Sparano, Joseph A.Zhao, FengminMartino, SilvanaLigibel, Jennifer A.Perez, Edith A.Saphner, TomWolff, Antonio C.Sledge, George W.Wood, William C.Davidson, Nancy E.2017-05-232017-05-232015-07-20Sparano, J. A., Zhao, F., Martino, S., Ligibel, J. A., Perez, E. A., Saphner, T., … Davidson, N. E. (2015). Long-Term Follow-Up of the E1199 Phase III Trial Evaluating the Role of Taxane and Schedule in Operable Breast Cancer. Journal of Clinical Oncology, 33(21), 2353–2360. http://doi.org/10.1200/JCO.2015.60.92711527-7755https://hdl.handle.net/1805/12680PURPOSE: 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.en-USPublisher PolicyAntineoplastic Combined Chemotherapy Protocolstherapeutic useBreast Neoplasmsdrug therapyPaclitaxeladministration & dosageTaxoidsArticle