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. 2017 Aug 3;7:156. doi: 10.3389/fonc.2017.00156

Table 2.

Neoadjuvant trials that have assessed tumor-infiltrating lymphocytes (TILs).

Trial Treatments Subtype n pCR
GeparDuo (35)
  • Doxorubicin

  • Docetaxel

  • Cyclophosphamide

All 218 OR 1.38 of pCR per 10% iTILs (95% CI: 1.08–1.78, P = 0.012)
GeparTrio (35)
  • Doxorubicin

  • Docetaxel

  • Cyclophosphamide

  • Vinorelbine

  • Capecitabine

All 840 OR 1.21 of pCR per 10% iTILs (95% CI: 1.08–1.35, P = 0.001)
NeoALTTO (38)
  • Trastuzumab

  • Lapatinib

  • Paclitaxel

  • FEC

HER2+ 387
  • Every 1% increase in TILs was associated with a 3% decrease in the rate of an event [HR 0.97 (95% CI: 0.95–0.99; P = 0.002)]

  • pCR: TILs > 5% associated with higher pCR rates [OR 2.60 (95% CI: 1.26–5.39; P = 0.01)]

GeparQuattro (36)
  • Epirubicin

  • Cyclophosphamide

  • Docetaxel

  • Capecitabine

  • Trastuzumab

HER2 + 156 OR 1.16 of pCR per 10% sTILs (95% CI: 1.01–1.32, P = 0.038)
CHER-LOB (37)
  • Trastuzumab and/or lapatinib

  • Paclitaxel

  • FEC

HER2+ 105 Each 10% increase in iTIL and sTIL associated with a higher probability of a pCR (adjusted OR: 2.64, 95% CI: 1.46–4.79, P = 0.001 and 1.32 95% CI: 1.08–1.6, P = 0.006, respectively)
GeparSixto (19)
  • Paclitaxel

  • Liposomal doxorubicin

  • Carboplatin

  • Bevacizumab

  • Trastuzumab

HER2+ and TNBC 580
  • OR 1.2 of pCR per 10% sTILs (95% CI: 1.11–1.29, P < 0.001)

  • Significant test for interaction between increased TILs and response to carboplatin therapy

GeparQuinto (39)
  • Epirubicin

  • Cyclophosphamide

  • Taxane

  • Everolimus

ER+ and TNBC 313 OR 1.2 of pCR per 10% sTILs (95% CI: 1.0–1.3, P = 0.01)
EORTC 10994 and BIG 00–01 (40)
  • FEC

  • Docetaxel

ER- 111
  • High gTILs: pCR 74.2%

  • Low gTILs: pCR 31.3%

  • OR 6.42 of pCR for high versus low gTILs (95% CI: 2.08–19.83, P = 0.001)

Total patients 2,710

pCR, pathological complete response; iTIL, intratumoral TIL; sTIL, stromal TIL; gTIL, gene expression surrogate TIL.