Zheng Shan, Xu Fuqi, Chen Yun, Shao Zezhong, Wu Zenan, Liu Qun, Chen Ling, Zhu Youzhi, Chen Linying, Cao Dairong, Miao Weibing
Department of Nuclear Medicine, the First Affiliated Hospital, Fujian Medical University, No 20 Chazhong Road, Taijiang District, Fuzhou, 350005, Fujian Province, China.
Department of Nuclear Medicine, Binhai Campus of the First Affiliated Hospital, National Regional Medical Center, Fujian Medical University, Changle District, Fuzhou, 350212, China.
Eur J Nucl Med Mol Imaging. 2025 Jul 12. doi: 10.1007/s00259-025-07444-3.
To investigate the clinical utility of serial [⁶⁸Ga]Ga-FAPI-04 PET/CT for predicting pathological response and evaluating therapeutic efficacy in breast cancer (BC) patients receiving neoadjuvant chemotherapy (NAC).
A total of 64 biopsy-confirmed patients with BC were retrospectively included. Serial [Ga]Ga-FAPI-04 PET/CT scans were conducted at three time points: prior to NAC (baseline, PET), after two cycles of NAC (interim, PET), and before surgery (pre-surgery, PET). PET/CT parameters derived from the primary BC lesions were recorded before and after NAC. The changes in these parameters were compared between the pathological complete response (pCR) and the non-pCR group. Logistic regression was used to assess the predictive value of [Ga]Ga-FAPI-04 PET/CT parameters for predicting pCR. Receiver operating characteristic (ROC) curve analysis was employed to determine the optimal cutoff values for predicting pCR. DeLong's test was applied to statistically assess differences in the area under the ROC curves (AUC).
Significant reductions in [Ga]Ga-FAPI-04 PET/CT parameters (ΔSUVmax, ΔSUVmean, ΔFTV, ΔTLF) were observed among all patients, with significantly greater decreases in the pCR group compared to the non-pCR group (all P < 0.001). In the non-pCR group, the total FTV (ΔtFTV and ΔtFTV) of primary breast lesions and metastatic lymph nodes showed moderate correlation with the residual cancer burden (RCB) score. Multivariate logistic regression identified ΔSUVmean (P = 0.027), ΔFTV (P = 0.006), ΔSUVmean (P = 0.032), and ΔFTV (P = 0.010) as independent predictors for predicting pCR. On the basis of the ROC curve analysis, ΔSUVmean (AUC = 0.848) and ΔFTV (AUC = 0.906) showed slightly higher predictive performance than ΔSUVmean (AUC = 0.825) and ΔFTV (AUC = 0.869), respectively, but the difference was not statistically significant (P > 0.05).
This study demonstrates that serial [Ga]Ga-FAPI-04 PET/CT facilitates early prediction of pathological response to neoadjuvant chemotherapy in breast cancer, as well as assessment of therapeutic efficacy. Prospective studies with larger samples are needed.
探讨连续[⁶⁸Ga]Ga-FAPI-04 PET/CT在预测接受新辅助化疗（NAC）的乳腺癌（BC）患者的病理反应和评估治疗疗效方面的临床应用价值。
回顾性纳入64例经活检确诊的BC患者。在三个时间点进行连续的[⁶⁸Ga]Ga-FAPI-04 PET/CT扫描：NAC前（基线，PET）、NAC两个周期后（中期，PET）和手术前（术前，PET）。记录NAC前后原发性BC病变的PET/CT参数。比较病理完全缓解（pCR）组和非pCR组这些参数的变化。采用逻辑回归评估[⁶⁸Ga]Ga-FAPI-04 PET/CT参数对预测pCR的价值。采用受试者工作特征（ROC）曲线分析确定预测pCR的最佳截断值。应用DeLong检验对ROC曲线下面积（AUC）的差异进行统计学评估。
所有患者的[⁶⁸Ga]Ga-FAPI-04 PET/CT参数（ΔSUVmax、ΔSUVmean、ΔFTV、ΔTLF）均显著降低，pCR组的降低幅度显著大于非pCR组（所有P < 0.001）。在非pCR组中，原发性乳腺病变和转移性淋巴结的总FTV（ΔtFTV和ΔtFTV）与残余癌负担（RCB）评分呈中度相关。多因素逻辑回归确定ΔSUVmean（P = 0.027）、ΔFTV（P = 0.006）、ΔSUVmean（P = 0.032）和ΔFTV（P = 0.010）为预测pCR的独立预测因素。基于ROC曲线分析，ΔSUVmean（AUC = 0.848）和ΔFTV（AUC = 0.906）的预测性能分别略高于ΔSUVmean（AUC = 0.825）和ΔFTV（AUC = 0.869），但差异无统计学意义（P > 0.05）。
本研究表明，连续[⁶⁸Ga]Ga-FAPI-04 PET/CT有助于早期预测乳腺癌新辅助化疗的病理反应以及评估治疗疗效。需要进行更大样本量的前瞻性研究。
