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

Table 2 The optimal duration and optimal endocrine agents of neoadjuvant endocrine therapy

Clinical trial	Patient characteristics	Treatment arms (n)	Duration	Primary endpoint	ORR	BCS rate
Krainick-Strobel et al[23], 2008	ER+ and/or PR+; Postmenopausal	LET 2.5 mg/d (33)	4-8 mo	OR by clinical palpation, mammography, ultrasound, and BCS	55% vs 24% at 4 and > 4 mo	71% vs 80% at 4 and > 4 mo
Fontein et al[25], 2014	ER+; Postmenopausal	EXE (102)	3 mo vs 6 mo	OR by clinical palpation at 3 and 6 months	58.7% vs 68.3%	61.8% vs 70.6% (P = 0.012)
Carpenter et al[22], 2014	ER+ and/or PR+; Postmenopausal	LET 2.5 mg/d (146)	3–12 mo	Optimal duration to permit BCS	-	7.5 mo
Eiermann et al[7], 2001 (PO24)	ER+ and/or PR+; Postmenopausal	(A) LET 2.5 mg/d (162); (B) TAM 20 mg/d (223)	4 mo	OR by clinical palpation	55% vs 36% (P < 0.001)	45% vs 35% (P = 0.022)
Smith et al [26], 2005 (IMPACT)	ER+; Postmenopausal	(A) ANA 1 mg/d (113); (B) TAM 20 mg/d (108)	12 wk	OR by ultrasound	37% vs 36% (P < 0.087)	41% vs 31% (P = 0.23)
Catalioth et al[27], 2006 (PROACT)	ER+ and/or PR+; Postmenopausal	(A) ANA 1 mg/d (228); (B) TAM 20 mg/d (223)	3 mo	OR by ultrasound	50.0% vs 46.2% (P = 0.037)	38.1% vs 29.9% (P = 0.11)
Semiglazov et al[16], 2015	ER+ and/or PR+; Postmenopausal	(A) EXE (76); (B) TAM (75)	3 mo	OR by clinical palpation	76.3% vs 40% (P = 0.05)	36.8% vs 20% (P = 0.05)
Kuter et al[29], 2012 (NEWEST)	ER+; Postmenopausal	(A) FUL 500 mg/mo (109); (B) FUL 250 mg/mo (102)	16 wk	Expression of Ki67	17.4 vs 11.8% at week 4; 22.9 vs 20.6% at week 16	-
Quenel-Tueux et al[30], 2015	ER+; Postmenopausal	(A) ANA 1 mg/d (61); (B) FUL 500 mg/mo (59)	6 mo	OR by clinical palpation	58.9% vs 53.8%	58.9% vs 50%
Guarneri et al[31], 2014 (CARMINA 02)	ER+ and/or PR+ Her2-; Postmenopausal	(A) ANA 1 mg/d (59); (B) FUL 500 mg/mo (57)	6 mo	OR by clinical palpation	52.6% vs 36.8%	57.6% vs 50% (P = 0.5 not significant)
Ellis et al[32], 2011 (ACOSOG Z1031)	ER+ (Allred score 6-8) postmenopausal T2-T4cN0-3M0	(A) EXE 25 mg/d(124); (B) LET 2.5 mg/d (128); (C) ANA 1 mg/d(125);	16-18 wk	OR by clinical palpation	69.1% vs 62.9% vs 74.8%	45.2% vs 40% vs 48.7%
Torrisi et al[33], 2007	ER+ T2-T4N0N2; premenopausal	LET 2.5 mg/d plus GnRHa 11.25 mg/3 mo (32)	4 mo	OR by clinical palpation	50%	47%
Masuda et al [34], 2012 (STAGE)	ER+ and/or PR+ Her2-; Premenopausal	(A) ANA 1 mg/d (goseretin 3.6 mg/mo) (98); (B) TAM 20 mg/d (goseretin 3.6 mg/mo) (99)	24 wk	OR by ultrasound	70.4% vs 50.5% (P = 0.004)	85.7% vs 67.6%
Dellapasqua et al[35], 2019 (TREND)	ER+ and/or PR+ Her2-; Premenopausal	(A) Triptorelin + letrozole (26); (B) degarelix + letrozole (25)	6 mo	Time to optimal OFS	46.2% vs 44.0%	52.2% vs 42.3%

ER: Estrogen receptor; PR: Progesterone receptor; EXE: Exemestane; ANA: Anastrozole; LET: Letrozole; FUL: Fulvestrant; TAM: Tamoxifen; OR: Objective response; OFS: Ovarian function suppression; BCS: Breast-conserving surgery.