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A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer.

Author(s): Yardley DA, Burris HA 3rd, Spigel DR, Clark BL, Vazquez E, Shipley D, Barton J, Thompson D, Montes I, Greco FA, Hainsworth JD

Affiliation(s): Sarah Cannon Research Institute, Nashville, TN 37203, USA.

Publication date & source: 2009-11, Clin Breast Cancer., 9(4):247-52.

Publication type: Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

PURPOSE: We aim to compare the efficacy and toxicity of liposomal doxorubicin and weekly docetaxel as first-line treatments for patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients who had received no previous chemotherapy for MBC were eligible. Previous hormonal therapy, adjuvant chemotherapy, and radiation therapy were allowed. Patients were randomized to receive liposomal doxorubicin 40 mg/m(2) intravenously [I.V.] every 28 days or weekly docetaxel 36 mg/m(2) I.V. days 1, 8, and 15, repeated every 28 days. Patients with objective response or stable disease after 2 cycles continued treatment until tumor progression or unacceptable toxicity. At progression, patients were allowed to cross over to the other regimen. The trial was designed to detect a true difference of 10% in response rate with an 80% power. RESULTS: Between March 2001 and July 2007, 102 patients were randomized. The 2 groups had similar demographics; 68% of patients had received previous adjuvant chemotherapy. Liposomal doxorubicin and weekly docetaxel produced similar objective response rates (28% vs. 31%), disease control rates (48% vs. 44%), and progression-free survival (6.5 months vs. 5.5 months). Both agents were well tolerated. Both agents produced crossover responses as second-line treatment (liposomal doxorubicin, 35%; weekly docetaxel, 14%). CONCLUSION: Liposomal doxorubicin is well tolerated and has activity similar to weekly docetaxel in the first-line treatment of patients with MBC.

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