Steering Committee meeting, 24th September 2005

1
Steering Committee meeting, 24th September
2005 University of Oxford Examination Schools
2
ATLAS and aTTom

• Update on current status

adjuvant Tamoxifen Treatment offer more?
3
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 now CONTINUE for at least
• 5 more years

4
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.

5
Completion of recruitment phase in ATLAS and aTTom

• January 2005 ATLAS Steering Committee (TSC) with
  the aTTom TSC decided to close accrual
• gt 20,000 women now randomised in studies of 10 vs
  5 years of tamoxifen
• aTTom and ATLAS closed to recruitment in March
  2005.

6
12898
2354
7
15 254 women randomised from 30 countries
largest cancer treatment trial so far!
8
Cumulative recruitment figures into aTTom by
prior duration of tamoxifen
9
Accrual in trials of 10 vs 5 years of tamoxifen
10
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

11
AGE DISTRIBUTION
STOP CONTINUE
12
NODAL STATUS
STOP CONTINUE
13
ER status
14
Distribution of ER status in ATLAS

• ATLAS
• Older (n2354)
• ER poor 9
• ER unknown 68
• ER positive 23
• Newer (n12898)
• ER poor 10
• ER unknown 37
• ER positive 53

15
Survival among women in the older and newer
components of ATLAS
NB Women in STOP and CONTINUE arms combined in
each component ie this is non-randomised
16
Survival in ATLAS by nodal status
17
Survival in ATLAS by ER status
18
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.

19
Numbers of women where follow-up should be data
available
Denominators for main breast cancer analyses H
Denominators for main side-effect analyses
20
Compliance in older part of ATLAS
21
Compliance in newer part of ATLAS
22
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

23
Quality of follow-up data

• All forms should be completed in full!
• At least 80 of the ATLAS offices time is spent
  chasing follow-up queries

24
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

25
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

26
SummaryLong-term follow-up and good
compliance are required in ATLASIf we can get
these, we will get a reliable answer on whether
longer versus shorter tamoxifen improves survival
among women with early breast cancer
27
(No Transcript)
28

• 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 atlas_at_ctsu.ox.ac.uk