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Background <p>Neoadjuvant therapy (NAT) has become a standard treatment for HER2-positive breast cancer. However, patient responses vary substantially, and reliable methods for early response assessment are still lacking. This study aimed to evaluate the value of [<sup>68</sup>Ga]Ga-HER2 Affibody PET/CT for the early assessment of treatment outcome by predicting pathological complete response (pCR) in HER2-positive breast cancer.</p> Results <p>32 of the 54 enrolled patients achieved pCR (59.3%). Following two NAT cycles, [<sup>68</sup>Ga]Ga-HER2 Affibody PET/CT parameters decreased from baseline in all patients (<i>P</i> &lt; 0.001). Early percentage changes in PET parameters (ΔSUV%, ΔSUL%, ΔTLA%, ΔTBR%) and their absolute values after the second NAT cycle were associated with pCR (r range: -0.658 to -0.273; <i>P &lt;</i> 0.05). ΔTBR% demonstrated the best predictive value for pCR (AUC = 0.918), with 93.8% sensitivity and 86.4% specificity at a cutoff of -70.5%. In contrast, tumor size assessment based on RECIST 1.1 showed lower predictive performance, with a sensitivity of 56.3% (18/32) and a specificity of 45.5% (10/22).</p> Conclusion <p>This study demonstrates the potential of [<sup>68</sup>Ga]Ga-HER2 Affibody PET/CT to predict NAT outcome early in HER2-positive breast cancer, which could facilitate subsequent treatment optimization.</p>

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[68Ga]Ga-HER2 Affibody PET/CT for early prediction of neoadjuvant therapy outcome in HER2-positive breast cancer: a preliminary report

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月2日

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  • Yuhan Sun,
  • Ran An,
  • Ruoxi Yang,
  • Xiao Pang,
  • Xiaoshan Chen,
  • Mengjiao Wang,
  • Jianqiang Zhao,
  • Xiaolin Chen,
  • Qiang Fu,
  • Yunuan Liu,
  • Jingya Han,
  • Na Wang,
  • Yan Zhao,
  • Xinming Zhao

摘要

Background

Neoadjuvant therapy (NAT) has become a standard treatment for HER2-positive breast cancer. However, patient responses vary substantially, and reliable methods for early response assessment are still lacking. This study aimed to evaluate the value of [68Ga]Ga-HER2 Affibody PET/CT for the early assessment of treatment outcome by predicting pathological complete response (pCR) in HER2-positive breast cancer.

Results

32 of the 54 enrolled patients achieved pCR (59.3%). Following two NAT cycles, [68Ga]Ga-HER2 Affibody PET/CT parameters decreased from baseline in all patients (P < 0.001). Early percentage changes in PET parameters (ΔSUV%, ΔSUL%, ΔTLA%, ΔTBR%) and their absolute values after the second NAT cycle were associated with pCR (r range: -0.658 to -0.273; P < 0.05). ΔTBR% demonstrated the best predictive value for pCR (AUC = 0.918), with 93.8% sensitivity and 86.4% specificity at a cutoff of -70.5%. In contrast, tumor size assessment based on RECIST 1.1 showed lower predictive performance, with a sensitivity of 56.3% (18/32) and a specificity of 45.5% (10/22).

Conclusion

This study demonstrates the potential of [68Ga]Ga-HER2 Affibody PET/CT to predict NAT outcome early in HER2-positive breast cancer, which could facilitate subsequent treatment optimization.