Originally published as JCO Early Release 10.1200/JCO.2003.02.063 on February 7 2003

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Improved Outcomes From Adding Sequential Paclitaxel but Not From Escalating Doxorubicin Dose in an Adjuvant Chemotherapy Regimen for Patients With Node-Positive Primary Breast Cancer

I. Craig Henderson, Donald A. Berry, George D. Demetri, Constance T. Cirrincione, Lori J. Goldstein, Silvana Martino, James N. Ingle, M. Robert Cooper, Daniel F. Hayes, Katherine H. Tkaczuk, Gini Fleming, James F. Holland, David B. Duggan, John T. Carpenter, Emil Frei, III, Richard L. Schilsky, William C. Wood, Hyman B. Muss, Larry Norton

From the University of California at San Francisco, San, Francisco, CA; Cancer and Leukemia Group B (CALGB) Statistical Center, Durham; Wake Forest University School of Medicine, Winston-Salem, NC; University of Texas M.D. Anderson Cancer, Houston; Southwest Oncology Group Operations, San, Antonio, TX; Dana-Farber Cancer Institute, Boston, MA; Eastern Cooperative Oncology Group Operations, Philadelphia, PA; North Central Cancer Treatment Group Operations, Rochester, MN; Georgetown University Medical Center, Washington, DC; University of Michigan, Ann Arbor, MI; Greenbaum Cancer Center, Baltimore, MD; University of Chicago Medical Center; and CALGB Central Office, Chicago, IL; Mount Sinai School of Medicine; and Memorial Sloan-Kettering Cancer Center, New York; State University of New York Health Science Center at Syracuse, Syracuse, NY; University of Alabama at Birmingham, Birmingham, AL; and University of Vermont, Burlington, VT.

Address reprint requests to I. Craig Henderson, MD, University of California at San Francisco, 1600 Divisadero St, Box 1710, San Francisco, CA 94143; email: craig.henderson{at}accessoncology.com.

Purpose: This study was designed to determine whether increasing the dose of doxorubicin in or adding paclitaxel to a standard adjuvant chemotherapy regimen for breast cancer patients would prolong time to recurrence and survival.

Patients and Methods: After surgical treatment, 3,121 women with operable breast cancer and involved lymph nodes were randomly assigned to receive a combination of cyclophosphamide (C), 600 mg/m², with one of three doses of doxorubicin (A), 60, 75, or 90 mg/m², for four cycles followed by either no further therapy or four cycles of paclitaxel at 175 mg/m². Tamoxifen was given to 94% of patients with hormone receptor–positive tumors.

Results: There was no evidence of a doxorubicin dose effect. At 5 years, disease-free survival was 69%, 66%, and 67% for patients randomly assigned to 60, 75, and 90 mg/m², respectively. The hazard reductions from adding paclitaxel to CA were 17% for recurrence (adjusted Wald ² P = .0023; unadjusted Wilcoxon P = .0011) and 18% for death (adjusted P = .0064; unadjusted P = .0098). At 5 years, the disease-free survival (± SE) was 65% (± 1) and 70% (± 1), and overall survival was 77% (± 1) and 80% (± 1) after CA alone or CA plus paclitaxel, respectively. The effects of adding paclitaxel were not significantly different in subsets defined by the protocol, but in an unplanned subset analysis, the hazard ratio of CA plus paclitaxel versus CA alone was 0.72 (95% confidence interval, 0.59 to 0.86) for those with estrogen receptor–negative tumors and only 0.91 (95% confidence interval, 0.78 to 1.07) for patients with estrogen receptor–positive tumors, almost all of whom received adjuvant tamoxifen. The additional toxicity from adding four cycles of paclitaxel was generally modest.

Conclusion: The addition of four cycles of paclitaxel after the completion of a standard course of CA improves the disease-free and overall survival of patients with early breast cancer.

Supported in part by grant no. CA31946 from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD, to the CALGB (R.L.S.).

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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