Abstract
1038 Background: The results of a large clinical study comparing solvent-based paclitaxel 175 mg/m2 with 130-nM albumin-bound paclitaxel (nab-paclitaxel) 260 mg/m2 demonstrated that nab-paclitaxel had greater efficacy and a favorable safety profile in pts with MBC (Gradishar et al., JCO, 2005; 23:7794). The maximum tolerated dose of nab-paclitaxel was 300 mg/m2 infused over 30 minutes without premedication in Chinese pts with solid tumors (Teng et al., Ai Zheng, 2004;23:1431). The aim of this randomized study is to compare the response rates and to evaluate the safety of nab-paclitaxel with those of solvent-based paclitaxel in Chinese pts with MBC. Methods: In this open-label, multicenter study, 210 pts with MBC were assigned to either solvent-based paclitaxel 175 mg/m2 intravenously (IV) over 3 hours every 3 weeks (q3w) with standard premedication (steroids and antihistamines) or nab-paclitaxel 260 mg/m2 IV over 30 minutes q3w with no premedication for 1–6 cycles. The primary endpoints were the overall response rate (ORR, complete or partial response) and toxicity. Stable disease (SD) at =16 weeks was measured. All pts who received at least 1 dose of study drug were evaluable for study endpoints. Results: 210 pts (median age, 50 years; 70% postmenopausal) were enrolled from 29 June 2005 - 1 August 2006. Efficacy results are summarized in the Table . The common toxicities occurring at =20% were alopecia (78%), peripheral neuropathy (75%, 7% gr 3), neutropenia (65%), leucopenia (60%), myalgia (39%), arthralgia (23%), and nausea (21%) and were similar between groups (P = NS). Gr 3/4 neutropenia, measured on days 1 and 8, were similar between groups (p = 0.202). Conclusions: Compared to solvent- based paclitaxel, treatment with nab-paclitaxel was associated with a higher response rate and longer time to progression without increased toxicity. These comparative data in Chinese pts are almost identical to results previously reported in Caucasian pts (Gradishar et al, JCO, 2005). [Table: see text] [Table: see text]
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