Volume 374, Issue 9707, Pages (December 2009)

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Volume 374, Issue 9707, Pages 2055-2063 (December 2009) Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomised controlled trial Prof Kathy S Albain, MD, Prof William E Barlow, PhD, Prof Peter M Ravdin, MD, Prof William B Farrar, MD, Prof Gary V Burton, MD, Steven J Ketchel, MD, Charles D Cobau, MD, Ellis G Levine, MD, Prof James N Ingle, MD, Prof Kathleen I Pritchard, MD, Prof Allen S Lichter, MD, Daniel J Schneider, MD, Prof Martin D Abeloff, MD, Prof I Craig Henderson, MD, Prof Hyman B Muss, MD, Prof Stephanie J Green, PhD, Danika Lew, MA, Prof Robert B Livingston, MD, Silvana Martino, DO, Prof C Kent Osborne, MD The Lancet Volume 374, Issue 9707, Pages 2055-2063 (December 2009) DOI: 10.1016/S0140-6736(09)61523-3 Copyright © 2009 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile CAF-T=cyclophosphamide, doxorubicin, and fluorouracil (CAF) followed by tamoxifen. CAFT=CAF plus concurrent tamoxifen. ITT=intention-to-treat. The Lancet 2009 374, 2055-2063DOI: (10.1016/S0140-6736(09)61523-3) Copyright © 2009 Elsevier Ltd Terms and Conditions

Figure 2 Disease-free survival and overall survival distributions and 10-year estimates for major objectives Kaplan-Meier distributions for the intention-to-treat population. (A) Disease-free survival for the combined CAF plus tamoxifen groups (CAF-T plus CAFT) versus tamoxifen alone, log-rank p=0·002, stratified by number of positive nodes, hormone-receptor status, and time from definitive surgery. (B) Overall survival for the combined CAF plus tamoxifen groups versus tamoxifen alone, stratified log-rank p=0·043. (C) Disease-free survival for CAFT versus CAF-T, stratified log-rank p=0·055. (D) Overall survival for CAFT versus CAF-T, stratified log-rank p=0·27. CAF=cyclophosphamide, doxorubicin, and fluorouracil. CAF-T=CAF followed by tamoxifen. CAFT=CAF with concurrent tamoxifen. The Lancet 2009 374, 2055-2063DOI: (10.1016/S0140-6736(09)61523-3) Copyright © 2009 Elsevier Ltd Terms and Conditions

Figure 3 Hazard ratios and 95% CIs for disease-free survival, by subgroup The forest plot shows the disease-free survival advantage for chemotherapy by possible subgroups unadjusted for other covariates. The dashed vertical line represents the overall unadjusted hazard ratio in each plot. PgR=progesterone. The Lancet 2009 374, 2055-2063DOI: (10.1016/S0140-6736(09)61523-3) Copyright © 2009 Elsevier Ltd Terms and Conditions

Figure 4 Disease-free survival and overall survival by randomised treatment group Kaplan-Meier distributions for the intention-to-treat population. (A) Disease-free survival advantage for CAF-T, log-rank p=0·002, stratified by number of positive nodes, hormone-receptor status, and time of surgery. (B) Superior overall survival in the CAF-T group, stratified log-rank p=0·074. 10-year survival estimates and hazard ratios adjusted for prognostic covariates with 95% CIs are also shown. CAF-T=cyclophosphamide, doxorubicin, and fluorouracil (CAF) followed by tamoxifen. CAFT=CAF plus concurrent tamoxifen. The Lancet 2009 374, 2055-2063DOI: (10.1016/S0140-6736(09)61523-3) Copyright © 2009 Elsevier Ltd Terms and Conditions