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Clinical Evaluation of Mitoxantrone and Piroxicam in a Canine Model of Human Invasive Urinary Bladder Carcinoma¹

University of Missouri–Columbia College of Veterinary Medicine, Columbia, Missouri 65211 [C. J. H., D. L. M., S. E. T., M. A. S., M. L. H.]; University of Missouri–Columbia School of Medicine, Columbia, Missouri 65211 [C. J. H.]; Beltway Oncology Medicine Referral, Glendale, Maryland 20769 [L. B.]; South Paws Veterinary Referral Center, Springfield, Virginia 22150 [S. S.]; Department of Veterinary Clinical Sciences, University of Queensland, St. Lucia, Queensland, 4072, Australia [R. C. S.]; Colorado State University Animal Cancer Center, Fort Collins, Colorado 80523 [W. S. D.]; University of California, School of Veterinary Medicine, Davis, California 95616 [B. R. M.]; Sequoia Veterinary Hospital, Redwood City, California 94063 [L. J.]; and Kansas State University College of Veterinary Medicine, Manhattan, Kansas 66506 [R. C.]

Purpose: Cyclooxygenase inhibitors show promise in chemoprevention andtherapy of certain carcinomas, an effect that may be additiveto that of standard chemotherapy. The purpose of this studywas to evaluate the efficacy of combined therapy using thecyclooxygenase inhibitor, piroxicam, and mitoxantrone against a relevant canine model of human invasive bladder cancer.

Experimental Design: Fifty-five dogs with transitional cell carcinoma of the urinary bladder were enrolled in this nonrandomized one-armed prospective multi-institutional clinical trial. Mitoxantrone was administered i.v. (5 mg/m²) every 21 days for four treatments, and piroxicam was administered p.o. (0.3 mg/kg/day) for the study duration. Tumor staging was performed at baseline, day 42 and every 3 months after protocol completion. Endpoints included time-to-treatment failure and survival time (ST).

Results: Response data were available for 48 dogs and included one complete response, 16 partial responses, 22 with disease stabilization, and 9 with progressive disease for an overall 35.4% measurable response rate. Subjective improvement occurred in 75% of treated dogs. Median time-to-treatment failure and ST were 194 and 350 days, respectively. Using censoring and end point definitions similar to those of previous reports of dogs treated with piroxicam alone, the median ST in this study was 291 days, compared with 181 days with piroxicam alone. Diarrhea and azotemia were the most common treatment complications.

Conclusions: Mitoxantrone/piroxicam induced remission more frequently than previously reported for either drug as a single agent in this canine model of invasive human transitional cell carcinoma. Additional evaluation of these drugs in combination protocols should be explored.

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