PMID- 38459167
OWN - NLM
STAT- MEDLINE
DCOM- 20240506
LR  - 20240509
IS  - 1476-5551 (Electronic)
IS  - 0887-6924 (Print)
IS  - 0887-6924 (Linking)
VI  - 38
IP  - 5
DP  - 2024 May
TI  - Axicabtagene ciloleucel treatment is more effective in primary mediastinal large 
      B-cell lymphomas than in diffuse large B-cell lymphomas: the Italian CART-SIE 
      study.
PG  - 1107-1114
LID - 10.1038/s41375-024-02213-x [doi]
AB  - Axicabtagene ciloleucel showed efficacy for relapsed/refractory large B-cell 
      lymphomas (LBCL), including primary mediastinal B-cell lymphomas (PMBCL); 
      however, only few PMBCLs were reported. Aim was to evaluate efficacy and safety 
      of axicabtagene ciloleucel in patients with PMBCL compared to those with other 
      LBCL, enrolled in the Italian prospective observational CART-SIE study. PMBCLs 
      (n = 70) were younger, with higher percentage of bulky and refractory disease, 
      compared to other LBCLs (n = 190). Median follow-up time for infused patients was 
      12.17 months (IQR 5.53,22.73). The overall (complete + partial) response rate 
      (ORR,CR + PR) after bridging was 41% for PMBCL and 28% for other LBCL, 
      p = 0.0102. Thirty days ORR was 78% (53/68) with 50% (34) CR in PMBCL, and 75% 
      (141/187) with 53% (100) CR in other LBCL, p = 0.5457. Ninety days ORR was 69% 
      (45/65) with 65% (42) CR in PMBCL, and 54% (87/162) with 47% (76) CR in other 
      LBCL; progressive disease was 21% in PMBCL and 45% in other LBCL, p = 0.0336. 
      Twelve months progression-free survival was 62% (95% CI: 51-75) in PMBCL versus 
      48% (95% CI: 41-57) in other LBCL, p = 0.0386. Twelve months overall survival was 
      86% (95% CI: 78-95) in PMBCL versus 71% (95% CI: 64-79) in other LBCL, 
      p = 0.0034. All grade cytokine release syndrome was 88% (228/260); all grade 
      neurotoxicity was 34% (88/260), with 6% of fatal events in PMBCL. Non-relapse 
      mortality was 3%. In conclusion, PMBCLs achieved significantly better response 
      and survival rates than other LBCLs.
CI  - (c) 2024. The Author(s).
FAU - Chiappella, Annalisa
AU  - Chiappella A
AUID- ORCID: 0000-0002-2977-0098
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy. annalisa.chiappella@istitutotumori.mi.it.
FAU - Casadei, Beatrice
AU  - Casadei B
AD  - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia 
      "Seragnoli", Bologna, Italy.
FAU - Chiusolo, Patrizia
AU  - Chiusolo P
AUID- ORCID: 0000-0002-1355-1587
AD  - Department of Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, 
      Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.
FAU - Di Rocco, Alice
AU  - Di Rocco A
AD  - Hematology Section, Department of Translational and Precision Medicine, 
      "Sapienza" University of Rome, Roma, Italy.
FAU - Ljevar, Silva
AU  - Ljevar S
AD  - Unit of Biostatistics for Clinical Research, Department of Data Science, 
      Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
FAU - Magni, Martina
AU  - Magni M
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
FAU - Angelillo, Piera
AU  - Angelillo P
AD  - Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy.
FAU - Barbui, Anna Maria
AU  - Barbui AM
AD  - Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa 
      Giovanni XXIII, Bergamo, Italy.
FAU - Cutini, Ilaria
AU  - Cutini I
AD  - SOD Terapie Cellulari e Medicina Trasfusionale, Azienda Ospedaliero-Universitaria 
      Careggi, Firenze, Italy.
FAU - Dodero, Anna
AU  - Dodero A
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
FAU - Bonifazi, Francesca
AU  - Bonifazi F
AUID- ORCID: 0000-0003-1544-9911
AD  - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia 
      "Seragnoli", Bologna, Italy.
FAU - Tisi, Maria Chiara
AU  - Tisi MC
AD  - Hematology Unit, San Bortolo Hospital, A.U.L.S.S. 8 "Berica", Vicenza, Italy.
FAU - Bramanti, Stefania
AU  - Bramanti S
AD  - Department of Oncology/Hematology, IRCCS Humanitas Research Hospital, Rozzano, 
      Milano, Italy.
FAU - Musso, Maurizio
AU  - Musso M
AD  - UOC di oncoematologia e TMO "La Maddalena", Palermo, Italy.
FAU - Farina, Mirko
AU  - Farina M
AUID- ORCID: 0000-0002-2980-9028
AD  - Unit of Blood Disease and Bone Marrow Transplantation, and Unit of Hematology, 
      University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.
FAU - Martino, Massimo
AU  - Martino M
AD  - Stem Cell Transplantation and Cellular Therapies Unit (CTMO), Department of 
      Hemato-Oncology and Radiotherapy, Grande Ospedale Metropolitano 
      "Bianchi-Melacrino-Morelli", Reggio Calabria, Italy.
FAU - Novo, Mattia
AU  - Novo M
AUID- ORCID: 0000-0002-5127-3653
AD  - Division of Hematology, Citta della Salute e della Scienza Hospital and 
      University, Torino, Italy.
FAU - Grillo, Giovanni
AU  - Grillo G
AD  - Dipartimento di Ematologia e trapianto di midollo, ASST Grande Ospedale 
      Metropolitano Niguarda, Milano, Italy.
FAU - Patriarca, Francesca
AU  - Patriarca F
AD  - Clinica Ematologica ed Unita Terapie Cellulari, Azienda Sanitaria Universitaria 
      Friuli Centrale, Dipartimento di Area Medica, Universita di Udine, Udine, Italy.
FAU - Zacchi, Giulia
AU  - Zacchi G
AD  - SCDU Ematologia AO SS Antonio e Biagio e Cesare Arrigo ed Universita del Piemonte 
      Orientale, Alessandria, Italy.
FAU - Krampera, Mauro
AU  - Krampera M
AUID- ORCID: 0000-0002-7280-2040
AD  - UOC di Ematologia e Centro Trapianto di Midollo Osseo - Azienda Ospedaliera 
      Universitaria Integrata Verona Policlinico G.B. Rossi, Verona, Italy.
FAU - Pennisi, Martina
AU  - Pennisi M
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
FAU - Galli, Eugenio
AU  - Galli E
AD  - Department of Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, 
      Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.
FAU - Martelli, Maurizio
AU  - Martelli M
AD  - Hematology Section, Department of Translational and Precision Medicine, 
      "Sapienza" University of Rome, Roma, Italy.
FAU - Ferreri, Andres J M
AU  - Ferreri AJM
AUID- ORCID: 0000-0001-9606-6124
AD  - Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy.
FAU - Ferrari, Silvia
AU  - Ferrari S
AD  - Department of Oncology and Hematology, Azienda Socio-Sanitaria Territoriale Papa 
      Giovanni XXIII, Bergamo, Italy.
FAU - Saccardi, Riccardo
AU  - Saccardi R
AD  - SOD Terapie Cellulari e Medicina Trasfusionale, Azienda Ospedaliero-Universitaria 
      Careggi, Firenze, Italy.
FAU - Bermema, Anisa
AU  - Bermema A
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
FAU - Guidetti, Anna
AU  - Guidetti A
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
AD  - Chair of Hematology, University of Milano, Milano, Italy.
FAU - Miceli, Rosalba
AU  - Miceli R
AD  - Unit of Biostatistics for Clinical Research, Department of Data Science, 
      Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
FAU - Zinzani, Pier Luigi
AU  - Zinzani PL
AUID- ORCID: 0000-0002-2112-2651
AD  - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia 
      "Seragnoli", Bologna, Italy.
AD  - Dipartimento di Scienze Mediche e Chirurgiche, Universita di Bologna, Bologna, 
      Italy.
FAU - Corradini, Paolo
AU  - Corradini P
AUID- ORCID: 0000-0002-9186-1353
AD  - Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto 
      Nazionale dei Tumori, Milano, Italy.
AD  - Chair of Hematology, University of Milano, Milano, Italy.
LA  - eng
GR  - #PNC-E3-2022-23683269-PNC-HLS-TA/Ministero della Salute (Ministry of Health, 
      Italy)/
GR  - "Ricerca Finalizzata 2019" #RF-2019-12370243/Ministero della Salute (Ministry of 
      Health, Italy)/
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20240308
PL  - England
TA  - Leukemia
JT  - Leukemia
JID - 8704895
RN  - U2I8T43Y7R (axicabtagene ciloleucel)
RN  - 0 (Biological Products)
RN  - 0 (Antigens, CD19)
SB  - IM
MH  - Humans
MH  - *Lymphoma, Large B-Cell, Diffuse/drug therapy/pathology/mortality
MH  - Female
MH  - Male
MH  - Middle Aged
MH  - *Biological Products/therapeutic use
MH  - *Mediastinal Neoplasms/pathology/drug therapy/mortality
MH  - Adult
MH  - Prospective Studies
MH  - Italy/epidemiology
MH  - Aged
MH  - Immunotherapy, Adoptive/methods
MH  - Follow-Up Studies
MH  - Survival Rate
MH  - Antigens, CD19
MH  - Treatment Outcome
PMC - PMC11073993
COIS- AC - Advisory boards: Gilead-Sciences, Ideogen, Roche, SecuraBIO, Takeda; 
      honoraria for lectures/educational events: Abbvie, Eli Lilly, Gilead-Sciences, 
      Incyte, Janssen-Cilag, Novartis, Takeda. BC - Advisory boards and honoraria for 
      lectures/educational events: Kite Gilead, Novartis. FB - Advisory boards and 
      honoraria for lectures/educational events: Kite Gilead, Novartis. SB - Speaker 
      bureau: Bristol-Myers Squibb, Gilead, Novartis; advisory board: Novartis; Travel 
      accommodation: Novartis, Roche. AJMF has received speaker fees from Adienne, 
      AstraZeneca, Bristol-Myers Squibb, Gilead, Novartis, and Roche; was a member of 
      advisory boards of Abbvie, AstraZeneca, Bristol-Myers Squibb, Genmab, Gilead, 
      Incyte, Juno, Novartis, PletixaPharm, and Roche; and currently receives research 
      grants from Abbvie, Amgen, ADC Therapeutics, Bayer HealthCare Pharmaceuticals, 
      Beigene, Bristol Myers Squibb, Genmab, Gilead, Hutchison Medipharma, Incyte, 
      Janssen Research & Development, MEI Pharma, Novartis, Pfizer, Pharmacyclics, 
      PletixaPharm, Protherics, Roche, and Takeda; and holds patents on NGR-hTNF-alfa 
      in brain tumours and NGR-hTNF/R-CHOP in relapsed or refractory PCNSL and 
      SNGR-hTNF in brain tumors. PLZ - Consultant: MSD, Eusapharma, Novartis; Advisory 
      boards: ADC Therapeutics, Astrazeneca, BeiGene, BMS, Celltrion, Eusapharma, 
      Gilead, Incyte, Janssen-Cilag, KyowaKirin, MSD, Novartis, Roche, Sandoz, 
      SecuraBio, Servier, Takeda; speakers bureau: Astrazeneca, Beigene, BMS, 
      Celltrion, Eusapharma, Gilead, Incyte, Janssen-Cilag, Kyowa-Kirin, MSD, Novartis, 
      Roche, Servier, Takeda. PCo - Advisory boards: AbbVie, ADC Therapeutics, Amgen, 
      BeiGene, Celgene, Daiichi Sankyo, Gilead/Kite, GSK, Incyte, Janssen, KyowaKirin, 
      Nerviano Medical Science, Novartis, Roche, Sanofi, Takeda; honoraria for 
      lectures: AbbVie, Amgen, Celgene, Gilead/Kite, Janssen, Novartis, Roche, Sanofi, 
      Takeda. The other authors declare that they have no conflict of interest.
EDAT- 2024/03/09 10:42
MHDA- 2024/05/07 00:50
PMCR- 2024/03/08
CRDT- 2024/03/08 23:31
PHST- 2023/11/07 00:00 [received]
PHST- 2024/02/28 00:00 [accepted]
PHST- 2024/02/27 00:00 [revised]
PHST- 2024/05/07 00:50 [medline]
PHST- 2024/03/09 10:42 [pubmed]
PHST- 2024/03/08 23:31 [entrez]
PHST- 2024/03/08 00:00 [pmc-release]
AID - 10.1038/s41375-024-02213-x [pii]
AID - 2213 [pii]
AID - 10.1038/s41375-024-02213-x [doi]
PST - ppublish
SO  - Leukemia. 2024 May;38(5):1107-1114. doi: 10.1038/s41375-024-02213-x. Epub 2024 
      Mar 8.