Interaction of host immunity with HER2-targeted treatment and tumor heterogeneity in HER2-positive breast cancer

Griguolo, Gaia; Pascual, Tomás; Dieci, Maria Vittoria; Guarneri, Valentina; Prat, Aleix

doi:10.1186/s40425-019-0548-6

Table 1 Neoadjuvant trials with trastuzumab-containing regimens which assessed the prognostic values of TILs and immune related gene signatures

From: Interaction of host immunity with HER2-targeted treatment and tumor heterogeneity in HER2-positive breast cancer

Study	Treatment	N. pts.^a	Biomarker Tested	Outcome Tested	Association
CALGB 40601 [100] NCT00770809	P-H P-L P-HL	265	Immune gene signatures [100]	pCR	IgG signature independently associated with pCR at multivariate analysis
CherLOB [55] NCT00429299	P-H → FEC-H P-L → FEC-L P-HL → FEC-HL	105	TILs [55]	pCR	Associated with pCR at univariate analyses (no statistical significance beyond PAM50)
		105	TILs [55]	EFS	Associated with EFS at univariate analyses
		86	Immune gene signatures [55]	pCR	3 out of 4 signatures maintained association with pCR after correction for PAM50
GeparQuattro [57] NCT00288002	EC-H → D-H +/−X	178	TILs [57]	pCR	Associated with pCR at multivariate analysis
GeparQuinto [57] NCT00567554	EC-H → D-H	162	TILs [57]	pCR	Associated with pCR at multivariate analysis
GeparQuinto [57] NCT00567554	EC-L → D-L	158	TILs [57]	pCR	Not associated with pCR
GeparSixto [38] NCT01426880	PM-HL +/− C	266	TILs [38]	pCR	Associated with pCR at multivariate analyses
GeparSixto [38] NCT01426880	PM-HL +/− C	226	mRNA expression of immunologic genes	pCR	All 12 immune mRNA markers were associated with pCR (10/12 at multivariate analysis)
NeoALTTO [58] NCT00553358	P-H P-L P-HL	387	TILs [58]	pCR	Associated with pCR at multivariate analysis
		387	TILs [58]	EFS	Associated with EFS at multivariate analysis
		254	Immune gene signatures [59]	pCR	two T-cell immune signatures were associated with pCR (only confirmed at multivariate analysis in P-HL arm)
NOAH [75] ISRCTN86043495	AP → P → CMF	51	Four immune metagenes [45]	pCR	Not associated with pCR
NOAH [75] ISRCTN86043495	AP-H → P-H → CMF-H → H	63	Four immune metagenes [45]	pCR	3/4 associated with pCR
NeoSphere [45] NCT00545688	DH DPrtz DHPrtz HPrtz	243	TILs [45]	pCR	Not significantly associated with pCR
		305	PDL1 by IHC [45]	pCR	Not significantly associated with pCR
		337	Immune genes and metagenes [45]	pCR	5 associated with pCR at multivariate analysis (different results in the DHPrtz arm)
Tryphaena [44] NCT00976989	FEC → DHPrtz FECHPrtz→DHPrtz CycloDHPrtz	213	TILs [43]	pCR	Not significantly associated with pCR
		213	TILs [43]	EFS	Associated with EFS at multivariate analysis
		173	Immune signatures and genes [43]	pCR	2 signatures and 4 genes associated with pCR at multivariate analysis
		173	Immune signatures and genes [43]	EFS	Not associated with EFS at multivariate analysis
PAMELA [9] NCT01973660	HL	134	TILs at day15	pCR	Associated with pCR at multivariate analysis

^a Number of patients included in the biomarker analysis
A doxorubicin, C carboplatin, Cyclo cyclophosphamide, CMF cyclophosphamide-methotrexate-fluorouracil, D docetaxel, EC epirubicin-cyclophosphamide, EFS event-free survival, FEC fluorouracil-epirubicin-cyclophosphamide, H trastuzumab, IHC immunohistochemistry, L lapatinib, P paclitaxel, pCR pathologic complete response, PM weekly paclitaxel + non pegylated liposomal doxorubicin, Prtz pertuzumab, TIL tumor infiltrating lymphocytes, X capecitabine
Data from the GeparQuattro trial and from the EC-H→D-H arm of the GeparQuinto trial were analyzed jointly

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