Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast Cancer

<jats:sec><jats:title>Purpose</jats:title><jats:p> This randomized, controlled, multicenter, open-label, phase III study compared docetaxel versus paclitaxel in patients with advanced breast cancer that had progressed after an anthracycline-containing chemotherapy regimen. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients (n = 449) were randomly assigned to receive either docetaxel 100 mg/m<jats:sup>2</jats:sup> (n = 225) or paclitaxel 175 mg/m<jats:sup>2</jats:sup> (n = 224) on day 1, every 21 days until tumor progression, unacceptable toxicity, or withdrawal of consent. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In the intent-to-treat population, both the median overall survival (OS, 15.4 v 12.7 months; hazard ratio [HR], 1.41; 95% CI, 1.15 to 1.73; P = .03) and the median time to progression (TTP, 5.7 months v 3.6 months; HR, 1.64; 95% CI, 1.33 to 2.02; P < .0001) for docetaxel were significantly longer than for paclitaxel, and the overall response rate (ORR, 32% v 25%; P = .10) was higher for docetaxel. These results were confirmed by multivariate analyses. The incidence of treatment-related hematologic and nonhematologic toxicities was greater for docetaxel than for paclitaxel; however, quality-of-life scores were not statistically different between treatment groups over time. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Docetaxel was superior to paclitaxel in terms of OS and TTP. ORR was higher for docetaxel. Hematologic and nonhematologic toxicities occurred more frequently in the docetaxel group. The global quality-of-life scores were similar for both agents over time. </jats:p></jats:sec>