Table 1. Baseline Characteristics of Included Studies.

Authors and published years	Data collection	Pts No	Country of origin	Ethnicity	pCR definition	Cut-off value	Assay	Marker	Time	Location	Neoadjuvant regimen
Ladoire et al. 2008 [27]	Retrospective	56	France	Europe	ypT0	Scores>0	IHC	CD3, CD8, FOXP3	Pre-,post-NAC	IS	CEF,CEX, H,,DC
Aruga et al. 2009 [24]	Retrospective	87	Japan	Asia	Japanese criteria	Median	IHC	FOXP3	Pre-,post-NAC	IS	CEF,EC,EC-T,CEF-T
Denkert et al. 2010a [25]	Prospective	218	Germany	Europe	ypT0/TisypN0	10%,LPBC,10% INC	H&E	TILs	Pre-NAC	IS,SS	EC-T
Denkert et al. 2010b [25]	Prospective	840	Germany	Europe	ypT0/TisypN0	10%,LPBC,10% INC	H&E, IHC	TILs, CD3	Pre-NAC	IS,SS	TAC, NX
West et al. 2011 [33]	Prospective	113	Europe	Europe	Not clear	upper quartile	Gene-signature	TILs	Pre-NAC	BS	CEF,TET
Oda et al. 2012 [30]	Retrospective	180	Japan	Asia	ypT0 ypN0	median	IHC	CD8, FOXP3	Pre-,post-NAC	IS	CEF-T
Ono et al. 2012 [31]	Retrospective	180	Japan	Asia	ypT0	score>2	H&E	TILs	Pre-NAC	BS	AC,ACT,CEF,AT, CEF-T
Yamaguchi et al. 2012 [34]	Retrospective	68	Japan	Asia	ypT0	Score>1	H&E	TILs	Pre-NAC	BS	CEF-T
Liu et al. 2012 [28]	Retrospective	132	China	Asia	ypT0	median	IHC	FOXP3	Pre-,post-NAC	SS	CEF,CEX
Seo et al. 2013 [32]	Retrospective	153	Korea	Asia	ypT0 ypN0	median	IHC	CD4,CD8, FOXP3	Pre-NAC	IS	AC,AC-T,AD
Lee et al. 2013 [42]	Retrospective	175	Korea	Asia	ypT0 ypN0	10%,10% INC	IHC	CD3,CD8,FOXP3	Pre-NAC	SS	AT,AC-T,H
Loi et al. 2013 [43]	Retrospective	156	Germany	Europe	ypT0, ypTis	10% INC	H&E	TILs	Pre- NAC	SS	EC-TX, H,EC-T
Denkert et al. 2013 [41]	Prospective	580	Germany	Europe	ypT0ypN0	LPBC,10% INC,	H&E	TILs	Pre-NAC	IS,SS	PM+/−Cb,Bev,H,L
Issa-Nummer et al. 2013 [26]	Prospective	313	Germany,Switzerland	Europe	ypT0ypN0	10% INC	H&E	TILs	Pre- NAC	IS,SS	EC-T,Bev,EVE, L

Abbreviations: pts, patients; IHC, immunohistochemistry; HE, staining Hematoxylin-eosin staining; FOXP3, regulatory T-lymphocytes expressing forkhead box P 3 protein; NAC, neoadjuvant chemotherapy; CEF, cyclophosphamide/epirubicin/fluorouracil; CEX, epirubicin/cyclophosphamide/capecitabine; DC, docetaxel/carboplatin; EC, epirubicin/cyclophosphamide; EC-T, epirubicin/cyclophosphamide-taxane; CEF-T, cyclophosphamide/epirubicin/fluorouracil-taxane;T AC, docetaxel/doxorubicin/cyclophosphamide; NX, vinorelbine/capecitabine; TET, docetaxel-docetaxel/epirubicin; AC, doxorubicin/cyclophosphamide; AC-T, doxorubicin/cyclophosphamide-taxane; AD, doxorubicin/docetaxel; AT, doxorubicin/taxane; EC-TX, epirubicin/cyclophosphamide-docetaxel/capecitabine; EC-T-X, epirubicin/cyclophosphamide-docetaxel-capecitabine; PM, paclitaxle/non-pegylated liposomal doxorubicin; PMCb, paclitaxle/non-pegylated liposomal doxorubicin/carboplatin; H, trastuzumab; Bev, bevacizumab; L, lapatinib; EVE, everolimus; IS =  Intratumoral sites; SS =  stromal sites;BS, both sites;10% INC, 10 increment

a, GeparDuo.

b, GeparTrio.