Secondary primary malignancies after CD-19 directed CAR-T-cell therapy in lymphomas: A report from the Italian CART-SIE study.

MDS T‐cell lymphoma acute leukaemia immunotherapy late effects of therapy malignant lymphomas

Journal

British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544

Informations de publication

Date de publication:
15 Jun 2024
Historique:
received: 08 04 2024
accepted: 30 05 2024
medline: 15 6 2024
pubmed: 15 6 2024
entrez: 15 6 2024
Statut: aheadofprint

Résumé

Secondary primary malignancies (SPM) have been reported after anti-BCMA or anti-CD19 chimeric antigen receptor (CAR)-T-cell therapies. While the cytotoxic effect of antecedent therapies, including chemotherapy and radiotherapy, has been well established, few data are available on risk related to CAR-T immunotherapies. The study aimed to analyse the incidence of SPM in 651 patients enrolled in the Italian prospective observational CART-SIE study. SPMs were documented in 4.3% (28/651), and the most frequent SPMs were haematological malignancies. In conclusion, the frequency of SPMs in our cohort of heavily pretreated patients receiving CAR-T was relatively low and consistent with previous studies.

Identifiants

pubmed: 38877876
doi: 10.1111/bjh.19590
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : HORIZON EUROPE Health
ID : PNC-E3-2022-23683269-PNC-HLS-TA

Informations de copyright

© 2024 The Author(s). British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.

Références

Martelin E, Volin L, Itälä‐Remes M, Niittyvuopio R, Lindström V, Heiskanen J, et al. Incidence and risk factors of secondary cancers after allogeneic stem cell transplantation: analysis of a single centre cohort with a long follow‐up. Bone Marrow Transplant. 2019;54(2):334–337. https://doi.org/10.1038/s41409‐018‐0290‐6
Trab T, Baech J, Jakobsen LH, Husby S, Severinsen MT, Eloranta S, et al. Second primary malignancies in patients with lymphoma in Denmark after high‐dose chemotherapy and autologous haematopoietic stem‐cell transplantation: a population‐based, retrospective cohort study. Lancet Haematol. 2023;10(10):e838–e848.
Administration UFAD. FDA Investigating Serious Risk of T‐cell Malignancy Following BCMA‐ Directed or CD19‐Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies. 2023.
Neelapu SS, Jacobson CA, Ghobadi A, Miklos DB, Lekakis LJ, Oluwole OO, et al. Five‐year follow‐up of ZUMA‐1 supports the curative potential of axicabtagene ciloleucel in refractory large B‐cell lymphoma. Blood. 2023;141(19):2307–2315. https://doi.org/10.1182/blood.2022018893
Jacobson CA, Locke FL, Ma L, Asubonteng J, Hu ZH, Siddiqi T, et al. Real‐world evidence of Axicabtagene Ciloleucel for the treatment of large B cell lymphoma in the United States. Transpl Cellular Therapy. 2022;28(9):581.e1–581.e8.
Ghilardi G, Fraietta JA, Gerson JN, van Deerlin VM, Morrissette JJD, Caponetti GC, et al. T cell lymphoma and secondary primary malignancy risk after commercial CAR T cell therapy. Nat Med. 2024;30:984–989. https://doi.org/10.1038/s41591‐024‐02826‐w
Chong EA, Ruella M, Schuster SJ. Lymphoma program investigators at the University of Pennsylvania. Five‐year outcomes for refractory B‐cell lymphomas with CAR T‐cell therapy. N Engl J Med. 2021;384(7):673–674. https://doi.org/10.1056/NEJMc2030164
Jaeger U, Tam CS, Borchmann P, McGuirk JP, Johansen M, Waller EK, et al. Long‐term safety for patients with tisagenlecleucel‐treated relapsed/refractory diffuse large B‐cell lymphoma. Blood Adv. 2022;6(16):4816–4820. https://doi.org/10.1182/bloodadvances.2021006193
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, et al. Three‐year follow‐up of KTE‐X19 in patients with relapsed/refractory mantle cell lymphoma, including high‐risk subgroups, in the ZUMA‐2 study. J Clin Oncol. 2022;41(3):555–567.
Elsallab M, Ellithi M, Lunning MA, D'Angelo C, Ma J, Perales MA, et al. Second primary malignancies after commercial CAR T cell therapy: analysis of FDA adverse events reporting system (FAERS). Blood. 2024;143:2099–2105. https://doi.org/10.1182/blood.2024024166
Rejeski K, Perez A, Sesques P, Hoster E, Berger C, Jentzsch L, et al. CAR‐HEMATOTOX: a model for CAR T‐cell–related hematologic toxicity in relapsed/refractory large B‐cell lymphoma. Blood. 2021;138(24):2499–2513. https://doi.org/10.1182/blood.2020010543
Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc B Methodol. 1995;57(1):289–300. https://doi.org/10.1111/j.2517‐6161.1995.tb02031.x

Auteurs

Angelica Barone (A)

Chair of Hematology, University of Milan, Milan, Italy.

Annalisa Chiappella (A)

Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Beatrice Casadei (B)

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Stefania Bramanti (S)

IRCCS Humanitas Research Hospital, Transplantation Unit Department of Oncology and Haematology, Rozzano, Italy.

Silva Ljevar (S)

Unit of Biostatistics for Clinical Research, Department of Data Science, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Patrizia Chiusolo (P)

Dipartimento di Scienze Microbiologiche Ed Ematologiche, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Sezione di Ematologia, Dipartimento di Scienze Radiologiche Ed Ematologiche, Università Cattolica del Sacro Cuore, Rome, Italy.

Alice Di Rocco (A)

Department of Translational and Precision Medicine, 'Sapienza' University of Rome, Rome, Italy.

Maria Chiara Tisi (MC)

Hematology Unit, San Bortolo Hospital, Vicenza, Italy.

Anna Maria Barbui (AM)

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.

Mirko Farina (M)

Unit of Hematology, ASST Spedali Civili di Brescia, Brescia, Italy.

Lucia Brunello (L)

SCDU Ematologia AOU SS Antonio e Biagio e Cesare Arrigo Alessandria Italy, Alessandria, Italy.

Maria Chiara Di Chio (MC)

Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Mattia Novo (M)

Division of Hematology, AOU Città Della Salute e Della Scienza di Torino, Torino, Italy.

Maurizio Musso (M)

UOC di Oncoematologia e TMO Dipartimento Oncologico La Maddalena Palermo, Palermo, Italy.

Jacopo Olivieri (J)

Clinica Ematologica, Centro Trapianti e Terapie Cellulari "Carlo Melzi", Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.

Gentiana Elena Trotta (GE)

Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
Ematologia, Dipartimento di Biomedicina e Prevenzione, Università Degli Studi di Roma Tor Vergata, Rome, Italy.

Anna Dodero (A)

Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Antonella Aiello (A)

Division of Pathology, Department of Advanced Diagnostics, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Paolo Corradini (P)

Chair of Hematology, University of Milan, Milan, Italy.
Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Classifications MeSH