Transient and fully reversible changes in laboratory parameters and modifications of the cytokine profile during blinatumomab treatment in children with relapsed or refractory B-cell acute lymphoblastic leukemia.

acute lymphoblastic leukemia bispecific T-cell engager blinatumomab clinical laboratory parameters pediatric patients

Journal

Pediatric blood & cancer
ISSN: 1545-5017
Titre abrégé: Pediatr Blood Cancer
Pays: United States
ID NLM: 101186624

Informations de publication

Date de publication:
28 May 2023
Historique:
revised: 06 04 2023
received: 15 12 2022
accepted: 02 05 2023
medline: 29 5 2023
pubmed: 29 5 2023
entrez: 29 5 2023
Statut: aheadofprint

Résumé

We analyzed changes in laboratory parameters, including blood counts, liver enzymes, inflammation and coagulation markers, and cytokines, from 70 blinatumomab-treated pediatric patients (NCT01471782). Overall, trends were consistent in responders and nonresponders. Platelets and lymphocytes peaked on day (D) 10 in cycle 1 and returned to baseline on D42 and D29, respectively. Neutrophils peaked on D2 and returned to baseline on D42. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and bilirubin peaked on D17, reversing to baseline on D29; total protein levels were constant. These findings indicate that blinatumomab-induced changes in laboratory parameters were transient, reversible, and not requiring treatment interruptions in responders and nonresponders.

Identifiants

pubmed: 37246348
doi: 10.1002/pbc.30435
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e30435

Informations de copyright

© 2023 Amgen Research (Munich) GmbH and The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.

Références

Apostolidou E, Swords R, Alvarado Y, Giles FJ. Treatment of acute lymphoblastic leukaemia: a new era. Drugs. 2007;67:2153-2171.
Maxwell MB, Maher KE. Chemotherapy-induced myelosuppression. Semin Oncol Nurs. 1992;8:113-123.
Thatishetty AV, Agresti N, O'Brien CB. Chemotherapy-induced hepatotoxicity. Clin Liver Dis. 2013;17:671-686, ix-x.
Haddad TC, Greeno EW. Chemotherapy-induced thrombosis. Thromb Res. 2006;118:555-568.
Miltenburg NC, Boogerd W. Chemotherapy-induced neuropathy: a comprehensive survey. Cancer Treat Rev. 2014;40:872-882.
Florescu M, Cinteza M, Vinereanu D. Chemotherapy-induced cardiotoxicity. Maedica (Bucur). 2013;8:59-67.
Ben Kridis W, Khanfir A, Frikha M. Acute pancreatitis induced by anticancer chemotherapy. Acta Clin Belg. 2013;68:309-310.
Bargou R, Leo E, Zugmaier G, et al. Tumor regression in cancer patients by very low doses of a T cell-engaging antibody. Science. 2008;321:974-977.
Jen EY, Xu Q, Schetter A, et al. FDA approval: blinatumomab for patients with B-cell precursor acute lymphoblastic leukemia in morphologic remission with minimal residual disease. Clin Cancer Res. 2019;25:473-477.
Nägele V, Kratzer A, Zugmaier G, et al. Changes in clinical laboratory parameters and pharmacodynamic markers in response to blinatumomab treatment of patients with relapsed/refractory ALL. Exp Hematol Oncol. 2017;6:14-27.
von Stackelberg A, Locatelli F, Zugmaier G, et al. Phase I/phase II study of blinatumomab in pediatric patients with relapsed/refractory acute lymphoblastic leukemia. J Clin Oncol. 2016;34:4381-4389.
Klinger M, Brandl C, Zugmaier G, et al. Immunopharmacologic response of patients with B-lineage acute lymphoblastic leukemia to continuous infusion of T cell-engaging CD19/CD3-bispecific BiTE antibody blinatumomab. Blood. 2012;119:6226-6233.
Hoofnagle JH, Bjornsson ES. Drug-induced liver injury - types and phenotypes. N Engl J Med. 2019;381:264-273.
Grigorian A, O'Brien CB. Hepatotoxicity secondary to chemotherapy. J Clin Transl Hepatol. 2014;2:95-102.
Wu M-y, Yao L, Wang Y, et al. Clinical evaluation of potential usefulness of serum lactate dehydrogenase (LDH) in 2019 novel coronavirus (COVID-19) pneumonia. Respir Res. 2020;21:171-176.
Topp MS, Gokbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16:57-66.
Juluri KR, Wu QV, Voutsinas J, et al. Severe cytokine release syndrome is associated with hematologic toxicity following CD19 CAR T-cell therapy. Blood Adv. 2022;6:2055-2068.

Auteurs

Franco Locatelli (F)

Department of Hematology and Oncology, IRCCS Bambino Gesù Children's Hospital, Catholic University of the Sacred Heart, Rome, Italy.

Ana Markovic (A)

Amgen Inc., Thousand Oaks, California, USA.

Matthias Klinger (M)

Amgen Research (Munich) GmbH, Munich, Germany.

Ting Zeng (T)

Amgen Inc., Thousand Oaks, California, USA.

Gerhard Zugmaier (G)

Amgen Research (Munich) GmbH, Munich, Germany.

Classifications MeSH