High efficacy of pre-operative trastuzumab combined with paclitaxel following doxorubicin & cyclophosphamide in operable breast cancer

Figures & data

Table I.  Distribution of patients’ characteristics at diagnosis.

	Chemotherapy alone (N = 37)	Chemotherapy plus trastuzumab (N = 24)	Overall P
Mean age (range, years)	49 (29-68)	49 (29-66)	0.5
Menopausal Status (N,%)
Pre-menopausal	18 (49)	12 (50)	0.41
Post-menopausal	19 (51)	12 (50)
Histology (N,%)
IDC*	34 (92)	22 (92)	0.9
Other	3 (8)	2 (8)
Clinical T stage (N,%)
Tx	1 (3)	2 (8)	0.19
T1	3 (8)	2 (8)
T2	10 (27)	11 (46)
T3	14 (38)	8 (34)
T4	9 (24)	1 (4)
Clinical Nodal (N,%)			0.4
Node negative	9 (24)	4 (17)
Node positive	28 (76)	20 ( 83)
HR** Status (N,%)			0.05
Positive	24 (65)	9(37)
Negative	13 (35)	15 (63)

*IDC: Invasive duct carcinoma; **HR: hormone receptor.

Table II.  Response to therapy.

	Chemotherapy Alone (N,%)	Chemotherapy and Trastuzumab (N,%)	Overall P
cCR*	12 (32)	19 (79)	0.0006
pCR†	9 (24)	18 (75)	0.0002
pCR in breast	10/36†† (28)	18 (75)	0.0005
pCR in lymph nodes**	8/28 (29)	19/20 (95)	0.0001
Breast conserving surgery	25 (68)	18 (75)	0.38

*cCR, clinical complete response; † pCR, pathological complete response; †† calculated per number of patients with clinically T1-4 pre-treatment; **calculated per number of patients with pre-treatment biopsy proven positive lymph nodes pre-treatment.

Table III.  Adverse events (total number of incidents in study).

	Chemotherapy Alone	Chemotherapy and Trastuzumab
	N = 37	N = 24
Treatment delays	2	2
Dose reductions	1	3
Protocol adjustments	5	0
Incidents of grade 3–4 Non-hematologic toxicity	7	8
Incidents of grade 3–4 hematologic toxicity	3	4
Incidents of febrile neutropenia	3	3
Mean pre-trastuzumab LVEF	N/A	64%
Mean post-trastuzumab LVEF	N/A	63%
LVEF reduction of ≥ 10% (N,%)	N/A	5 (21)
LVEF reduction to <50%	0	0
Symptomatic congestive heart failure	0	0

Table IV.  Summary of published trials of pre-operative trastuzumab.

	Inclusion criteria (staging)	Pre-operative Treatment	Week on Trastuzumab	Number of patients	pCR
Current study	I-IIIB	AC-T	–	37	24%
		AC-T-H	12	24	75%
Buzdar et al. [16]	II-IIIA	T-FEC	–	19	25%
		T-FEC-H	24	23	67%
Burstein et al. [17]	II-III	TH	12	40	18%
Limentani et al. [18]	IIB-IIIB	DV-H	12	31	39%
Gennari et al. [19]	II-IIIA	H	4	11	9%
Coudert et al. [20]	II-IIIA	DH	18	33	47%
Hurley et al. [21]	III	DP-H	12	48	23%
Coudert et al. [22]	II-IIIA	DC-H	18	72	39%

Abbreviations: T, paclitaxel; FEC, fluorouracil, epirubicin, cyclophosphamide; H, trastuzumab; DV, docetaxel, navelbine; DH, docetaxel, trastuzmab, DP, docetaxel, cisplatin; DC, docetaxel, carboplatin; pCR, pathological complete response; N/A, not applicable.