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Exemestane Versus Tamoxifen
1. Results of the first planned analysis of the TEAM (tamoxifen exemestane adjuvant multinational) prospective randomized phase III trial in hormone sensitive postmenopausal early breast cancer 1 US Oncology Research, Houston, TX, USA; 2 Erasmus MC Daniel Den Hoed, Rotterdam, the Netherlands; 3 University Hospital Freiburg, Freiburg, Germany; 4 The University of Birmingham, Birmingham, United Kingdom; 5 Institut du Sein Henri Hartmann (ISHH), Neuilly sur Seine, France; 6 U. Z. Gasthuisberg, Leuven, Belgium; 7 Athens University Medical School, Greece; 8 Jichi Medical University, Shimotsuke, Japan; 9 Leiden University Medical Center, Leiden, The Netherlands; 10 Helios Medical Center Aue, Germany; 11 Pfizer, New York; USA; 12 Endocrine Cancer Group, Edinburgh University, Scotland S.E. Jones 1 , C. Seynaeve 2 , A. Hasenburg 3 , D. Rea 4 , JM. Vannetzel 5 , R. Paridaens 6 , C. Markopoulos 7 , Y. Hozumi 8 , H. Putter 9 , E. Hille 9 , D. Kieback 10 , L. Asmar 1 , J. Smeets 11 , R. Urbanski 11 , J.M.S. Bartlett 12 , C.J.H. van de Velde 9
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4. TEAM Trial: Revised Design 2004 Exemestane Tamoxifen Total of 5 years’ treatment Diagnosis and adequate primary therapy of early breast cancer N = 9775 accrued Postmenopausal receptor-positive women Exemestane IES Positive Results Co-primary end points DFS at 2.75 years DFS at 5 years R A N D O M I Z A T I O N
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8. RESULTS Of First Planned Analysis at 2.75 Years All Patients Censored at 2.75 Years 9600+ Patients Followed for 2.75 Years Results
9. The TEAM Trial: Accrual by Country Total number of patients = 9775 UK/Ireland: 1275 France: 1230 Greece: 207 NL/Belgium: 3167 Germany: 1480 USA: 2232 Japan: 184
10. TEAM Trial Flow Chart 9775 Patients Randomized 4874 Randomized to Tamoxifen 4901 Randomized to Exemestane 4898 Exemestane in Efficacy Analysis 4853 Exemestane For Safety Analysis 4868 Tamoxifen in Efficacy Analysis 4817 Tamoxifen For Safety Analysis 6 Withdrawn Consent 51 Treatment Not Started 143 Ineligible 188 Lost to FU<2.75y 1434 Treatment Stopped <2.75y 3 Withdrawn Consent 45 Treatment Not Started 130 Ineligible 139 Lost to FU<2.75y 926 Treatment Stopped <2.75y
11. Patient Demographics Characteristic Tamoxifen (n=4868) Exemestane (n=4898) Mean age (range) 64 (35-91) 65 (36-96) Histological grade, n (%) G1 (well) G2 (moderate) G3-G4 (poor) 834 (19) 2362 (53) 1232 (27) 843 (19) 2433 (54) 1206 (27) T Stage, n (%) T1 (≤2 cm) T2 (>2 cm and ≤5 cm) T3 (>5 cm) 2848 (59) 1763 (36) 174 (4) 2843 (58) 1828 (37) 161 (3) N Stage, n (%) N negative N positive Unknown 2555 (52) 2279 (47) 34 (1) 2558 (52) 2306 (47) 34 (1) ER and/or PgR positive, n (%) 4859 (100) 4887(100) Most extensive surgery, n (%) Mastectomy Wide local excision 2183 (45) 2680 (55) 2148 (44) 2744 (56) Adjuvant chemotherapy 1743 (36) 1774 (36) Radiotherapy 3314 (69) 3376 (70)
17. DFS Events (ITT) Event, n (%) Tamoxifen n=4868 Exemestane n=4898 Total N=9766 Total DFS events 388 (8.0) 352 (7.2) 740 (7.6) Local recurrence (includes ipsilateral breast cancer) 45 (0.9) 42 (0.9) 87 (0.9) Distant metastases 244 (5.0) 201 (4.1) 445 (4.6) New primary BC (no distant metastasis) 17 (0.3) 21 (0.4) 38 (0.4) Intercurrent deaths 82 (1.7) 88 (1.8) 170 (1.7)
18. Numbers at risk: Tamoxifen Exemestane 4898 36/4809 73/4708 53/4615 62/4473 128/4179 Cumulative Probability Probability Years since randomization 4868 33/4765 79/4636 69/4516 86/4364 121/4099 DFS Comparison at 2.75 Years (ITT) HR=0.89 (95% CI 0.77-1.03) Adjusted Log rank P = 0.12 0.00 0.02 0.04 0.06 0.08 0.10 0.0 0.5 1.0 1.5 2.0 2.5 Tamoxifen Exemestane Tamoxifen Exemestane
19. DFS: On-Study Drug and Pre-Switch — Excluding 96 Never Treated Patients Numbers at risk: Tamoxifen: 4817 28/4510 72/4207 63/3962 71/3664 87/2817 Exemestane: 4853 33/4552 64/4343 53/4210 47/4067 114/3779 Cumulative Probability HR 0.83 (95% CI 0.71-0.97, P =0.02) Probability 0.00 0.02 0.04 0.06 0.08 0.10 Years since randomization 0.0 0.5 1.0 1.5 2.0 2.5 Tamoxifen Exemestane
20. Relapse-Free Survival (ITT) Cumulative Probability HR=0.85 (0.72–1.00; P =0.05) Probability 0.00 0.02 0.04 0.06 0.08 0.10 Tamoxifen Exemestane Years since randomization 0.0 0.5 1.0 1.5 2.0 2.5 Numbers at risk: Tamoxifen: 4868 21/4765 62/4636 61/4516 65/4364 97/4099 Exemestane: 4898 25/4809 60/4708 40/4615 47/4473 92/4179
21. Cumulative Incidence of Distant Metastasis (ITT) Numbers at risk: Tamoxifen Exemestane 4868 26/4771 69/4652 53/4547 71/4406 110/4146 4898 29/4815 54/4733 47/4646 56/4510 112/4219 Time to Distant Metastases (ITT) HR=0.81 (0.67 - 0.98; P <0.03) Probability 0.00 0.02 0.04 0.06 0.08 0.10 Years since randomization 0.0 0.5 1.0 1.5 2.0 2.5 Tamoxifen Exemestane
22. TEAM Trial Flow Chart 29.5% 18.9% 9775 Patients Randomized 4874 Randomized to Tamoxifen 4901 Randomized to Exemestane 4898 Exemestane in Efficacy Analysis 4853 Exemestane For Safety Analysis 4868 Tamoxifen in Efficacy Analysis 4817 Tamoxifen For Safety Analysis 6 Withdrawn Consent 51 Treatment Not Started 143 Ineligible 188 Lost to FU<2.75y 1434 treatment stopped <2.75y 3 Withdrawn Consent 45 Treatment Not Started 130 Ineligible 139 Lost to FU<2.75y 926 treatment stopped <2.75y