Open AccessA Phase II Clinical Trial of Vinorelbine in Dogs with Cutaneous Mast Cell Tumors
Author(s) -
Grant I.A.,
Rodriguez C.O.,
Kent M.S.,
Sfilgoi G.,
Gordon I.,
Davis G.,
Lord L.,
London C.A.
Publication year - 2008
Publication title -
journal of veterinary internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.356
H-Index - 103
eISSN - 1939-1676
pISSN - 0891-6640
DOI - 10.1111/j.1939-1676.2008.0051.x
Subject(s) - medicine , vinorelbine , neutropenia , gastroenterology , vinblastine , anorexia , vomiting , adverse effect , phases of clinical research , clinical trial , chemotherapy , cisplatin
Background: Few effective drugs are available to treat dogs with locally aggressive or metastatic mast cell disease. Hypothesis: Vinorelbine, a semisynthetic derivative of vinblastine, is an effective drug for the treatment of canine mast cell tumors (MCT). Animals: Twenty‐four dogs with cutaneous MCT. Methods: Dogs with at least 1 measurable, cytologically confirmed, and previously untreated cutaneous MCT received a single treatment with vinorelbine at the previously established dosage of 15 mg/m 2 IV. Tumor measurements and CBC were evaluated before and 7 days after treatment. Adverse events were graded according to Veterinary Cooperative Oncology Group (VCOG) guidelines. Statistics: Data were accrued in accordance with a Simon's 2‐stage design with a noninteresting response rate of .05, a target response of .25, and α and β values of .10. Results: Three of 24 dogs (13%) had a response to treatment, including 1 measurable complete response and 1 measurable partial response. The 3rd dog had microscopic complete response to treatment with stable measurable disease. Twenty other dogs (83%) had stable disease and 1 dog (4%) had progressive disease. Neutropenia occurred in 13 dogs (54%) (grade 1, n = 4; grade 3, n = 6; grade 4, n = 3). Gastrointestinal toxicity occurred in 11 dogs (46%) (anorexia: grade 1, n = 3; grade 2, n = 1; grade 3, n = 1; diarrhea: grade 1, n = 2; grade 3, n = 1; vomiting: grade 1, n = 5; grade 3, n = 1). Conclusions and Clinical Importance: Vinorelbine was associated with an overall response rate of 13% and a high prevalence of neutropenia. Additional studies are indicated to determine if repeated dosing of vinorelbine or combination of vinorelbine with other drugs increases the observed biologic activity against canine MCT.