Multicenter, randomized, double-blinded, placebo-controlled study of rabacfosadine in dogs with lymphoma.
J Vet Intern Med
; 36(1): 215-226, 2022 Jan.
Article
en En
| MEDLINE
| ID: mdl-34952995
ABSTRACT
BACKGROUND:
Rabacfosadine (RAB, Tanovea-CA1) is a novel chemotherapy agent conditionally approved for the treatment of lymphoma in dogs. HYPOTHESIS/OBJECTIVES:
To determine the efficacy and safety of RAB in dogs with lymphoma. ANIMALS One hundred and fifty-eight client-owned dogs with naïve or relapsed multicentric lymphoma were prospectively enrolled from January to October 2019.METHODS:
Dogs were randomized to receive RAB or placebo at a 3 1 ratio. Treatment was given every 21 days for up to 5 treatments. Study endpoints included progression-free survival (PFS), overall response rate (ORR) at a given visit, best overall response rate (BORR), and percent progression free 1 month after treatment completion. Safety data were also collected.RESULTS:
The median PFS was significantly longer in the RAB group compared to placebo (82 vs 21 days; P < .0001, HR 6.265 [95% CI 3.947-9.945]). The BORR for RAB-treated dogs was 73.2% (50.9% complete response [CR], 22.3% partial response [PR]) and 5.6% (0% CR, 5.6% PR) for placebo-treated dogs (P < .0001). One month after the last treatment, 37 RAB-treated dogs (33%) were progression free compared with no placebo-treated dogs (P < .0001). The most common adverse events observed in the RAB group were diarrhea (87.5%), decreased appetite (68.3%), and vomiting (68.3%) and were generally low grade and reversible. Serious adverse events were reported in 24 RAB-treated (20%) and 5 placebo-treated dogs (13%). CONCLUSIONS AND CLINICAL IMPORTANCE Rabacfosadine demonstrated statistically significant antitumor efficacy in dogs with lymphoma when administered every 21 days for up to 5 treatments as compared to placebo.Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Enfermedades de los Perros
/
Linfoma
Límite:
Animals
Idioma:
En
Revista:
J Vet Intern Med
Asunto de la revista:
MEDICINA INTERNA
/
MEDICINA VETERINARIA
Año:
2022
Tipo del documento:
Article
País de afiliación:
Estados Unidos