Randomized comparison of adjuvant aromatase inhibitor exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor positive (HR+) early breast cancer (BC):

1. SOFT (Suppression of Ovarian
Function Trial)
and
TEXT (Tamoxifen and Exemestane
Trial)
Dr Kundan
Department of Surgical Oncology
Mahavir Cancer Sansthan

6. Study Type: Interventional
Study Design:
• Allocation: Randomized;
• Intervention Model: Parallel Assignment;
• Masking: None (Open Label);
• Primary Purpose: Treatment

12. Reporting Groups
Description
Tamoxifen Tamoxifen 20mg orally daily for 5 years
T+OFS Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS;
triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or
surgical oophorectomy; or ovarian irradiation)
E+OFS Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS;
triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or
surgical oophorectomy; or ovarian irradiation)

14. • Breast Cancer-free Interval
the time from randomization to invasive breast cancer
recurrence at local, regional, or distant site, or invasive
contralateral breast cancer; or censored at date of last follow
up.
• Distant Recurrence-free Interval
the time from randomization to invasive breast cancer
recurrence at distant site, or invasive contralateral breast
cancer; or censored at date of last follow up.
• Overall Survival
the time from randomization to death from any cause; or
censored at date last known alive.

41. 2018 Update of SOFT & TEXT trial
• adding ovarian function suppression to tamoxifen significantly
decreased the relative risk of disease-free survival events by 24%
versus tamoxifen-alone in the overall population after 8 years
median follow-up, resulting in a 4.2% absolute benefit at 8 years.
• The absolute benefit was larger in women who remained
premenopausal after receiving chemotherapy before starting
ovarian suppression.
• The clinical benefit was particularly clear in women under age 35,
with an 8.6% absolute benefit at 8 years.
• Further reduction in recurrence was seen with the use of the
aromatase inhibitor exemestane plus ovarian function suppression.
An overall survival benefit is now seen at 8 years, with the use of
ovarian function suppression, particularly in women who remained
premenopausal after receiving adjuvant chemotherapy. However,
the frequency of side effects was higher than reported for
treatment with tamoxifen alone.

42. • statistically significant improvements in disease outcomes
with exemestane versus tamoxifen used in combination
with ovarian suppression.
• Adjuvant exemestane plus ovarian function suppression,
compared with tamoxifen plus ovarian function
suppression, showed sustained absolute improvements in
disease-free survival and freedom from distant recurrence
of 4.0% and 2.1% at 8 years, respectively.
• Women with HER2-negative breast cancer experienced the
most clinical benefit, especially those who also received
adjuvant chemotherapy due to a higher risk of recurrence.
• In these higher-risk groups, absolute improvements in
disease-free survival and freedom from distant recurrence
were 7-9% and 5-7% across TEXT and SOFT, respectively
with exemestane plus ovarian suppression.
• No difference in overall survival after 9 years median
follow-up was observed when comparing the two groups
treated with ovarian suppression.

43. Acknowledgement