| | Study | Type | Design | Country | Clinical
Stage | Cases
(n) | Neoadjuvant
treatment | Age | Arm | HER2+
% | HR+
% | Limitations of the Study | Ref |
| MD Anderson,
2005 & 2007 | Peer reviewed | Open-label | United States | II-IIIA | 42 | CT
C | 52
48 | 23
19 | 100
100 | 56
58 | Small sample size, unoptimal imaging modalities or cancer markers used,
unclear description about building of outcome assessment, premature termination | [40, 41] |
| Pierga,
2010 | Peer reviewed | Multicentre,
open-label,
phase II | France | II-III | 120 | CT
C | 47
47 | 62
58 | 100
100 | 55
63 | Absence of long-term outcome | [42] |
| NOAH,
2010 & 2014 | Peer reviewed | Multicentre,
open-label, phase III | Europe and North America
6 counties | T3N1 or T4 or any T N2-3 | 235 | CT
C | NR | 117
118 | 100 | 35
35 | Unclear description about building of outcome assessment. | [43, 44] |
| H2269s,
2010 | Peer reviewed | Open-label | United States | T2-4 | 29 | CT
C | 50 | 15
14 | 100 | NR | Small sample size, absence of HR status data, unclear description about building of outcome assessment, different pCR definition used, absence of long-term outcome | [45, 46] |
| LPT 109096
2011 | Abstract | Multicentre,
open-label,
phase II | United States | T2-4, N0-2 | 100 | CTL
CT
CL | 49
51
51 | 33
33
34 | 100 | NR | Full-text unavailable, small sample size. | [47] |
| GeparQuinto–GBG44
2012 | Peer reviewed | Multicentre,
open-label,
phase III | Germany
| T1 pNSLN+, T2cN+, T3-4, | 615 | CT
CL | 50
50 | 309
311 | 100
100 | 55
56 | Unmasked allocation concealment, absence of long-term outcome | [48] |
| NeoALTTO,
2012 & 2014 | Peer reviewed | Multicentre,
open-label,
phase III | International
25 countries | T2-4 | 455 | CTL
CT
CL | 50
49
50 | 152
149
154 | 100
100
100 | 51
50
52 | More patients had to stop treatment due to side-effects in the lapatinib-containing groups | [49, 50] |
| CHER-LOB,
2012 | Peer reviewed | Multicentre,
open-label phase IIb | Italy
| II-IIIA | 121 | CTL
CT
CL | 49
50
49 | 46
36
39 | 100
100
100 | 61
58
62 | Small sample size, absence of HR status data, absence of long-term outcome | [51] |
| NeoSphere,
2012 & 2016 | Peer reviewed | Multicentre,
open-label, phase II | International
19 countries | T2-4 | 417 | CTL
TP
CT
CP | 50
49
50
49 | 107
107
107
96 | 100
100
100
100 | 47
47
47
48 | Not been identified | [52, 53] |
| NSABP B41,
2013 | Peer reviewed | Muticentre
open-label, phase III | North America
3 countries | T2-T3, N0-N2a | 519 | CTP
CT
CL | NR | 174
181
174 | 100
100
100 | 62
67
58 | Unmasked allocation concealment, unclear description about building of outcome assessment, | [54] |
| TRIO-US B07,
2013 | Abstract | Multicentre,
open-label,
phase II | United States | I-III | 106 | CTL
CT
CL | NR | 58
34
36 | 100
100
100 | NR | Unbalanced baseline characteristic, small sample size, absence of HR status data, absence of long-term outcome | [55] |
| ABCSG-24,
2013 | Peer reviewed | Multicentre
open-label,
phase III | Austria
| T1-4 | 93 | CT
C | 50
48 | 44
49 | 100
100 | 41
38 | Small sample size, key regimen is not used internationally, absence of long-term outcome | [56] |
| GEICAM,
2014 | Peer reviewed | Multicentre,
open-label,
phase II | Spain
| I-III or inflammatory | 99 | CT
CL | 49
48 | 50
52 | 100
100 | 60
56 | Absence of long-term outcome, small sample size | [57] |
| EORTC 10054,
2014 | Peer reviewed | Multicentre,
open-label,
phase IIb | Europe
5 countries | IIA-IIC | 122 | CTL
CT
CL | 49
47
50 | 52
53
23 | 100
100
100 | 52
52
68 | Unbalanced baseline characteristic, small sample size, premature termination, absence of long-term outcome | [58] |
| KRISTINE,
2016 | Abstract | Multicentre,
open-label, phase III | International,
11 countries | II-IIIC | 444 | MP
CTP | NR | 223
221 | 100
100 | 51
49 | Full-text unavailable | [59, 60] |
| CALGB 40601,
2016 | Peer reviewed | Multicentre,
open-label,
phase III | United States | II-III | 295 | CTL
CT
CL | 48
50
50 | 118
120
67 | 100
100
100 | 59
59
58 | Premature termination, absence of long-term outcome | [61] |
|
|
Note. C indicates chemotherapy alone; CL, chemotherapy plus lapatinib; CP, chemotherapy plus pertuzumab; CT, chemotherapy plus trastuzumab; CTL, chemotherapy plus trastuzumab plus lapatinib; CTP, chemotherapy plus trastuzumab plus pertuzumab; HER2, human epidermal growth factor receptor-2; HR, hormone receptor; MP, trastuzumab emtansine plus pertuzumab; NR, not reported; TP, trastuzumab plus pertuzumab.
|
