比较基于 PET/CT 的 VISION 和 TheraP 试验标准在接受放射性配体治疗的晚期前列腺癌患者中的适用性。

Comparison of PET/CT-based eligibility according to VISION and TheraP trial criteria in end-stage prostate cancer patients undergoing radioligand therapy.

机构信息

Department of Nuclear Medicine, University Hospital Würzburg, Oberdürrbacher Straße 6, 97080, Würzburg, Germany.

Department of Urology and Paediatric Urology, University Hospital Würzburg, Oberdürrbacher Straße 6, 97080, Würzburg, Germany.

出版信息

Ann Nucl Med. 2024 Feb;38(2):87-95. doi: 10.1007/s12149-023-01874-5. Epub 2023 Oct 27.

BACKGROUND

Two randomized clinical trials demonstrated the efficacy of prostate-specific membrane antigen (PSMA) radioligand therapy (PSMA RLT) in metastatic castration-resistant prostate cancer (mCRPC). While the VISION trial used criteria within PSMA PET/CT for inclusion, the TheraP trial used dual tracer imaging including FDG PET/CT. Therefore, we investigated whether the application of the VISION criteria leads to a benefit in overall survival (OS) or progression-free survival (PFS) for men with mCRPC after PSMA RLT.

METHODS

Thirty-five men with mCRPC who had received PSMA RLT as a last-line option and who had undergone pretherapeutic imaging with FDG and [Ga]Ga-PSMA I&T or [F]PSMA-1007 were studied. Therapeutic eligibility was retrospectively evaluated using the VISION and TheraP study criteria.

RESULTS

26 of 35 (74%) treated patients fulfilled the VISION criteria (= VISION+) and only 17 of 35 (49%) fulfilled the TheraP criteria (= TheraP+). Significantly reduced OS and PFS after PSMA RLT was observed in patients rated VISION- compared to VISION+ (OS: VISION-: 3 vs. VISION+: 12 months, hazard ratio (HR) 3.1, 95% confidence interval (CI) 1.0-9.1, p < 0.01; PFS: VISION-: 1 vs. VISION+: 5 months, HR 2.7, 95% CI 1.0-7.8, p < 0.01). For patients rated TheraP-, no significant difference in OS but in PFS was observed compared to TheraP+ patients (OS: TheraP-: 5.5 vs. TheraP+: 11 months, HR 1.6, 95% CI 0.8-3.3, p = 0.2; PFS: TheraP-: 1 vs. TheraP+: 6 months, HR 2.2, 95% CI 1.0-4.5, p < 0.01).

CONCLUSION

Retrospective application of the inclusion criteria of the VISION study leads to a benefit in OS and PFS after PSMA RL, whereas TheraP criteria appear to be too strict in patients with end-stage prostate cancer. Thus, performing PSMA PET/CT including a contrast-enhanced CT as proposed in the VISION trial might be sufficient for treatment eligibility of end-stage prostate cancer patients.

背景

两项随机临床试验证明了前列腺特异性膜抗原（PSMA）放射性配体疗法（PSMA RLT）在转移性去势抵抗性前列腺癌（mCRPC）中的疗效。虽然 VISION 试验使用了 PSMA PET/CT 中的标准进行纳入，但 TheraP 试验使用了包括 FDG PET/CT 的双重示踪剂成像。因此，我们研究了在接受 PSMA RLT 作为最后一线治疗的 mCRPC 男性中，应用 VISION 标准是否会在 PSMA RLT 后带来总生存（OS）或无进展生存（PFS）的获益。

方法

研究了 35 名接受 PSMA RLT 作为最后一线治疗且接受 FDG 和 [Ga]Ga-PSMA I&T 或 [F]PSMA-1007 治疗前成像的 mCRPC 男性。使用 VISION 和 TheraP 研究标准回顾性评估治疗的适宜性。

结果

35 名接受治疗的患者中，有 26 名（74%）符合 VISION 标准（= VISION+），只有 17 名（49%）符合 TheraP 标准（= TheraP+）。与 VISION+相比，PSMA RLT 后 OS 和 PFS 显著降低的患者被评为 VISION-（OS：VISION-：3 个月 vs. VISION+：12 个月，风险比（HR）3.1，95%置信区间（CI）1.0-9.1，p<0.01；PFS：VISION-：1 个月 vs. VISION+：5 个月，HR 2.7，95% CI 1.0-7.8，p<0.01）。对于被评为 TheraP-的患者，与 TheraP+相比，OS 无显著差异，但 PFS 有显著差异（OS：TheraP-：5.5 个月 vs. TheraP+：11 个月，HR 1.6，95% CI 0.8-3.3，p=0.2；PFS：TheraP-：1 个月 vs. TheraP+：6 个月，HR 2.2，95% CI 1.0-4.5，p<0.01）。