Randomised trial evaluating chemotherapy alone or chemotherapy and a novel monoclonal antibody for canine T‐cell lymphoma: A multicentre US study

BACKGROUND: Canine peripheral nodal T‐cell lymphoma is considered chemotherapy resistant and carries a relatively poor prognosis. Prospective evaluations reporting the impact of chemotherapy on progression‐free survival (PFS) and overall survival time for dogs with T‐cell lymphoma are lacking. This study examined the impact of L‐CHOP (L‐asparaginase, doxorubicin, cyclophosphamide, vincristine, prednisone) chemotherapy or L‐CHOP in combination with AT‐005, a US Department of Agriculture‐licensed caninised monoclonal antibody, on PFS and response rates in dogs with clinical intermediate‐ and high‐grade peripheral nodal T‐cell lymphoma. METHODS: A prospective, randomised, placebo‐controlled, investigator‐ and owner‐blinded, multicentre study was completed. All dogs received a 19‐week L‐CHOP chemotherapy protocol with randomisation (1:1) into placebo or AT‐005 groups. Response was evaluated via the Veterinary Cooperative Oncology Group criteria for canine lymphoma. RESULTS: Forty‐nine dogs were enrolled (25 received placebo and 24 received AT‐005). Most demographic factors were similar between the two groups, with the exception that more dogs with stage IV and V disease were treated with AT‐005 (34% vs. 8%; p = 0.03). Median PFS was 103 days (95% confidence interval [CI], 56–118) in the placebo group versus 64 days (95% CI, 36–118) in the AT‐005 group. The overall response rate (ORR) for all dogs was 98% (48 of 49); complete response rate in the placebo group (64%) was not different from the AT‐005 group (67%). CONCLUSIONS: To the best of the authors’ knowledge, this is the first prospective study to document that treatment with L‐CHOP chemotherapy, with or without AT‐005, may result in a high ORR, but relatively brief PFS in dogs with clinical intermediate‐ and high‐grade T‐cell lymphoma.