Interaction entre Exémestane et Tamoxifène

Percent Change in BMD from Baseline to 24 months, Exemestane vs. Control 1 IES 027 BMD Exemestane N=29 Tamoxifen 1 N=38 Exemestane N=59 Placebo 1 N=65 Lumbar spine (%) -3.1 -0.2 -3.5 -2.4 Femoral neck (%) -4.2 -0.3 -4.6 -2.6 During adjuvant treatment with exemestane, women with osteoporosis or at risk of osteoporosis should have their bone mineral density formally…

Laboratory Abnormalities In patients with early breast cancer, the incidence of hematological abnormalities of Common Toxicity Criteria (CTC) grade ≥1 was lower in the exemestane treatment group, compared with tamoxifen.

CTC grade 3–4 increases in bilirubin occurred in 0.9% of exemestane treated patients compared to 0.1% of tamoxifen treated patients.

Table 1 describes changes in BMD from baseline to 24 months in patients receiving exemestane compared to patients receiving tamoxifen (IES) or placebo (027).

In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving exemestane than either tamoxifen or placebo.

Aromatase Inhibitors Anastrozole The combination of anastrozole and tamoxifen did not demonstrate any benefit when compared to tamoxifen alone and should be avoided in all patients [see Clinical Studies (14.2) ] .