Adjuvant Ovarian Suppression in Premenopausal Breast Cancer

ABSTRACT SOFT(Suppression of Ovarian Function Trial) TEXT(Tamoxifen and Exemestane Trial ) E-3193(INT-0142)

Suppression of Ovarian Function Trial(SOFT) Prudence A. Francis,et al. N Engl J Med, 2015, 372;5

Fig. 3A: At 5 years, 88.4% (95% CI, 86.1 to 90.3) of the patients assigned to receive tamoxifen plus ovarian suppression remained free from breast cancer, as compared with 86.4% (95% CI, 84.0 to 88.5) of those assigned to receive tamoxifen alone (hazard ratio for recurrence, 0.81; 95% CI, 0.63 to 1.03; P = 0.09)

Fig. 3B :Recurrence of breast cancer at a distant site was reported in 185 patients (9.1%), with no significant difference between those assigned to tamoxifen plus ovarian suppression and those assigned to tamoxifen alone (hazard ratio for recurrence, 0.88; 95% CI, 0.66 to 1.18; P = 0.40)

Fig. 3C :Among patients who did not receive chemotherapy, more than 95% remained free from breast cancer at 5 years in each group

Fig. 3D: Among patients who did not receive chemotherapy, few distant recurrences at 5 years in each group

Fig. 3E: Most recurrences of breast cancer were in patients who remained premenopausal after receiving chemotherapy

Fig. 3F: Most recurrences of breast cancer at a distant site occurred in the patients who had received chemotherapy previously.

Results of SOFT The addition of ovarian suppression to adjuvant tamoxifen did not significantly improve disease-free survival. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes.

Tamoxifen and Exemestane Trial (TEXT) Olivia Pagani, M.D.,et al. N Engl J Med 2014,371;2

CONCLUSIONS In premenopausal women with hormone-receptor–positive early breast cancer, adjuvant treatment with exemestane plus ovarian suppression, as compared with tamoxifen plus ovarian suppression, significantly reduced recurrence.

E-3193 INT-0142 Amye J. Tevaarwerk,et al. J Clin Oncol, 2014 ,32:3948

Table 2:The most common grade 3 or higher toxicities were hot flashes, weight gain, neuropsychiatric adverse effects, such as anxiety or depression, and neurologic adverse effects, such as somnolence and confusion. The proportion of grade 3 or greater toxicity was higher for tamoxifen plus OFS compared with tamoxifen (22.4% v 12.3%; P=.004).

Conclusion When added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen

SUMMARY SOFT(Suppression of Ovarian Function Trial) TEXT(Tamoxifen and Exemestane Trial ) E-3193(INT-0142)