Info
Suppression of Ovarian Function Trial
- SOFT and TEXT 軟字的 → 結果：Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer
- July 12, 2018
- N Engl J Med 2018; 379:122-137
- DOI: 10.1056/NEJMoa1803164
- Design: Randomized, phase III trial.
- Number of patients: Not reported.
- Patients characteristics: Women with hormone-receptor positive breast cancer.
- Agents: Tamoxifen, exemestane, and ovarian suppression.
- Treatment line: Adjuvant therapy after surgery and chemotherapy.
- Trial Name/NCT Number: SOFT.
- Comparison of three groups in a markdown table:
| Group/Outcome | Tamoxifen | Tamoxifen + ovarian suppression | Exemestane + ovarian suppression |
|---|---|---|---|
| 8-year Disease-Free Survival Rate | 78.9% | 83.2% | 85.9% |
| 8-year Overall Survival Rate | 91.5% | 93.3% | 92.1% |
| 8-year Overall Survival Rate (premenopausal patients after chemotherapy) | 85.1% | 89.4% | 87.2% |
| 8-year Rate of Distant Recurrence (HER2-negative patients who received chemotherapy) | Not reported | Lower with exemestane + ovarian suppression (by 7.0% in SOFT and by 5.0% in TEXT) | Not reported |
| Grade 3 or higher adverse events | 24.6% | 31.0% | 32.3% |