Table 1. Trials of adjuvant tamoxifen alone, and tamoxifen with chemotherapy.
| Study | Patient population | Treatment | Results | Ref |
|---|---|---|---|---|
| NATO (N = 605) | LN+, premenopausal LN+ or LN-, postmenopausal | Tam 20 mg 2 yr (N = 300) vs No treatment (N = 305) |
Better PFS and OS with Tam | [26] |
| NSABP B-14 (N = 2,644) | LN-, ER+ ≤49 yr and ≥50 yr |
Tam 20 mg 5 yr vs Placebo |
Tam > placebo DFS 83 vs 77%; Tam decr RR 44%; No OS difference |
[27] |
| NSABP B-14 Tam > 5 years (N = 1,172) |
LN-, ER+ ≤49 yr and ≥50 yr (after 5 yr Tam) |
Tam 20 mg 5 more yr (N = 593) vs Placebo (N = 579) |
No DFS/OS difference at 4 yr; Tam < placebo at 7 yr |
[28] |
| Scottish trial (N = 1,323) | LN-, premenopausal LN-, postmenopausal |
Tam 20 mg 5 yr adjuvant (N = 667) vs Tam 20 mg after relapse (N = 656) |
Tam > no treatment DFS/RFS No impact on OS |
[29] |
| Scottish trial Tam beyond 5 yr (N = 342) | LN- (after 5 yr Tam) | Tam 20 mg (N = 173) vs No further therapy (N = 169) |
No difference except increase in endometrial cancer with Tam > 5 yr | [30, 31] |
| GROCTA trial (N = 504) | LN+, ER+ Premenopausal (N = 237) | Tam ×5 yr vs CMF × 6, E × 4 vs CMF × 6, E × 4, Tam × 5 yr |
No difference in DFS/OS between Tam and chemo in premenopausal women, except an excess of loco-regional recurrences with Tam | [32] |
| GABG study (N = 331) | LN+, ER+, <50 yr | CMF × 6 vs Tam × 5 yr |
CMF>Tam for DFS/OS | [33] |
| ECOG study (N = 533) | LN+, ER+ and ER- | chemotherapy vs chemotherapy, Tam × 5–10 yr |
Tam no treatment after chemotherapy | [34] |
| IBCSG 13-93 (N = 1,246) | LN+, pre- and perimenopausal | AC × 4, CMF × 3, Tam × 5 yr vs AC × 4, CMF × 3, no treatment |
Tam> no treatment for DFS | [35] |
NATO = Nolvadex Adjuvant Trial Organization; NSABP = National Surgical Adjuvant Breast and Bowel Project; Tam = Tamoxifen; LN = lymph node; ER = estrogen receptor; yr = years; vs = versus; N = number; PFS = progression free survival; OS = overall survival; DFS = disease free survival; decr = decrease; RR = relapse rate; RFS = relapse free survival; GROCTA = Gynecological Adjuvant Breast Group; CMF = cyclophosphamide/metho-trexate/5-fluorouracil; E = epirubicin; DFS = disease-free survival; GABG = Gynecological Adjuvant Breast Group; ECOG = Eastern Cooperative Oncology Group; IBCSG = International Breast Cancer Study Group; AC = Doxorubicin/Cyclophosphamide