Randomized Phase III Trial of Piroxicam in Combination with Mitoxantrone or Carboplatin for First‐Line Treatment of Urogenital Tract Transitional Cell Carcinoma in Dogs

Abstract

BackgroundReported response rates of transitional cell carcinoma (TCC) in dogs to piroxicam in combination with either mitoxantrone or carboplatin are similar; however, it is unknown whether either drug might provide superior duration of response.Hypothesis/ObjectivesTo determine if the progression‐free interval (PFI) of dogs with TCC treated with mitoxantrone and piroxicam was different than that of dogs receiving carboplatin and piroxicam. The hypothesis was that the efficacy of mitoxantrone is no different from carboplatin.AnimalsFifty dogs with TCC without azotemia.MethodsProspective open‐label phase III randomized study. Either mitoxantrone or carboplatin was administered every 3 weeks concurrently with piroxicam with restaging at 6‐week intervals. Twenty‐four dogs received carboplatin and 26 received mitoxantrone.ResultsResponse was not different between groups (P = .56). None of the dogs showed complete response. In the mitoxantrone group, there were 2 (8%) partial responses (PR) and 18 (69%) dogs with stable disease (SD). In the carboplatin group, there were 3 PR (13%) and 13 (54%) dogs with SD. The PFI was not significantly different between groups (mitoxantrone = 106 days; carboplatin = 73.5 days; P = .62; hazard ratio 0.86; 95% confidence interval 0.47–1.56). Dogs with prostatic involvement experienced a shorter survival (median, 109 days) compared to dogs with urethral, trigonal, or apically located tumors; this difference was significant (median 300, 190, and 645 days, respectively; P = .005).Conclusions and Clinical ImportanceThis study did not detect a different in outcome in dogs with TCC treated with either mitoxantrone or carboplatin in combination with piroxicam.

A pilot study of toceranib/vinblastine therapy for canine transitional cell carcinoma

“…This drug combination is often used to treat TCC although the reported median survival time is only 291 days from the date of diagnosis. More recently, a clinical trial directly compared the use of carboplatin/piroxicam versus mitoxantrone/piroxicam therapy for the treatment of canine TCC [21]. There was no difference in the objective response rate (13 vs 8%) or progression free interval (73 vs 106 days) between the treatment groups.…”

Management of a postoperative vaginal stricture by perendoscopic balloon dilation in a dog

“…Compared with cisplatin, the association of mitoxantrone and piroxicam seems to be a valuable alternative with an MST of 291 days and a lower rate of gastrointestinal (18 per cent) and renal (6 per cent) toxicosis, leading to treatment discontinuation in only 2 per cent of the dogs (Henry and others 2003). Recently, no difference in outcome in dogs with transitional cell carcinoma treated with either mitoxantrone or carboplatin in combination with piroxicam was found (Allstadt and others 2015). However, a shorter survival time was observed in dogs with prostatic involvement (MST 109 days) compared with urethral (MST 300 days), trigonal (190 days) or apical (645 days) location.…”

Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges

“…The use and reporting of ITT and PP methods in both the human42, 46, 47 and veterinary3, 4, 5, 6, 7, 8, 9, 13 medical literature varies widely. In many studies, key pieces of information, including original number of patients recruited and randomized, how missing data was treated, and exactly which analysis methods and data sets were used, are lacking 48, 49.…”

“…A glance through recent issues of the Journal of Veterinary Internal Medicine identifies prospective randomized clinical trials (RCTs) involving dogs,1, 2, 3, 4, 5, 6, 7, 8, 9 cats,10, 11, 12, 13 cows,14, 15 and horses16, 17 that cover the fields of neurology,1, 8 oncology,3, 5 cardiology,4, 6, 12 and internal medicine 2, 9, 10, 11, 13, 14, 15, 16, 17. Collectively, these findings suggest that we have entered into an era of prospective veterinary RCTs.…”