دورية أكاديمية
FINAL outcome ANALYSIS FROM THE PHASE II TUXEDO-1 TRIAL OF TRASTUZUMAB-DERUXTECAN IN HER2-positive breast cancer PATIENTS WITH active brain metastases.
| العنوان: | FINAL outcome ANALYSIS FROM THE PHASE II TUXEDO-1 TRIAL OF TRASTUZUMAB-DERUXTECAN IN HER2-positive breast cancer PATIENTS WITH active brain metastases. |
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| المؤلفون: | Bartsch R; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Berghoff AS; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Furtner J; Department of Radiology, Medical University of Vienna, Vienna, Austria.; Research Center for Medical Image Analysis and Artificial Intelligence (MIAAI), Faculty of Medicine and Dentistry, Danube Private University, Krems, Austria., Marhold M; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Bergen ES; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Roider-Schur S; Department of Oncology, St. Joseph's Hospital, Vienna, Austria., Mair MJ; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Starzer AM; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Forstner H; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Rottenmanner B; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Aretin MB; Hospital Pharmacy, Vienna General Hospital and Medical University of Vienna, Vienna, Austria., Dieckmann K; Department of Radio-Oncology, Medical University of Vienna, Vienna, Austria., Bago-Horvath Z; Department of Pathology, Medical University of Vienna, Vienna, Austria., Haslacher H; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria., Widhalm G; Department of Neurosurgery, Medical University of Vienna, Vienna, Austria., Ilhan-Mutlu A; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Minichsdorfer C; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Fuereder T; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria., Szekeres T; Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria., Oehler L; Research Center for Medical Image Analysis and Artificial Intelligence (MIAAI), Faculty of Medicine and Dentistry, Danube Private University, Krems, Austria., Gruenberger B; Department of Oncology, LKH Wiener Neustadt, Wiener Neustadt, Austria., Pfeiler G; Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria., Singer C; Department of Obstetrics and Gynaecology, Medical University of Vienna, Vienna, Austria., Weltermann A; Department of Medicine 1, Elisabethinen Hospital Linz, Ordensklinikum Linz, Linz, Austria., Berchtold L; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.; Institute of Medical Statistics, Center for Medical Data Science, Medical University of Vienna, Vienna, Austria., Preusser M; Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria. |
| المصدر: | Neuro-oncology [Neuro Oncol] 2024 Jul 04. Date of Electronic Publication: 2024 Jul 04. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 100887420 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1523-5866 (Electronic) Linking ISSN: 15228517 NLM ISO Abbreviation: Neuro Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2010- : Oxford : Oxford University Press Original Publication: 1999-<2002> : Charlottesville, VA : Carden Jennings Pub., |
| مستخلص: | Background: Brain metastases (BM) are a devastating complication of HER2-positive metastatic breast cancer (BC) and treatment strategies providing optimized local and systemic disease control are urgently required. The antibody-drug conjugate (ADC) trastuzumab deruxtecan (T-DXd) improved progression-free survival (PFS) and overall survival (OS) over trastuzumab emtansine but data regarding intracranial activity is limited. In the primary outcome analysis of TUXEDO-1, a high intracranial response rate (RR) was reported with T-DXd. Here, we report final PFS and OS results. Patients and Methods: TUXEDO-1 accrued adult patients with HER2-positive BC and active BM (newly diagnosed or progressing) without indication for immediate local therapy. The primary endpoint was intracranial RR; secondary endpoints included PFS, OS, safety, quality-of-life (QoL), and neurocognitive function. PFS and OS were estimated with the Kaplan-Meier method and analysed in the per-protocol population. Results: At 26.5 months median follow-up, median PFS was 21 months (95% CI 13.3-n.r.) and median OS was not reached (95% CI 22.2-n.r.). With longer follow-up, no new safety signals were observed. The most common grade 3 adverse event was fatigue (20%). Grade 2 interstitial lung disease and a grade 3 symptomatic drop of left-ventricular ejection fraction were observed in one patient each. QoL was maintained over the treatment period. Discussion: T-DXd yielded prolonged intra- and extracranial disease control in patients with active HER2-positive BC BM in line with results from the pivotal trials. These results support the concept of ADCs as systemic therapy for active BM. (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.) |
| فهرسة مساهمة: | Keywords: Brain metastases; HER2-positive; breast cancer; trastuzumab deruxtecan |
| تواريخ الأحداث: | Date Created: 20240704 Latest Revision: 20240704 |
| رمز التحديث: | 20240705 |
| DOI: | 10.1093/neuonc/noae123 |
| PMID: | 38963808 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1523-5866 |
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| DOI: | 10.1093/neuonc/noae123 |