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Medline ® Abstract for Reference 30

of 'Adjuvant chemotherapy for HER2-negative breast cancer'

30
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Long-Term Follow-Up of the E1199 Phase III Trial Evaluating the Role of Taxane and Schedule in Operable Breast Cancer.
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Sparano JA, Zhao F, Martino S, Ligibel JA, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE
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J Clin Oncol. 2015 Jul;33(21):2353-60. Epub 2015 Jun 15.
 
PURPOSE: To determine long-term outcomes in a clinical trial evaluating the role of taxane type and schedule in operable breast cancer and evaluate the impact of obesity and black race on outcome.
PATIENTS AND METHODS: A total of 4,954 eligible women with stage II to III breast cancer treated with four cycles of doxorubicin plus cyclophosphamide were randomly assigned to receive paclitaxel or docetaxel every 3 weeks for four doses or weekly for 12 doses using a 2×2 factorial design. The primary end point was disease-free survival (DFS). Results are expressed as hazard ratios (HRs) from Cox proportional hazards models. All P values are two sided.
RESULTS: When compared with the standard every-3-week paclitaxel arm, after a median follow-up of 12.1 years, DFS significantly improved and overall survival (OS) marginally improved only for the weekly paclitaxel (HR, 0.84; P = .011 and HR, 0.87; P = .09, respectively) and every-3-week docetaxel arms (HR, 0.79; P = .001 and HR, 0.86; P = .054, respectively). Weekly paclitaxel improved DFS and OS (HR, 0.69; P = .010 and HR, 0.69; P = .019, respectively) in triple-negative breast cancer. For hormone receptor-positive, human epidermal growth factor receptor 2-nonoverexpressing disease, no experimental arm improved OS, and black race and obesity were associated with increased risk of breast cancer recurrence and death.
CONCLUSION: Improved outcomes initially observed for weekly paclitaxel were qualitatively similar but quantitatively less pronounced with longer follow-up, although exploratory analysis suggested substantial benefit in triple-negative disease. Further research is required to understand why obesity and race influence clinical outcome in hormone receptor-positive disease.
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Joseph A. Sparano, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY; Fengmin Zhao and Jennifer A. Ligibel, Dana-Farber Cancer Institute-Harvard University, Boston, MA; Silvana Martino, John Wayne Cancer Institute, Santa Monica, CA; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Tom Saphner, Vince Lombardi Cancer Center, Two Rivers, WI; Antonio C. Wolff, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD; George W. Sledge Jr, Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN; William C. Wood, Winship Cancer Center, Emory University, Atlanta, GA; and Nancy E. Davidson, University of Pittsburgh Cancer Institute and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA. jsparano@montefiore.org.
PMID