The likely possibility of predicting treatment outcomes of cervical lesions using serum FOXP3 and P16INK4A as shown by a cohort study in South Western Uganda

Abstract

Introduction: There is a need to assess the potential of blood-based biomarkers to detect treatment outcomes of cervical lesions. We determined the association between serum P16ink4A and FOXP3 concentrations and treatment outcomes of cervical lesions at a clinic in Southwestern Uganda. Methods: In this prospective cohort study, participants with cytologically and/or histologically confirmed cervical intraepithelial neoplasia (CIN) (n=90) and cervical cancer (CC) (n=90) were monitored for 12 months. After consent, clinical and demographic data were recorded, blood was collected, and serum P16ink4A and FOXP3 were measured (quantitative ELISA) at baseline and 12 months’ post-treatment. With multinomial logistic regression, we determined the association between treatment outcomes and serum P16ink4A and FOXP3 concentrations in STATA 17 using P-values of <0.05 as statistically significant. Results: Of the 180 participants initially enrolled, 62 returned for the 12-month follow-up assessment. At this time point, 47 participants presented with cleared lesions, 6 with persistent lesions, and 9 with progressed lesions. All participants exhibiting disease progression (n=9) were CC cases, while 82.98% (39/47) of those with cleared lesions had LSIL. For raised (>0.0545 ng/ml), relative to reduced serum FOXP3 (≤0.0545 ng/ml), the risk of progression relative to clearance of invasive cervical cancer would increase by 27.82. Also raised (>0.946 ng/ml) relative to reduced (≤0.946 ng/ml) serum P16INK4A, the risk of persistence relative to clearance of low grade cervical lesions would increase by 5.16 times, given other variables remain constant. Conclusion: Though results are not statistically significant and imprecise, serum FOXP3 and P16ink4A concentrations are likely associated with persistence and progression of cervical lesions. Their measurement may benefit the prognostic monitoring of cervical lesions.