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

ATLAS Steering Committee: 24 September 2005 ATLAS and aTTom Update on current status adjuvant Tamoxifen Treatment: offer more?

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

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.

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.

ATLAS Steering Committee: 24 September

ATLAS Steering Committee: 24 September women randomised from 30+ countries: largest cancer treatment trial so far!

ATLAS Steering Committee: 24 September 2005 Cumulative recruitment figures into aTTom by prior duration of tamoxifen

ATLAS Steering Committee: 24 September 2005 Accrual in trials of 10 vs 5 years of tamoxifen

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

ATLAS Steering Committee: 24 September 2005 AGE DISTRIBUTION STOP CONTINUE

ATLAS Steering Committee: 24 September 2005 STOP CONTINUE NODAL STATUS

ATLAS Steering Committee: 24 September 2005 ER status

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

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

ATLAS Steering Committee: 24 September 2005 Survival in ATLAS by nodal status

ATLAS Steering Committee: 24 September 2005 Survival in ATLAS by ER status

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.

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 <4 years pre- randomisation Subtotal: Mean follow-up (years): 4+ years pre- randomisation Subtotal: Mean follow-up (years): * Denominators for main breast cancer analyses H Denominators for main side-effect analyses

ATLAS Steering Committee: 24 September 2005 Compliance in older part of ATLAS

ATLAS Steering Committee: 24 September 2005 Compliance in newer part of ATLAS

ATLAS Steering Committee: 24 September 2005 Completeness of follow-up data We must have up to date information on all women especially with respect to -Compliance -Recurrence -Death (and if died, date and cause of death) -Other primary cancers

ATLAS Steering Committee: 24 September 2005 Quality of follow-up data All forms should be completed in full! At least 80% of the ATLAS office’s time is spent chasing follow-up queries

ATLAS Steering Committee: 24 September 2005 Most common problems with follow-up forms Not returned! Not completed in full Doctors writing “Lost to follow-up” Dates of events missing Cause of death not provided Hospital admission diagnosis and date missing

ATLAS Steering Committee: 24 September 2005 Use the information we have to help ensure long-term follow-up Identifiers Responsible doctor Patient name Date of birth Hospital number National identification number Address Alternative contact details

ATLAS Steering Committee: 24 September 2005 Summary Long-term follow-up and good compliance are required in ATLAS: If we can get these, we will get a reliable answer on whether longer versus shorter tamoxifen improves survival among women with early breast cancer

ATLAS Steering Committee: 24 September 2005

I want to thank everyone personally for all they have done to make this collaboration work! Dr Christina Davies, ATLAS Coordinator For further information on any of this presentation, please contact