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Quantitative 68Ga-PSMA-11 PET and Clinical Outcomes in Metastatic Castration-resistant Prostate Cancer Following 177Lu-PSMA-617 (VISION Trial).
Radiology ( IF 12.1 ) Pub Date : 2024-08-01 , DOI: 10.1148/radiol.233460
Phillip H Kuo 1 , Michael J Morris 1 , Jacob Hesterman 1 , A Tuba Kendi 1 , Kambiz Rahbar 1 , Xiao X Wei 1 , Bruno Fang 1 , Nabil Adra 1 , Rohan Garje 1 , Jeff M Michalski 1 , Kim Chi 1 , Johann de Bono 1 , Karim Fizazi 1 , Bernd Krause 1 , Oliver Sartor 1 , Scott T Tagawa 1 , Samson Ghebremariam 1 , Marcia Brackman 1 , Connie C Wong 1 , Ana M Catafau 1 , Taylor Benson 1 , Andrew J Armstrong 1 , Ken Herrmann 1
Radiology ( IF 12.1 ) Pub Date : 2024-08-01 , DOI: 10.1148/radiol.233460
Phillip H Kuo 1 , Michael J Morris 1 , Jacob Hesterman 1 , A Tuba Kendi 1 , Kambiz Rahbar 1 , Xiao X Wei 1 , Bruno Fang 1 , Nabil Adra 1 , Rohan Garje 1 , Jeff M Michalski 1 , Kim Chi 1 , Johann de Bono 1 , Karim Fizazi 1 , Bernd Krause 1 , Oliver Sartor 1 , Scott T Tagawa 1 , Samson Ghebremariam 1 , Marcia Brackman 1 , Connie C Wong 1 , Ana M Catafau 1 , Taylor Benson 1 , Andrew J Armstrong 1 , Ken Herrmann 1
Affiliation
Background Lutetium 177 [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) is a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC). Quantitative PSMA PET/CT analysis could provide information on 177Lu-PSMA-617 treatment benefits. Purpose To explore the association between quantitative baseline gallium 68 [68Ga]Ga-PSMA-11 (68Ga-PSMA-11) PET/CT parameters and treatment response and outcomes in the VISION trial. Materials and Methods This was an exploratory secondary analysis of the VISION trial. Eligible participants were randomized (June 2018 to October 2019) in a 2:1 ratio to 177Lu-PSMA-617 therapy (7.4 GBq every 6 weeks for up to six cycles) plus standard of care (SOC) or to SOC only. Baseline 68Ga-PSMA-11 PET parameters, including the mean and maximum standardized uptake value (SUVmean and SUVmax), PSMA-positive tumor volume, and tumor load, were extracted from five anatomic regions and the whole body. Associations of quantitative PET parameters with radiographic progression-free survival (rPFS), overall survival (OS), objective response rate, and prostate-specific antigen response were investigated using univariable and multivariable analyses (with treatment as the only other covariate). Outcomes were assessed in subgroups based on SUVmean quartiles. Results Quantitative PET parameters were well balanced between study arms for the 826 participants included. The median whole-body tumor SUVmean was 7.6 (IQR, 5.8-9.9). Whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy, with a hazard ratio (HR) range of 0.86-1.43 for all outcomes (all P < .001). A 1-unit whole-body tumor SUVmean increase was associated with a 12% and 10% decrease in risk of an rPFS event and death, respectively. 177Lu-PSMA-617 plus SOC prolonged rPFS and OS in all SUVmean quartiles versus SOC only, with no identifiable optimum among participants receiving 177Lu-PSMA-617. Higher baseline PSMA-positive tumor volume and tumor load were associated with worse rPFS (HR range, 1.44-1.53 [P < .05] and 1.02-1.03 [P < .001], respectively) and OS (HR range, 1.36-2.12 [P < .006] and 1.04 [P < .001], respectively). Conclusion Baseline 68Ga-PSMA-11 PET/CT whole-body tumor SUVmean was the best predictor of 177Lu-PSMA-617 efficacy in participants in the VISION trial. Improvements in rPFS and OS with 177Lu-PSMA-617 plus SOC were greater among participants with higher whole-body tumor SUVmean, with evidence for benefit at all SUVmean levels. ClinicalTrials.gov identifier: NCT03511664 Published under a CC BY 4.0 license. Supplemental material is available for this article.
中文翻译:
定量 68Ga-PSMA-11 PET 和 177Lu-PSMA-617 后转移性去势抵抗性前列腺癌的临床结果(VISION 试验)。
背景 Lutetium 177 [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) 是一种前列腺特异性膜抗原 (PSMA) 靶向放射配体治疗转移性去势抵抗性前列腺癌 (mCRPC)。定量 PSMA PET/CT 分析可提供有关 177Lu-PSMA-617 治疗益处的信息。目的: 探讨定量基线镓 68 [68Ga]Ga-PSMA-11 (68Ga-PSMA-11) PET/CT 参数与 VISION 试验中治疗反应和结果之间的关联。材料和方法 这是对 VISION 试验的探索性二次分析。符合条件的参与者以 2:1 的比例随机分配(2018 年 6 月至 2019 年 10 月)接受 177Lu-PSMA-617 治疗(每 6 周 7.4 GBq,最多 6 个周期)加标准护理 (SOC) 或仅接受 SOC。从 5 个解剖区域和全身提取基线 68Ga-PSMA-11 PET 参数,包括平均和最大标准化摄取值 (SUVmean 和 SUVmax)、PSMA 阳性肿瘤体积和肿瘤载量。使用单变量和多变量分析 (治疗是唯一的其他协变量) 研究定量 PET 参数与影像学无进展生存期 (rPFS) 、总生存期 (OS) 、客观缓解率和前列腺特异性抗原反应的相关性。根据 SUVmean 四分位数在亚组中评估结局。结果 826 名参与者的研究组之间的定量 PET 参数平衡良好。中位全身肿瘤 SUVmean 为 7.6 (IQR, 5.8-9.9)。全身肿瘤 SUVmean 是 177Lu-PSMA-617 疗效的最佳预测因子,所有结局的风险比 (HR) 范围为 0.86-1.43 (均 P < .001)。全身肿瘤 SUVmean 增加 1 个单位与 rPFS 事件和死亡风险降低 12% 和 10% 分别相关。 与仅 SOC 相比,177Lu-PSMA-617 加 SOC 延长了所有 SUVmean 四分位数的 rPFS 和 OS,在接受 177Lu-PSMA-617 的参与者中没有可识别的最佳值。较高的基线 PSMA 阳性肿瘤体积和肿瘤负荷与较差的 rPFS (HR 范围,分别为 1.44-1.53 [P < .05] 和 1.02-1.03 [P < .001])和 OS (HR 范围,分别为 1.36-2.12 [P < .006] 和 1.04 [P < .001])相关。结论 基线 68Ga-PSMA-11 PET/CT 全身肿瘤 SUVmean 是 VISION 试验参与者 177Lu-PSMA-617 疗效的最佳预测因子。在全身肿瘤 SUVmean 较高的参与者中,177Lu-PSMA-617 联合 SOC 的 rPFS 和 OS 改善更大,有证据表明在所有 SUVmean 水平上都有益处。ClinicalTrials.gov 标识符:NCT03511664 在 CC BY 4.0 许可下发布。本文提供了补充材料。
更新日期:2024-08-01
中文翻译:
定量 68Ga-PSMA-11 PET 和 177Lu-PSMA-617 后转移性去势抵抗性前列腺癌的临床结果(VISION 试验)。
背景 Lutetium 177 [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) 是一种前列腺特异性膜抗原 (PSMA) 靶向放射配体治疗转移性去势抵抗性前列腺癌 (mCRPC)。定量 PSMA PET/CT 分析可提供有关 177Lu-PSMA-617 治疗益处的信息。目的: 探讨定量基线镓 68 [68Ga]Ga-PSMA-11 (68Ga-PSMA-11) PET/CT 参数与 VISION 试验中治疗反应和结果之间的关联。材料和方法 这是对 VISION 试验的探索性二次分析。符合条件的参与者以 2:1 的比例随机分配(2018 年 6 月至 2019 年 10 月)接受 177Lu-PSMA-617 治疗(每 6 周 7.4 GBq,最多 6 个周期)加标准护理 (SOC) 或仅接受 SOC。从 5 个解剖区域和全身提取基线 68Ga-PSMA-11 PET 参数,包括平均和最大标准化摄取值 (SUVmean 和 SUVmax)、PSMA 阳性肿瘤体积和肿瘤载量。使用单变量和多变量分析 (治疗是唯一的其他协变量) 研究定量 PET 参数与影像学无进展生存期 (rPFS) 、总生存期 (OS) 、客观缓解率和前列腺特异性抗原反应的相关性。根据 SUVmean 四分位数在亚组中评估结局。结果 826 名参与者的研究组之间的定量 PET 参数平衡良好。中位全身肿瘤 SUVmean 为 7.6 (IQR, 5.8-9.9)。全身肿瘤 SUVmean 是 177Lu-PSMA-617 疗效的最佳预测因子,所有结局的风险比 (HR) 范围为 0.86-1.43 (均 P < .001)。全身肿瘤 SUVmean 增加 1 个单位与 rPFS 事件和死亡风险降低 12% 和 10% 分别相关。 与仅 SOC 相比,177Lu-PSMA-617 加 SOC 延长了所有 SUVmean 四分位数的 rPFS 和 OS,在接受 177Lu-PSMA-617 的参与者中没有可识别的最佳值。较高的基线 PSMA 阳性肿瘤体积和肿瘤负荷与较差的 rPFS (HR 范围,分别为 1.44-1.53 [P < .05] 和 1.02-1.03 [P < .001])和 OS (HR 范围,分别为 1.36-2.12 [P < .006] 和 1.04 [P < .001])相关。结论 基线 68Ga-PSMA-11 PET/CT 全身肿瘤 SUVmean 是 VISION 试验参与者 177Lu-PSMA-617 疗效的最佳预测因子。在全身肿瘤 SUVmean 较高的参与者中,177Lu-PSMA-617 联合 SOC 的 rPFS 和 OS 改善更大,有证据表明在所有 SUVmean 水平上都有益处。ClinicalTrials.gov 标识符:NCT03511664 在 CC BY 4.0 许可下发布。本文提供了补充材料。