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Previous Volume 358:1663-1671 April 17, 2008 Number 16 Next

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ABSTRACT

Background We compared the efficacy of two different taxanes, docetaxel and paclitaxel, given either weekly or every 3 weeks, in the adjuvant treatment of breast cancer.

Methods We enrolled 4950 women with axillary lymph node–positive or high-risk, lymph node–negative breast cancer. After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival.

Results As compared with patients receiving standard therapy (paclitaxel every 3 weeks), the hazard ratio for disease-free survival was 1.27 among those receiving weekly paclitaxel (P=0.006), 1.23 among those receiving docetaxel every 3 weeks (P=0.02), and 1.09 among those receiving weekly docetaxel (P=0.29) (with an hazard ratio >1 favoring the groups receiving experimental therapy). As compared with standard therapy, weekly paclitaxel was also associated with improved survival (hazard ratio, 1.32; P=0.01). An exploratory analysis of a subgroup of patients whose tumors expressed no human epidermal growth factor receptor type 2 protein found similar improvements in disease-free and overall survival with weekly paclitaxel treatment, regardless of hormone-receptor expression. Grade 2, 3, or 4 neuropathy was more frequent with weekly paclitaxel than with paclitaxel every 3 weeks (27% vs. 20%).

Conclusions Weekly paclitaxel after standard adjuvant chemotherapy with doxorubicin and cyclophosphamide improves disease-free and overall survival in women with breast cancer. (ClinicalTrials.gov number, NCT00004125 [ClinicalTrials.gov] .)

Source Information

From the Eastern Cooperative Oncology Group, Philadelphia (J.A.S., M.W., T.S., A.C.W., G.W.S., W.C.W., N.E.D.); the Southwest Oncology Group, Ann Arbor, MI (S.M.); the Cancer and Leukemia Group B, Chicago (V.J.); and the North Central Cancer Treatment Group, Rochester, MN (E.A.P.).

Address reprint requests to Dr. Sparano at Montefiore Medical Center–Weiler Division, 1825 Eastchester Rd., 2 South, Rm. 47, Bronx, NY 10461, or at jsparano{at}montefiore.org.

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