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 language | English (US) |
|---|---|
| Pages (from-to) | 1569-1574 |
| Number of pages | 6 |
| Journal | Journal of Veterinary Internal Medicine |
| Volume | 28 |
| Issue number | 5 |
| DOIs | |
| State | Published - Sep 1 2014 |
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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 journal › Article
}
TY - JOUR
T1 - Phase II Evaluation of VDC-1101 in Canine Cutaneous T-Cell Lymphoma
AU - Morges, M. A.
AU - Burton, Jenna H
AU - Saba, C. F.
AU - Vail, D. M.
AU - Burgess, K. E.
AU - Thamm, D. H.
PY - 2014/9/1
Y1 - 2014/9/1
N2 - 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.
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-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.
KW - Cancer
KW - Chemotherapy
KW - Dog
KW - Mycosis fungoides
UR - http://www.scopus.com/inward/record.url?scp=84908220312&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84908220312&partnerID=8YFLogxK
U2 - 10.1111/jvim.12429
DO - 10.1111/jvim.12429
M3 - Article
VL - 28
SP - 1569
EP - 1574
JO - Journal of Veterinary Internal Medicine
JF - Journal of Veterinary Internal Medicine
SN - 0891-6640
IS - 5
ER -