Paclitaxel activity, dose, and schedule: data from phase III trials in metastatic breast cancer.

Results from phase III trials comparing paclitaxel with doxorubicin suggest that although it is an effective first-line treatment for patients with metastatic breast cancer, paclitaxel cannot be considered an alternative to doxorubicin. Phase III trials are ongoing to define the role of paclitaxel/anthracycline-containing regimens. In these trials, the combination of paclitaxel and anthracycline is compared with standard anthracycline-based combinations in advanced breast cancer patients receiving first-line treatments. Results are eagerly awaited for the year 2000. Data from randomized trials are available to define the best dose and schedule of paclitaxel for patients with metastatic breast cancer. From these trials it can be concluded that the dose of 175 mg/m2 is better tolerated and as effective as higher doses. With regard to the duration of paclitaxel infusion, although a trend to an amelioration of response rates may be observed with a prolonged infusion, a similar time to treatment failure and overall survival and a more complex support required for prolonged infusion discourage this practice; therefore, the 3-hour infusion should still be considered as the standard schedule.