Comparing the clinical performance and cost efficacy of [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 in the diagnosis of recurrent prostate cancer: a Markov chain decision analysis,European Journal of Nuclear Medicine and Molecular Imaging

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Comparing the clinical performance and cost efficacy of [68Ga]Ga-PSMA-11 and [18F]PSMA-1007 in the diagnosis of recurrent prostate cancer: a Markov chain decision analysis
European Journal of Nuclear Medicine and Molecular Imaging ( IF 8.6 ) Pub Date : 2021-11-13 , DOI: 10.1007/s00259-021-05620-9
Ian Alberts _{1,

2} , Clemens Mingels _{1,

2} , Helle D Zacho _{2,

3} , Sabine Lanz _{1,

2} , Heiko Schöder _{2,

4} , Axel Rominger _{1,

2} , Marcel Zwahlen _{2,

4} , Ali Afshar-Oromieh _{1,

2}

Affiliation

Purpose

Amongst others, [⁶⁸Ga]Ga-PSMA-11 and [¹⁸F]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.

Methods

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.

Results

The PET positivity rate was non-significantly higher for [¹⁸F]PSMA-1007 compared to [⁶⁸Ga]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 [⁶⁸Ga]Ga-PSMA-11 (0.90, 95% CI 0.70-0.98) vs. [¹⁸F]PSMA-1007 (0.81, 95% CI 0.66–0.91). A significantly (p < 0.0001) higher PPV for [⁶⁸Ga]Ga-PSMA-11 (0.99, 95% CI 0.99–1.0 vs. 0.86) was found compared to [¹⁸F]PSMA-1007 (0.86, 95% CI 0.82–1.00). Intervention efficacy analysis favoured [⁶⁸Ga]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 [⁶⁸Ga]Ga-PSMA-11 in three of the four jurisdictions analysed where health economic data was available (Switzerland, Israel, Australia) and [¹⁸F]PSMA-1007 in one jurisdiction (Denmark).

Conclusion

The analysis reveals a non-significantly higher PET positivity rate for [¹⁸F]PSMA-1007, but finds significantly greater rates of uncertain findings and false positive findings when compared to [⁶⁸Ga]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.

中文翻译：

比较 [68Ga]Ga-PSMA-11 和 [18F]PSMA-1007 在诊断复发性前列腺癌中的临床表现和成本效益：马尔可夫链决策分析

目的

其中，[ ⁶⁸ Ga]Ga-PSMA-11 和 [ ¹⁸ F]PSMA-1007 可用于检测复发性前列腺癌 (rPC)。目前比较这两种放射性配体在临床结果或成本效益方面的性能的数据有限，这是本研究旨在解决的问题。

方法

本研究对 244 名因 rPC 接受 PSMA PET/CT 的患者进行了回顾性分析（每种放射性药物各 122 名患者），以得出 PET 阳性率、阴性率和不清楚的结果。患者接受随访以确定额外检查的比例并确认 PET 结果。实施马尔可夫链决策分析来模拟临床决策过程并分析两种示踪剂的临床表现。我们使用常规使用这两种放射性示踪剂的几个国家的成本数据来确定其临床成本效益。

结果

与 [ ⁶⁸ Ga]Ga-PSMA-11 相比，[ ¹⁸ F]PSMA-1007 的 PET 阳性率非显着较高（91.8% vs. 86.9%， p = 0.68），而不确定结果的发生率显着更高（17.2% 与 8.25%， p = 0.02）。 [ ⁶⁸ Ga]Ga-PSMA-11 (0.90, 95% CI 0.70-0.98) 与 [ ¹⁸ F]PSMA-1007 (0.81, 95% CI 0.66-0.91) 相比，真阳性结果的概率更高。与 [ ¹⁸ F]PSMA-1007 (0.86, 95% CI) 相比，[ ⁶⁸ Ga]Ga-PSMA-11 (0.99, 95% CI 0.99–1.0 vs. 0.86) PPV 显着升高 ( p < 0.0001) 0.82–1.00）。干预功效分析有利于[ ⁶⁸ Ga]Ga-PSMA-11，其中成像所需的数量（以获得真阳性结果）为10.58，而伤害成像所需的数量（以获得假阳性结果）为- 8.08。成本效益分析在可获得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）中支持 [ ⁶⁸ Ga]Ga-PSMA-11，在一个司法管辖区（丹麦）中支持 [ ¹⁸ F]PSMA-1007。