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Long-term safety assessment of a cohort of post-menopausal women treated with Anastrozole as adjuvant treatment for
hormone-dependent breast cancer. Baseline data
T. Delozier, EC. Antoine, A. Fontana, JP. Guastalla, C. Roux, L. Mauriac, Eric Vicaut, CLCC F. Baclesse, Caen ; Clinique Hartmann, Neuilly ; Hôpital E. Herriot, Lyon ; CLCC L. Bérard, Lyon ; Hôpital Cochin, Paris ; Institut
Bergonié, Bordeaux. Hopital Fernand Widal Paris
36.5% of patients had adjuvant or neoadjuvant chemotherapy (anthracyline :96.7%, taxanes : 69.2%).
Osteoarticular symptoms at baseline :
Anastrozole was mostly introduced after radiotherapy and/or chemotherapy.
Osteoarticular symptoms were present in 46% of patients (706 patients) prior to any treatment with
The analysis of the ATAC trial, comparing anastrozole to tamoxifen in early breast cancer in
Patients experienced these symptoms since a mean of 4.5 ± 8.3 years.
postmenopausal women, has shown a significantly higher efficacy (disease-free survival, time to
Mean length of menopause, years (SD)
recurrence, time to distant recurrence, incidence of new controlateral breast cancer) for anastrozole, a
lower frequency of vascular events and endometrial cancers with anastrozole, but a higher frequency
As about 25000 women are likely to be treated in France each year by an adjuvant treatment of breast
cancer, it was important to assess in a naturalistic situation and in a large population of French patients
treated in current clinical practice, the long-term safety of anastrozole and the expression of feelings
Patient’s disease history:
and complaints raised by the patients over the time.
Thus, a long-term observational, non interventional, longitudinal survey of post-menopausal women
Most patients were diagnosed during a screening mammography.
with a breast cancer, hormone-receptor positive, treated with anastrozole (1 mg daily during 5 years)
Cardiovascular risk factors at baseline:
as adjuvant therapy has been set-up and the patients’ characteristics before starting anastrozole
A wide range of cardiovascular risk factors is found in this survey: about 1 woman out of 3 is treated for hypertension, 1 out of 3 has dyslipidemia disorders.
% of patients (N=706)
Primary tumour was located in the right breast for 48.2 % of the women, in the left breast for
Main objective: describe long-term tolerability of anastrozole in clinical practice.
Localisation of the osteoarticular symptoms at baseline:
Secondary objectives: to describe the available data in an attempt to draw conclusions about their
inter-dependence and their impact on tolerance and assess possible changes over time:
- describe the characteristics of breast cancer,
- describe the nature and modalities of care,
- describe patient’s reported compliance
Treatment of osteoarticular symptoms at baseline :
patients are treated with
The objective of this interim analysis is to describe characteristics of the study population at
baseline before treatment with anastrozole.
Materials & Methods
Topical products for joint and muscular pain (1.4%)
Drugs affecting bone structure and mineralization (15.1%)
A French observational, non interventional, prospective, multicentre, longitudinal survey is ongoing
Symptoms patients assessment (Self questionnaire) at baseline:
Patients were asked to evaluate their bone and osteoarticular pains prior to any intake of anastrozole:
67% of subjects reported pre-existing osteoarticular pain, about 1 out of 3 qualified their pain as
“moderately” to “a lot” (cf. figure 7).
The population targeted by the survey includes women followed within their usual healthcare visit for
their disease. The decision to treat these women with anastrozole was taken by their physicians
Osteoarticular assessment at baseline:
Bone and/or osteoarticular pains (n=1389)
(adjuvant treatment of breast cancer in postmenopausal women with hormone receptor positive).
An osteoarticular disease was present in 47.4 % of the patients (742 patients).
- during scheduled consultations (every 6 months during the first 2 years, and annually during 3 years)
- each year, in the first 3 months after the scheduled consultation during a phone call
Breast cancer treatment
A cohort of 1567 women, recruited by 117 specialists was constituted.
Demographic and clinical patients characteristics:
A high percentage of patients showed osteoarticular symptoms, osteoporosis and
At study entry, mean age of patients was 63.6 ± 8.5 years with mean menopause duration of 14.1 ±
cardiovascular risk factors at baseline prior to receiving anastrozole.
These data should be taken into account when interpreting the long-term
% patients (N=742)
Breast cancer treatment is considered to be, in 5.9% of the cases, responsible for the menopause
tolerability of treatment during the 5 years follow-up.
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