6533b858fe1ef96bd12b5bbc
RESEARCH PRODUCT
Real‐world evidence of tisagenlecleucel for the treatment of relapsed or refractory large B‐cell lymphoma
Lucía López CorralAnna SuredaCarlos SolanoPau AbrisquetaJuan-manuel SanchoPere BarbaGuillermo VillacampaJavier BrionesJavier BrionesRafael HernaniMi KwonGeltamo Spanish Groups GethManuel GuerreiroGloria IacoboniJosé María Raya SánchezAlberto MussettiAna Carolina CaballeroAna Carolina CaballeroAlejandro Martin Garcia-sanchoJuan Luis Reguera-ortegaRebeca BailenNuria Martínez-cibriansubject
Male0301 basic medicine:aminoácidos péptidos y proteínas::proteínas::proteínas de membranas::receptores de superficie celular::receptores inmunológicos::receptores de antígenos::receptores de antígenos de linfocitos T [COMPUESTOS QUÍMICOS Y DROGAS]Cancer Researchnon‐Hodgkin's lymphomaBest Overall Responsehematological cancer:Other subheadings::Other subheadings::/drug therapy [Other subheadings]Non- Hodgkin's lymphomaGastroenterology0302 clinical medicineMedicine research:Other subheadings::/therapeutic use [Other subheadings]CàncerB-cell lymphomaRC254-282CancerOriginal ResearchReceptors Chimeric AntigenNeoplasms. Tumors. Oncology. Including cancer and carcinogensnon‐Standard of CareMiddle AgedPatologiaHodgkin&aposProgression-Free SurvivalCytokine release syndromeclinical cancer researchOncology:neoplasias::neoplasias por tipo histológico::linfoma::linfoma no Hodgkin::linfoma de células B::linfoma de células B grandes difuso [ENFERMEDADES]030220 oncology & carcinogenesisCytokinesFemaleLymphoma Large B-Cell Diffusenon-Hodgkin's lymphomamedicine.medical_specialtyReceptors Antigen T-CellCèl·lules B - Tumors - Tractament:Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores]Investigació mèdicaReal world evidence03 medical and health sciencess lymphoma:Neoplasms::Neoplasms by Histologic Type::Lymphoma::Lymphoma Non-Hodgkin::Lymphoma B-Cell::Lymphoma Large B-Cell Diffuse [DISEASES]Refractoryclinical observationsInternal medicinemedicineHumansRadiology Nuclear Medicine and imagingLeukapheresis:Amino Acids Peptides and Proteins::Proteins::Membrane Proteins::Receptors Cell Surface::Receptors Immunologic::Receptors Antigen::Receptors Antigen T-Cell [CHEMICALS AND DRUGS]AgedRetrospective Studies:Otros calificadores::/uso terapéutico [Otros calificadores]business.industryTeràpia cel·lularClinical Cancer ResearchLeukapheresismedicine.diseaseMalaltia de HodgkinNon-Hodgkin's lymphomaLymphoma030104 developmental biologyHodgkin's diseaseNeoplasm Recurrence Localbusinessdescription
Abstract Tisagenlecleucel (tisa‐cel) is a second‐generation autologous CD19‐targeted chimeric antigen receptor (CAR) T‐cell therapy approved for relapsed/refractory (R/R) large B‐cell lymphoma (LBCL). The approval was based on the results of phase II JULIET trial, with a best overall response rate (ORR) and complete response (CR) rate in infused patients of 52% and 40%, respectively. We report outcomes with tisa‐cel in the standard‐of‐care (SOC) setting for R/R LBCL. Data from all patients with R/R LBCL who underwent leukapheresis from December 2018 until June 2020 with the intent to receive SOC tisa‐cel were retrospectively collected at 10 Spanish institutions. Toxicities were graded according to ASTCT criteria and responses were assessed as per Lugano 2014 classification. Of 91 patients who underwent leukapheresis, 75 (82%) received tisa‐cel therapy. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 5% and 1%, respectively; non‐relapse mortality was 4%. Among the infused patients, best ORR and CR were 60% and 32%, respectively, with a median duration of response of 8.9 months. With a median follow‐up of 14.1 months from CAR T‐cell infusion, median progression‐free survival and overall survival were 3 months and 10.7 months, respectively. At 12 months, patients in CR at first disease evaluation had a PFS of 87% and OS of 93%. Patients with an elevated lactate dehydrogenase showed a shorter PFS and OS on multivariate analysis. Treatment with tisa‐cel for patients with relapsed/refractory LBCL in a European SOC setting showed a manageable safety profile and durable complete responses.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2021-05-01 | Cancer Medicine |