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Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study

Our objective was to develop version 1.0 of a novel framework for response evaluation criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) and a composite response classification that combines responses by prostate-specific antigen (PSA) measurements and by RECIP 1.0 (PSA + RECIP). M...

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Autores principales: Gafita, Andrei, Rauscher, Isabel, Weber, Manuel, Hadaschik, Boris, Wang, Hui, Armstrong, Wesley R., Tauber, Robert, Grogan, Tristan R., Czernin, Johannes, Rettig, Matthew B., Herrmann, Ken, Calais, Jeremie, Weber, Wolfgang A., Benz, Matthias R., Fendler, Wolfgang P., Eiber, Matthias
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Society of Nuclear Medicine 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635677/
https://www.ncbi.nlm.nih.gov/pubmed/35422442
http://dx.doi.org/10.2967/jnumed.121.263072
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author Gafita, Andrei
Rauscher, Isabel
Weber, Manuel
Hadaschik, Boris
Wang, Hui
Armstrong, Wesley R.
Tauber, Robert
Grogan, Tristan R.
Czernin, Johannes
Rettig, Matthew B.
Herrmann, Ken
Calais, Jeremie
Weber, Wolfgang A.
Benz, Matthias R.
Fendler, Wolfgang P.
Eiber, Matthias
author_facet Gafita, Andrei
Rauscher, Isabel
Weber, Manuel
Hadaschik, Boris
Wang, Hui
Armstrong, Wesley R.
Tauber, Robert
Grogan, Tristan R.
Czernin, Johannes
Rettig, Matthew B.
Herrmann, Ken
Calais, Jeremie
Weber, Wolfgang A.
Benz, Matthias R.
Fendler, Wolfgang P.
Eiber, Matthias
author_sort Gafita, Andrei
collection PubMed
description Our objective was to develop version 1.0 of a novel framework for response evaluation criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) and a composite response classification that combines responses by prostate-specific antigen (PSA) measurements and by RECIP 1.0 (PSA + RECIP). Methods: This was an international multicenter, retrospective study. One hundred twenty-four men with metastatic castration-specific prostate cancer (mCRPC) who underwent (177)Lu-PSMA therapy and received PSMA PET/CT at baseline and at an interim time point of 12 wk were included. Pairs of baseline interim PET/CT scans were interpreted by consensus among 3 masked readers for appearance of new lesions. Tumor lesions were segmented, and total PSMA-positive tumor volume (PSMA-VOL) was obtained. Appearance of new lesions and changes in PSMA-VOL were combined to develop RECIP 1.0, which included classifications of complete response (RECIP-CR: absence of any PSMA-ligand uptake on interim PET/CT), partial response (RECIP-PR: decline ≥ 30% in PSMA-VOL and no appearance of new lesions), progressive disease (RECIP-PD: increase ≥ 20% in PSMA-VOL and appearance of new lesions), and stable disease (RECIP-SD: any condition but RECIP-PR or RECIP-PD). Changes in PSA levels at 12 wk by Prostate Cancer Working Group Criteria 3 were recorded. PSA + RECIP results were defined as response (PSA decline ≥ 50% or RECIP-PR/CR) or progression (PSA increase ≥ 25% or RECIP-PD). The study’s primary outcome measure was the prognostic value of RECIP 1.0 for overall survival (OS). The secondary outcome measure was the prognostic accuracy (C-index) of PSA + RECIP versus PSA responses. Results: Patients with RECIP-PD (n = 39; 8.3 mo) had a shorter OS than patients with stable disease (RECIP-SD) (n = 47; 13.1 mo; P < 0.001) or RECIP-PR (n = 38; 21.7 mo; P < 0.001). In identifying responders and progressors, PSA + RECIP had C-indices superior to those of PSA only: 0.65 versus 0.62 (P = 0.028) and 0.66 versus 0.63 (P = 0.044), respectively. Conclusion: PSMA PET/CT by RECIP 1.0 is prognostic for OS and can be used as a response biomarker to monitor early efficacy of (177)Lu-PSMA in men with mCRPC. PSA + RECIP may be used as a novel composite endpoint in mCRPC clinical trial design.
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spelling pubmed-96356772023-05-01 Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study Gafita, Andrei Rauscher, Isabel Weber, Manuel Hadaschik, Boris Wang, Hui Armstrong, Wesley R. Tauber, Robert Grogan, Tristan R. Czernin, Johannes Rettig, Matthew B. Herrmann, Ken Calais, Jeremie Weber, Wolfgang A. Benz, Matthias R. Fendler, Wolfgang P. Eiber, Matthias J Nucl Med Clinical Investigation Our objective was to develop version 1.0 of a novel framework for response evaluation criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) and a composite response classification that combines responses by prostate-specific antigen (PSA) measurements and by RECIP 1.0 (PSA + RECIP). Methods: This was an international multicenter, retrospective study. One hundred twenty-four men with metastatic castration-specific prostate cancer (mCRPC) who underwent (177)Lu-PSMA therapy and received PSMA PET/CT at baseline and at an interim time point of 12 wk were included. Pairs of baseline interim PET/CT scans were interpreted by consensus among 3 masked readers for appearance of new lesions. Tumor lesions were segmented, and total PSMA-positive tumor volume (PSMA-VOL) was obtained. Appearance of new lesions and changes in PSMA-VOL were combined to develop RECIP 1.0, which included classifications of complete response (RECIP-CR: absence of any PSMA-ligand uptake on interim PET/CT), partial response (RECIP-PR: decline ≥ 30% in PSMA-VOL and no appearance of new lesions), progressive disease (RECIP-PD: increase ≥ 20% in PSMA-VOL and appearance of new lesions), and stable disease (RECIP-SD: any condition but RECIP-PR or RECIP-PD). Changes in PSA levels at 12 wk by Prostate Cancer Working Group Criteria 3 were recorded. PSA + RECIP results were defined as response (PSA decline ≥ 50% or RECIP-PR/CR) or progression (PSA increase ≥ 25% or RECIP-PD). The study’s primary outcome measure was the prognostic value of RECIP 1.0 for overall survival (OS). The secondary outcome measure was the prognostic accuracy (C-index) of PSA + RECIP versus PSA responses. Results: Patients with RECIP-PD (n = 39; 8.3 mo) had a shorter OS than patients with stable disease (RECIP-SD) (n = 47; 13.1 mo; P < 0.001) or RECIP-PR (n = 38; 21.7 mo; P < 0.001). In identifying responders and progressors, PSA + RECIP had C-indices superior to those of PSA only: 0.65 versus 0.62 (P = 0.028) and 0.66 versus 0.63 (P = 0.044), respectively. Conclusion: PSMA PET/CT by RECIP 1.0 is prognostic for OS and can be used as a response biomarker to monitor early efficacy of (177)Lu-PSMA in men with mCRPC. PSA + RECIP may be used as a novel composite endpoint in mCRPC clinical trial design. Society of Nuclear Medicine 2022-11 /pmc/articles/PMC9635677/ /pubmed/35422442 http://dx.doi.org/10.2967/jnumed.121.263072 Text en © 2022 by the Society of Nuclear Medicine and Molecular Imaging. https://creativecommons.org/licenses/by/4.0/Immediate Open Access: Creative Commons Attribution 4.0 International License (CC BY) allows users to share and adapt with attribution, excluding materials credited to previous publications. License: https://creativecommons.org/licenses/by/4.0/. Details: http://jnm.snmjournals.org/site/misc/permission.xhtml.
spellingShingle Clinical Investigation
Gafita, Andrei
Rauscher, Isabel
Weber, Manuel
Hadaschik, Boris
Wang, Hui
Armstrong, Wesley R.
Tauber, Robert
Grogan, Tristan R.
Czernin, Johannes
Rettig, Matthew B.
Herrmann, Ken
Calais, Jeremie
Weber, Wolfgang A.
Benz, Matthias R.
Fendler, Wolfgang P.
Eiber, Matthias
Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study
title Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study
title_full Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study
title_fullStr Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study
title_full_unstemmed Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study
title_short Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study
title_sort novel framework for treatment response evaluation using psma pet/ct in patients with metastatic castration-resistant prostate cancer (recip 1.0): an international multicenter study
topic Clinical Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635677/
https://www.ncbi.nlm.nih.gov/pubmed/35422442
http://dx.doi.org/10.2967/jnumed.121.263072
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