A prospective single-center cohort study: integrating PET imaging and genomics to identify early biomarkers of response to dual-targeted PH neoadjuvant therapy in breast cancer

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BACKGROUND: We aimed to investigate potential biomarkers for predicting pathological complete response (pCR) to neoadjuvant therapy in HER2-positive breast cancer, with a focus on early-stage indicators. METHODS: We conducted a comprehensive analysis incorporating genomic and PET imaging data from 61 patients undergoing neoadjuvant treatment. Genomic profiling and PET/CT scans were performed at baseline (T1) and after one treatment cycle (T2). Various clinical and molecular parameters were assessed, including HER2 gene status, maximum standardized uptake value, and genomic alterations. RESULTS: Our findings revealed several candidate biomarkers associated with treatment response. Early changes in 18 F-FDG PET/CT and baseline 68 Ga-HER2 PET/CT emerged as potential predictors for pCR. Genomic analysis identified differences in mutation frequencies, with notable changes after one treatment cycle. A multivariate predictive model, incorporating PET imaging and clinical characteristics, demonstrated excellent performance in forecasting treatment response. CONCLUSIONS: The study underscores the significance of early biomarkers in predicting neoadjuvant treatment outcomes for HER2-positive breast cancer. Integrating genomic and imaging data provides a comprehensive approach for tailoring therapeutic strategies. The identified biomarkers hold promise for guiding treatment escalation or de-escalation, presenting a step forward in personalized management for HER2-positive breast cancer patients.