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Early prediction of endocrine responsiveness in ER+/HER2-negative metastatic breast cancer (MBC): pilot study with 18F-fluoroestradiol (18F-FES) CT/PET. ​

文献信息 ​

DOI10.1016/j.annonc.2024.02.007
PMID38423389
期刊Annals of oncology : official journal of the European Society for Medical Oncology
影响因子65.4
JCR 分区Q1
发表年份2024
被引次数9
关键词(18)F-氟雌二醇PET/CT、内分泌敏感性、分子影像学、随机临床试验、标准摄取值（SUV）
文献类型Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial
ISSN0923-7534
页码549-558
期号35(6)
作者A Gennari, E Brain, A De Censi, O Nanni, R Wuerstlein, A Frassoldati, J Cortes, V Rossi, M Palleschi, J L Alberini, F Matteucci, A Piccardo, G Sacchetti, H Ilhan, F D'Avanzo, B Ruffilli, S Nardin, M Monti, M Puntoni, V Fontana, L Boni, N Harbeck

一句话小结 ​

本研究评估了18F-氟雌二醇（FES）PET/CT在雌激素受体阳性（ER+）/人表皮生长因子受体2阴性（HER2-）转移性乳腺癌患者中的内分泌反应性，结果显示SUV值≥2的患者对内分泌治疗反应良好，而SUV值<2的患者中化疗疗效优于内分泌治疗，揭示了该人群的异质性及FES PET/CT在预测治疗反应中的潜在价值。该研究为个体化治疗提供了重要依据，有助于优化转移性乳腺癌的治疗策略。

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(18)F-氟雌二醇PET/CT · 内分泌敏感性 · 分子影像学 · 随机临床试验 · 标准摄取值（SUV）

摘要 ​

背景
18F-氟雌二醇（FES）正电子发射断层扫描（PET）/计算机断层扫描（CT）被认为是确定全身内分泌反应性的准确诊断工具。在内分泌治疗（ET）-FES试验中，我们评估了18F-FES PET/CT作为雌激素受体阳性（ER+）/人表皮生长因子受体2阴性（HER2-）转移性乳腺癌（MBC）的预测工具。

患者与方法
符合条件的患者在基线时接受了18F-FES PET/CT检查。标准摄取值（SUV）≥ 2的患者接受单药内分泌治疗，直到疾病进展；SUV < 2的患者被随机分配到单药内分泌治疗（A组）或化疗（B组）。主要目标是比较SUV < 2的患者中一线内分泌治疗与化疗的疗效。

结果
总共招募了147名患者；117名患者的18F-FES SUV ≥ 2并接受了内分泌治疗；30名SUV < 2的患者被随机分配到内分泌治疗或化疗。经过中位随访62.4个月后，104名患者（73.2%）出现疾病进展，53名患者去世（37.3%）。在SUV < 2的A组患者中，中位无进展生存期（PFS）为12.4个月[95%置信区间（CI）3.1-59.6个月]，而B组中为23.0个月（95% CI 7.7-30.0个月），[风险比（HR）= 0.71，95% CI 0.3-1.7]；SUV ≥ 2的接受内分泌治疗患者的中位PFS为18.0个月（95% CI 11.2-23.1个月）。SUV < 2的A组患者的中位总生存期（OS）为28.2个月（95% CI 14.2个月-无法估算），而B组（化疗）为52.8个月（95% CI 16.2个月-无法估算）。SUV ≥ 2的患者未达到中位OS。A组的60个月OS率为41.6%（95% CI 10.4%至71.1%），B组为42.0%（95% CI 14.0%至68.2%），而SUV ≥ 2的患者为59.6%（95% CI 48.6%至69.0%）。在SUV ≥ 2的患者中，接受芳香化酶抑制剂（AIs）治疗的60个月OS率为72.6%，而使用富马酸或他莫昔芬的患者为40.6%（P < 0.005）。

结论
ET-FES试验表明，ER+/HER2- MBC患者是一个异质性群体，其内分泌反应性基于18F-FES CT/PET SUV存在不同水平。

英文摘要 ​

BACKGROUND 18F-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) is considered an accurate diagnostic tool to determine whole-body endocrine responsiveness. In the endocrine therapy (ET)-FES trial, we evaluated 18F-FES PET/CT as a predictive tool in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC).

PATIENTS AND METHODS Eligible patients underwent an 18F-FES PET/CT at baseline. Patients with standardized uptake value (SUV) ≥ 2 received single-agent ET until progressive disease; patients with SUV < 2 were randomized to single-agent ET (arm A) or chemotherapy (ChT) (arm B). The primary objective was to compare the activity of first-line ET versus ChT in patients with 18F-FES SUV < 2.

RESULTS Overall, 147 patients were enrolled; 117 presented with 18F-FES SUV ≥ 2 and received ET; 30 patients with SUV < 2 were randomized to ET or ChT. After a median follow-up of 62.4 months, 104 patients (73.2%) had disease progression and 53 died (37.3%). Median progression-free survival (PFS) was 12.4 months [95% confidence interval (CI) 3.1-59.6 months] in patients with SUV < 2 randomized to arm A versus 23.0 months (95% CI 7.7-30.0 months) in arm B, [hazard (HR) = 0.71, 95% CI 0.3-1.7 months]; median PFS was 18.0 months (95% CI 11.2-23.1 months) in patients with SUV ≥ 2 treated with ET. Median overall survival (OS) was 28.2 months (95% CI 14.2 months-not estimable) in patients with SUV < 2 randomized to ET (arm A) versus 52.8 months (95% CI 16.2 months-not estimable) in arm B (ChT). Median OS was not reached in patients with SUV ≥ 2. 60-month OS rate was 41.6% (95% CI 10.4% to 71.1%) in arm A, 42.0% (95% CI 14.0% to 68.2%) in arm B, and 59.6% (95% CI 48.6% to 69.0%) in patients with SUV ≥ 2. In patients with SUV ≥ 2, 60-month OS rate was 72.6% if treated with aromatase inhibitors (AIs) versus 40.6% in case of fulvestrant or tamoxifen (P < 0.005).

CONCLUSIONS The ET-FES trial demonstrated that ER+/HER2- MBC patients are a heterogeneous population, with different levels of endocrine responsiveness based on 18F-FES CT/PET SUV.

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主要研究问题 ​

  1. 18F-FES PET/CT在预测ER+/HER2-转移性乳腺癌患者内分泌反应性方面的局限性是什么？
  2. 在不同的内分泌治疗方案中，18F-FES SUV值对治疗选择的影响如何？
  3. 如何评估18F-FES PET/CT在其他类型乳腺癌中的应用潜力？
  4. 该研究中不同SUV值的患者在长期生存率方面表现如何？
  5. 是否有其他生物标志物可以与18F-FES结合使用，以提高内分泌反应性的预测准确性？

核心洞察 ​

1. 研究背景和目的 ​

该研究旨在评估18F-氟雌二醇（FES）正电子发射断层扫描（PET）/计算机断层扫描（CT）作为预测工具，以早期判断雌激素受体阳性（ER+）和人表皮生长因子受体2阴性（HER2-）转移性乳腺癌（MBC）患者的内分泌治疗（ET）反应性。通过这一研究，期望能够为患者提供更精准的治疗方案，从而优化临床决策。

2. 主要方法和发现 ​

在这项以ET-FES为名的试验中，共有147名符合条件的患者参与。所有患者在基线都接受了18F-FES PET/CT扫描。根据标准摄取值（SUV）进行分组：SUV ≥ 2的117名患者接受单药内分泌治疗，而30名SUV < 2的患者则被随机分为ET（A组）和化疗（ChT，B组）两组。经过62.4个月的中位随访，结果显示，SUV < 2组中，A组的中位无进展生存期（PFS）为12.4个月，而B组为23.0个月；SUV ≥ 2组的中位PFS为18.0个月。此外，SUV < 2组的中位总生存期（OS）分别为A组28.2个月，B组52.8个月，而SUV ≥ 2组的OS未达到。60个月的OS率显示，SUV ≥ 2组患者使用芳香酶抑制剂（AIs）治疗的生存率显著高于使用他莫昔芬或福美斯坦的患者。

3. 核心结论 ​

研究结果表明，ER+/HER2- MBC患者在内分泌反应性方面存在显著的异质性，且这一反应性可以通过18F-FES CT/PET的SUV值进行分层。SUV ≥ 2的患者对内分泌治疗的反应更佳，而SUV < 2的患者则可能更适合进行化疗。

4. 研究意义和影响 ​

这一研究为转移性乳腺癌的个体化治疗提供了重要的临床依据，强调了利用FES PET/CT进行早期预测的潜力。这种方法可以帮助临床医生在制定治疗方案时更精准地评估患者的内分泌治疗反应性，从而提高治疗效果并延长患者生存期，最终改善患者的预后。这项研究的成果有望在未来的临床实践中推广应用，促进转移性乳腺癌患者的精准医疗发展。

引用本文的文献 ​

  1. Radiotracer Innovations in Breast Cancer Imaging: A Review of Recent Progress. - Mohamad Haidar;Joe Rizkallah;Omar El Sardouk;Nour El Ghawi;Nadine Omran;Zeinab Hammoud;Nina Saliba;Arafat Tfayli;Hiba Moukadem;Ghina Berjawi;Lara Nassar;Fahad Marafi;Partha Choudhary;Habibollah Dadgar;Alyaa Sadeq;Alain S Abi-Ghanem - Diagnostics (Basel, Switzerland) (2024)
  2. Novel Molecular Classification of Breast Cancer with PET Imaging. - Ngô Minh Toàn - Medicina (Kaunas, Lithuania) (2024)
  3. Predictive and prognostic value of 18F-FES PET/CT for patients with recurrent or metastatic breast cancer treated with endocrine therapy plus cyclin-dependent kinase 4/6 inhibitors. - Hyehyun Jeong;Jeongryul Ryu;Jae Ho Jeong;Sangwon Han;Jaewon Hyung;Jin-Hee Ahn;Kyung Hae Jung;Sung-Bae Kim;Byung-Kwan Jeong;Hee Jin Lee;Gyungyub Gong;Dae Hyuk Moon - European journal of nuclear medicine and molecular imaging (2025)
  4. [18F]F-FES PET for diagnosis, staging, and endocrine therapy prediction in ER-positive breast cancer: a systematic review and meta-analysis. - Ying Xu;Ru Yao;Zhixin Hao;Fangyuan Chen;Bowen Liu;Qiang Sun;Bo Pan;Li Huo;Yidong Zhou - EJNMMI research (2025)
  5. Evaluating Automated Tools for Lesion Detection on 18F Fluoroestradiol PET/CT Images and Assessment of Concordance with Standard-of-Care Imaging in Metastatic Breast Cancer. - Renee Miller;Mark Battle;Kristen Wangerin;Daniel T Huff;Amy J Weisman;Song Chen;Timothy G Perk;Gary A Ulaner - Radiology. Imaging cancer (2025)
  6. The Role of [18F]FES PET/CT in Breast Cancer Management: An Umbrella Review. - Marco Cuzzocrea;Rosa Di Micco;Giorgia Elisabeth Colombo;Stefania Maria Rita Rizzo;Gaetano Paone;Virginia Casati;Turki Alkhaldii;Fatemah Khajah;Claudia Rauh;Maggie Banys-Paluchowsky;Nina Ditsch;Thorsten Kuehn;Oreste D Gentilini;Giorgio Treglia;Maria Luisa Gasparri - Cancers (2025)
  7. 18F-fluoroestradiol (18F-FES) PET/CT for guiding first-line treatment in patients with HR + /HER2- metastatic breast cancer: impact on progression free survival. - Yizhao Xie;Yifan Chen;Cheng Liu;Yannan Zhao;Chengcheng Gong;Shuyi Lin;Shaoli Song;Biyun Wang;Zhongyi Yang - European journal of nuclear medicine and molecular imaging (2025)
  8. Resistance to neoadjuvant chemotherapy in breast cancers: a metabolic perspective. - Manon Desgres;Melis Poyraz;Buse Sari;François P Duhoux;Cédric van Marcke;Cyril Corbet - Journal of experimental & clinical cancer research : CR (2025)
  9. Could 18F-FES PET Be a New Driver in Therapeutic Choice for Metastatic HR+/HER2- Patients? - Maria Vita Sanò;Alessandro Russo;Lorenza Marino;Sarah Pafumi;Martina Di Pietro;Giuseppina Rosaria Rita Ricciardi - Diagnostics (Basel, Switzerland) (2025)

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