Table 3.

Selected studies assessing the role of TILs in metastatic HER2-positive breast cancer

Trial	Sample size in TIL analysis	Regimen	TIL cut-off	Association with PFS	Association with OS
CLEOPATRA65	678	TH ± P	Continuous variable (10% increase)	✕	✓
MA.3166	614	T + H versus L	5%	✓a	N/A
PANACEA69	50	H + pembrolizumab	Continuous variable (1% increase)	✓	N/A
KATE280	190	T-DM1 ±atezolizumab	5%	✓	N/A

Green: positive association, red: negative association, gray: not studied/not applicable.

H, trastuzumab; HL, trastuzumab + lapatinib; OS, overall survival; P, pertuzumab; PFS, progression-free survival; sTIL, stromal tumor-infiltrating lymphocyte; T-DM1, trastuzumab emtansine; TH, trastuzumab + docetaxel.

^aOnly for tumors with low CD8+ sTILs.