Abstract
BACKGROUND: De novo stage IV breast cancer presents a significant challenge due to its advanced nature and poor prognosis. Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy have emerged as effective treatments for hormone receptor-positive HER2-negative breast cancers. However, predicting patient responses remains difficult. This study aimed to evaluate the prognostic value of FDG PET/CT in predicting therapeutic response and progression-free survival (PFS) in patients with de novo stage IV breast cancer undergoing CDK4/6i treatment. METHODS: A retrospective analysis was conducted on 106 patients with de novo stage IV breast cancer who were treated with CDK4/6i between 2016 and 2023. All patients underwent FDG PET/CT before treatment and 68 patients underwent follow-up FDG PET/CT. The relationship between SUVmax and clinicopathological factors was analyzed using t-test and ANOVA. PFS was assessed via Kaplan-Meier analysis and Cox proportional hazards models, with a focus on SUVmax parameters, including the SUVmax values of the primary tumor (SUVmax_primary), metastatic regional lymph node (SUVmax_LN), distant metastasis (SUVmax_distant), the highest SUVmax value along the entire body (SUVmax_whole), and their proportional responses during follow-up. RESULTS: Lower Ki-67 score (1+) was significantly associated with lower SUVmax_primary (P = 0.002) and SUVmax_whole (P = 0.007) scores than higher Ki-67 scores. SUVmax_whole was a significant predictor of PFS at baseline (hazard ratio, HR = 2.45, P = 0.012) and follow-up (HR = 4.32, P = 0.002). Patients with higher SUVmax reductions showed better PFS outcomes (HR = 0.22, P < 0.001). Neither the initial SUVmax of the primary lesion (HR = 1.81, P = 0.067) nor its response (HR = 0.49, P = 0.063) on follow-up were significant predictors of PFS. CONCLUSIONS: This study highlights the prognostic value of FDG PET/CT in evaluating the therapeutic response to CDK4/6i in de novo stage IV breast cancer. SUVmax_whole and its proportional response serve as important predictors of PFS, emphasizing the need to assess metabolic activity across the entire body rather than just in the primary tumor.