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Background <p>While CDK4/6 inhibitors combined with endocrine therapy (CDK4/6i+ET) have revolutionized treatment for HR+/HER2- metastatic breast cancer (MBC), inter-lesional estrogen receptor (ER) heterogeneity limits therapeutic efficacy in a subset of patients. Whole-body <sup>18</sup>F-fluoroestradiol (<sup>18</sup>F-FES) PET/CT enables non-invasive ER quantification across all metastatic sites. However, whether <sup>18</sup>F-FES-guided therapy selection improves clinical outcomes in relatively large sample cohorts is not yet well-established.</p> Patients and methods <p>We screened all 1613 HR+/HER2- metastatic breast cancer (MBC) patients from 2020 to 2024 at Fudan University Shanghai Cancer Center. Patients who received standard first line treatment were enrolled in this retrospective study.</p> Results <p>A total of 473 patients were included in the study. 156(33.0%) and 317 (67.0%) patients were screened or unscreened by <sup>18</sup>F-FES-PET before first-line treatment. 111 patients with all-FES positive metastatic lesions and 17 patients with FES heterogeneity received CDK4/6 inhibitors combined with endocrine therapy. 21 patients with all-FES negative metastatic lesions and 7 patients with FES heterogeneity received chemotherapy (CT). As for the unscreened group, 236 received CDK4/6 inhibitors combined with endocrine therapy and 81 received CT. In CDK4/6 inhibitors combined with endocrine therapy cohort, FES-screened group showed a significantly prolonged progression-free survival (PFS) compared with unscreened group (mPFS 32.4&#xa0;months versus 17.3&#xa0;months, Hazard Ratio = 0.49; 95% CI, 0.34 to 0.69; <i>p</i> &lt; 0.0001). And chemotherapy cohort showed superior PFS for screened patients as well (mPFS 11.38&#xa0;months versus 8.91&#xa0;months, Hazard Ratio = 0.56; 95% CI, 0.33 to 0.94; <i>p</i> = 0.026).</p> Conclusions <p>HR + /HER2- MBC patients with FES-guided initial treatment showed significantly better efficacy than those who had not been assessed by <sup>18</sup>F-FES-PET/CT. This retrospective study highlights the crucial instructive role of FES assessment in evaluating ER expression in patients prior to administering first-line treatment. In the present study, improved PFS was observed when first-line therapy was guided by <sup>18</sup>F-FES-PET in newly diagnosed HR+/HER2- MBC patients. </p>

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18F-fluoroestradiol (18F-FES) PET/CT for guiding first-line treatment in patients with HR + /HER2- metastatic breast cancer: impact on progression free survival

  • 期刊论文

  • 发表日期：

    2025年7月19日

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  • Yizhao Xie,
  • Yifan Chen,
  • Cheng Liu,
  • Yannan Zhao,
  • Chengcheng Gong,
  • Shuyi Lin,
  • Shaoli Song,
  • Biyun Wang,
  • Zhongyi Yang

摘要

Background

While CDK4/6 inhibitors combined with endocrine therapy (CDK4/6i+ET) have revolutionized treatment for HR+/HER2- metastatic breast cancer (MBC), inter-lesional estrogen receptor (ER) heterogeneity limits therapeutic efficacy in a subset of patients. Whole-body 18F-fluoroestradiol (18F-FES) PET/CT enables non-invasive ER quantification across all metastatic sites. However, whether 18F-FES-guided therapy selection improves clinical outcomes in relatively large sample cohorts is not yet well-established.

Patients and methods

We screened all 1613 HR+/HER2- metastatic breast cancer (MBC) patients from 2020 to 2024 at Fudan University Shanghai Cancer Center. Patients who received standard first line treatment were enrolled in this retrospective study.

Results

A total of 473 patients were included in the study. 156(33.0%) and 317 (67.0%) patients were screened or unscreened by 18F-FES-PET before first-line treatment. 111 patients with all-FES positive metastatic lesions and 17 patients with FES heterogeneity received CDK4/6 inhibitors combined with endocrine therapy. 21 patients with all-FES negative metastatic lesions and 7 patients with FES heterogeneity received chemotherapy (CT). As for the unscreened group, 236 received CDK4/6 inhibitors combined with endocrine therapy and 81 received CT. In CDK4/6 inhibitors combined with endocrine therapy cohort, FES-screened group showed a significantly prolonged progression-free survival (PFS) compared with unscreened group (mPFS 32.4 months versus 17.3 months, Hazard Ratio = 0.49; 95% CI, 0.34 to 0.69; p < 0.0001). And chemotherapy cohort showed superior PFS for screened patients as well (mPFS 11.38 months versus 8.91 months, Hazard Ratio = 0.56; 95% CI, 0.33 to 0.94; p = 0.026).

Conclusions

HR + /HER2- MBC patients with FES-guided initial treatment showed significantly better efficacy than those who had not been assessed by 18F-FES-PET/CT. This retrospective study highlights the crucial instructive role of FES assessment in evaluating ER expression in patients prior to administering first-line treatment. In the present study, improved PFS was observed when first-line therapy was guided by 18F-FES-PET in newly diagnosed HR+/HER2- MBC patients.