Neoadjuvant endocrine therapy: A potential strategy for ER-positive breast cancer

Table 1 Neoadjuvant endocrine therapy and neoadjuvant chemo-endocrine therapy as potential approaches in the neoadjuvant settings

Clinical trial	Treatment arms (n)	Duration	Primary endpoint	ORR	BCS rate
Semiglazov et al[16], 2007	(A) NAE: EXE 25 mg/d or ANA 1 mg/d (121); (B) NAC: doxorubicin 60 mg/m2 pluspaclitaxel 200 mg/m2 (118)	3 mo	OR by clinical palpation	64% vs 64% (P > 0.5)	33% vs 24 (P = 0.58)
Alba et al[5], 2012	(A) NAE: EXE 25 mg/d (41-47); (B) NAC: Epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 then docetaxel 100 mg/ m2 (EC-T) (41-48)	24 wk	OR by MRI	48% vs 66% (P = 0.075)	56% vs 47 (P = 0.2369)
Palmieri et al[17],2014 (NEOCENT)	(A) NAE: LET 2.5 mg/d (22); (B) NAC: 5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 (FE100C) (22)	18-23 wk	OR by ultrasound and mammography	59.1% vs 54.5% (P = 0.32)
Nakayama et al[18], 2018 (Neo-ACET BC)	(A) NAE: ANA 1mg/d (29); (B) NCET: ANA 1mg/d plus tegafur/uracil (UFT) 270 mg/m2 (28)	24 wk	OR by MRI and CT	39.3% vs 14.3% (P = 0.0683)
Sato et al[19], 2018	(A) NAE: EXE 25mg/d (14); (B) NCET: EXE 25 mg/d plus cyclophosphamide 50 mg/d (42)	24 wk	OR by clinical palpation	85% vs 54% (at weeks 24); 71% vs 71% (at weeks 36)	No increased rate shown
Mohammadianpanah et al [20], 2012	(A) NCT: 5-fluorouracil 600 mg/m2, doxorubicin 60 mg/m2, and cyclophosphamide 600 mg/m2 (FAC) (51); (B) NCET: letrozole 2.5 mg/d plus FAC (50)	9–13 wk	OR by clinical palpation	10.2% vs 25.5% (P = 0.049)
Yu et al[21], 2019 (CSCSG-036)	(A) NCT: EC-T or FEC-T (124); (B) NCET: letrozole 2.5 mg/d plus EC-T or FEC-T (Tleuprorelin) (125)	8-9 wk	OR by MRI	72.6% vs 84.8% (P = 0.02)

NAE: Neoadjuvant endocrine therapy; NAC: Neoadjuvant chemotherapy; NCET: Neoadjuvant chemo-endocrine therapy; EXE: Exemestane; ANA: Anastrozole; LET: Letrozole; OR: Objective response; BCS: Breast-conserving surgery.