Prospective Randomized Trial of Docetaxel Versus Doxorubicin in Patients With Metastatic Breast Cancer

Reviewers: Li Liu, MD
Source: Journal of Clinical Oncology, Vol 17, Issue 8 (August), 1999: 2341-2354

Introduction

Docetaxel is an effective chemotherapeutic agent for advanced breast cancer, with significant activity as both first-line therapy (J Clin Oncol. 1996 Feb;14(2):422-8) and as second-line therapy in patients previously treated with anthracyclines (J Clin Oncol 1999 May;17(5):1413-24). In this randomized phase III study, the researchers compared docetaxel with doxorubicin in patients with metastatic breast cancer.

Materials and Methods

A total of 326 patients with metastatic breast cancer previously treated with alkylating agent chemotherapy were included. Of them, 161 were randomized to treatment with docetaxel of 75mg/m2 every 3 weeks and 165 patients to the doxorubicin 75 mg/m2 every 3 weeks for a maximum of 7 treatment cycles.

Results

• The overall response rate was significantly higher in the docetaxel group than in the doxorubicin group, 47.8% vs. 33.3% (p=0.008).
• Median time to progression was longer in the docetaxel group than in the doxorubicin group, 26 weeks vs. 21 week, but not significantly different.
• The median overall survival was similar in the two treatment groups.
• Treatment related deaths were higher in the doxorubicin group (3%) than in the docetaxel group (1.2%).
• The cumulative toxicities were comparable between the two groups, although the toxicity profiles were different between the two.

Discussion

In this study, docetaxel offered better overall response rate than doxorubicin in patients with metastatic breast cancer. Docetaxel also appears to have activity in breast cancer patients that exhibit resistance to paclitaxel (J Clin Oncol 1998 Oct;16(10):3362-8) and doxorubicin (J Clin Oncol 1999 May;17(5):1413-24). These results confirm prospectively the concept of potential non-cross-resistance between doxorubicin, paclitaxel, and docetaxel. Such studies will further establish the role of taxanes in the management of breast cancer.