Blinatumomab in Children and Adolescents with Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia: A Real-Life Multicenter Retrospective Study in Seven AIEOP (Associazione Italiana di Ematologia e Oncologia Pediatrica) Centers

Five-year event-free survival in pediatric B-cell precursor acute lymphoblastic leukemia (BCP-ALL) currently exceeds 80-85%. However, 15-20% of patients still experience a relapsed/refractory disease. From 1 January 2015 to 31 December 2020, thirty-nine patients, 0-21 years old with r/r BCP-ALL were...

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Published in:Cancers 2022-01, Vol.14 (2), p.426
Main Authors: Beneduce, Giuliana, De Matteo, Antonia, Stellato, Pio, Testi, Anna M, Bertorello, Nicoletta, Colombini, Antonella, Putti, Maria C, Rizzari, Carmelo, Cesaro, Simone, Cellini, Monica, Barisone, Elena, Petruzziello, Fara, Menna, Giuseppe, Parasole, Rosanna
Format: Article
Language:English
Subjects:
Acute lymphoblastic leukemia
Adverse events
Anemia
Antigens
Bone marrow
CD19 antigen
CD3 antigen
Cell survival
Chemotherapy
Children
Clinical trials
Cytokines
FDA approval
Hematology
Leukemia
Lymphatic leukemia
Lymphocytes B
Lymphocytes T
Medical prognosis
Morphology
Patients
Pediatrics
Remission
Remission (Medicine)
Response rates
Thrombocytopenia
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Summary:Five-year event-free survival in pediatric B-cell precursor acute lymphoblastic leukemia (BCP-ALL) currently exceeds 80-85%. However, 15-20% of patients still experience a relapsed/refractory disease. From 1 January 2015 to 31 December 2020, thirty-nine patients, 0-21 years old with r/r BCP-ALL were treated with blinatumomab with the aim of inducing remission ( = 13) or reducing MRD levels ( = 26) in the frame of different multiagent chemotherapy schedules, in seven AIEOP centers. Patients were treated in compassionate and/or off-label settings and were not enrolled in any controlled clinical trials. Treatment was well tolerated; 22 (56.4%) patients reported adverse events (AE) on a total of 46 events registered, of which 27 (58.7%) were ≤2 grade according to CTCAE. Neurological AEs were 18 (39.1%); only two patients required transient blinatumomab discontinuation. Complete remission (CR) rate was 46% for the 13 patients treated with ≥5% blasts and 81% PCR/FC MRD negativity in the 26 patients with blasts < 5%. Median relapse-free survival was 33.4 months (95% CI; 7.5-59.3); median overall survival was not reached over a mean follow-up of 16 months. In our study, as in other real-life experiences, blinatumomab proved to be effective and well-tolerated, able to induce a high rate of CR and MRD negativity.
ISSN:2072-6694
2072-6694
DOI:10.3390/cancers14020426