In all subjects, exemestane plus ovarian suppression significantly improved DFS compared to tamoxifen plus ovarian suppression. In the combined SOFT and TEXT population, the 8 year DFS rate was 86.8% vs 82.8% respectively (HR=0.77; 95% CI, 0.67 to 0.90; P<0.001). The 8 year rate of OS was similar in both the exemestane plus ovarian suppression group and the tamoxifen plus ovarian suppression group (93.4% vs 93.3% respectively, HR=0.98, 95% CI, 0.79 to 1.22, P=0.84).r
In patients who did not receive chemotherapy, distant recurrence was reported in 26 patients (1.8%) in SOFT after 8 years and 37 patients (3.5%) in TEXT after 9 years.
In patients who had chemotherapy, exemestane plus ovarian suppression reduced 5 year breast cancer recurrence by 35% (absolute risk reduced from 22% to 14.3%, HR=0.65; 95% CI, 0.49 to 0.87) compared to tamoxifen alone.r The 8 year rate of freedom from distant recurrence in patients with previous chemotherapy was 80.0% with tamoxifen alone, 82.1% with tamoxifen plus ovarian suppression, and 84.5% with exemestane plus ovarian suppression.r
In patients who were less than 35 years old, regardless of chemotherapy, exemestane plus ovarian suppression reduced 5 year breast cancer recurrence by 49% (absolute risk reduced from 32.3% to 16.6%, statistical significance not reported) compared to tamoxifen alone.r
The 8 year rate of freedom from distant recurrence was 91.8% with exemestane plus ovarian suppression and 89.7% with tamoxifen plus ovarian suppression (HR=0.80; 95% CI, 0.66 to 0.96; P=0.02).r
Kaplan-Meier curves of DFS (A), freedom from distant recurrence (B), and OS (C) in the combined SOFT and TEXT populationr
© N Engl J Med 2015
Quality of life measurements were similar between exemestane plus ovarian suppression and tamoxifen plus ovarian suppression but was not reported for tamoxifen alone.