曲妥珠单抗德鲁昔单抗（T-DXd）在HER2阳性/HER2低表达转移性乳腺癌患者中的真实世界安全性和疗效：一项多中心回顾性队列研究。

Real-world safety and efficacy of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive/HER2-low metastatic breast cancer: a multicenter retrospective cohort study.

作者信息

Kotteas Elias, Panagiotou Εmmanouil, Grammoustianou Μaria, Rousia Εvanthia, Kokkalis Αlexandros, Dimaras Pantelis, Papadimitriou Theodora, Gkoumas Georgios, Vathiotis Ioannis A, Stefanou Dimitra T, Laschos Κonstantinos, Gogas Helen, Mavroudis Dimitrios, Kotsakis Αthanasios, Koutras Αngelos, Syrigos Nikolaos K

机构信息

Oncology Unit, Third Department of Internal Medicine, Sotiria General Hospital for Chest Diseases, National and Kapodistrian University of Athens, Athens, Greece.

Division of Oncology, Department of Medicine, University Hospital, Medical School, University of Patras, Patras, Greece.

出版信息

Future Oncol. 2025 Sep 14:1-8. doi: 10.1080/14796694.2025.2560678.

DOI:10.1080/14796694.2025.2560678

PMID:40947843

Abstract

PURPOSE

The efficacy of trastuzumab deruxtecan (T-DXd) has been demonstrated in large, phase III studies in HER2-positive (HER2+) and HER2-low metastatic breast cancer. Nevertheless, real-world data on T-DXd use are still limited.

METHODS

Patients with HER2+ or HER2-low metastatic breast cancer treated in six tertiary hospitals in Greece between September 2021 and May 2025 were included. Objective response rate, real-world progression-free survival (rwPFS), overall survival (rwOS), and safety were assessed.

RESULTS

Ninety-seven patients were included in the analysis; 49 had HER2+ and 48 had HER2-low disease. In the HER2+ cohort, median rwPFS was 14.9 months (95% Confidence Interval [CI], 10.97- not reached [NR]) and median rwOS was NR; rwPFS was shorter in patients with brain metastases (10.9 months vs 37.5 months, HR 3.28, p = 0.03). In the HER2-low cohort, rwPFS was 6.1 months (95% CI, 5.43-10.5) and rwOS was 14.1 months (95% CI, 9.6-NR). The rate of TRAEs was 41.1%; the rate of pneumonitis/interstitial lung disease was 6.7%. Dose interruptions and treatment discontinuation were reported in 4.4% and 1.1% cases, respectively.

CONCLUSIONS

Our study confirms the efficacy and safety of T-DXd in daily clinical practice. Further research and longer patient follow-up are needed to elucidate optimal therapy sequencing.

摘要

目的

曲妥珠单抗德鲁替康（T-DXd）的疗效已在HER2阳性（HER2+）和HER2低表达转移性乳腺癌的大型III期研究中得到证实。然而，关于T-DXd使用的真实世界数据仍然有限。

方法

纳入2021年9月至2025年5月在希腊六家三级医院接受治疗的HER2+或HER2低表达转移性乳腺癌患者。评估客观缓解率、真实世界无进展生存期（rwPFS）、总生存期（rwOS）和安全性。

结果

97例患者纳入分析；49例为HER2+疾病，48例为HER2低表达疾病。在HER2+队列中，中位rwPFS为14.9个月（95%置信区间[CI]，10.97-未达到[NR]），中位rwOS未达到；脑转移患者的rwPFS较短（10.9个月对37.5个月，HR 3.28，p = 0.03）。在HER2低表达队列中，rwPFS为6.1个月（95%CI，5.43-10.5），rwOS为14.1个月（95%CI，9.6-NR）。治疗相关不良事件（TRAE）发生率为41.1%；肺炎/间质性肺疾病发生率为6.7%。分别有4.4%和1.1%的病例报告了剂量中断和治疗停药。