Table 1.
Endocrine therapy in ABC.
| Trial/ Phase | Intervention Comparison | T# | # pt | Pt characteristics | Disease characteristics | Previous therapy | Survival | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age | Menopausal status | |||||||||||||
| Pre meno | Post meno | HR +ve | HER2 –ve | Chemo | Endocrine | OS | PFS or TTP | CBR | ORR | |||||
| ENDOCRINE THERAPY | ||||||||||||||
| Di Leo et al. (29) | Fulvestrant 500 mg | 2 | 374 | 61 | 0 | 100 | 100 | NR | 0 | 100 | 22.03 | PFS, 5.5 | 39.6 | NR |
| Phase 3 | Fulvestrant 250 mg | 362 | 61 | 0 | 100 | 100 | NR | 0 | 100 | 26.4 | 6.5 | 45.6 | NR | |
| p | <0.05 | <0.05 | NR | |||||||||||
| Howell et al. (30) | Fulvestrant 250 mg | 1 | 313 | 67 | 0 | 100 | 78.9 | NR | 22.7 | 22 | 36.9 | TTP, 6.8 | 54.3 | 31.6 |
| Phase 3 | Tamoxifen | 274 | 66 | 0 | 100 | 77.4 | NR | 24.1 | 24.8 | 38.7 | 8.3 | 62 | 33.9 | |
| p | 0.04 | 0.088 | 0.026 | 0.45 | ||||||||||
| Mouridsen et al. (31) | Letrozole | 1 | 458 | 65 | 0 | 100 | 65 | NR | 30 | 19 | 34 | TTP, 9.4 | 50 | 32 |
| Phase 3 | Tamoxifen | 458 | 64 | 0 | 100 | 67 | NR | 34 | 18 | 30 | 6 | 38 | 21 | |
| p | 0.53 | <0.0001 | 0.0004 | 0.0002 | ||||||||||
| Robertson et al. (32) | Fulvestrant 500 mg | 1 | 230 | 64 | 0 | 100 | 100 | 100 | 16 | 1 | NR | PFS, 16.6 | 78 | 46 |
| Phase 3 | Anastrozole | 232 | 62 | 0 | 100 | 100 | 100 | 19 | <1 | NR | 13.8 | 74 | 45 | |
| p | 0.0486 | 0.3045 | 0.7290 | |||||||||||
| Chia et al. (33) | Fulvestrant 500–>250 | 2 | 351 | 63 | 0 | 100 | 98.3 | NR | 24.8 | 89.2 | NR | TTP, 3.7 | 32.2 | NR |
| Phase 3 | Exemestane | 342 | 63 | 0 | 100 | 98.2 | NR | 21.6 | 86 | NR | 3.7 | 31.5 | NR | |
| p | NS | NS | ||||||||||||
| Bergh et al. (34) | Anastrozole alone | 1 | 256 | 63 | NR | NR | 97.7 | NR | 49.6 | 65.6 | 38.2 | TTP, 10.2 | NR | NR |
| Phase 3 | Fulvestrant + anastrozole | 258 | 65 | NR | NR | 98.4 | NR | 41.9 | 69.8 | 37.8 | 10.8 | NR | NR | |
| p | NS | NS | ||||||||||||
| Mehta et al. (35) Phase 3 | Anastrozole alone –> Fluvestrant | 1 | 345 | 65 | 0 | 100 | 100 | 91.5 | 29.9 | 40 | 41.3 | PFS, 13.5 | 70 | NR |
| Anastrozole + fulvestrant | 349 | 65 | 0 | 100 | 100 | 89.6 | 37 | 40 | 47.7 | 15 | 73 | NR | ||
| p | 0.05 | 0.05 | NS | |||||||||||
| Johnston et al. (36) | Fulvestrant + placebo | 2 | 231 | 63.4 | 0 | 100 | 99.1 | 61/94 | NR | 100 | 19.4 | PFS, 4.8 | 32 | 8 |
| Phase 3 | Fulvestrant + anastrozole | 243 | 63.8 | 0 | 100 | 100 | 50/93 | NR | 100 | 20.2 | 4.4 | 34 | 8 | |
| Exemestane | 249 | 66 | 0 | 100 | 99.6 | 57/93 | NR | 100 | 21.6 | 3.4 | 27 | 4 | ||
| P | NS | NS | NS | NS | ||||||||||
T#, Treatment line; # pt, Number of patients; OS, Overall survival; PFS, Progression free survival; TTP, Time to progression; CBR, Clinical benefit rate; ORR, Objective response rate; NR, Not reported; NS, Not significant.