Ovarian ablation, tamoxifen, and chemotherapy

The largest study (SOFT [NCT00066690]) to examine the addition of ovarian ablation to tamoxifen with or without chemotherapy randomly assigned 2,033 premenopausal women (53% of whom had received previous chemotherapy) to receive tamoxifen or tamoxifen plus ovarian suppression with triptorelin or ablation with surgery or radiation therapy.[53][Level of evidence B1]

The largest study (SOFT [NCT00066690]) to examine the addition of ovarian ablation to tamoxifen with or without chemotherapy randomly assigned 2,033 premenopausal women (53% of whom had received previous chemotherapy) to receive tamoxifen or tamoxifen plus ovarian suppression with triptorelin or ablation with surgery or radiation therapy.[53][Level of evidence B1]

Upon initial report, with a median follow-up of 5.6 years, there was no significant difference in the primary outcome of DFS (HR, 0.83; 95% CI, 0.66–1.04; P = .10); the 5-year DFS rate was 86% in the tamoxifen-plus-ovarian-suppression group versus 84.7% in the tamoxifen-alone group. However, updated results with a median follow-up of 8 years, demonstrated improved DFS with tamoxifen plus ovarian suppression compared with tamoxifen alone (HR, 0.76; 95% CI, 0.62–0.93; P = .009); the 8-year DFS rate was 83.2% in the tamoxifen-plus-ovarian-suppression group versus 78.9% in the tamoxifen-alone group.

The largest study (SOFT [NCT00066690]) to examine the addition of ovarian ablation to tamoxifen with or without chemotherapy randomly assigned 2,033 premenopausal women (53% of whom had received previous chemotherapy) to receive tamoxifen or tamoxifen plus ovarian suppression with triptorelin or ablation with surgery or radiation therapy.[53][Level of evidence B1]

In addition, OS at 8 years was improved with tamoxifen plus ovarian suppression compared with tamoxifen alone (HR, 0.67; 95% CI, 0.48–0.92; P = .01); the 8-year OS rate was 93.3% in the tamoxifen-plus-ovarian-suppression group versus 91.5% in the tamoxifen-alone group.Despite overall negative initial results, subgroup analysis suggested a benefit with ovarian suppression in women who underwent chemotherapy and remained premenopausal afterwards. Follow-up results at 8 years, however, did not demonstrate heterogeneity of treatment effect according to whether chemotherapy was administered, although recurrences were more frequent among patients who received chemotherapy.[54]

A Korean Breast Cancer Study Group trial (NCT00912548) included 1,293 premenopausal women younger than 45 years, all of whom had received adjuvant chemotherapy and either retained ovarian function or regained it after 2 years of tamoxifen. Patients were randomly assigned to receive either ovarian function suppression with goserelin plus tamoxifen or tamoxifen alone.[55]

A Korean Breast Cancer Study Group trial (NCT00912548) included 1,293 premenopausal women younger than 45 years, all of whom had received adjuvant chemotherapy and either retained ovarian function or regained it after 2 years of tamoxifen. Patients were randomly assigned to receive either ovarian function suppression with goserelin plus tamoxifen or tamoxifen alone.[55]

In the intent-to-treat analysis of 1,282 patients, the 5-year DFS rate was 89.8% for patients in the goserelin-plus-tamoxifen group and 87.3% for patients in the tamoxifen-alone group (HR, 0.69; 95% CI, 0.49–0.98; P = .036).

A Korean Breast Cancer Study Group trial (NCT00912548) included 1,293 premenopausal women younger than 45 years, all of whom had received adjuvant chemotherapy and either retained ovarian function or regained it after 2 years of tamoxifen. Patients were randomly assigned to receive either ovarian function suppression with goserelin plus tamoxifen or tamoxifen alone.[55]

OS was a secondary end point and was also improved for patients in the goserelin-plus-tamoxifen group (HR, 0.31; 95% CI, 0.10–0.95; P = .039).[55][Level of evidence A1]