Elias Kotteas, Εmmanouil Panagiotou, Μaria Grammoustianou, Εvanthia Rousia, Αlexandros Kokkalis, Pantelis Dimaras, Theodora Papadimitriou, Georgios Gkoumas, Ioannis A Vathiotis, Dimitra T Stefanou, Κonstantinos Laschos, Helen Gogas, Dimitrios Mavroudis, Αthanasios Kotsakis, Αngelos Koutras, Nikolaos K Syrigos
{"title":"曲妥珠单抗德鲁西替康（T-DXd）治疗her2阳性/低her2转移性乳腺癌患者的安全性和有效性：一项多中心回顾性队列研究","authors":"Elias Kotteas, Εmmanouil Panagiotou, Μaria Grammoustianou, Εvanthia Rousia, Αlexandros Kokkalis, Pantelis Dimaras, Theodora Papadimitriou, Georgios Gkoumas, Ioannis A Vathiotis, Dimitra T Stefanou, Κonstantinos Laschos, Helen Gogas, Dimitrios Mavroudis, Αthanasios Kotsakis, Αngelos Koutras, Nikolaos K Syrigos","doi":"10.1080/14796694.2025.2560678","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":12672,"journal":{"name":"Future oncology","volume":" ","pages":"3189-3196"},"PeriodicalIF":2.6000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12520084/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Elias Kotteas, Εmmanouil Panagiotou, Μaria Grammoustianou, Εvanthia Rousia, Αlexandros Kokkalis, Pantelis Dimaras, Theodora Papadimitriou, Georgios Gkoumas, Ioannis A Vathiotis, Dimitra T Stefanou, Κonstantinos Laschos, Helen Gogas, Dimitrios Mavroudis, Αthanasios Kotsakis, Αngelos Koutras, Nikolaos K Syrigos\",\"doi\":\"10.1080/14796694.2025.2560678\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":12672,\"journal\":{\"name\":\"Future oncology\",\"volume\":\" \",\"pages\":\"3189-3196\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12520084/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Future oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14796694.2025.2560678\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/9/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Future oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14796694.2025.2560678","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/9/14 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
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.
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.
期刊介绍：
Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community.
The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
