Moxetumomab pasudotox-tdfk for relapsed/refractory hairy cell leukemia: a review of clinical considerations.

Autor: Nobre CF; Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, MD, 21287, USA. cnobre1@jhmi.edu., Newman MJ; Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, MD, 21287, USA., DeLisa A; Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, MD, 21287, USA., Newman P; Department of Pharmacy, The Johns Hopkins Hospital, Baltimore, MD, 21287, USA.
Jazyk: angličtina
Zdroj: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2019 Aug; Vol. 84 (2), pp. 255-263. Date of Electronic Publication: 2019 May 27.
DOI: 10.1007/s00280-019-03875-6
Abstrakt: Purpose: Hairy cell leukemia (HCL) is a rare mature B cell leukemia. Purine analogs are the mainstay of treatment of HCL, but relapse after purine analog therapy is common. Outcomes of treatment of relapsed/refractory HCL typically diminish with each successive line of therapy. Moxetumomab pasudotox-tdfk is a novel recombinant immunotoxin approved for the treatment of patients with relapsed/refractory HCL who have received at least two prior therapies, including a purine analog. This article reviews HCL treatment, focusing on moxetumomab pasudotox-tdfk, its place in therapy, considerations for preparation and administration, and strategies for prevention and management of toxicities.
Methods: A literature search was conducted in the PubMed database from inception to January 2019, using the following terms: moxetumomab, hairy cell leukemia, relapsed/refractory hairy cell leukemia, immunotoxin, and CD22. The package insert and available posters and abstracts were also reviewed.
Results: FDA approval of moxetumomab pasudotox-tdfk was based on a phase III single-arm, open-label trial in 80 patients. Treatment with moxetumomab pasudotox-tdfk yielded a durable complete response rate of 30% with a median duration of response that had not yet been reached at a median follow-up of 16.7 months. The objective response rate was 75% based on blinded independent central review. The most common adverse reactions were infusion-related reactions, edema, nausea, fatigue, headache, pyrexia and anemia. Serious adverse events include capillary leak syndrome and hemolytic uremic syndrome.
Conclusions: Clinicians providing care for patients receiving moxetumomab pasudotox-tdfk should be aware of the strategies required for safe administration, including the management of serious adverse events.
Databáze: MEDLINE
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