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Conference abstract - Peer-reviewed, 2007

Efficacy and toxicity of a new formulation of paclitaxel (Paclical® Vet) in a phase I+II study for the treatment of malignant tumours in dogs

Rivera, Patricio; Häggström, Jens; Nyman, Helena; Wikström, Niklas; von, Euler Henrik
Von Euler, Henrik (ed.)

Abstract

Effi cacy and toxicity of a new formulation of Paclitaxel (Paclical® Vet) in a phase I + II study for the treatment of malignant tumours in dogs P. Rivera1, J. Haggstrom1, H. Nyman2, N. Wikstrom1, H. von Euler1 1Department of Clinical Sciences, Division of Small Animal Clinical Sciences and 2The University Animal Hospital, Division of Diagnostic Imaging; Swedish University of Agricultural Sciences (SLU), SE-750 07 Uppsala, Sweden Introduction: Paclitaxel (Taxol®) in humans and dogs requires extensive premedication and slow infusion (3–24 hours) due to side effects caused by the solvent Cremophor EL®. The purpose of this ongoing phase I + II study is to determine the maximum tolerated dose, toxicity and effi cacy of a new Cremophor EL®-free formulation of paclitaxel (Paclical® Vet) in dogs with refractory or recurrent solid tumours and high stage lymphomas. Methods: Paclical® Vet (Oasmia Pharmaceuticals, Uppsala, Sweden), dissolved in Ringer-Acetate, was given as an 15–30 min IV infusion of 175 mg/m2 with subsequent dose reduction if toxicity was observed (range 175–100 mg/m2). Treatment was repeated every 21 days for at least 3 cycles or until disease progression. No premedication, besides sedation, was routinely administered. A pharmacokinetic study was performed in 24 dogs. Results: Twenty-eight dogs received paclitaxel. Dose-limiting neutropenia at day 4 was observed at 175 mg/m2, whereas the mean dose 150 mg/m2 was generally tolerated. Other side effects included alopecia, transient inappetence, vomiting/diarrhoea. One case of mild hypersensitivity was detected in 90 doses administered. No drug-related cardiotoxicity was detected. Overall response (complete# and partial#) was 67%. Mastocytomas (7) and squamous cell carcinomas (4) responded 100%. Pharmacokinetics revealed a fast tissue distribution of paclitaxel, with an α-T1/2 of 10 minutes. The median clearance was 16.6 L/h/ m2, which is similar to humans. Conclusions: This is the fi rst successful trial of a paclitaxel formulation in dogs. Although survival analysis and response duration is not yet determined, the tumour response and controllable side-effects call for a multicentre trial in selected diagnoses

Published in

Veterinary and Comparative Oncology
2007, Volume: 1/6, pages: 77

Conference

ESVONC:s Spring Meeting