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. 2020 Jun 5;15(3):208–216. doi: 10.1159/000508758

b Relevant adjuvant studies

Trial Design Histology Chemotherapy Median
TILs
LPBC Tumors with LPBC phenotype Outcome (per 10% increase in lymphocye infiltration) Other outcomes
Loi [52], 2013: patients from the BIG 02-98 trial Retrosp. TNBC Doxorubicin −> CMF or doxorubicin + CP −> CMF vs. doxorubicin + docetaxel −> CMF or doxorubicin −> docetaxel followed by CMF 10%
(sTILS)
2% (iTILS)
>50% 10.6% 17% reduction in the risk of relapse
27% reduction in the risk of death
5-year DFS: 92.3% LPBC vs. 61.9% non-LPBC
5-year OS: 92.3% LPBC vs. 71.0% non-LPBC

Loi [53], 2014: patients from the FinHER trial Retrosp. TNBC Docetaxel or VNR ×3 −> FEC ×3 >50% 14.3% 21% reduction in the risk of distant recurrence
20% reduction in the risk of death

Adams [54], 2014: patients from ECOG 2197 and ECOG 1199 trials Retrosp. TNBC E2197: doxorubicin + CP vs. docetaxel ×4 E1199: doxorubicin + CP ×4 −> different taxane regimens 10%
(sTILS)
0% (iTILS)
>50% 4.4% 18% reduction in the risk of distant recurrence
19% reduction in the risk of death

Pruneri [55], 2016: from the IEO Breast Cancer Database Retrosp. TNBC CMF or CMF + AC 20% >50% 21.9% 21% reduction in the risk of distant recurrence
21% reduction in the risk of death
10-year DFS (LPBC) 71%
10-year DDFS (LPBC) 84%
10-year OS (LPBC) 96%

Kotoula [56], 2016: patients from 4 prospective trials Retrosp. TNBC Anthracycline − taxane regimens 7% sTILS (all tumors) >50% 26% 7-year DFS: 96.3%
(LPBC) vs. 72.8%
(non-LPBC)
7-year OS: 100%
(LPBC) vs. 76.3%
(non-LPBC)

sTILs, stromal tumor-infiltrating lymphocytes; iTIL, intratumoral tumor-infiltrating lymphocytes; DD, dose dense; CP, cyclophosphamide; TAC, docetaxel, doxorubicin, and cyclophosphamide; VNR, vinorelbine; CBDCA, carboplatin; CMF, cyclophosphamide, methotrexate, and fluorouracil; FEC, fluorouracil, epirubicin, and cyclophosphamide; AC, Adriamycin and cyclophosphamide; pCR, pathological complete response; DFS, disease-free survival; DDFS, distant DFS; OS, overall survival.