Phase II Evaluation of VDC-1101 in Canine Cutaneous T-Cell Lymphoma

M. A. Morges, Jenna H Burton, C. F. Saba, D. M. Vail, K. E. Burgess, D. H. Thamm

Research output: Contribution to journalArticle

11 Citations (Scopus)

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. Hypothesis/Objectives: 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). Animals: 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 and Clinical Importance: VDC-1101 has activity against canine CTCL and could provide another treatment option in a disease process with a poor prognosis.

Original languageEnglish (US)
Pages (from-to)1569-1574
Number of pages6
JournalJournal of Veterinary Internal Medicine
Volume28
Issue number5
DOIs
StatePublished - Sep 1 2014

Fingerprint

Cutaneous T-Cell Lymphoma
lymphoma
Canidae
T-lymphocytes
Dogs
dogs
Disease-Free Survival
skin (animal)
Skin
Alopecia
Prodrugs
Erythema
Pruritus
Prednisone
prednisone
Lymphoma
erythema
pruritus
Nucleotides
alopecia

Keywords

  • Cancer
  • Chemotherapy
  • Dog
  • Mycosis fungoides

ASJC Scopus subject areas

  • veterinary(all)

Cite this

Phase II Evaluation of VDC-1101 in Canine Cutaneous T-Cell Lymphoma. / Morges, M. A.; Burton, Jenna H; Saba, C. F.; Vail, D. M.; Burgess, K. E.; Thamm, D. H.

In: Journal of Veterinary Internal Medicine, Vol. 28, No. 5, 01.09.2014, p. 1569-1574.

Research output: Contribution to journalArticle

Morges, M. A. ; Burton, Jenna H ; Saba, C. F. ; Vail, D. M. ; Burgess, K. E. ; Thamm, D. H. / Phase II Evaluation of VDC-1101 in Canine Cutaneous T-Cell Lymphoma. In: Journal of Veterinary Internal Medicine. 2014 ; Vol. 28, No. 5. pp. 1569-1574.
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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. Hypothesis/Objectives: 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). Animals: Twelve dogs with chemotherapy-na{\"i}ve 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 and Clinical Importance: VDC-1101 has activity against canine CTCL and could provide another treatment option in a disease process with a poor prognosis.",
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