Abstract
11505 Background: nab-paclitaxel is a novel solvent-free, 130-nM albumin-bound (nab™) formulation of paclitaxel. In previous studies, nab-paclitaxel demonstrated higher volume of distribution and clearance than that of paclitaxel formulated with Cremophor (Cr-PAC) in Caucasian patients (Sparreboom, Clin Cancer Res 2005;11:4136) and had greater response rate and favorable safety profile in pts with MBC (Gradishar et al., JCO, 2005;23:7794) . The aim of this study was to evaluate nab-paclitaxel blood pharmacokinetics (PK) and compare it with that of Cr-PAC in Chinese MBC patients.Methods: In this randomized controlled, open-label study, patients were assigned to either nab-paclitaxel 260 mg/m2 intravenously (iv) over 30 minutes q3w or Cr-PAC 175 mg/m2 iv over 3 hours q3w. At cycle 1, 12 patients in each treatment group participated in the PK study and then continued treatment until PD or unacceptable toxicity. Plasma samples from pts were analyzed for PK parameters. The primary clinical endpoints were ORR and toxicity (Guan et al; submitted, ASCO, 2007). Results: 24 female pts (median age 44.5 years) participated. No statistically significant between group differences were noted in age, height, weight, or baseline liver function. Paclitaxel blood PK parameters in 2 treatment groups are summarized in the Table. ORR: nab-paclitaxel, 75%; Cr-PAC, 25% (P = 0.018). The maximum grade (G) of neutropenia and neuropathy in the nab-paclitaxel and Cr-PAC groups were G3 and G2, respectively, with no significant between-group difference. Conclusion: nab-Paclitaxel had a greater distribution volume, clearance, and smaller dose adjusted AUC0-inf compared with that of Cr-PAC. There was no significant difference in T1/2 in the 2 groups. PK results in Chinese pts are identical to data reported in Caucasian pts. The lower CL and Vz for Cr-PAC are probably related to sequestration of paclitaxel in the blood by Cremophor. * dose adjusted AUC0-inf [Table: see text] [Table: see text]
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