SOFT & TEXT
For younger women, shutting down the ovaries and adding an aromatase inhibitor prevents more recurrences than tamoxifen alone, with the largest gains in the highest-risk women.
Combined 12-13-year analysis: exemestane + OFS improved DFS and distant recurrence-free interval over tamoxifen + OFS (absolute 4-5%) without an OS difference; SOFT 12-year: adding OFS to tamoxifen improved OS in the chemotherapy cohort (HR ~0.79). Basis for OFS in premenopausal women at higher risk.
Setting
Premenopausal HR+ early breast cancer: ovarian function suppression + exemestane vs + tamoxifen vs tamoxifen alone
Phase
Phase 3
Sponsor
IBCSG
Registry
Headline result
Exemestane + OFS: DFS and DRFI improved; no OS difference at 12 years.
Reported
2014
Enrolled
5738
Replication
Consistent with the ABCSG-12 and EBCTCG meta-analyses on OFS.
In plain words
What these results mean for people, not percentages
12-year disease-free survival (TEXT+SOFT)primarysurrogate endpoint
- 80.5 vs 75.9 out of 100 alive without the cancer coming back at 12 years with Exemestane + OFS compared with Tamoxifen + OFS; 4.6 more per 100.
- Roughly one extra person helped for every 22 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 21 percent lower chance of the event at any given time (hazard ratio 0.79, likely range 0.7 to 0.9).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Premenopausal HR+ early breast cancer: ovarian function suppression + exemestane vs + tamoxifen vs tamoxifen alone. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
5,738 participants enrolled.
12-year disease-free survival (TEXT+SOFT)primary
HR 0.79 (0.7–0.9)
Exemestane + OFS80.5 of 100
Tamoxifen + OFS75.9 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 12-year disease-free survival (TEXT+SOFT)primary | Exemestane + OFS | — | 80.5% | 0.79 (0.7–0.9) | — | link |
| Tamoxifen + OFS | — | 75.9% |
Replication
Consistent with the ABCSG-12 and EBCTCG meta-analyses on OFS.cancers
1technologies
1drugs
4ApprovedSmall-molecule steroidal aromatase inactivator
Exemestane · Aromasin
ApprovedGnRH agonist
Goserelin / leuprolide (ovarian function suppression) · Zoladex; Lupron
ApprovedSmall-molecule aromatase inhibitor
Letrozole (and other aromatase inhibitors) · Femara; anastrozole (Arimidex); exemestane (Aromasin)
ApprovedSmall-molecule SERM
Tamoxifen · Nolvadex