Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma
Abstract: Multiple myeloma (MM) remains incurable, with poor outcomes in heavily pretreated patients. Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment; however, outcomes after such therapy in patients with soft-tissue plasmacytomas and other bone lesions remain poo...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-02-01
|
| Series: | Blood Advances |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2473952924006797 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832576402535219200 |
|---|---|
| author | Inés Zugasti Marta Tormo-Ratera Aina Oliver-Caldés Juan Carlos Soler-Perromat Verónica González-Calle David F. Moreno Valentín Cabañas Nieves López-Muñoz Álvaro Bartolomé-Solanas Marta Español-Rego Juan Luis Reguera-Ortega Laura Rosiñol Lucía López-Corral Natalia Tovar Luis Gerardo Rodríguez-Lobato Rosa Maria Alvarez Perez Sara Varea Eulàlia Olesti Adolfo Gomez-Grande Laura Frutos Pilar Tamayo Manel Juan José M. Moraleda Álvaro Urbano-Ispizua E. Azucena González-Navarro Joaquín Martínez-López Maria-Victoria Mateos Xavier Tomás Xavier Setoain Carlos Fernández de Larrea |
| author_facet | Inés Zugasti Marta Tormo-Ratera Aina Oliver-Caldés Juan Carlos Soler-Perromat Verónica González-Calle David F. Moreno Valentín Cabañas Nieves López-Muñoz Álvaro Bartolomé-Solanas Marta Español-Rego Juan Luis Reguera-Ortega Laura Rosiñol Lucía López-Corral Natalia Tovar Luis Gerardo Rodríguez-Lobato Rosa Maria Alvarez Perez Sara Varea Eulàlia Olesti Adolfo Gomez-Grande Laura Frutos Pilar Tamayo Manel Juan José M. Moraleda Álvaro Urbano-Ispizua E. Azucena González-Navarro Joaquín Martínez-López Maria-Victoria Mateos Xavier Tomás Xavier Setoain Carlos Fernández de Larrea |
| author_sort | Inés Zugasti |
| collection | DOAJ |
| description | Abstract: Multiple myeloma (MM) remains incurable, with poor outcomes in heavily pretreated patients. Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment; however, outcomes after such therapy in patients with soft-tissue plasmacytomas and other bone lesions remain poorly understood. This study included 63 patients with relapsed/refractory MM treated either in the CARTBCMA-HCB-01 clinical trial (ARI0002h; academic B-cell maturation antigen [BCMA]–targeted CAR T-cell therapy) or in compassionate use. The aim was to evaluate the impact of soft-tissue involvement (extramedullary [EMD] and paraskeletal [PS] plasmacytomas) in response, survival and safety. Baseline [18F]fluorodeoxyglucose (FDG)–positron emission tomography (PET)/computed tomography (CT) from 5 participating centers were reviewed centrally. Of 63 patients, 52.4% presented plasmacytomas at the time of inclusion (21 PS, exclusively; and 12 EMD). Per responses, there were no significant differences between patients with and without plasmacytomas. A correlation was present between International Myeloma Working Group responses and those obtained by [18F]FDG-PET/CT at day 100 (Bologna criteria). No differences were observed in progression-free survival (PFS) or overall survival (OS) between patients with or without plasmacytomas. However, both PFS and OS were significantly shorter in patients with EMD. Interestingly, [18F]FDG-PET/CT response assessed on day 100, in accordance with the Bologna criteria, was predictive of survival outcomes. A metabolic tumor volume of ≥25 cm3 at baseline [18F]FDG-PET/CT was associated with earlier disease progression and shorter OS. These results highlight the importance of EMD evaluation by [18F]FDG-PET/CT before and after CAR T-cell infusion. This trial was registered at www.ClinicalTrials.gov as #NCT04309981; and EudraCT, 2019-001472-11. |
| format | Article |
| id | doaj-art-4b2dbaa26bcb4e47984106163a001c5a |
| institution | Kabale University |
| issn | 2473-9529 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Blood Advances |
| spelling | doaj-art-4b2dbaa26bcb4e47984106163a001c5a2025-01-31T05:12:10ZengElsevierBlood Advances2473-95292025-02-0193571582Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myelomaInés Zugasti0Marta Tormo-Ratera1Aina Oliver-Caldés2Juan Carlos Soler-Perromat3Verónica González-Calle4David F. Moreno5Valentín Cabañas6Nieves López-Muñoz7Álvaro Bartolomé-Solanas8Marta Español-Rego9Juan Luis Reguera-Ortega10Laura Rosiñol11Lucía López-Corral12Natalia Tovar13Luis Gerardo Rodríguez-Lobato14Rosa Maria Alvarez Perez15Sara Varea16Eulàlia Olesti17Adolfo Gomez-Grande18Laura Frutos19Pilar Tamayo20Manel Juan21José M. Moraleda22Álvaro Urbano-Ispizua23E. Azucena González-Navarro24Joaquín Martínez-López25Maria-Victoria Mateos26Xavier Tomás27Xavier Setoain28Carlos Fernández de Larrea29Hospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain; Hospital Universitari Son Espases, Fundació Institut d'Investigació Sanitària Illes Balears, Palma de Mallorca, Mallorca, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínico Universitario Virgen de la Arrixaca, IMIB Pascual Parrilla, Universidad de Murcia, Murcia, SpainHospital Universitario 12 de Octubre, Complutense University, i+12, Centro Nacional de Investigaciones Oncológicas, Madrid, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (CIBERONC), Universidad de Sevilla, Sevilla, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Universitario Virgen del Rocío, Instituto de Biomedicina de Sevilla (CIBERONC), Universidad de Sevilla, Sevilla, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Universitario 12 de Octubre, Complutense University, i+12, Centro Nacional de Investigaciones Oncológicas, Madrid, SpainHospital Clínico Universitario Virgen de la Arrixaca, IMIB Pascual Parrilla, Universidad de Murcia, Murcia, SpainHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínico Universitario Virgen de la Arrixaca, IMIB Pascual Parrilla, Universidad de Murcia, Murcia, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Universitario 12 de Octubre, Complutense University, i+12, Centro Nacional de Investigaciones Oncológicas, Madrid, SpainHospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Instituto Universitario de Biología Molecular y Celular del Cáncer, Universidad de Salamanca, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Salamanca, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain; Biomedical Imaging Group, Biomedical Research Networking Center in Bioengineering, Biomaterials and Nanomedicine, Barcelona, SpainHospital Clínic de Barcelona, Institut d’Investigació Biomèdica August Pi i Sunyer, Universitat de Barcelona, Barcelona, Spain; Correspondence: Carlos Fernández de Larrea, Department of Hematology, Amyloidosis and Myeloma Unit, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Villarroel 170, 08036 Barcelona, Spain;Abstract: Multiple myeloma (MM) remains incurable, with poor outcomes in heavily pretreated patients. Chimeric antigen receptor (CAR) T-cell therapy has emerged as a promising treatment; however, outcomes after such therapy in patients with soft-tissue plasmacytomas and other bone lesions remain poorly understood. This study included 63 patients with relapsed/refractory MM treated either in the CARTBCMA-HCB-01 clinical trial (ARI0002h; academic B-cell maturation antigen [BCMA]–targeted CAR T-cell therapy) or in compassionate use. The aim was to evaluate the impact of soft-tissue involvement (extramedullary [EMD] and paraskeletal [PS] plasmacytomas) in response, survival and safety. Baseline [18F]fluorodeoxyglucose (FDG)–positron emission tomography (PET)/computed tomography (CT) from 5 participating centers were reviewed centrally. Of 63 patients, 52.4% presented plasmacytomas at the time of inclusion (21 PS, exclusively; and 12 EMD). Per responses, there were no significant differences between patients with and without plasmacytomas. A correlation was present between International Myeloma Working Group responses and those obtained by [18F]FDG-PET/CT at day 100 (Bologna criteria). No differences were observed in progression-free survival (PFS) or overall survival (OS) between patients with or without plasmacytomas. However, both PFS and OS were significantly shorter in patients with EMD. Interestingly, [18F]FDG-PET/CT response assessed on day 100, in accordance with the Bologna criteria, was predictive of survival outcomes. A metabolic tumor volume of ≥25 cm3 at baseline [18F]FDG-PET/CT was associated with earlier disease progression and shorter OS. These results highlight the importance of EMD evaluation by [18F]FDG-PET/CT before and after CAR T-cell infusion. This trial was registered at www.ClinicalTrials.gov as #NCT04309981; and EudraCT, 2019-001472-11.http://www.sciencedirect.com/science/article/pii/S2473952924006797 |
| spellingShingle | Inés Zugasti Marta Tormo-Ratera Aina Oliver-Caldés Juan Carlos Soler-Perromat Verónica González-Calle David F. Moreno Valentín Cabañas Nieves López-Muñoz Álvaro Bartolomé-Solanas Marta Español-Rego Juan Luis Reguera-Ortega Laura Rosiñol Lucía López-Corral Natalia Tovar Luis Gerardo Rodríguez-Lobato Rosa Maria Alvarez Perez Sara Varea Eulàlia Olesti Adolfo Gomez-Grande Laura Frutos Pilar Tamayo Manel Juan José M. Moraleda Álvaro Urbano-Ispizua E. Azucena González-Navarro Joaquín Martínez-López Maria-Victoria Mateos Xavier Tomás Xavier Setoain Carlos Fernández de Larrea Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma Blood Advances |
| title | Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma |
| title_full | Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma |
| title_fullStr | Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma |
| title_full_unstemmed | Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma |
| title_short | Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma |
| title_sort | clinical impact of 18f fdg pet ct in ari0002h treatment a car t against bcma for relapsed refractory multiple myeloma |
| url | http://www.sciencedirect.com/science/article/pii/S2473952924006797 |
| work_keys_str_mv | AT ineszugasti clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT martatormoratera clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT ainaolivercaldes clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT juancarlossolerperromat clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT veronicagonzalezcalle clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT davidfmoreno clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT valentincabanas clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT nieveslopezmunoz clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT alvarobartolomesolanas clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT martaespanolrego clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT juanluisregueraortega clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT laurarosinol clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT lucialopezcorral clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT nataliatovar clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT luisgerardorodriguezlobato clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT rosamariaalvarezperez clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT saravarea clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT eulaliaolesti clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT adolfogomezgrande clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT laurafrutos clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT pilartamayo clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT maneljuan clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT josemmoraleda clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT alvarourbanoispizua clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT eazucenagonzaleznavarro clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT joaquinmartinezlopez clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT mariavictoriamateos clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT xaviertomas clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT xaviersetoain clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma AT carlosfernandezdelarrea clinicalimpactof18ffdgpetctinari0002htreatmentacartagainstbcmaforrelapsedrefractorymultiplemyeloma |