ATLAS Steering Committee: 24 September 2005 Steering Committee meeting, 24 th September 2005 University of Oxford Examination Schools.

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  • Slide 1
  • ATLAS Steering Committee: 24 September 2005 Steering Committee meeting, 24 th September 2005 University of Oxford Examination Schools
  • Slide 2
  • ATLAS Steering Committee: 24 September 2005 ATLAS and aTTom Update on current status adjuvant Tamoxifen Treatment: offer more?
  • Slide 3
  • ATLAS Steering Committee: 24 September 2005 ATLAS and aTTom study design After several years on adjuvant tamoxifen, patient and doctor both SUBSTANTIALLY UNCERTAIN about whether to stop now or continue RANDOMISE STOP tamoxifen nowCONTINUE for at least 5 more years
  • Slide 4
  • ATLAS Steering Committee: 24 September 2005 Sample size sought To confirm, or refute, a 3% difference in absolute survival (e.g. 75% to 78%), 8,000 patients would have to be randomised to have a 90% chance of detecting this difference (at a 5% statistical significance level) between the two groups. To detect a 2% difference in absolute survival (e.g. 75% to 77%), 20,000 patients would be needed.
  • Slide 5
  • ATLAS Steering Committee: 24 September 2005 Completion of recruitment phase in ATLAS and aTTom January 2005: ATLAS Steering Committee (TSC) with the aTTom TSC decided to close accrual > 20,000 women now randomised in studies of 10 vs 5 years of tamoxifen aTTom and ATLAS closed to recruitment in March 2005.
  • Slide 6
  • ATLAS Steering Committee: 24 September 2005 12898 2354
  • Slide 7
  • ATLAS Steering Committee: 24 September 2005 15 254 women randomised from 30+ countries: largest cancer treatment trial so far!
  • Slide 8
  • ATLAS Steering Committee: 24 September 2005 Cumulative recruitment figures into aTTom by prior duration of tamoxifen
  • Slide 9
  • ATLAS Steering Committee: 24 September 2005 Accrual in trials of 10 vs 5 years of tamoxifen
  • Slide 10
  • ATLAS Steering Committee: 24 September 2005 Baseline data of women randomised in ATLAS: Identifiers Responsible doctor Patient name Date of birth Hospital number National identification number Address Alternative contact details Clinical Date of diagnosis ER status Nodal status Recurrence (including contralateral breast cancer) Other primary cancer Menopausal status Ovarian ablation Dose of tamoxifen (daily) and prior duration
  • Slide 11
  • ATLAS Steering Committee: 24 September 2005 AGE DISTRIBUTION STOP CONTINUE
  • Slide 12
  • ATLAS Steering Committee: 24 September 2005 STOP CONTINUE NODAL STATUS
  • Slide 13
  • ATLAS Steering Committee: 24 September 2005 ER status
  • Slide 14
  • ATLAS Steering Committee: 24 September 2005 ATLAS Older (n=2354) ER poor9% ER unknown68% ER positive23% Newer (n=12898) ER poor10% ER unknown37% ER positive53% Distribution of ER status in ATLAS
  • Slide 15
  • ATLAS Steering Committee: 24 September 2005 NB: Women in STOP and CONTINUE arms combined in each component ie this is non- randomised Survival among women in the older and newer components of ATLAS
  • Slide 16
  • ATLAS Steering Committee: 24 September 2005 Survival in ATLAS by nodal status
  • Slide 17
  • ATLAS Steering Committee: 24 September 2005 Survival in ATLAS by ER status
  • Slide 18
  • ATLAS Steering Committee: 24 September 2005 ATLAS: the next few years Compliance with random allocation Completeness of follow-up At present, women with a prior duration of 4 or more years of tamoxifen before randomisation have a median follow-up of ~3 years. An absolute minimum of five more years of follow-up is needed for a proper assessment of the benefits and risks of long-term tamoxifen.
  • Slide 19
  • ATLAS Steering Committee: 24 September 2005 Numbers of women where follow-up should be data available Number entered before 11/2004 Number entered from 11/2004 Total

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