JOURNAL CLUB

.. 531010086
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INTRODUCTION
ER positive breast cancer ; treatment for 5 years
with Tamoxifen reduces the rate of recurrence
10 years of treatment have greater effect on
breast cancer recurrence and mortality is not
known.
Endometrial cancer & thromboembolic disease is
likely to increase.
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INTRODUCTION

Main analysis

METHODS
Participants
Inclusion criteria
women had early breast cancer
received Tamoxifen
free of disease (local recurrence removed, no
distant recurrence detected)
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METHODS
Participants
Exclusion criteria
Pregnancy
Breastfeeding
retinopathy
need for coagulation therapy
endometrial hyperplasia
other serious toxicity

METHODS
Study design
use Clinical Trial Service Unit (CTSU) random
1:1
continue tamoxifen 20 mg/day to 10 years (stopping
only definite contraindication)
stop immediately at 5 years

Allocated by country and major prognostic factor

(age group, node status, tumour diameter, and ER
status)

METHODS
Data sources
ATLAS recruited from 36 countries or regions during
1996-2005

Ethical approval; Oxford Tropical Research Ethics

Committee, national and regional ethics committee

METHODS
Procedures
Central organisers sent forms to clinicians every year

other adjuvant endocrine treatment

breast cancer recurrence
new primary cancer incidence (endometrial cancer)
reason for any hospital admission
cause of death (breast cancer, endometrial cancer, MI)

recurrence first recurrence after ATLAS entry

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METHODS
Statistical analysis
20,000 patients need to be randomised

Intention-to-treat

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METHODS
Outcomes measures
recurrence and breast cancer motality in ER-positive
specific side-effects of 10 years and 5 years of Tamoxifen
differ

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RESULTS
Trial profile

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RESULTS
Characteristics

13

RESULTS
Characteristics

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RESULTS
ER positive
continue tamoxifen reduced the risk of recurrence
(617 recurrence in 3428 woman allocated to continue Vs 711
in 3418 controls) RR 0.84, 95% CI 0.76-0.94, p=0.002
reduced breast cancer mortality
(331 death in woman allocated to continue Vs 397 in
controls) p=0.01
reduced overall mortality
(639 death in woman allocated to continue Vs 722 in
controls) p=0.01
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RESULTS

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1.
lancet
impact factor 39.207

2.

3.
?

4.
36 Europe, Australia, New
zealand, USA, South afriaca (European origin), Latin America
(Argentina, Brazil, Chie, Columbia, Cuba, Mexico, Paraguay), Asia
(India, China,)

5.

aTTom trial
MA. 17 extended adjuvant trial

6.
objective, study design, patients, intervention,
main outcome, results, conclusion
setting

7.


tamoxifen 5 1-2
10

breast cancer recurrence mortality

8.

9.





protocol

10.



Pregnancy Tamoxifen cat D
Breastfeeding Tamoxifen inhibit lactation
retinopathy Tamoxifen blur vision
need for coagulation therapy
endometrial hyperplasia
other serious toxicity

11.

20000
trial MA.17 trial
endocrine
treatment tamoxifen 5

12.
Allocated by country and major prognostic
factor (age group, node status, tumour diameter,
and ER status)
tamoxifen 5 Vs tamoxifen

13.

tamoxifen 5 treatment
treatment

14.

1:1
treatmet control

15.

treatment 20 mg/day

16.


drug interaction

17.
open control
outcome

objective out come recurrence,
mortality

18.
recurrence mortality rate
tamoxifen

19.

20.

21.
demographics

22.

23.

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THANK YOU

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