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

Journal of Veterinary Internal Medicine

M.A. Morges⁵  J.H. Burton⁴  C.F. Saba²  D.M. Vail³  K.E. Burgess¹ 

[1] Foster Hospital for Small Animals, Cummings School of Veterinary Medicine, Tufts University, North Grafton, MA;College of Veterinary Medicine, The University of Georgia, Athens, GA;School of Veterinary Medicine, University of Wisconsin-Madison, Madison, WI;School of Veterinary Medicine, University of California, Davis, CA;Flint Animal Cancer Center, Colorado State University, Fort Collins, CO

关键词: Cancer;    Chemotherapy;    Dog;    Mycosis fungoides;   

DOI  :  10.1111/jvim.12429

来源: Wiley

【 摘 要 】

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.

【 授权许可】

Unknown   
Copyright © 2014 by the American College of Veterinary Internal Medicine