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Ovarian cancer is an immune reactive malignancy with a complex immune suppressive network that blunts successful immune eradication. This suppressive microenvironment may be mediated by recruitment or induction of CD4 +  regulatory T cells (Tregs). Our study sought to investigate the association of tumor-infiltrating CD4 + CD25 + FOXP3 +  Tregs, and other immune factors, with clinical outcome in serous ovarian cancer patients. We performed immunofluorescence and quantification of intraepithelial tumor-infiltrating triple positive Tregs (CD4 + CD25 + FOXP3 + ), as well as CD4 + CD25 + FOXP3 - , CD3 +  and CD8 +  T cells in tumor specimens from 52 patients with high stage serous ovarian carcinoma. Thirty-one of the patients had good survival (i.e. > 60 months) and 21 had poor survival of < 18 months. Total cell counts as well as cell ratios were compared among these two outcome groups. The total numbers of CD4 + CD25 + FOXP3 +  Tregs, CD4 + CD25 + FOXP3 - , CD3 +  and CD8 +  cells were not significantly different between the groups. However, higher ratios of CD8 + /CD4 + CD25 + FOXP3 +  Treg, CD8 + /CD4 +  and CD8/CD4 + CD25 + FOXP3 -  cells were seen in the good outcome group when compared to the patients with poor outcome. These data show for the first time that the ratios of CD8 +  to both CD4 + CD25 + FOXP3 +  Tregs and CD4 + CD25 + FOXP3 -  T cells are associated with disease outcome in ovarian cancer. The association being apparent in ratios rather than absolute count of T cells suggests that the effector/suppressor ratio may be a more important indicator of outcome than individual cell count. Thus, immunotherapy strategies that modify the ratio of CD4 + CD25 + FOXP3 +  Tregs or CD4 + CD25 + FOXP3 -  T cells to CD8 +  effector cells may be useful in improving outcomes in ovarian cancer.

The Ratios of CD8+ T Cells to CD4+CD25+ FOXP3+ and FOXP3- T Cells Correlate with Poor Clinical Outcome in Human Serous Ovarian Cancer