Phase III trial of doxorubicin, paclitaxel and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193)

This randomized trial compared response and survival in metastatic breast cancer patients treated with either single-agent doxorubicin, paclitaxel, or the two combined at slightly lower doses, given as first-line CT. The response rate and time to treatment failure were identical in the doxorubicinand paclitaxel-treated patients. Although the response rate and time to treatment failure were superior in the combination arm, survival was similar in all three arms. Twenty percent and 14% of the patients who were crossed over to paclitaxel and doxorubicin, respectively, responded after having progressed with the first drug assigned. QOL appeared to be similar in all three arms, but hematologic toxicity and injections were higher in the combination arm.