Soroush Rais-Bahrami MD , Mark Fleming MD , Benjamin Gartrell MD , William C. Lavely MD , Albert Chau MSc , Phillip Davis MD , David M. Schuster MD
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This post hoc analysis of SPOTLIGHT evaluates the diagnostic performance of <sup>18</sup>F-flotufolastat in AA patients.</p></div><div><h3>Methods and Materials</h3><p>Patients underwent positron emission tomography/computed tomography 50 to 70 minutes after intravenous administration of 296 MBq <sup>18</sup>F-flotufolastat. Three blinded readers evaluated all images, with the majority read (agreement of ≥2 readers) result reported here. Standard of truth (SoT) was established with histopathology or correlative imaging. Data from AA patients were evaluated to determine the <sup>18</sup>F-flotufolastat overall detection rate (DR), positive predictive value (PPV), and verified DR (VDR). VDR (SoT-verified) is equivalent to DR × PPV.</p></div><div><h3>Results</h3><p>In total, 61 of 366 (17%) patients were AAs. Although baseline characteristics were broadly similar, fewer AA patients (56%) had undergone prostatectomy than non-AA patients (82%). The patient-level DR was 93% (57/61) in AA patients, increasing from 67% at prostate-specific antigen <0.5 ng/mL to 100% at prostate-specific antigen ≥10 ng/mL. Patient-level DR was marginally lower in all other patients (87%, 264/305). However, when stratifying by prior treatment, DRs were similar across ethnic groups in postprostatectomy patients, but in patients with intact prostates, AA patients had higher prostate DR than non-AA patients. SoT-verification (predominantly with conventional imaging [79%]) gave a VDR of 64% and PPV of 68% in AA patients, versus 55% and 64%, respectively, in all other patients.</p></div><div><h3>Conclusions</h3><p><sup>18</sup>F-Flotufolastat DRs were marginally higher in AA patients than in all other patients enrolled in SPOTLIGHT. High VDR and PPV were also achieved in AA patients from across all participating centers, indicating the broad applicability of newly US Food and Drug Administration–approved <sup>18</sup>F-flotufolastat to the US population as a whole.</p></div>","PeriodicalId":7390,"journal":{"name":"Advances in Radiation Oncology","volume":"9 9","pages":"Article 101571"},"PeriodicalIF":2.2000,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2452109424001349/pdfft?md5=6326106769069cc5cc663bad23d491c8&pid=1-s2.0-S2452109424001349-main.pdf","citationCount":"0","resultStr":"{\"title\":\"18F-Flotufolastat Positron Emission Tomography in African American Patients With Suspected Prostate Cancer Recurrence: Findings From the Phase 3 SPOTLIGHT Study\",\"authors\":\"Soroush Rais-Bahrami MD , Mark Fleming MD , Benjamin Gartrell MD , William C. 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This post hoc analysis of SPOTLIGHT evaluates the diagnostic performance of <sup>18</sup>F-flotufolastat in AA patients.</p></div><div><h3>Methods and Materials</h3><p>Patients underwent positron emission tomography/computed tomography 50 to 70 minutes after intravenous administration of 296 MBq <sup>18</sup>F-flotufolastat. Three blinded readers evaluated all images, with the majority read (agreement of ≥2 readers) result reported here. Standard of truth (SoT) was established with histopathology or correlative imaging. Data from AA patients were evaluated to determine the <sup>18</sup>F-flotufolastat overall detection rate (DR), positive predictive value (PPV), and verified DR (VDR). VDR (SoT-verified) is equivalent to DR × PPV.</p></div><div><h3>Results</h3><p>In total, 61 of 366 (17%) patients were AAs. Although baseline characteristics were broadly similar, fewer AA patients (56%) had undergone prostatectomy than non-AA patients (82%). 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引用次数: 0
摘要
目的虽然非裔美国人（AA）患者罹患前列腺癌的比例很高，但他们在肿瘤临床试验中的代表性往往不足。SPOTLIGHT研究（NCT04186845）在复发性前列腺癌患者中评估了新型诊断性正电子发射断层扫描放射性药物18F-氟夫司他（18F-rhPSMA-7.3）。参加 SPOTLIGHT 的 AA 患者比例（17%）高于一般肿瘤试验的比例（8.5%），在美国人口中也具有代表性（14%）。本研究对 SPOTLIGHT 进行了事后分析，评估了 18F 氟氟司特对 AA 患者的诊断效果。方法与材料患者在静脉注射 296 MBq 18F 氟氟司特后 50 至 70 分钟接受正电子发射断层扫描/计算机断层扫描。三位盲读者对所有图像进行了评估，并在此报告了多数读数（≥2 位读者一致）的结果。真实标准（SoT）由组织病理学或相关成像确定。对AA患者的数据进行评估，以确定18F-氟唑司特的总检出率（DR）、阳性预测值（PPV）和验证DR（VDR）。VDR（SoT-验证）相当于DR×PPV。结果在366名患者中，共有61名（17%）为AA患者。虽然基线特征大致相似，但接受过前列腺切除术的 AA 患者（56%）少于非 AA 患者（82%）。AA患者的患者水平DR为93%（57/61），从前列腺特异性抗原为0.5纳克/毫升时的67%增加到前列腺特异性抗原≥10纳克/毫升时的100%。所有其他患者的患者水平 DR 略低（87%，264/305）。不过，如果按先前的治疗进行分层，不同种族群体的前列腺切除术后患者的前列腺特异性抗原含量相似，但在前列腺完整的患者中，AA 患者的前列腺特异性抗原含量高于非 AA 患者。SoT验证（主要采用常规成像[79%]）显示，AA患者的VDR为64%，PPV为68%，而所有其他患者的VDR和PPV分别为55%和64%。所有参与中心的 AA 患者都获得了较高的 VDR 和 PPV，这表明美国食品药品管理局新近批准的 18F 氟氟司特可广泛适用于整个美国人群。
18F-Flotufolastat Positron Emission Tomography in African American Patients With Suspected Prostate Cancer Recurrence: Findings From the Phase 3 SPOTLIGHT Study
Purpose
Although African American (AA) patients are disproportionately affected by prostate cancer, they are often underrepresented in oncology clinical trials. The SPOTLIGHT study (NCT04186845) assessed the novel diagnostic positron emission tomography radiopharmaceutical, 18F-flotufolastat (18F-rhPSMA-7.3), in patients with recurrent prostate cancer. The proportion of AA patients enrolled in SPOTLIGHT (17%) was greater than typically enrolled in oncology trials (8.5%) and was representative of the US population (14%). This post hoc analysis of SPOTLIGHT evaluates the diagnostic performance of 18F-flotufolastat in AA patients.
Methods and Materials
Patients underwent positron emission tomography/computed tomography 50 to 70 minutes after intravenous administration of 296 MBq 18F-flotufolastat. Three blinded readers evaluated all images, with the majority read (agreement of ≥2 readers) result reported here. Standard of truth (SoT) was established with histopathology or correlative imaging. Data from AA patients were evaluated to determine the 18F-flotufolastat overall detection rate (DR), positive predictive value (PPV), and verified DR (VDR). VDR (SoT-verified) is equivalent to DR × PPV.
Results
In total, 61 of 366 (17%) patients were AAs. Although baseline characteristics were broadly similar, fewer AA patients (56%) had undergone prostatectomy than non-AA patients (82%). The patient-level DR was 93% (57/61) in AA patients, increasing from 67% at prostate-specific antigen <0.5 ng/mL to 100% at prostate-specific antigen ≥10 ng/mL. Patient-level DR was marginally lower in all other patients (87%, 264/305). However, when stratifying by prior treatment, DRs were similar across ethnic groups in postprostatectomy patients, but in patients with intact prostates, AA patients had higher prostate DR than non-AA patients. SoT-verification (predominantly with conventional imaging [79%]) gave a VDR of 64% and PPV of 68% in AA patients, versus 55% and 64%, respectively, in all other patients.
Conclusions
18F-Flotufolastat DRs were marginally higher in AA patients than in all other patients enrolled in SPOTLIGHT. High VDR and PPV were also achieved in AA patients from across all participating centers, indicating the broad applicability of newly US Food and Drug Administration–approved 18F-flotufolastat to the US population as a whole.
期刊介绍：
The purpose of Advances is to provide information for clinicians who use radiation therapy by publishing: Clinical trial reports and reanalyses. Basic science original reports. Manuscripts examining health services research, comparative and cost effectiveness research, and systematic reviews. Case reports documenting unusual problems and solutions. High quality multi and single institutional series, as well as other novel retrospective hypothesis generating series. Timely critical reviews on important topics in radiation oncology, such as side effects. Articles reporting the natural history of disease and patterns of failure, particularly as they relate to treatment volume delineation. Articles on safety and quality in radiation therapy. Essays on clinical experience. Articles on practice transformation in radiation oncology, in particular: Aspects of health policy that may impact the future practice of radiation oncology. How information technology, such as data analytics and systems innovations, will change radiation oncology practice. Articles on imaging as they relate to radiation therapy treatment.
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