. 2017 Feb 17;163(1):177–190. doi: 10.1007/s10549-017-4160-5

Table 1.

Baseline patient and tumor characteristics

Treatment	Study 1^a	Study 2^a	Study 3A^b	Study 3B^b
Treatment	Doxorubicin	FUMI	Epirubicin	Paclitaxel
Patients	90	34	119	121
Accrual	1991–1997	1993–2001	1997–2003	1997–2003
Age (years)
Range	32–88	37–82	28–70	25–70
Median	64	67	49	48
T stage
T2^c	3	2	1	1
T3	54	15	99	90
T4	33	17	18	30
N stage
N0^d	30	9	52	45
N1	34	14	48	59
N2	26	11	17	17
N3	0	0	1	0
M stage
M0	78	24	109	106
M1	12	10	10	15
ER
Negative	13^e	11^e	52	49
Positive	77	23	66	69
Unknown	0	0	1	3
HER2
Negative^f	24	27	63	66
Positive	6	6	30	28
Unknown	60	1	26	27
TP53
TP53 wt^g	64	16	84	89
TP53 mut.	26	18	23	25
Unknown	0	0	12	7
Response^h
PD	5	9	10	14
SD	45	13	49	47
PR	31	10	56	47
CR	0	0	4	5
Unknown	0	0	0	8
TMAⁱ
Stage 3	0	0	88	81
Stage 4	0	0	7	11
RNA/DNA^j
Stage 3	71	22	90	99
Stage 4	10	10	9	14
PTEN ^k
PTEN wt	0	0	80	99
PTEN mut.	0	0	2	2
Unknown	0	0	27	4
PIK3CA ^l
PIK3CA wt	26	20	82	92
PIK3CA mut.	4	12	25	22
Unknown	51	0	12	7

^aData from Studies 1–2 were pooled for statistical analysis due to a low number of patients in Study 2

^bData from Study 3 were split into Study 3a (epirubicin) and 3b (paclitaxel), based on the primary chemotherapy given

^cT2 tumors only included if axilla stage N2. T stage and all subsequent tumor characteristics given for stage 3 and 4 combined

^dN stage by clinical assessment alone

^eER negative if tumor ER concentration <10 fmol/mg in Study 1–2. ER assessed by standard IHC in Study 3

^fFor Studies 1–2; HER2 assessment available from a subset of the tumors by in situ hybridization only. For Study 3: HercepTest IHC was performed on all tumors, and HER2 in situ hybridization for tumors with staining score 2 by IHC

^g TP53 mutation status, whole exome assessed by Sanger sequencing. wt wild-type, mut mutation

^hProgressive disease (PD), stable disease (SD), partial response (PR), complete response (CR)

ⁱSubset of patients from whom formalin-fixed paraffin-embedded (FFPE) tumor tissue was available for protein analysis to correlate against gene expression results (PTEN), response rates (stage 3 and 4 disease), or survival (stage 3 only)

^jSubset of patients from whom tumor RNA was available for gene expression analysis to correlate against response rates (stage 3 and 4 disease) or survival (stage 3 only)

^kSubset of patients from whom tumor DNA was available for PTEN mutation analysis

^lSubset of patients from whom tumor DNA was available for PIK3CA mutation analysis to correlate against response rates (stage 3 and 4 disease) or survival (stage 3 only)