Table 3.
Overview of largest trials evaluating the addition of OFS to adjuvant chemotherapy for fertility preservation in premenopausal women with breast cancer.
| Trial name | Randomized patients, N | Clinical characteristics | Follow up, years | Median age | Treatment arms | Outcomes |
|---|---|---|---|---|---|---|
| POEMS/SWOG (65, 66) Phase 3 |
218 | Premenopausal Early-stage BC |
2 (POF) 5 (pregnancy) |
Overall, 38 years Chemotherapy alone, 38.7 years Chemotherapy plus OFS, 37.6 years |
Neoadjuvant/adjuvant cyclophosphamide-containing chemotherapy alone vs. chemotherapy plus 3.6 mg 4-weekly goserelin | POF defined as amenorrhea for the preceding 6 months and FSH levels in the postmenopausal range at 2 yearsa
POF rate chemotherapy alone, 22% POF rate chemotherapy plus OFS, 8% POF OR: 0.30 (95% CI 0.09–0.97); P = 0.04 5-year cumulative incidence of pregnancy: chemotherapy alone, 12.2% chemotherapy plus OFS, 23.1% OR: 2.34 (95% CI 1.07–5.11); P = 0.03 |
| PROMISE-GIM6 (67, 68) Phase 3 |
281 | Premenopausal BC |
1 (POF) 7.3 (menstrual resumption; pregnancy) |
39 years | Chemotherapy alone vs. chemotherapy plus 3.75 mg 4-weekly triptorelin | POF defined as no resumption of menstrual activity or the presence of postmenopausal levels of FSH and E2 for 1 year after the end of chemotherapy POF rate chemotherapy alone, 25.9% POF rate chemotherapy plus OFS, 8.9% Absolute difference: −17%; P < 0.001 5-year cumulative incidence of menstrual resumption: chemotherapy alone, 64.0% chemotherapy plus OFS, 72.6% 5-year incidence of pregnancy: chemotherapy alone, 1.6% chemotherapy plus OFS, 2.1% |
| Anglo Celtic Group OPTION (69) | 227 | Early-stage BC | 1–2 | Chemotherapy alone, 38.8 years Chemotherapy plus OFS, 37.9 years |
Cyclophosphamide- and/or anthracycline-containing chemotherapy alone vs. chemotherapy plus 3.6 mg 4-weekly goserelin | Primary outcome was amenorrhea at 12–24 months after end of chemotherapy Amenorrhea rate chemotherapy alone, 38% Amenorrhea rate chemotherapy plus OFS, 22% (P = 0.015) POF defined as the presence of amenorrhea and elevated FSH (> 25 IU/L) POF rate chemotherapy alone, 34.8% POF rate chemotherapy plus OFS, 18.5% |
a
POF was evaluated in 135 patients for whom data were available at 2 years.
BC, breast cancer; CI, confidence interval; E2, estradiol; FSH, follicle-stimulating hormone; IU, international units; OFS, ovarian function suppression; OR, odds ratio; POF, premature ovarian failure.