Premenopausal women

In one study (NCT00295646), 1,803 women who received goserelin were randomly assigned to a 2 × 2 factorial design trial that compared anastrozole and tamoxifen, with or without zoledronic acid.[56]

In one study (NCT00295646), 1,803 women who received goserelin were randomly assigned to a 2 × 2 factorial design trial that compared anastrozole and tamoxifen, with or without zoledronic acid.[56]

At a median follow-up of 62 months, there was no difference in DFS (HR, 1.08; 95% CI, 0.81–1.44; P = .59).

In one study (NCT00295646), 1,803 women who received goserelin were randomly assigned to a 2 × 2 factorial design trial that compared anastrozole and tamoxifen, with or without zoledronic acid.[56]

OS was superior with tamoxifen (HR, 1.75; 95% CI, 1.08–2.83; P = .02).

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57]

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57]

The use of exemestane resulted in a significant difference in DFS. The 8-year DFS rate was 86.8% in the exemestane-ovarian suppression group vs. 82.8% in the tamoxifen-ovarian suppression group (HR, 0.77; 95% CI, 0.67–0.90; P < .001).[57][Level of evidence B1]

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57]

The 8-year rate of freedom from distant recurrence was also higher in the exemestane-ovarian suppression group (91.8% vs. 89.7%; HR, 0.80; 95% CI, 0.66–0.96; P = .02).

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57]

Despite improvements in DFS and freedom from distant recurrence, no difference in OS was observed in the exemestane-ovarian suppression group compared with the tamoxifen-ovarian suppression group (93.4% vs. 93.3%; HR, 0.98; 95% CI, 0.79–1.22; P = .84).[57][Level of evidence A1] However, after a median follow-up of 12 years in the SOFT trial, the 12-year OS rate was 89.4% in the exemestane-ovarian suppression group and 86.8% in a tamoxifen-alone group from that study (HR, 0.80; 95% CI, 0.62–1.04).[58]

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57]

A follow-up report on the differences in quality of life (QOL) for the exemestane-ovarian suppression group versus the tamoxifen-ovarian suppression group observed the following results (the differences cited below were all significant at P < .001 and occurred in patients who did and did not receive chemotherapy):[59]

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57] › A follow-up report on the differences in quality of life (QOL) for the exemestane-ovarian suppression group versus the tamoxifen-ovarian suppression group observed the following results (the differences cited below were all significant at P < .001 and occurred in patients who did and did not receive chemotherapy):[59]

Patients who received tamoxifen plus ovarian function suppression were more affected by hot flashes and sweats over 5 years than were those who received exemestane plus ovarian function suppression, although these symptoms improved.

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57] › A follow-up report on the differences in quality of life (QOL) for the exemestane-ovarian suppression group versus the tamoxifen-ovarian suppression group observed the following results (the differences cited below were all significant at P < .001 and occurred in patients who did and did not receive chemotherapy):[59]

Patients who received exemestane plus ovarian function suppression reported more vaginal dryness, greater loss of sexual interest, and more difficulties becoming aroused than did patients who received tamoxifen plus ovarian function suppression. These differences persisted over time.

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57] › A follow-up report on the differences in quality of life (QOL) for the exemestane-ovarian suppression group versus the tamoxifen-ovarian suppression group observed the following results (the differences cited below were all significant at P < .001 and occurred in patients who did and did not receive chemotherapy):[59]

An increase in bone or joint pain was more pronounced, particularly in the short term, in patients who received exemestane plus ovarian function suppression than in patients who received tamoxifen plus ovarian function suppression.

In two unblinded studies that were analyzed together (TEXT [NCT00066703] and SOFT [NCT00066690]), exemestane was also compared with tamoxifen in 4,690 premenopausal women who underwent ovarian ablation.[57] › A follow-up report on the differences in quality of life (QOL) for the exemestane-ovarian suppression group versus the tamoxifen-ovarian suppression group observed the following results (the differences cited below were all significant at P < .001 and occurred in patients who did and did not receive chemotherapy):[59]

Changes in global QOL indicators from baseline were small and similar between treatments over the 5 years.[59][Level of evidence A3]