title: Prospective evaluation of the safety of compounded bulk material L-asparaginase in dogs with lymphoma.
abstract: Use of compounded L-asparaginase became routine in veterinary oncology when manufacturing of Elspar®was discontinued in 2012. The objective of this study was to evaluate the safety of compounded L-asparaginase (CLASP, KRS Global Biotechnology, Boca Raton, FL, USA) in comparison with Elspar®(Lundbeck LLC, Deerfield, IL, USA). In addition, we documented the response to CLASP in combination with a corticosteroid in this population of dogs with lymphoma. Dogs were prospectively treated with 10 000 IU/m2CLASP or Elspar®subcutaneously. Corticosteroids were administered concurrently. Adverse events (AE) were assessed according to the Veterinary Cooperative Oncology Group Common Terminology Criteria for Adverse Events v1.1 (VCOG-CTCAE). Response was recorded. Seventy-three dogs received 75 treatments (CLASP, n = 47; Elspar®, n = 28). No AE were attributed to CLASP. Grade I and II AE probably or possibly related to treatment were observed following two Elspar®treatments. The overall response rate to the combination of CLASP and a corticosteroid was 80% (24% CR and 56% PR). In combination with a steroid, the compounded L-asparaginase evaluated in this study is safe and demonstrates activity against canine lymphoma. In the face of the discontinuation of Elspar®, veterinarians should seek compounded LASP products that have been tested for activity, purity, and sterility.
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Thiman
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA. northrup@uga.edu.
authors.forename: N
authors.initials: N
authors.lastname: Northrup
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA.
authors.forename: C
authors.initials: C
authors.lastname: Saba
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Clarke
authors.affiliation: Bluepearl Georgia Veterinary Specialists, Sandy Springs, GA, USA.
authors.forename: R
authors.initials: R
authors.lastname: Regan
authors.affiliation: Bluepearl Georgia Veterinary Specialists, Sandy Springs, GA, USA.
authors.forename: T
authors.initials: T
authors.lastname: Hamilton
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA.
authors.forename: H
authors.initials: H
authors.lastname: Lindell
authors.affiliation: Department of Small Animal Medicine and Surgery, College of Veterinary Medicine, University of Georgia, Athens, GA, USA.
authors.forename: E
authors.initials: E
authors.lastname: Hofmeister
mesh_terms: D000818:Animals; D001215:Asparaginase / Q000009:adverse effects* / Q000737:chemistry / Q000627:therapeutic use; D015331:Cohort Studies; D003345:Corticosterone; D004283:Dog Diseases / Q000188:drug therapy*; D004285:Dogs; D004339:Drug Compounding; D008223:Lymphoma / Q000188:drug therapy / Q000662:veterinary*
chemical_list: D001215:Asparaginase; D003345:Corticosterone