SlideShare une entreprise Scribd logo
1  sur  42
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
[object Object],Exemestane 25 mgs daily Tamoxifen 20 mgs daily N = 5,800 + Total of 5 years treatment DFS at 5 years Primary end point: Diagnosis and adequate prior therapy of early breast cancer Original Study Design (2001) R A N D O M I Z A T I O N
Why the TEAM Study Design  Was Amended ,[object Object],[object Object],[object Object],[object Object],[object Object],*Coombes RC, et al.  N Eng J Med.  2004;350:1081-92.  For scientific and ethical reasons, the Global Steering Committee decided to amend the TEAM protocol to evaluate sequential therapy with 2.5 to 3 years of tamoxifen followed by exemestane for a total of 5 yrs compared with upfront exemestane for 5 yrs
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
TEAM Study Overview ,[object Object],[object Object],[object Object],[object Object],[object Object]
TEAM : Key Eligibility Criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Efficacy Endpoints & Analyses ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
RESULTS Of First Planned Analysis at 2.75 Years All Patients Censored at 2.75 Years 9600+ Patients Followed for 2.75 Years Results
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
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
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)
RESULTS MedDRA Coding Adverse Events Gynecologic, Cardiovascular, Musculoskeletal categories
Selected Gynecologic Events Exemestane Tamoxifen P  value Vaginal discharge 112 2.3% 333 6.8% < 0.0001 Vaginal haemorrhage 78 1.6% 153 3.1% < 0.0001 Vaginal infection 34 0.7% 108 2.2% < 0.0001 Uterine polyp 4 0.1% 25 0.5% < 0.0001 Endometrial hyperplasia 3 0.0% 96 2.0% < 0.0001 Endometrial cancer 7 0.1% 12 0.2% NS
Selected Cardiac/Vascular Events Exemestane (4853) Tamoxifen (4817) P  value Cardiac disorders - Myocardial ischemia/infarction 41 0.8% 31 0.6% NS - Cardiac deaths 18 0.4% 11 0.2% NS Vascular disorders - Hot flush/flushing 1384 28.5% 1606 33.3% < 0.001 - Hypertension 163 3.3% 104 2.1% < 0.001 - Thromboembolic events 44 0.9% 113 2.3% < 0.001
  Selected Musculoskeletal Events Exemestane (4853) Tamoxifen (4817) P  value Arthralgia 875 17.9% 447 9.2% < 0.001 Arthritis 147 3.0% 83 1.7% < 0.001 Reported osteoporosis 228 4.7% 104 2.1% < 0.001 Reported fractures 133 2.7% 111 2.3% NS
Results Outcomes
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)
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
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
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
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
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
Conclusions (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Conclusions (2) ,[object Object],[object Object],[object Object],[object Object]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Acknowledgments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Contenu connexe

Tendances

Prostate cancer nemrock 2015 sanofi
Prostate cancer nemrock 2015   sanofiProstate cancer nemrock 2015   sanofi
Prostate cancer nemrock 2015 sanofi
Mohamed Abdulla
 
ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...
ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...
ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...
European School of Oncology
 
MCO 2011 - Slide 26 - C. Faivre-Finn - Radiotherapy
MCO 2011 - Slide 26 - C. Faivre-Finn - RadiotherapyMCO 2011 - Slide 26 - C. Faivre-Finn - Radiotherapy
MCO 2011 - Slide 26 - C. Faivre-Finn - Radiotherapy
European School of Oncology
 

Tendances (19)

Prostate cancer nemrock 2015 sanofi
Prostate cancer nemrock 2015   sanofiProstate cancer nemrock 2015   sanofi
Prostate cancer nemrock 2015 sanofi
 
Intervencionismo en Cardiopatía Isquémica
Intervencionismo en Cardiopatía IsquémicaIntervencionismo en Cardiopatía Isquémica
Intervencionismo en Cardiopatía Isquémica
 
Prostate cancer
Prostate cancer   Prostate cancer
Prostate cancer
 
ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...
ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...
ABC1 - I.E. Krop, US - New and future therapies for HER-2+ advanced breast ca...
 
2 predicting response to adt msk.eso 4.3.2011
2 predicting response to adt msk.eso 4.3.20112 predicting response to adt msk.eso 4.3.2011
2 predicting response to adt msk.eso 4.3.2011
 
MCO 2011 - Slide 26 - C. Faivre-Finn - Radiotherapy
MCO 2011 - Slide 26 - C. Faivre-Finn - RadiotherapyMCO 2011 - Slide 26 - C. Faivre-Finn - Radiotherapy
MCO 2011 - Slide 26 - C. Faivre-Finn - Radiotherapy
 
What is New for the Prostate Cancer Patient with Non-Metastatic Castration Re...
What is New for the Prostate Cancer Patient with Non-Metastatic Castration Re...What is New for the Prostate Cancer Patient with Non-Metastatic Castration Re...
What is New for the Prostate Cancer Patient with Non-Metastatic Castration Re...
 
Palumbo auto hsct in multiple myeloma n engl j med 2014
Palumbo auto hsct in multiple myeloma n engl j med 2014Palumbo auto hsct in multiple myeloma n engl j med 2014
Palumbo auto hsct in multiple myeloma n engl j med 2014
 
Tpbc
TpbcTpbc
Tpbc
 
NET - Kennecke
NET - KenneckeNET - Kennecke
NET - Kennecke
 
Protec t trial- Journal club
Protec t trial- Journal clubProtec t trial- Journal club
Protec t trial- Journal club
 
2015 ASCO Genitourinary Cancers Update
2015 ASCO Genitourinary Cancers Update2015 ASCO Genitourinary Cancers Update
2015 ASCO Genitourinary Cancers Update
 
10 Antiangiogenicos en Cáncer de Pulmón
10 Antiangiogenicos en Cáncer de Pulmón10 Antiangiogenicos en Cáncer de Pulmón
10 Antiangiogenicos en Cáncer de Pulmón
 
Surgery vs IMRT for High Risk Prostate Cancer Debate - ACRO 2015
Surgery vs IMRT for High Risk Prostate Cancer Debate - ACRO 2015Surgery vs IMRT for High Risk Prostate Cancer Debate - ACRO 2015
Surgery vs IMRT for High Risk Prostate Cancer Debate - ACRO 2015
 
11 Terapias dirigidas Cáncer de Pulmón
11 Terapias dirigidas Cáncer de Pulmón11 Terapias dirigidas Cáncer de Pulmón
11 Terapias dirigidas Cáncer de Pulmón
 
Sequencing therapy for crcp a practical approach
Sequencing therapy for crcp  a practical approachSequencing therapy for crcp  a practical approach
Sequencing therapy for crcp a practical approach
 
12 Quimioterapia, 1ª - 2ª línea y mantenimiento. Cáncer de Pulmón
12 Quimioterapia, 1ª - 2ª línea y mantenimiento. Cáncer de Pulmón12 Quimioterapia, 1ª - 2ª línea y mantenimiento. Cáncer de Pulmón
12 Quimioterapia, 1ª - 2ª línea y mantenimiento. Cáncer de Pulmón
 
Management of crpc
Management of crpcManagement of crpc
Management of crpc
 
Pertuzumab for HER2 Positive Metastatic Breast Cancer
Pertuzumab for HER2 Positive Metastatic Breast CancerPertuzumab for HER2 Positive Metastatic Breast Cancer
Pertuzumab for HER2 Positive Metastatic Breast Cancer
 

En vedette (20)

Tomotherapy Based Image Guided Imrt
Tomotherapy Based Image  Guided ImrtTomotherapy Based Image  Guided Imrt
Tomotherapy Based Image Guided Imrt
 
Very Nice Photos
Very Nice PhotosVery Nice Photos
Very Nice Photos
 
Frankfurt auto
Frankfurt autoFrankfurt auto
Frankfurt auto
 
Exceptional Photographs
Exceptional PhotographsExceptional Photographs
Exceptional Photographs
 
Assessment Of Recurrent Brain Tumor
Assessment Of  Recurrent  Brain  TumorAssessment Of  Recurrent  Brain  Tumor
Assessment Of Recurrent Brain Tumor
 
The center of the bible
The center of the bibleThe center of the bible
The center of the bible
 
Bladder Cancer Post Aua 2008
Bladder Cancer Post Aua 2008Bladder Cancer Post Aua 2008
Bladder Cancer Post Aua 2008
 
Photoshop
PhotoshopPhotoshop
Photoshop
 
A Woman Needs 4 Animals
A Woman Needs 4 AnimalsA Woman Needs 4 Animals
A Woman Needs 4 Animals
 
Women Or Cars
Women Or CarsWomen Or Cars
Women Or Cars
 
Satellite
SatelliteSatellite
Satellite
 
Incredible Photos
Incredible PhotosIncredible Photos
Incredible Photos
 
funny Sports
funny Sportsfunny Sports
funny Sports
 
Climate Changes
Climate ChangesClimate Changes
Climate Changes
 
Women V Men
Women V MenWomen V Men
Women V Men
 
If Dads Took Care Of Babies!!!
If Dads Took Care Of Babies!!!If Dads Took Care Of Babies!!!
If Dads Took Care Of Babies!!!
 
Funny comics
Funny comicsFunny comics
Funny comics
 
Photos Dw
Photos DwPhotos Dw
Photos Dw
 
Afghanistan Images
Afghanistan ImagesAfghanistan Images
Afghanistan Images
 
Funny Cartoons
Funny CartoonsFunny Cartoons
Funny Cartoons
 

Similaire à Exemestane Versus Tamoxifen

ABC1 - B. Kaufman - Endocrine resistance mechanisms and solutions
ABC1 - B. Kaufman - Endocrine resistance mechanisms and solutionsABC1 - B. Kaufman - Endocrine resistance mechanisms and solutions
ABC1 - B. Kaufman - Endocrine resistance mechanisms and solutions
European School of Oncology
 
Selective Use Of Postoperative Radiotherapy AftEr MastectOmy
Selective Use Of Postoperative Radiotherapy AftEr MastectOmySelective Use Of Postoperative Radiotherapy AftEr MastectOmy
Selective Use Of Postoperative Radiotherapy AftEr MastectOmy
fondas vakalis
 
Estudio Paramount cáncer de pulmón 2014
Estudio Paramount cáncer de pulmón 2014Estudio Paramount cáncer de pulmón 2014
Estudio Paramount cáncer de pulmón 2014
Martín Lázaro
 
BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...
BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...
BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...
European School of Oncology
 
Multivariable model development and internal validation for prostate cancer s...
Multivariable model development and internal validation for prostate cancer s...Multivariable model development and internal validation for prostate cancer s...
Multivariable model development and internal validation for prostate cancer s...
Max Peters
 
Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...
Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...
Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...
European School of Oncology
 
BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...
BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...
BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...
European School of Oncology
 
Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...
Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...
Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...
European School of Oncology
 

Similaire à Exemestane Versus Tamoxifen (20)

ABC1 - B. Kaufman - Endocrine resistance mechanisms and solutions
ABC1 - B. Kaufman - Endocrine resistance mechanisms and solutionsABC1 - B. Kaufman - Endocrine resistance mechanisms and solutions
ABC1 - B. Kaufman - Endocrine resistance mechanisms and solutions
 
CCO_HER2_Breast_Cancer_Updates_Downloadable_1.pptx
CCO_HER2_Breast_Cancer_Updates_Downloadable_1.pptxCCO_HER2_Breast_Cancer_Updates_Downloadable_1.pptx
CCO_HER2_Breast_Cancer_Updates_Downloadable_1.pptx
 
C:\Documents And Settings\User\Desktop\Head And Neck
C:\Documents And Settings\User\Desktop\Head And NeckC:\Documents And Settings\User\Desktop\Head And Neck
C:\Documents And Settings\User\Desktop\Head And Neck
 
Radiologieinterventionnellechctdebaere
RadiologieinterventionnellechctdebaereRadiologieinterventionnellechctdebaere
Radiologieinterventionnellechctdebaere
 
Selective Use Of Postoperative Radiotherapy AftEr MastectOmy
Selective Use Of Postoperative Radiotherapy AftEr MastectOmySelective Use Of Postoperative Radiotherapy AftEr MastectOmy
Selective Use Of Postoperative Radiotherapy AftEr MastectOmy
 
Rectal cancer Preoperative Radiotherapy- Short vs long course
Rectal cancer Preoperative Radiotherapy- Short vs long courseRectal cancer Preoperative Radiotherapy- Short vs long course
Rectal cancer Preoperative Radiotherapy- Short vs long course
 
Estudio Paramount cáncer de pulmón 2014
Estudio Paramount cáncer de pulmón 2014Estudio Paramount cáncer de pulmón 2014
Estudio Paramount cáncer de pulmón 2014
 
What’s New With HER2?
What’s New With HER2?What’s New With HER2?
What’s New With HER2?
 
BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...
BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...
BALKAN MCO 2011 - T. Cufer - Hormonal therapy options/management in metastati...
 
Tamoxifen And CYP2D6: Using Pharmacogenetics to discover a new drug
Tamoxifen And CYP2D6:  Using Pharmacogenetics to discover a new drugTamoxifen And CYP2D6:  Using Pharmacogenetics to discover a new drug
Tamoxifen And CYP2D6: Using Pharmacogenetics to discover a new drug
 
Multivariable model development and internal validation for prostate cancer s...
Multivariable model development and internal validation for prostate cancer s...Multivariable model development and internal validation for prostate cancer s...
Multivariable model development and internal validation for prostate cancer s...
 
Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...
Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...
Gene Profiling in Clinical Oncology - Slide 2 - T. Le Chevalier - Treatment o...
 
ASTRO 07 PROS IGRT
ASTRO 07 PROS IGRTASTRO 07 PROS IGRT
ASTRO 07 PROS IGRT
 
Treatment paradigms in the management of mbc bgicc 2014
Treatment paradigms in the management of mbc bgicc 2014 Treatment paradigms in the management of mbc bgicc 2014
Treatment paradigms in the management of mbc bgicc 2014
 
2.1 adj cht cufer
2.1 adj cht cufer2.1 adj cht cufer
2.1 adj cht cufer
 
BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...
BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...
BALKAN MCO 2011 - T. Cufer - Chemotherapy: when, why, prognostic factors, reg...
 
Update from CROI 2018: Focus on TB and Other Opportunistic Infections
Update from CROI 2018: Focus on TB and Other Opportunistic InfectionsUpdate from CROI 2018: Focus on TB and Other Opportunistic Infections
Update from CROI 2018: Focus on TB and Other Opportunistic Infections
 
Esmo io symposium 111915 v11_bgb_onsite_rcc
Esmo io symposium 111915 v11_bgb_onsite_rccEsmo io symposium 111915 v11_bgb_onsite_rcc
Esmo io symposium 111915 v11_bgb_onsite_rcc
 
Targeted therapy in mNSCLC
Targeted therapy in mNSCLCTargeted therapy in mNSCLC
Targeted therapy in mNSCLC
 
Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...
Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...
Gene Profiling in Clinical Oncology - Slide 10 - H. Rugo - Why genomic tools ...
 

Plus de fondas vakalis

radiotherapy-pancreatic cancer
radiotherapy-pancreatic cancerradiotherapy-pancreatic cancer
radiotherapy-pancreatic cancer
fondas vakalis
 
radiotherapy of bone metastases,Vakalis
radiotherapy of bone metastases,Vakalisradiotherapy of bone metastases,Vakalis
radiotherapy of bone metastases,Vakalis
fondas vakalis
 
sbrt for inoperable lung cancer
sbrt for inoperable lung cancersbrt for inoperable lung cancer
sbrt for inoperable lung cancer
fondas vakalis
 
Spinal cord compression bhf aos study day mar 2014 final
Spinal cord compression bhf  aos study day mar 2014 finalSpinal cord compression bhf  aos study day mar 2014 final
Spinal cord compression bhf aos study day mar 2014 final
fondas vakalis
 
Vakalis breast radiotherapy
Vakalis breast radiotherapyVakalis breast radiotherapy
Vakalis breast radiotherapy
fondas vakalis
 
Vakalis - RT for prostate cancer
Vakalis  - RT for prostate cancerVakalis  - RT for prostate cancer
Vakalis - RT for prostate cancer
fondas vakalis
 
Her2 positive metastatic breast ca
Her2 positive metastatic breast caHer2 positive metastatic breast ca
Her2 positive metastatic breast ca
fondas vakalis
 
Advanced breast cancer
Advanced breast cancerAdvanced breast cancer
Advanced breast cancer
fondas vakalis
 
Second line therapy for nsclc
Second line therapy for nsclcSecond line therapy for nsclc
Second line therapy for nsclc
fondas vakalis
 
HER2 negative metastatic breast ca
HER2 negative metastatic breast caHER2 negative metastatic breast ca
HER2 negative metastatic breast ca
fondas vakalis
 
Radiobiology behind dose fractionation
Radiobiology behind dose fractionationRadiobiology behind dose fractionation
Radiobiology behind dose fractionation
fondas vakalis
 
2012-michael joiner-hypofractionation
2012-michael joiner-hypofractionation2012-michael joiner-hypofractionation
2012-michael joiner-hypofractionation
fondas vakalis
 
RECTAL CA - VAKALIS . X
RECTAL CA - VAKALIS . XRECTAL CA - VAKALIS . X
RECTAL CA - VAKALIS . X
fondas vakalis
 
Vakalis - gastric ca radiotherapy
Vakalis - gastric ca radiotherapyVakalis - gastric ca radiotherapy
Vakalis - gastric ca radiotherapy
fondas vakalis
 

Plus de fondas vakalis (20)

Esophageal squamous Cancer-therapy-Vakalis
Esophageal squamous Cancer-therapy-VakalisEsophageal squamous Cancer-therapy-Vakalis
Esophageal squamous Cancer-therapy-Vakalis
 
radiotherapy-pancreatic cancer
radiotherapy-pancreatic cancerradiotherapy-pancreatic cancer
radiotherapy-pancreatic cancer
 
radiotherapy of bone metastases,Vakalis
radiotherapy of bone metastases,Vakalisradiotherapy of bone metastases,Vakalis
radiotherapy of bone metastases,Vakalis
 
sbrt for inoperable lung cancer
sbrt for inoperable lung cancersbrt for inoperable lung cancer
sbrt for inoperable lung cancer
 
Spinal cord compression bhf aos study day mar 2014 final
Spinal cord compression bhf  aos study day mar 2014 finalSpinal cord compression bhf  aos study day mar 2014 final
Spinal cord compression bhf aos study day mar 2014 final
 
Vakalis breast radiotherapy
Vakalis breast radiotherapyVakalis breast radiotherapy
Vakalis breast radiotherapy
 
Vakalis - RT for prostate cancer
Vakalis  - RT for prostate cancerVakalis  - RT for prostate cancer
Vakalis - RT for prostate cancer
 
Her2 positive metastatic breast ca
Her2 positive metastatic breast caHer2 positive metastatic breast ca
Her2 positive metastatic breast ca
 
nonsquamous NSCLC
nonsquamous NSCLCnonsquamous NSCLC
nonsquamous NSCLC
 
Advanced breast cancer
Advanced breast cancerAdvanced breast cancer
Advanced breast cancer
 
Second line therapy for nsclc
Second line therapy for nsclcSecond line therapy for nsclc
Second line therapy for nsclc
 
Vegf in colorectal ca
Vegf in colorectal caVegf in colorectal ca
Vegf in colorectal ca
 
HER2 negative metastatic breast ca
HER2 negative metastatic breast caHER2 negative metastatic breast ca
HER2 negative metastatic breast ca
 
817731 slides
817731 slides817731 slides
817731 slides
 
Radiobiology behind dose fractionation
Radiobiology behind dose fractionationRadiobiology behind dose fractionation
Radiobiology behind dose fractionation
 
2012-michael joiner-hypofractionation
2012-michael joiner-hypofractionation2012-michael joiner-hypofractionation
2012-michael joiner-hypofractionation
 
RECTAL CA - VAKALIS . X
RECTAL CA - VAKALIS . XRECTAL CA - VAKALIS . X
RECTAL CA - VAKALIS . X
 
Vakalis - gastric ca radiotherapy
Vakalis - gastric ca radiotherapyVakalis - gastric ca radiotherapy
Vakalis - gastric ca radiotherapy
 
Vakalis.X H&N CANCER
Vakalis.X  H&N CANCERVakalis.X  H&N CANCER
Vakalis.X H&N CANCER
 
Vakalis pancreas
Vakalis pancreasVakalis pancreas
Vakalis pancreas
 

Dernier

Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls * UPA...
Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls  * UPA...Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls  * UPA...
Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls * UPA...
mahaiklolahd
 
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
Call Girls In Delhi Whatsup 9873940964 Enjoy Unlimited Pleasure
 
Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...
Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...
Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...
adilkhan87451
 
Call Girls in Gagan Vihar (delhi) call me [🔝 9953056974 🔝] escort service 24X7
Call Girls in Gagan Vihar (delhi) call me [🔝  9953056974 🔝] escort service 24X7Call Girls in Gagan Vihar (delhi) call me [🔝  9953056974 🔝] escort service 24X7
Call Girls in Gagan Vihar (delhi) call me [🔝 9953056974 🔝] escort service 24X7
9953056974 Low Rate Call Girls In Saket, Delhi NCR
 
Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...
Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...
Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...
chetankumar9855
 
Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...
Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...
Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...
Sheetaleventcompany
 

Dernier (20)

(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
(Low Rate RASHMI ) Rate Of Call Girls Jaipur ❣ 8445551418 ❣ Elite Models & Ce...
 
Call Girls Rishikesh Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Rishikesh Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Rishikesh Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Rishikesh Just Call 8250077686 Top Class Call Girl Service Available
 
Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls * UPA...
Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls  * UPA...Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls  * UPA...
Call Girl in Indore 8827247818 {LowPrice} ❤️ (ahana) Indore Call Girls * UPA...
 
Top Rated Pune Call Girls (DIPAL) ⟟ 8250077686 ⟟ Call Me For Genuine Sex Serv...
Top Rated Pune Call Girls (DIPAL) ⟟ 8250077686 ⟟ Call Me For Genuine Sex Serv...Top Rated Pune Call Girls (DIPAL) ⟟ 8250077686 ⟟ Call Me For Genuine Sex Serv...
Top Rated Pune Call Girls (DIPAL) ⟟ 8250077686 ⟟ Call Me For Genuine Sex Serv...
 
Top Rated Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...
Top Rated  Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...Top Rated  Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...
Top Rated Hyderabad Call Girls Chintal ⟟ 9332606886 ⟟ Call Me For Genuine Se...
 
Call Girls Madurai Just Call 9630942363 Top Class Call Girl Service Available
Call Girls Madurai Just Call 9630942363 Top Class Call Girl Service AvailableCall Girls Madurai Just Call 9630942363 Top Class Call Girl Service Available
Call Girls Madurai Just Call 9630942363 Top Class Call Girl Service Available
 
Andheri East ^ (Genuine) Escort Service Mumbai ₹7.5k Pick Up & Drop With Cash...
Andheri East ^ (Genuine) Escort Service Mumbai ₹7.5k Pick Up & Drop With Cash...Andheri East ^ (Genuine) Escort Service Mumbai ₹7.5k Pick Up & Drop With Cash...
Andheri East ^ (Genuine) Escort Service Mumbai ₹7.5k Pick Up & Drop With Cash...
 
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
🌹Attapur⬅️ Vip Call Girls Hyderabad 📱9352852248 Book Well Trand Call Girls In...
 
Call Girls Amritsar Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Amritsar Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Amritsar Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Amritsar Just Call 8250077686 Top Class Call Girl Service Available
 
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service AvailableCall Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
Call Girls Rishikesh Just Call 9667172968 Top Class Call Girl Service Available
 
Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...
Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...
Russian Call Girls Lucknow Just Call 👉👉7877925207 Top Class Call Girl Service...
 
Independent Call Girls Service Mohali Sector 116 | 6367187148 | Call Girl Ser...
Independent Call Girls Service Mohali Sector 116 | 6367187148 | Call Girl Ser...Independent Call Girls Service Mohali Sector 116 | 6367187148 | Call Girl Ser...
Independent Call Girls Service Mohali Sector 116 | 6367187148 | Call Girl Ser...
 
Call Girls Mumbai Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Mumbai Just Call 8250077686 Top Class Call Girl Service AvailableCall Girls Mumbai Just Call 8250077686 Top Class Call Girl Service Available
Call Girls Mumbai Just Call 8250077686 Top Class Call Girl Service Available
 
Call Girls in Gagan Vihar (delhi) call me [🔝 9953056974 🔝] escort service 24X7
Call Girls in Gagan Vihar (delhi) call me [🔝  9953056974 🔝] escort service 24X7Call Girls in Gagan Vihar (delhi) call me [🔝  9953056974 🔝] escort service 24X7
Call Girls in Gagan Vihar (delhi) call me [🔝 9953056974 🔝] escort service 24X7
 
Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...
Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...
Call Girl In Pune 👉 Just CALL ME: 9352988975 💋 Call Out Call Both With High p...
 
Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...
Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...
Dehradun Call Girls Service {8854095900} ❤️VVIP ROCKY Call Girl in Dehradun U...
 
Call Girls Kolkata Kalikapur 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...
Call Girls Kolkata Kalikapur 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...Call Girls Kolkata Kalikapur 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...
Call Girls Kolkata Kalikapur 💯Call Us 🔝 8005736733 🔝 💃 Top Class Call Girl Se...
 
Call Girls Service Jaipur {9521753030 } ❤️VVIP BHAWNA Call Girl in Jaipur Raj...
Call Girls Service Jaipur {9521753030 } ❤️VVIP BHAWNA Call Girl in Jaipur Raj...Call Girls Service Jaipur {9521753030 } ❤️VVIP BHAWNA Call Girl in Jaipur Raj...
Call Girls Service Jaipur {9521753030 } ❤️VVIP BHAWNA Call Girl in Jaipur Raj...
 
Call Girls Jaipur Just Call 9521753030 Top Class Call Girl Service Available
Call Girls Jaipur Just Call 9521753030 Top Class Call Girl Service AvailableCall Girls Jaipur Just Call 9521753030 Top Class Call Girl Service Available
Call Girls Jaipur Just Call 9521753030 Top Class Call Girl Service Available
 
Top Rated Call Girls Kerala ☎ 8250092165👄 Delivery in 20 Mins Near Me
Top Rated Call Girls Kerala ☎ 8250092165👄 Delivery in 20 Mins Near MeTop Rated Call Girls Kerala ☎ 8250092165👄 Delivery in 20 Mins Near Me
Top Rated Call Girls Kerala ☎ 8250092165👄 Delivery in 20 Mins Near Me
 

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
  • 2.
  • 3.
  • 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
  • 5.
  • 6.
  • 7.
  • 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)
  • 12. RESULTS MedDRA Coding Adverse Events Gynecologic, Cardiovascular, Musculoskeletal categories
  • 13. Selected Gynecologic Events Exemestane Tamoxifen P value Vaginal discharge 112 2.3% 333 6.8% < 0.0001 Vaginal haemorrhage 78 1.6% 153 3.1% < 0.0001 Vaginal infection 34 0.7% 108 2.2% < 0.0001 Uterine polyp 4 0.1% 25 0.5% < 0.0001 Endometrial hyperplasia 3 0.0% 96 2.0% < 0.0001 Endometrial cancer 7 0.1% 12 0.2% NS
  • 14. Selected Cardiac/Vascular Events Exemestane (4853) Tamoxifen (4817) P value Cardiac disorders - Myocardial ischemia/infarction 41 0.8% 31 0.6% NS - Cardiac deaths 18 0.4% 11 0.2% NS Vascular disorders - Hot flush/flushing 1384 28.5% 1606 33.3% < 0.001 - Hypertension 163 3.3% 104 2.1% < 0.001 - Thromboembolic events 44 0.9% 113 2.3% < 0.001
  • 15. Selected Musculoskeletal Events Exemestane (4853) Tamoxifen (4817) P value Arthralgia 875 17.9% 447 9.2% < 0.001 Arthritis 147 3.0% 83 1.7% < 0.001 Reported osteoporosis 228 4.7% 104 2.1% < 0.001 Reported fractures 133 2.7% 111 2.3% NS
  • 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
  • 23.
  • 24.
  • 25.  
  • 26.  
  • 27.  
  • 28.  
  • 29.  
  • 30.  
  • 31.  
  • 32.  
  • 33.  
  • 34.  
  • 35.  
  • 36.  
  • 37.  
  • 38.  
  • 39.  
  • 40.  
  • 41.  
  • 42.