Phase II Evaluation of VDC‐1101 in Canine Cutaneous T‐Cell Lymphoma. (September 2014)

• Record Type: Journal Article
• Authors: Morges, M.A.; Burton, J.H.; Saba, C.F.; Vail, D.M.; Burgess, K.E.; Thamm, D.H.
• Is Part Of: Journal of veterinary internal medicine. Volume 28:Number 5(2014:Sep./Oct.)
• Page Start: 1569
• Page End: 1574
• Publication Date: 2014-09
• Subjects: Veterinary medicine -- Periodicals; 636.0896
• DOI: 10.1111/jvim.12429
• Languages: English
• ISSNs: 0891-6640

Abstract

<abstract abstract-type="main" id="jvim12429-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="jvim12429-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="jvim12429-sec-0002" sec-type="section"> <title>Hypothesis/Objectives</title> <p>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).</p> </sec> <sec id="jvim12429-sec-0003" sec-type="section"> <title>Animals</title> <p>Twelve dogs with chemotherapy‐naïve or relapsed, histologically and immunohistochemically confirmed CTCL.</p> </sec> <sec id="jvim12429-sec-0004" sec-type="section"> <title>Methods</title> <p>Dogs received VDC‐1101 as a 30‐minute IV infusion once every 21 days. Prednisone (1 mg/kg PO q48h) was administered concurrently.</p> </sec> <sec id="jvim12429-sec-0005" sec-type="section"> <title>Results</title> <p>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.</p> </sec> <sec id="jvim12429-sec-0006" sec-type="section"> <title>Conclusions and Clinical Importance</title> <p>VDC‐1101 has activity against canine CTCL and could provide another treatment option in a disease process with a poor prognosis.</p> </sec> </abstract>