Multicenter, randomized, double‐blinded, placebo‐controlled study of rabacfosadine in dogs with lymphoma. (24th December 2021)

• Record Type: Journal Article
• Authors: Weishaar, Kristen M.; Wright, Zachary M.; Rosenberg, Mona P.; Post, Gerald S.; McDaniel, Jennifer A.; Clifford, Craig A.; Phillips, Brenda S.; Bergman, Philip J.; Randall, Elissa K.; Avery, Anne C.; Thamm, Douglas H.; Christman Hull, Abigail A.; Gust, Cathy M.; Donoghue, Ann R.
• Is Part Of: Journal of veterinary internal medicine. Volume 36:Number 1(2022)
• Page Start: 215
• Page End: 226
• Publication Date: 2021-12-24
• Subjects: canine -- chemotherapy -- multicentric -- neoplasia; Veterinary medicine -- Periodicals; 636.0896
• DOI: 10.1111/jvim.16341
• Languages: English
• ISSNs: 0891-6640

Abstract

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.