Background: Hairy cell leukemia (HCL) is a rare B-cell malignancy, diagnosed in ~1000 new patients a year in the US.1 Purine nucleoside analogs (PNAs) are the recommended first-line treatment; however, 30% to 40% of patients relapse within 5 to 10 years of treatment,2 when PNAs become less effective and are associated with cumulative toxicity. Moxetumomab pasudotox-tdfk is a CD22-directed cytotoxin that was FDA approved in 2018 for adults with relapsed/refractory HCL who received ≥2 prior systemic therapies, including a PNA.
Objectives: To educate oncology nurses about the mechanism of action, clinical profile, and best practices for proactive management and monitoring of patients receiving moxetumomab pasudotox-tdfk.
Methods: Approval of moxetumomab pasudotox-tdfk was based on a multicenter, single-arm, open-label phase 3 trial (NCT01829711) in 80 patients with relapsed/refractory HCL.
Results: The objective response rate was 75%, with 41% of patients achieving a complete response (CR) and 30% achieving a durable CR.3 The most common nonlaboratory-based adverse reactions (≥20%) were infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea. Laboratory abnormalities were also observed. The most common grade 3/4 adverse reactions (≥5%) were hypertension, febrile neutropenia, and hemolytic uremic syndrome (HUS), with HUS the most frequent reaction leading to discontinuation (5%).4
It is recommended that moxetumomab pasudotox-tdfk be administered at 0.04 mg/kg/dose as a 30-minute intravenous infusion on days 1, 3, and 5 of each 28-day cycle, for a maximum of 6 cycles, until disease progression or unacceptable toxicity.4 To maintain adequate hydration, patients should receive isotonic fluids (up to 1 L) intravenously before and after each infusion. Patients are advised to hydrate during days 1-8 of each cycle (up to 3 L of fluids/day). Recommended premedications are histamine receptor antagonists, antihistamines, and acetaminophen. To reduce thrombosis risk, low-dose aspirin should be considered on days 1-8. During the 24 hours postinfusion, antihistamines and acetaminophen should be considered, as well as oral corticosteroids to decrease nausea and vomiting. A proactive approach should be taken to monitor for and manage adverse events, including capillary leak syndrome, HUS, renal toxicity, infusion-related reactions, and laboratory abnormalities.
Conclusions: Oncology nurses may have limited knowledge of moxetumomab pasudotox-tdfk because it is a first-in-class molecule, which was recently approved for relapsed/refractory HCL. Strategies for nurses to support high-quality care will be emphasized.
Funding: Supported by AstraZeneca.
- Troussard X, Cornet E. Hairy cell leukemia 2018: Update on diagnosis, risk-stratification, and treatment. Am J Hematol. 2017;92(12):1382-1390.
- Teras LR, DeSantis CE, Cerhan JR, et al. US lymphoid malignancy statistics by World Health Organization subtypes. CA Cancer J Clin. 2016;66(6):443-459.
- Kreitman RJ, Dearden C, Zinzani PL, et al. Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. Leukemia. 2018;32(8):1768-1777.
- LUMOXITI [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018.