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Objective <p><?tk 4?>To evaluate early ΔSUVmax% for predicting pathological complete response (pCR) in HER2-positive breast cancer patients undergoing neoadjuvant therapy (NAT), to build a combined [<sup>68</sup>Ga]Ga-HER2 Affibody PET/CT model, and to compare its performance with magnetic resonance imaging (MRI).</p> Methods <p><?tk 4?>45 patients underwent both [<sup>68</sup>Ga]Ga-HER2 Affibody PET/CT and MRI at baseline and after two cycles of NAT. Univariate logistic regression identified parameters associated with pCR. After assessing multicollinearity, combined PET (ΔSUVmax%, TBR2) and MRI (ADC2,ΔADC%) models were constructed. The model performance was evaluated using leave-one-out cross-validation (LOOCV) method. Receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis were performed.</p> Results <p><?tk 4?>27 of the 45 enrolled patients achieved pCR (60%). After treatment, the pCR group showed significantly lower PET/CT parameters, a significantly higher ΔSUVmax%, and significantly higher MRI-derived ADC and ΔADC% values compared to the non-pCR group. The combined PET model showed a LOOCV AUC of 0.887 (95% CI: 0.781–0.969), significantly higher than that of the combined MRI model (0.642, 95% CI: 0.474–0.803, <i>p</i> = 0.015). Calibration was numerically better for the PET model (<i>p</i> = 0.404) than for the MRI model (<i>p</i> = 0.309), indicating a relative advantage for PET. Decision curve analysis indicated higher clinical net benefit for the PET model across threshold probabilities of 10%-90%.</p> Conclusion <p><?tk 4?>ΔSUVmax% is a promising early predictor of pCR.The [<sup>68</sup>Ga]Ga-HER2 Affibody PET/CT combined model provides superior predictive value compared with MRI‑based model and could serve as a promising biomarker to guide personalized treatment decisions.</p>

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Comparison of [68Ga]Ga-HER2 Affibody PET/CT and MRI for the early prediction of response to targeted neoadjuvant therapy in breast cancer

  • 期刊论文

  • 发表日期：

    2026年5月29日

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  • Ran An,
  • Yuhan Sun,
  • Ruoxi Yang,
  • Mengjiao Wang,
  • Xiaoshan Chen,
  • Xiao Pang,
  • Jianqiang Zhao,
  • Xiaolin Chen,
  • Fangyu Shi,
  • Qiang Fu,
  • Bin Guo,
  • Jingya Han,
  • Xinming Zhao

摘要

Objective

To evaluate early ΔSUVmax% for predicting pathological complete response (pCR) in HER2-positive breast cancer patients undergoing neoadjuvant therapy (NAT), to build a combined [68Ga]Ga-HER2 Affibody PET/CT model, and to compare its performance with magnetic resonance imaging (MRI).

Methods

45 patients underwent both [68Ga]Ga-HER2 Affibody PET/CT and MRI at baseline and after two cycles of NAT. Univariate logistic regression identified parameters associated with pCR. After assessing multicollinearity, combined PET (ΔSUVmax%, TBR2) and MRI (ADC2,ΔADC%) models were constructed. The model performance was evaluated using leave-one-out cross-validation (LOOCV) method. Receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis were performed.

Results

27 of the 45 enrolled patients achieved pCR (60%). After treatment, the pCR group showed significantly lower PET/CT parameters, a significantly higher ΔSUVmax%, and significantly higher MRI-derived ADC and ΔADC% values compared to the non-pCR group. The combined PET model showed a LOOCV AUC of 0.887 (95% CI: 0.781–0.969), significantly higher than that of the combined MRI model (0.642, 95% CI: 0.474–0.803, p = 0.015). Calibration was numerically better for the PET model (p = 0.404) than for the MRI model (p = 0.309), indicating a relative advantage for PET. Decision curve analysis indicated higher clinical net benefit for the PET model across threshold probabilities of 10%-90%.

Conclusion

ΔSUVmax% is a promising early predictor of pCR.The [68Ga]Ga-HER2 Affibody PET/CT combined model provides superior predictive value compared with MRI‑based model and could serve as a promising biomarker to guide personalized treatment decisions.