Safety and efficacy of blinatumomab: a real world data.


Journal

Annals of hematology
ISSN: 1432-0584
Titre abrégé: Ann Hematol
Pays: Germany
ID NLM: 9107334

Informations de publication

Date de publication:
Apr 2020
Historique:
received: 08 05 2019
accepted: 18 11 2019
pubmed: 23 2 2020
medline: 10 4 2020
entrez: 21 2 2020
Statut: ppublish

Résumé

Despite improvement in survival of newly diagnosed adult precursor B-acute lymphoblastic leukemia/lymphoma (B-ALL), the results of relapsed/refractory disease are poor. Blinatumomab, a bispecific monoclonal antibody directed against CD19/CD3 show clinical activity against relapsed/refractory B-ALL and in minimal residual disease (MRD)-positive patients.We report our "real-world" experience with blinatumomab in patients with relapsed/refractory B-ALL.Twenty-one patients, at a median age 52 years with median disease duration of 10 months, were included. Indications for treatment were hematological relapse (n = 17), MRD positivity (n = 2), inability to continue intensive chemotherapy (n = 1), and bridging to a second alloSCT (n = 1). Blinatumomab was given as first salvage in 11 patients and after at least one prior salvage treatment in eight.Complete response (CR) was newly achieved in 47% and was maintained in 75% of patients with baseline CR. At a median follow-up of 12.4 months, 13 patients were alive, and 11 in CR. Median leukemia-free survival was 8.7 months, and median overall survival was 15.2 months. Median leukemia-free survival and overall survival were not reached in patients proceeding to alloSCT compared to 5.1 and 15.2 months, respectively, for patients who did not receive stem cell transplantation.Treatment was well tolerated with neurological events reported in two patients (10%) and GI events in three patients (14%). Cytokine storm was reported in four patients (19%).In conclusion, treatment with blinatumomab is effective and tolerable in adult patients with relapsed/refractory B-ALL outside of a clinical trial stetting.

Identifiants

pubmed: 32076826
doi: 10.1007/s00277-019-03854-0
pii: 10.1007/s00277-019-03854-0
doi:

Substances chimiques

Antibodies, Bispecific 0
Antigens, CD19 0
Antigens, Neoplasm 0
Antineoplastic Agents, Immunological 0
CD19 molecule, human 0
CD3 Complex 0
Cytokines 0
blinatumomab 4FR53SIF3A

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

835-838

Auteurs

Arie Apel (A)

Hematology Department, Shamir (Asaf Harofe) Medical Center, Zerifin, Israel. ariea@shamir.health.gov.il.

Yishai Ofran (Y)

Department of Hematology and Bone Marrow transplantation, Rambam Health Care Campus, Haifa, Israel.

Ofir Wolach (O)

Institute of Hematology, Davidoff Cancer Center, Belinson Hospital, Rabin Medical Center, Petach-Tikva, Israel.

Shai Shimony (S)

Institute of Hematology, Davidoff Cancer Center, Belinson Hospital, Rabin Medical Center, Petach-Tikva, Israel.

Ron Ram (R)

Bone Marrow Transplantation Unit, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Itai Levi (I)

Institute of Hematology, Faculty of Health Sciences, Soroka University Medical Center, Beer Sheba, Israel.

Miri Zektser (M)

Soroka medical center, Beer Sheba, Israel.

Maya Koren-Michowitz (M)

Hematology Department, Shamir (Asaf Harofe) Medical Center, Zerifin, Israel.
Sacklar School of Medicine, Tel Aviv University, Tel Aviv, Israel.

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Classifications MeSH