Toxicity Profile of PEG-Asparaginase in Adult Patients With Acute Lymphoblastic Leukemia in Brazil: A Multicenter Cross-Sectional Study

Clin Lymphoma Myeloma Leuk. 2020 Aug;20(8):e523-e528. doi: 10.1016/j.clml.2020.04.001. Epub 2020 Apr 13.

Abstract

Background: Currently, pediatric-inspired regimens are commonly applied to adults with acute lymphoblastic leukemia (ALL) after the recent recognition that these protocols improve survival. While asparaginase in whatever available formulation is a key component of modern treatment of ALL, many adult oncologists and hematologists struggle to deal with its particular toxicities in clinical practice. We reviewed toxicity outcomes of pegylated asparaginase (PEG-ASP) in adults with ALL treated in 3 reference centers in Brazil.

Patients and methods: This was a cross-sectional retrospective chart-review study encompassing patients aged 15 years and older diagnosed with ALL or ambiguous-lineage leukemia who received at least one dose of PEG-ASP, regardless of the adopted regimen.

Results: A total of 57 patients were included (age range, 15-57 years). Most patients (70%) received 2000 IU/m2 as the initial dose, by intravenous route (72%). The incidence of thromboembolic events was 17.5%, and the main site was cerebral venous sinus (4/10). Thrombosis was more frequent in patients receiving second-line treatment. In obese patients, grade 3 hepatotoxicity and hyperbilirubinemia were more common. Clinical pancreatitis (grade 3 or higher) was found in 2 of 57 cases. PEG-ASP had to be discontinued in 19.3% of exposed patients (11/57).

Conclusion: By reviewing the medical charts of adult patients with ALL from 3 reference centers, we found that our incidence of thrombotic and hepatic adverse events is similar to those reported in other trials involving PEG-ASP. Usually these effects should not preclude further use of the drug because most events are manageable in routine clinical practice.

Keywords: Acute lymphoblastic leukemia; Asparaginase; Liver toxicity; Pediatric-inspired regimen; Thrombosis.

Publication types

  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use*
  • Asparaginase / adverse effects*
  • Asparaginase / pharmacology
  • Asparaginase / therapeutic use*
  • Cross-Sectional Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • Retrospective Studies
  • Young Adult

Substances

  • Antineoplastic Agents
  • Asparaginase