Department of Clinical Sciences, Division of Small Animal Clinical Sciences, Swedish University of Agricultural Sciences (SLU), Uppsala, Sweden.
Vet Comp Oncol. 2013 Dec;11(4):243-55. doi: 10.1111/j.1476-5829.2011.00314.x. Epub 2012 Mar 9.
A new formulation of water-soluble paclitaxel (Paccal® Vet) has been developed for canine cancer patients, without the need for pre-medication (traditionally required in non-water-soluble paclitaxel formulations). The objective of the study was to determine a clinically safe and efficacious dose of Paccal Vet and to estimate progression-free and overall survival and to evaluate single-dose pharmacokinetics in tumour-bearing dogs. A positive risk:benefit ratio was established for Paccal Vet administered at 150 mg m(-2) intravenous (IV) for three or more treatment cycles. Preliminary efficacy was demonstrated by best objective response rate (86%), median time to response (14 days) and median progression-free survival (131 days). Paccal Vet was associated with expected adverse events (AE) (e.g. myelosuppression), however the majority were transient, clinically silent and manageable. This is the first clinical report of a water-soluble formulation of paclitaxel suggesting successful administration and being safely used without pre-medication in dogs.
已为犬癌症患者开发出水溶性紫杉醇（Paccal® Vet）的新配方，无需进行预治疗（在非水溶性紫杉醇配方中传统需要进行预治疗）。本研究的目的是确定 Paccal Vet 的临床安全有效剂量，并估计无进展生存期和总生存期，并评估荷瘤犬的单次剂量药代动力学。在 150 mg/m²静脉注射（IV）时，Paccal Vet 用于三个或更多治疗周期，具有阳性风险效益比。最佳客观缓解率（86%）、中位缓解时间（14 天）和中位无进展生存期（131 天）证明了初步疗效。Paccal Vet 与预期的不良反应（AE）相关（例如骨髓抑制），但大多数是短暂的、临床无症状的和可管理的。这是第一个关于紫杉醇水溶性配方的临床报告，表明其在犬中成功给药，并且无需预治疗即可安全使用。
