Table 2.
Trial | Number of subjects | Treatment | Results | |
---|---|---|---|---|
Ovarian suppression trials | Early Breast Cancer Trialists’ Collaborative Group53 | n=37,000 | Ovarian ablation/suppression (OA/S) versus control | 1. Disease free survival OA/S 45% vs 39% 2. Overall Survival OA/S 52% vs 46% |
Klijn et al61 | n=507 | 1. LHRH agonist 2. LHRH agonist with Tamoxifen |
Overall survival improved with combination (HR 0.78) | |
Austrian Breast Cancer Study Group 566 | n=1,034 | 1. LHRH agonist and Tamoxifen 2. Chemotherapy (Fluorouracil, Epirubicin, Cyclophosphamide |
1. Disease free survival: no difference between the groups (76% vs 72%) 2. Overall Survival: no difference between the groups (91% vs 88%) |
|
Cuzick et al68 | n=11,906 | 1. LHRH agonist 2. LHRH agonist and Tamoxifen 3. Tamoxifen 4. LHRH agonist with chemotherapy (+Tamoxifen) |
1. Disease free survival improved with LHRH agonist with chemotherapy with or without Tamoxifen (HR 0.88) 2. Overall Survival after recurrence improved with LHRH agonist with chemotherapy with or without Tamoxifen (HR 0.85) |
|
Austrian Breast Cancer Study Group 1267 | n=1803 | 1. Goserelin and Tamoxifen 2. Goserelin and Anastrozole 4. Goserelin and Tamoxifen with zoledronic acid 5. Goserelin and Anastrozole with zoledronic acid |
3. Disease free survival: no difference between the groups (92.8% vs 92%) 4. Overall Survival was worse with anastrazole (HR 1.75) |
|
Suppression of Ovarian Function with Triptorlein (SOFT) Trial69 | In progress | 1. Tamoxifen 2. Tamoxifen and ovarian function suppresion (OFS) 3. Exemestane and OFS (OFS by GrRH agonist-triptorelin, oophrectomy or irridaiation) |
Pending | |
Tamoxifen and Exemestrane Trial (TEXT)69 | In progress | 1. OFS and Tamoxifen 2. OFS and Exemestrane |
Pending | |
Premature ovarian failure trials | Del Mastro91 | n=133 | 1. Triptorelin 2. No triptorelin |
Triptorelin decrases rate of early menopause (8.9% vs 25.9%) |
Zoladex Rescue of Ovarian Function92 | n=60 | 1. Goserelin 2. No goserelin |
No difference in return of menses (70% vs 56.7%) | |
Prevention of Early Menopause (POEM)90 | n = 218 | 1. Goserelin 2. No goserelin |
1. Decreased premature ovarian failure with goserelin (22% vs 8%) 2. Increased pregnancies (22 vs 13) 3. Disease free survival in ER negative premenopausal patients improved 4. Overall survival ER negative premenopausal patients improved |
Abbreviations: ER, estrogen receptor; GrRH, gonadotropin releasing hormone; HR, hazard ratio; LHRH, luteinizing hormone releasing hormone; OA/S, ovarian ablation/suppression; OFS, ovarian function suppression.