to generate rates of PET positivity, negativity and unclear findings. Patients underwent follow-up to determine the rate of additional examinations and to confirm PET findings. A Markov chain decision analysis was implemented to model clinical decision-making processes and to analyse clinical performance of the two tracers. We determine their clinical cost efficacies using cost data from several countries where both radiotracers are in routine use.
The PET positivity rate was non-significantly higher for [F]PSMA-1007 compared to [Ga]Ga-PSMA-11 (91.8% vs. 86.9%, p = 0.68), whereas the rate of uncertain findings was significantly greater (17.2% vs. 8.25%, p = 0.02). The probability of a true positive finding was higher for [Ga]Ga-PSMA-11 (0.90, 95% CI 0.70-0.98) vs. [F]PSMA-1007 (0.81, 95% CI 0.66-0.91). A significantly (p < 0.0001) higher PPV for [Ga]Ga-PSMA-11 (0.99, 95% CI 0.99-1.0 vs. 0.86) was found compared to [F]PSMA-1007 (0.86, 95% CI 0.82-1.00). Intervention efficacy analysis favoured [Ga]Ga-PSMA-11, where the number needed to image (to achieve a true positive finding) was 10.58 and the number needed to image to harm (to achieve a false positive finding) was - 8.08. A cost efficacy analysis favours [Ga]Ga-PSMA-11 in three of the four jurisdictions analysed where health economic data was available (Switzerland, Israel, Australia) and [F]PSMA-1007 in one jurisdiction (Denmark).
The analysis reveals a non-significantly higher PET positivity rate for [F]PSMA-1007, but finds significantly greater rates of uncertain findings and false positive findings when compared to [Ga]Ga-PSMA-11. We find differences in the two tracers in terms of clinical performance and cost efficacy. The method presented herein is generalisable and can be used with clinical or cost data for other countries or tracers.
[镓]Ga-PSMA-11和[氟]PSMA-1007等可用于检测复发性前列腺癌(rPC)。目前,关于这两种放射性配体在临床结果或成本效益方面的性能比较数据有限,本研究旨在解决这一问题。
本研究对244例因rPC接受PSMA PET/CT检查的患者进行回顾性分析(每种放射性药物各122例),以得出PET阳性、阴性和结果不明确的发生率。对患者进行随访,以确定额外检查的发生率并确认PET检查结果。实施马尔可夫链决策分析,以模拟临床决策过程并分析两种示踪剂的临床性能。我们使用来自两种放射性示踪剂均常规使用的几个国家的成本数据来确定它们的临床成本效益。
与[镓]Ga-PSMA-11相比,[氟]PSMA-1007的PET阳性率略高(91.8%对86.9%,p = 0.68),而结果不确定的发生率显著更高(17.2%对8.25%,p = 0.02)。[镓]Ga-PSMA-11的真阳性发现概率更高(0.90,95%CI 0.70 - 0.98),而[氟]PSMA-1007为(0.81,95%CI 0.66 - 0.91)。与[氟]PSMA-1007(0.86,95%CI 0.82 - 1.00)相比,[镓]Ga-PSMA-11的阳性预测值显著更高(p < 0.0001)(0.99,95%CI 0.99 - 1.0对0.86)。干预疗效分析支持[镓]Ga-PSMA-11,其成像所需数量(以获得真阳性发现)为10.58,成像导致伤害所需数量(以获得假阳性发现)为 - 8.08。在有卫生经济数据的四个司法管辖区中的三个(瑞士、以色列、澳大利亚),成本效益分析支持[镓]Ga-PSMA-11,而在一个司法管辖区(丹麦)支持[氟]PSMA-1007。
分析显示[氟]PSMA-1007的PET阳性率略高,但与[镓]Ga-PSMA-11相比,结果不确定和假阳性的发生率显著更高。我们发现这两种示踪剂在临床性能和成本效益方面存在差异。本文介绍的方法具有通用性,可用于其他国家或示踪剂的临床或成本数据。