title: Phase II evaluation of VDC-1101 in canine cutaneous T-cell lymphoma.
abstract: BACKGROUND
  Canine cutaneous T-cell lymphoma (CTCL) is an uncommon disease for which efficacious therapies are lacking. The novel anticancer nucleotide prodrug VDC-1101 (formerly known as GS-9219) has shown efficacy in dogs with multicentric lymphoma. One of the observed adverse effects with this drug was a skin change characterized by hair loss, erythema, and pruritus, implying delivery of VDC-1101 to the skin.
  
  
  OBJECTIVE
  The primary study objective was to identify the objective response rate (ORR) to VDC-1101 in canine CTCL; secondary objectives included characterization of progression-free survival (PFS) and adverse events (AEs).
  
  
  METHODS
  Twelve dogs with chemotherapy-naïve or relapsed, histologically and immunohistochemically confirmed CTCL.
  
  
  METHODS
  Dogs received VDC-1101 as a 30-minute IV infusion once every 21 days. Prednisone (1 mg/kg PO q48h) was administered concurrently.
  
  
  RESULTS
  In 11 evaluable patients, responses included 1 complete response (CR), 4 partial responses (PR), 2 stable disease (SD), and 4 progressive disease for an ORR of 45% and biologic response rate (CR/PR/SD) of 64%. The median PFS was 37.5 days (26 to >399 days), which includes 1 durable and ongoing CR (>1 year). Gastrointestinal and hematologic AEs were mild; no dogs developed grade 3 or 4 AEs. Three dogs developed dermatopathies and 1 of these dogs was removed from the study as a result of this AE.
  
  
  CONCLUSIONS
  VDC-1101 has activity against canine CTCL and could provide another treatment option in a disease process with a poor prognosis.
authors.affiliation: Flint Animal Cancer Center, Colorado State University, Fort Collins, CO.
authors.forename: M A
authors.initials: MA
authors.lastname: Morges
authors.forename: J H
authors.initials: JH
authors.lastname: Burton
authors.forename: C F
authors.initials: CF
authors.lastname: Saba
authors.forename: D M
authors.initials: DM
authors.lastname: Vail
authors.forename: K E
authors.initials: KE
authors.lastname: Burgess
authors.forename: D H
authors.initials: DH
authors.lastname: Thamm
mesh_terms: D000409:Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004283:Dog Diseases / Q000188:drug therapy*; D004285:Dogs; D005260:Female; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy / Q000662:veterinary*; D008297:Male; D011687:Purines / Q000009:adverse effects / Q000627:therapeutic use*; D012871:Skin Diseases / Q000139:chemically induced / Q000662:veterinary; D012878:Skin Neoplasms / Q000188:drug therapy / Q000662:veterinary*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011687:Purines; C531423:rabacfosadine; D000409:Alanine
keywords: Cancer; Chemotherapy; Dog; Mycosis fungoides