Phase I II T rial o f D oxorubicin, P aclitaxel, a nd t he Combination o f D oxorubicin a nd P aclitaxel a s F ront-Line Chemotherapy f or M etastatic B reast C ancer: An I ntergroup T rial ( E1193)

m 2 ), paclitaxel (175 mg/m 2 /24 h), and the combination of doxorubicin and paclitaxel (AT, 50 mg/m 2 and 150 mg/ m 2 /24 h, plus granulocyte colony-stimulating factor 5 mg/ kg) as first-line therapy. Patients receiving single-agent doxorubicin or paclitaxel were crossed over to the other agent at time of progression. Patients and Methods: Patients were well balanced for on-study characteristics. Results: Responses (complete response and partial response) were seen in 36% of doxorubicin, 34% of paclitaxel, and 47% of AT patients (P .84 for doxorubicin v paclitaxel, P .007 for v AT, P .004 for paclitaxel v AT). Median time to treatment failure (TTF) is 5.8, 6.0, and 8.0 months for doxorubicin, paclitaxel, and AT, respectively (P .68 for doxorubicin v paclitaxel, P .003 for doxorubicin v AT, P .009 for paclitaxel v AT). Median survivals are 18.9 months for patients taking doxorubicin, 22.2 months for patients taking paclitaxel, and 22.0 months for patients taking AT (P not significant). Responses were seen in 20% of patients crossing from doxorubicin3 paclitaxel and 22% of patients crossing from paclitaxel3 doxorubicin (P not significant). Changes in global quality-of-life measurements from on-study to week 16 were similar in all three groups. Conclusion: (1) doxorubicin and paclitaxel, in the doses used here, have equivalent activity; (2) the combination of AT results in superior overall response rates and time to TTF; and (3) despite these results, combination therapy with AT did not improve either survival or quality of life compared to sequential single-agent therapy. J Clin Oncol 21:588-592. © 2003 by American Society of Clinical Oncology.