Clinical efficacy and safety of a water‐soluble micellar paclitaxel (Paccal Vet) in canine mastocytomas

Abstract

Objective To determine the clinical efficacy and safety of a cremophor‐free formulation of paclitaxel (Paccal Vet, Oasmia Pharmaceuticals) in dogs with mast cell tumours. Methods Paccal Vet was administered at a median dose of 145 (range, 135 to 150) mg/m2intravenously once every 21 days for three cycles to 29 dogs with macroscopic grade 2 or 3 mast cell tumour. Efficacy was assessed by tumour response (Response Evaluation Criteria in Solid Tumours version 1.0) and performance status score. Progression‐free survival, quality of life and safety/adverse events were also evaluated. Clinical safety was assessed by clinicopathological analyses and recording of adverse events. Results Complete or partial response was observed in 59% of dogs. Performance status score remained constant or improved for 20 dogs and decreased by one grade for 9 dogs. Median time to progression was 247 (range, 42 to 268) days. Expected, transient frequently subclinical adverse events (primarily grade 3/4 neutropenia and grade 1/2 leukopenia) were observed in the majority of dogs. Nine dogs were euthanased and one dog died due to disease progression. Clinical Significance Paccal Vet appears to be a clinically safe and effective treatment for canine mast cell tumours. Further controlled confirmatory investigation is warranted.

In vivo model for mastocytosis: A comparative review

“…itching, flushing, palpitations, cardiovascular collapse) [103]. A recent study evaluated the clinical safety and efficacy of a cremophor-free formulation of paclitaxel (Paccal Vet, Oasmia Pharmaceuticals) in dogs with MCTs [104]. Paclitaxel acts blocking the mitotic spindle, with cell-cycle arrest and subsequent apoptosis of tumor cells.…”

“…Paclitaxel acts blocking the mitotic spindle, with cell-cycle arrest and subsequent apoptosis of tumor cells. Furthermore, itmay display anti-angiogenic properties targeting endothelial cells and, given its low specificity, it is indicated for both c-kit mutated and wild-type MCTs treatment, compared to the targeted MCTs therapies [104]. The new formulation of paclitaxel (Paccal Vet) consists of a water-soluble drug, since the molecule is formulated in nanoparticles.…”

A Review of Paclitaxel and Novel Formulations Including Those Suitable for Use in Dogs

“…Results from this phase I/II study of Paccal Vet ® led to a multi‐center European, open label, single‐arm study of Paccal Vet ® to determine the efficacy and safety in dogs with grade II or III mast cell tumors . The study resulted in the accrual of 29 dogs with mast cell tumors.…”

“…As such, further discussion in this manuscript of Paccal ® 's use on cancers, whether published or not, that do not fall under this conditionally approved label has been limited. We nonetheless recognize the reasonable interest of the oncology community in these published studies, that include early phase studies in several cancer types, and more prominent later phase randomized studies in dogs with mast cell tumors. Briefly, the activity of Paccal ® in dogs with a variety of measurable cancers in early phase studies was demonstrated and may be considered to be reasonable evidence of its expected activity in a variety of canine cancers in dogs .…”

Use of accelerometry to investigate physical activity in dogs receiving chemotherapy

“…, Rivera et al . ). The inclusion of questions regarding PA confirms the importance of its evaluation in QOL assessment but using this methodology, it is difficult to quantify changes in PA and the results may be biased by client preconceptions of chemotherapy.…”