Current status of therapy for breast cancer worldwide and in Japan

Table 1 Phase III trial of nanoparticle albumin-bound paclitaxel (ABI-007) compared with polyethylated castor oil-based paclitaxel (standard paclitaxel) in women with breast cancer

Response	No. of patients/total No. ofpatients (%)		P
	ABI-007 (260 mg/m2)	Paclitaxel (175 mg/m2)
Complete and partial response
All patients	76/229 (33)	42/225 (19)	0.001
First-line therapy	41/97 (42)	24/89 (27)	0.029
Second-line or greater therapy	35/132 (27)	18/136 (13)	0.006
Prior anthracycline therapy
Adjuvant and/or metastatic	60/176 (34)	32/175 (18)	0.002
Metastatic only	31/115 (27)	18/130 (14)	0.010
Dominant metastatic organ site
Visceral	59/176 (34)	34/182 (19)	0.002
Non-visceral	17/50 (34)	8/43 (19)	NS
Age (yr)
< 65	68/199 (34)	36/193 (19)	< 0.001
≥ 65	8/30 (27)	6/32 (19)	NS

NS: Not significant statistically. Response rates (33% vs 19%, P = 0.001). (Source: Table 2 in reference 12).

Table 2 Molecule targeted therapeutic drugs

Target	Drug name
HER2	Trastuzumab
HER1/2	Lapatinib
HER2 (dimerization domain) (Pertuzumab inhibits the dimerization of the HER2 with other HER family receptors)	Pertuzumab
HER1/2/4	Neratinib
VEGF	Bevacizumab
Multi target (VEGFR, PDGFR etc)	Axitinib, sunitinib, pazopanib

HER: Human epidermal growth factor receptor; VEGF: Vascular endothelial cell growth factor; VEGFR: VEGF receptor; PDGFR: Platelet-derived growth factor receptor.

Table 3 Adjuvant trials of trastuzumab

Trial	Regimen	DFS	OS
HERA[11]	CT alone	36% events reduction, HR = 0.64,	2HR = 0.66, P = 0.0115 at 2 yr
	CT + H 1 yr	P < 0.0001 at 2 yr
NSABP B-31 and	AC × 4 → P × 4	52% events reduction, HR = 0.48,	33% mortality reduction;
NCCTG N-9831[12]	AC × 4 → P × 4 + H1	P < 0.0001 at 2 yr	HR = 0.66, P = 0.015 at 2 yr
BCIRG 006[13]	AC × 4 → T × 4	HR = 0.61, P < 0.00013	HR = 0.59, P < 0.0043
	AC × 4 → T × 4 + H2	HR = 0.67, P = 0.00033	HR = 0.66, P = 0.00173
	T + Carbo × 6 + H2	At 3 yr	At 3 yr

AC: Doxorubicin + cyclophosphamide; BCIRG: Breast Cancer International Research Group; Carbo: Carboplatin; CT: Chemotherapy; DFS: Disease-free survival; FEC: Fluorouracil + epirubicin + cyclophosphamide; FinHer: Finland Herceptin; H: Trastuzumab; HERA: Herceptin Adjuvant; HR: Hazard ratio; NCCTG: North Central Cancer Treatment Group; NSABP: National Surgical Adjuvant Breast and Bowel Project; OS: Overall survival; P: Paclitaxcel; T: Docetaxel.

¹Total of 52 wk beginning with paclitaxel;

²Weekly during docetaxel treatment and then every 3 wk for 1 year;

³Compared with AC × 4 → T × 4.