Therapeutic options for HER-2 positive breast cancer: Perspectives and future directions

Table 1 Selected clinical trials in the adjuvant setting for human epidermal growth factor receptor-2 positive breast cancer

Drug or studyname	Populationincluded	No. ofpatients	Comparison	Medianfollow-up	DFS	OS	CHF/Drop LVEF	Ref.
Trastuzumab (H)
NCCTG N9831	LN (+) or	1087	AC → T vs		71.8% (5-yr)	88.4% (5-yr)	0%/0%	Perez et al[14]
	high risk LN (-)	949	AC → T → H (52 wk) vs AC	72 mo	80.1% (5-yr)	89.7% (5-yr)	2.2%/7%
		954	→ TH (H then 40 wk)		84.4% (5-yr)	91.9% (5-yr)	1.5%/3.6%
HERA	LN (+) or	1552	Std QT → H (52 wk) vs	96 mo	75.9% (5-yr)	86.9% (5-yr)	1%/7.2%	Goldhirsch et al[16]
	high risk LN (-)	1553	Std QT → H (104 wk) vs		76.5% (5-yr)	88.7% (5-yr)	0.8%/4.1%
		1697	Std QT → Observation		70.0% (5-yr)	84.5% (5-yr)	0.1%/0.9%
FINHER	LN (+) or	58	Docetaxel → FEC vs	62 mo	74.1% (5-yr)	82.0% (5-yr)	1.7%/10.5%	Joensuu et al[18]
	high risk LN (-)	58	Vinorelbine → FEC vs		72.0% (5-yr)	82.8% (5-yr)	(QT only)
		54	Docetaxel + H → FEC vs		92.5% (5-yr)	94.4% (5-yr)	0.9%/6.8%
		61	Vinorelbine + H → FEC		75.2% (5-yr)	88.4% (5-yr)	(QT + H)
BCIRG 006	LN (+) or	1073	AC → Docetaxel vs	65 mo	75% (5-yr)	87% (5-yr)	0.7%/11.2%	Slamon et al[19]
	high risk LN (-)	1074	AC → Docetaxel + H vs		84% (5-yr)	92% (5-yr)	2.0%/18.6%
		1075	TCH		81% (5-yr)	91% (5-yr)	0.4%/9.4%
PACS 04	LN (+)	260	FE100C or ED75 → Obser vs	62 mo	77.9% (3-yr)	96% (3-yr)	0.3%/14.2%	Spielmann et al[20]
		268	FE100C or ED75 → H		80.9% (3-yr)	95% (3-yr)	1.5%/35.4%
PHARE	HER-2 (+) early breast cancer	1690	Std QT → H (26 wk) vs	42.5 mo	91.1% (2-yr)	96.1% (2-yr)	5.7% (both)	Pivot et al[21]
		1690	Std QT → H (52 wk)		93.8% (2-yr)	94.5% (2-yr)	1.9% (both)
Lapatinib (L)
TEACH	Stage I-IIIc – H naïve	1230 (HER-2 +)	Std QT → L (52 wk) vs	47.4 mo	87% (4-yr)	94% (4-yr)	3.0% (both)	Goss et al[22]
		1260 (HER-2 +)	Std QT → Observation	48.3 mo	83% (4-yr)	94% (4-yr	3.0% (both)

LN: Lymph nodes; AC → T: Adriamycin cyclophosphamide paclitaxel; FEC: 5-FU epirubicin cyclophosphamide; ED: Epirubicin docetaxel; Std QT: Standard chemotherapy; OS: Overall survival; DFS: Disease free survival; CHF: Cardiac heart failure; LVEF: Left ventricular ejection fraction.