PMID- 25274443 OWN - NLM STAT- MEDLINE DCOM- 20150626 LR - 20240325 IS - 1939-1676 (Electronic) IS - 0891-6640 (Print) IS - 0891-6640 (Linking) VI - 28 IP - 5 DP - 2014 Sep-Oct TI - Phase II evaluation of VDC-1101 in canine cutaneous T-cell lymphoma. PG - 1569-74 LID - 10.1111/jvim.12429 [doi] AB - 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-naive 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. CI - Copyright (c) 2014 by the American College of Veterinary Internal Medicine. FAU - Morges, M A AU - Morges MA AD - Flint Animal Cancer Center, Colorado State University, Fort Collins, CO. FAU - Burton, J H AU - Burton JH FAU - Saba, C F AU - Saba CF FAU - Vail, D M AU - Vail DM FAU - Burgess, K E AU - Burgess KE FAU - Thamm, D H AU - Thamm DH LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Vet Intern Med JT - Journal of veterinary internal medicine JID - 8708660 RN - 0 (Antineoplastic Agents) RN - 0 (Purines) RN - 0 (rabacfosadine) RN - OF5P57N2ZX (Alanine) SB - IM MH - Alanine/adverse effects/*analogs & derivatives/therapeutic use MH - Animals MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Dog Diseases/*drug therapy MH - Dogs MH - Female MH - Lymphoma, T-Cell, Cutaneous/drug therapy/*veterinary MH - Male MH - Purines/adverse effects/*therapeutic use MH - Skin Diseases/chemically induced/veterinary MH - Skin Neoplasms/drug therapy/*veterinary MH - Treatment Outcome PMC - PMC4895598 OTO - NOTNLM OT - Cancer OT - Chemotherapy OT - Dog OT - Mycosis fungoides EDAT- 2014/10/03 06:00 MHDA- 2015/06/27 06:00 PMCR- 2014/09/01 CRDT- 2014/10/03 06:00 PHST- 2014/02/12 00:00 [received] PHST- 2014/06/17 00:00 [revised] PHST- 2014/07/07 00:00 [accepted] PHST- 2014/10/03 06:00 [entrez] PHST- 2014/10/03 06:00 [pubmed] PHST- 2015/06/27 06:00 [medline] PHST- 2014/09/01 00:00 [pmc-release] AID - JVIM12429 [pii] AID - 10.1111/jvim.12429 [doi] PST - ppublish SO - J Vet Intern Med. 2014 Sep-Oct;28(5):1569-74. doi: 10.1111/jvim.12429.