Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer
Joseph A. Sparano, M.D., Molin Wang, Ph.D., Silvana Martino, D.O., Vicky Jones, M.D., Edith A. Perez, M.D., Tom Saphner, M.D., Antonio C. Wolff, M.D., George W. Sledge, Jr., M.D., William C. Wood, M.D., and Nancy E. Davidson, M.D.
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–positiveor high-risk, lymph node–negative breast cancer. Afterrandomization, all patients first received 4 cycles of intravenousdoxorubicin and cyclophosphamide at 3-week intervals and werethen assigned to intravenous paclitaxel or docetaxel given at3-week intervals for 4 cycles or at 1-week intervals for 12cycles. 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-freesurvival 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) (withan hazard ratio >1 favoring the groups receiving experimentaltherapy). As compared with standard therapy, weekly paclitaxelwas also associated with improved survival (hazard ratio, 1.32;P=0.01). An exploratory analysis of a subgroup of patients whosetumors expressed no human epidermal growth factor receptor type2 protein found similar improvements in disease-free and overallsurvival with weekly paclitaxel treatment, regardless of hormone-receptorexpression. Grade 2, 3, or 4 neuropathy was more frequent withweekly paclitaxel than with paclitaxel every 3 weeks (27% vs.20%).
Conclusions Weekly paclitaxel after standard adjuvant chemotherapywith doxorubicin and cyclophosphamide improves disease-freeand overall survival in women with breast cancer. (ClinicalTrials.govnumber, 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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A correction has been published: N Engl J Med 2009;360(16):1685.
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