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. 2012 Feb 24;6(2):222–236. doi: 10.1016/j.molonc.2012.02.003

Table 2.

Summary of selected adjuvant hormonal therapy studies with tamoxifen

Intervention Trial Patient characteristics Regimen Benefit Notes
Tamoxifen ABCSG‐5 (Jakesz et al., 2002) N =1034 CMF×6 (iv) vs. Goserelin×3 years plus Tam×5 years Premenopausal ER and/or PR+ Stage I or II RR for relapse: 1.4 favoring hormonal treatment, P=0.037 RR for OS: not significant, P=0.195
IBCSG 13–93 (IBCSG, 2006) N =1246 Premenopausal Node+ER+ or − Chemo (AC/EC×4→CMF×3)vs. Chemo+Tam For ER+: HR for DFS 0.59, P<0.0001 HR for survival 0.86, P=0.36 For ER−: HR for DFS 1.02, P=0.89 HR for survival 0.92, P=0.63 Benefit in DFS only if ER+ with Tam after chemo
NSABP B‐14 (Fisher et al., 1996) N =2818 ER+ Node (−) Tam vs. Placebo 10 year follow‐up DFS: RR=0.66 favoring Tam OS: RR=0.84 Favoring Tam Advantage found to discontinue Tam after 5 years; Detriment to disease‐free survival for >5 years Tam
EORTC (Morales et al., 2007) N =1724 Pre‐ and postmenopausal Stages I–IIIA ER/PR+ or − CMF or anthracycline vs. chemo→Tam For all patients: HR for RFS favoring Tam 0.84, P=0.0349 HR for OS 0.97, P=0.7377 For ER/PR+: 5‐year RFS on Tam 77%, 70% control, P=0.014
EBCTCG, 2011 N =21,712 All studies with duration of Tam at least 2–3 years Benefit to Tam in reduction of risk of recurrence: RR=0.53 Benefit in survival: RR=0.71 Benefit to tamoxifen seen in weakly ER+, but not ER− Benefit to tam is independent of: Age, nodes, tumor grade or size, and use of chemotherapy