Table 1 Summary of previous studies on the prognostic value of TILs in ER+ breast cancer.
Study | Patient population | Treatment | Method of lymphocyte assessment | Impact of sTILs in prognosis | Impact of iTILs on prognosis |
|---|---|---|---|---|---|
Loi et al.78 | BIG 02-98 trial (n = 1078) | Adjuvant anthracycline chemotherapy ± taxane | Full face H&E sections—TILs assessed as a continuous variable | Each 10% increment in sTILs associated with worse OS (HR: 1.1, p = 0.04044) on univariate analysis | No association with DFS or OS. |
Ali et al.86 | Mixed RCT samples and clinical cohorts (n = 5961) | Variable (adjuvant) | IHC for CD8+ cells on tissue microarrays (TILs assessed as a categorical variable, present vs. not present) | No association with BCSS. | The presence of any iTILs is associated with worse BCSS (HR: 1.16; 95% CI: 1.02–1.32]). |
Association lost on multivariate analysis. | |||||
Dieci et al.87 | Two RCT cohorts (n = 463) | Adjuvant chemotherapy vs. no chemotherapy | Full face H&E sections. TILs assessed as both continuous and categorical variables. | No association with DFS or OS. | No association with DFS or OS. |
Denkert al.9 | Meta-analysis of 6 neoadjuvant trials (n = 832) | Various neoadjuvant chemotherapy regimens | Core biopsies. TILs were classified as low (0–10%), intermediate (11–59%), or high (60–100%). | Intermediate TILs were associated with worse DFS (HR: 1.50, 95% CI: 1.09–2.06) and OS (HR: 2.45, 95% CI: 1.61–3.70) vs. low TILs. | N/A |
High TILs associated with worse OS (HR: 1.79, 95% CI: 1.02–3.15) vs. low TILs. No association with DFS. | |||||
Sobral-Leite et al.88 | Retrospective analysis of a multicenter trial (n = 563) | Tamoxifen or no adjuvant therapy | IHC for CD4, CD8, and FOXP3 cells | CD4 and FOXP3 lymphocytes were not significantly associated with prognosis. Patients with high CD8 cells had an increased risk of recurrence (HR = 1.98; 95% CI: 1.14–3.41) | N/A |
