PhaseIIEvaluation ofVDC‐1101 in Canine Cutaneous T‐Cell Lymphoma

• DOI: 10.1111/jvim.12429
• Publication Date: 2014-10-01T17:48:48Z
• Authors: M.A. Morges; J.H. Burton; C.F. Saba; D.M. Vail; K.E. Burgess; D.H. Thamm
• Keywords: Mycosis fungoides; Veterinary sciences; Male; Skin Neoplasms; Lymphoma; Veterinary and Food Sciences; Antineoplastic Agents; Skin Diseases; 0403 veterinary science; Rare Diseases; Dogs; Dog; Chemotherapy; Animals; Veterinary Sciences; Dog Diseases; Cancer; Agricultural; Alanine; Hematology; 04 agricultural and veterinary sciences; T-Cell; Standard Articles; Lymphoma, T-Cell, Cutaneous; 3. Good health; Cutaneous; Treatment Outcome; Purines; Female

BackgroundCanine 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/ObjectivesThe primary study objective was to identify the objective response rate (ORR) to VDC‐1101 in canineCTCL; secondary objectives included characterization of progression‐free survival (PFS) and adverse events (AEs).AnimalsTwelve dogs with chemotherapy‐naïve or relapsed, histologically and immunohistochemically confirmedCTCL.MethodsDogs received VDC‐1101 as a 30‐minute IV infusion once every 21 days. Prednisone (1 mg/kg PO q48h) was administered concurrently.ResultsIn 11 evaluable patients, responses included 1 complete response (CR), 4 partial responses (PR), 2 stable disease (SD), and 4 progressive disease for anORRof 45% and biologic response rate (CR/PR/SD) of 64%. The medianPFSwas 37.5 days (26 to >399 days), which includes 1 durable and ongoingCR(>1 year). Gastrointestinal and hematologicAEs were mild; no dogs developed grade 3 or 4AEs. Three dogs developed dermatopathies and 1 of these dogs was removed from the study as a result of thisAE.Conclusions and Clinical ImportanceVDC‐1101 has activity against canineCTCLand could provide another treatment option in a disease process with a poor prognosis.