Combining PSMA-PET and PROMISE to re-define disease stage and risk in patients with prostate cancer: a multicentre retrospective study.

IF 41.6 1区 医学 Q1 ONCOLOGY
Lancet Oncology Pub Date : 2024-09-01 Epub Date: 2024-07-29 DOI:10.1016/S1470-2045(24)00326-7
Madeleine J Karpinski, Johannes Hüsing, Kevin Claassen, Lennart Möller, Hiltraud Kajüter, Florian Oesterling, Viktor Grünwald, Lale Umutlu, Jens Kleesiek, Tugce Telli, Anja Merkel-Jens, Anika Hüsing, Claudia Kesch, Ken Herrmann, Matthias Eiber, Sebastian Hoberück, Philipp T Meyer, Felix Kind, Kambiz Rahbar, Michael Schäfers, Andreas Stang, Boris A Hadaschik, Wolfgang P Fendler
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We aimed to compare the prognostic value of PSMA-PET by PROMISE (PPP) stage with established clinical nomograms in a large prostate cancer dataset with follow-up data for overall survival.</p><p><strong>Methods: </strong>In this multicentre retrospective study, we used data from patients of any age with histologically proven prostate cancer who underwent PSMA-PET at the University Hospitals in Essen, Münster, Freiburg, and Dresden, Germany, between Oct 30, 2014, and Dec 27, 2021. We linked a subset of patient hospital records with patient data, including mortality data, from the Cancer Registry North-Rhine Westphalia, Germany. Patients from Essen University Hospital were randomly assigned to the development or internal validation cohorts (2:1). Patients from Münster, Freiburg, and Dresden University Hospitals were included in an external validation cohort. 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Performance was measured using Harrell's C-index in the internal and external validation cohorts and compared with established clinical risk scores (International Staging Collaboration for Cancer of the Prostate [STARCAP], European Association of Urology [EAU], and National Comprehensive Cancer Network [NCCN] risk scores) and a previous nomogram defined by Gafita et al (hereafter referred to as GAFITA) using receiver operating characteristic (ROC) curves and area under the ROC curve (AUC) estimates.</p><p><strong>Findings: </strong>We analysed 2414 male patients (1110 included in the development cohort, 502 in the internal cohort, and 802 in the external validation cohort), among whom 901 (37%) had died as of data cutoff (June 30, 2023; median follow-up of 52·9 months [IQR 33·9-79·0]). Predictors in the quantitative PPP nomogram were locoregional lymph node metastases (molecular imaging N2), distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases), tumour volume (in L), and tumour mean standardised uptake value. Predictors in the visual PPP nomogram were distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases) and total tumour lesion count. In the internal and external validation cohorts, C-indices were 0·80 (95% CI 0·77-0·84) and 0·77 (0·75-0·78) for the quantitative nomogram, respectively, and 0·78 (0·75-0·82) and 0·77 (0·75-0·78) for the visual nomogram, respectively. 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引用次数: 0

Abstract

Background: Prostate-specific membrane antigen (PSMA)-PET was introduced into clinical practice in 2012 and has since transformed the staging of prostate cancer. Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria were proposed to standardise PSMA-PET reporting. We aimed to compare the prognostic value of PSMA-PET by PROMISE (PPP) stage with established clinical nomograms in a large prostate cancer dataset with follow-up data for overall survival.

Methods: In this multicentre retrospective study, we used data from patients of any age with histologically proven prostate cancer who underwent PSMA-PET at the University Hospitals in Essen, Münster, Freiburg, and Dresden, Germany, between Oct 30, 2014, and Dec 27, 2021. We linked a subset of patient hospital records with patient data, including mortality data, from the Cancer Registry North-Rhine Westphalia, Germany. Patients from Essen University Hospital were randomly assigned to the development or internal validation cohorts (2:1). Patients from Münster, Freiburg, and Dresden University Hospitals were included in an external validation cohort. Using the development cohort, we created quantitative and visual PPP nomograms based on Cox regression models, assessing potential PPP predictors for overall survival, with least absolute shrinkage and selection operator penalty for overall survival as the primary endpoint. Performance was measured using Harrell's C-index in the internal and external validation cohorts and compared with established clinical risk scores (International Staging Collaboration for Cancer of the Prostate [STARCAP], European Association of Urology [EAU], and National Comprehensive Cancer Network [NCCN] risk scores) and a previous nomogram defined by Gafita et al (hereafter referred to as GAFITA) using receiver operating characteristic (ROC) curves and area under the ROC curve (AUC) estimates.

Findings: We analysed 2414 male patients (1110 included in the development cohort, 502 in the internal cohort, and 802 in the external validation cohort), among whom 901 (37%) had died as of data cutoff (June 30, 2023; median follow-up of 52·9 months [IQR 33·9-79·0]). Predictors in the quantitative PPP nomogram were locoregional lymph node metastases (molecular imaging N2), distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases), tumour volume (in L), and tumour mean standardised uptake value. Predictors in the visual PPP nomogram were distant metastases (extrapelvic nodal metastases, bone metastases [disseminated or diffuse marrow involvement], and organ metastases) and total tumour lesion count. In the internal and external validation cohorts, C-indices were 0·80 (95% CI 0·77-0·84) and 0·77 (0·75-0·78) for the quantitative nomogram, respectively, and 0·78 (0·75-0·82) and 0·77 (0·75-0·78) for the visual nomogram, respectively. In the combined development and internal validation cohort, the quantitative PPP nomogram was superior to STARCAP risk score for patients at initial staging (n=139 with available staging data; AUC 0·73 vs 0·54; p=0·018), EAU risk score at biochemical recurrence (n=412; 0·69 vs 0·52; p<0·0001), and NCCN pan-stage risk score (n=1534; 0·81 vs 0·74; p<0·0001) for the prediction of overall survival, but was similar to GAFITA nomogram for metastatic hormone-sensitive prostate cancer (mHSPC; n=122; 0·76 vs 0·72; p=0·49) and metastatic castration-resistant prostate cancer (mCRPC; n=270; 0·67 vs 0·75; p=0·20). The visual PPP nomogram was superior to EAU at biochemical recurrence (n=414; 0·64 vs 0·52; p=0·0004) and NCCN across all stages (n=1544; 0·79 vs 0·73; p<0·0001), but similar to STARCAP for initial staging (n=140; 0·56 vs 0·53; p=0·74) and GAFITA for mHSPC (n=122; 0·74 vs 0·72; p=0·66) and mCRPC (n=270; 0·71 vs 0·75; p=0·23).

Interpretation: Our PPP nomograms accurately stratify high-risk and low-risk groups for overall survival in early and late stages of prostate cancer and yield equal or superior prediction accuracy compared with established clinical risk tools. Validation and improvement of the nomograms with long-term follow-up is ongoing (NCT06320223).

Funding: Cancer Registry North-Rhine Westphalia.

结合 PSMA-PET 和 PROMISE 重新定义前列腺癌患者的疾病分期和风险:一项多中心回顾性研究。
背景:前列腺特异性膜抗原(PSMA)-PET 于 2012 年被引入临床实践,自此改变了前列腺癌的分期。前列腺癌分子影像标准化评估(PROMISE)标准的提出旨在规范 PSMA-PET 的报告。我们的目的是在一个有总生存期随访数据的大型前列腺癌数据集中,比较PSMA-PET按PROMISE(PPP)分期与既有临床提名图的预后价值:在这项多中心回顾性研究中,我们使用了2014年10月30日至2021年12月27日期间在德国埃森、明斯特、弗莱堡和德累斯顿大学医院接受PSMA-PET检查的任何年龄的组织学证实的前列腺癌患者的数据。我们将患者医院记录子集与德国北莱茵威斯特法伦州癌症登记处的患者数据(包括死亡率数据)进行了链接。埃森大学医院的患者被随机分配到开发队列或内部验证队列(2:1)。明斯特、弗莱堡和德累斯顿大学医院的患者被纳入外部验证队列。利用开发队列,我们基于 Cox 回归模型创建了定量和直观的 PPP 直方图,评估总生存期的潜在 PPP 预测因子,并将总生存期的最小绝对缩小和选择操作者惩罚作为主要终点。在内部和外部验证队列中使用 Harrell's C-index 对性能进行了测量,并使用接收器操作特征曲线(ROC)和 ROC 曲线下面积(AUC)估算值与既定的临床风险评分(国际前列腺癌分期协作组 [STARCAP]、欧洲泌尿外科协会 [EAU] 和美国国立综合癌症网络 [NCCN] 风险评分)和 Gafita 等人之前定义的提名图(以下简称 GAFITA)进行了比较:我们分析了 2414 名男性患者(其中 1110 人纳入开发队列,502 人纳入内部队列,802 人纳入外部验证队列),截至数据截止日(2023 年 6 月 30 日;中位随访时间为 52-9 个月 [IQR 33-9-79-0]),其中 901 人(37%)已经死亡。定量PPP提名图中的预测因素包括局部淋巴结转移(分子影像学N2)、远处转移(骨盆外结节转移、骨转移[扩散或弥漫性骨髓受累]和器官转移)、肿瘤体积(以L计)和肿瘤平均标准化摄取值。可视化PPP提名图中的预测因子为远处转移(骨盆外结节转移、骨转移[扩散或弥漫性骨髓受累]和器官转移)和肿瘤病灶总数。在内部和外部验证队列中,定量提名图的C指数分别为0-80(95% CI 0-77-0-84)和0-77(0-75-0-78),视觉提名图的C指数分别为0-78(0-75-0-82)和0-77(0-75-0-78)。在联合开发和内部验证队列中,定量PPP提名图在患者初始分期时优于STARCAP风险评分(有分期数据的人数=139;AUC 0-73 vs 0-54;P=0-018),在生化复发时优于EAU风险评分(人数=412;0-69 vs 0-52;P解释:我们的PPP提名图能准确地对前列腺癌早期和晚期的高危和低危人群的总生存期进行分层,与已有的临床风险工具相比,预测准确率相当或更高。目前正在通过长期随访验证和改进提名图(NCT06320223):北莱茵威斯特伐利亚州癌症登记处。
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来源期刊
Lancet Oncology
Lancet Oncology 医学-肿瘤学
CiteScore
62.10
自引率
1.00%
发文量
913
审稿时长
3-8 weeks
期刊介绍: The Lancet Oncology is a trusted international journal that addresses various topics in clinical practice, health policy, and global oncology. It covers a wide range of cancer types, including breast, endocrine system, gastrointestinal, genitourinary, gynaecological, haematological, head and neck, neurooncology, paediatric, thoracic, sarcoma, and skin cancers. Additionally, it includes articles on epidemiology, cancer prevention and control, supportive care, imaging, and health-care systems. The journal has an Impact Factor of 51.1, making it the leading clinical oncology research journal worldwide. It publishes different types of articles, such as Articles, Reviews, Policy Reviews, Personal Views, Clinical Pictures, Comments, Correspondence, News, and Perspectives. The Lancet Oncology also collaborates with societies, governments, NGOs, and academic centers to publish Series and Commissions that aim to drive positive changes in clinical practice and health policy in areas of global oncology that require attention.
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