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An open-label, multicenter study of polyethylene glycol-L-asparaginase for the treatment of acute lymphoblastic leukemia.

Publication ,  Journal Article
Ettinger, LJ; Kurtzberg, J; Voûte, PA; Jürgens, H; Halpern, SL
Published in: Cancer
March 1, 1995

BACKGROUND: L-asparaginase has been a mainstay of therapy along with vincristine and prednisone in the treatment of acute lymphoblastic leukemia (ALL) in children for almost 30 years. Because L-asparaginase is a foreign protein, the potential exists for severe, dose-limiting hypersensitivity reactions. To reduce this toxicity, L-asparaginase has been linked with polyethylene glycol (PEG). METHODS: Patients with ALL in relapse were entered in a Phase II, open-label clinical trial (ASP-201A) to evaluate the toxicity and efficacy of PEG-L-asparaginase. PEG-L-asparaginase has demonstrated potential low immunogenicity and a prolonged plasma half-life relative to native enzyme. PEG-L-asparaginase (2000 IU/m2 every 2 weeks) was used as single-agent induction therapy during an initial 14-day investigational window. Thereafter, the regimen consisted of PEG-L-asparaginase, vincristine, and prednisone. Patients also were allowed to receive doxorubicin and intrathecal chemotherapy beginning on day 14. All patients had been treated previously with one or more courses of native L-asparaginase; one of these patients was hypersensitive to L-asparaginase at enrollment. RESULTS: During the 14-day investigational window with PEG-L-asparaginase monotherapy, 22% of patients examined achieved a complete or partial remission. By completion of the 35-day induction period, 78% (or 14 of 18) of evaluated patients achieved complete or partial remission. Anaphylaxis did not occur during treatment. Mild urticaria and mild local allergic reactions occurred in five patients but did not cause discontinuation of treatment. The incidence of hyperglycemia and pancreatitis was less than expected from historic data published for previous studies with native L-asparaginase. CONCLUSIONS: As administered in this study, PEG-L-asparaginase can be given safely with a spectrum of toxicity similar to that of native L-asparaginase. Single-agent activity was documented in patients with ALL in bone marrow relapse.

Duke Scholars

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

March 1, 1995

Volume

75

Issue

5

Start / End Page

1176 / 1181

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Polyethylene Glycols
  • Oncology & Carcinogenesis
  • Male
  • Infant
  • Humans
  • Female
  • Child, Preschool
  • Child
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ettinger, L. J., Kurtzberg, J., Voûte, P. A., Jürgens, H., & Halpern, S. L. (1995). An open-label, multicenter study of polyethylene glycol-L-asparaginase for the treatment of acute lymphoblastic leukemia. Cancer, 75(5), 1176–1181. https://doi.org/10.1002/1097-0142(19950301)75:5<1176::aid-cncr2820750519>3.0.co;2-y
Ettinger, L. J., J. Kurtzberg, P. A. Voûte, H. Jürgens, and S. L. Halpern. “An open-label, multicenter study of polyethylene glycol-L-asparaginase for the treatment of acute lymphoblastic leukemia.Cancer 75, no. 5 (March 1, 1995): 1176–81. https://doi.org/10.1002/1097-0142(19950301)75:5<1176::aid-cncr2820750519>3.0.co;2-y.
Ettinger LJ, Kurtzberg J, Voûte PA, Jürgens H, Halpern SL. An open-label, multicenter study of polyethylene glycol-L-asparaginase for the treatment of acute lymphoblastic leukemia. Cancer. 1995 Mar 1;75(5):1176–81.
Ettinger, L. J., et al. “An open-label, multicenter study of polyethylene glycol-L-asparaginase for the treatment of acute lymphoblastic leukemia.Cancer, vol. 75, no. 5, Mar. 1995, pp. 1176–81. Pubmed, doi:10.1002/1097-0142(19950301)75:5<1176::aid-cncr2820750519>3.0.co;2-y.
Ettinger LJ, Kurtzberg J, Voûte PA, Jürgens H, Halpern SL. An open-label, multicenter study of polyethylene glycol-L-asparaginase for the treatment of acute lymphoblastic leukemia. Cancer. 1995 Mar 1;75(5):1176–1181.
Journal cover image

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

March 1, 1995

Volume

75

Issue

5

Start / End Page

1176 / 1181

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Polyethylene Glycols
  • Oncology & Carcinogenesis
  • Male
  • Infant
  • Humans
  • Female
  • Child, Preschool
  • Child