التفاصيل البيبلوغرافية
| العنوان: |
Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer |
| المؤلفون: |
Yoshino, T. (Takayuki), Di-Bartolomeo, M. (Maria), Raghav, K. (Kanwal), Masuishi, T. (Toshiki), Loupakis, F. (Fotios), Kawakami, H. (Hisato), Yamaguchi, K. (Kensei), Nishina, T. (Tomohiro), Wainberg, Z. (Zev), Elez, E. (Elena), Rodríguez-Rodríguez, J. (Javier), Fakih, M. (Marwan), Ciardiello, F. (Fortunato), Saxena, F. (Kapil), Kobayashi, K. (Kojiro), Bako, E. (Emarjola), Okuda, Y. (Yasuyuki), Meinhardt, G. (Gerold), Grothey, A. (Axel), Siena, S. (Salvatore) |
| سنة النشر: |
2023 |
| المجموعة: |
dadun - Depósito Académico Digital Universidad de Navarra |
| مصطلحات موضوعية: |
Área de Medicina Clínica y Epidemiología, Trastuzumab deruxtecan (T-DXd), Metastatic colorectal cancer (mCRC), Objective response rate (ORR) |
| الوصف: |
DESTINY-CRC01 (NCT03384940) was a multicenter, open-label, phase 2 trial assessing the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-expressing metastatic colorectal cancer (mCRC) that progressed after >= 2 prior regimens; results of the primary analysis are published. Patients received T-DXd 6.4mg/kg every 3 weeks and were assigned to either: cohort A (HER2-positive, immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+), cohort B (IHC 2+/ISH-), or cohort C (IHC 1+). Primary endpoint was objective response rate (ORR) by independent central review in cohort A. Secondary endpoints included ORR (cohorts B and C), duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and safety of T-DXd. 86 patients were enrolled (53 in cohort A, 15 in cohort B, and 18 in cohort C). Results of the primary analysis are published, reporting an ORR of 45.3% in cohort A. Here, we report the final results. No responses occurred in cohorts B or C. Median progression-free survival, overall survival, and duration of response were 6.9, 15.5, and 7.0 months, respectively. Overall serum exposure (cycle 1) of T-DXd, total anti-HER2 antibody, and DXd were similar regardless of HER2 status. Most common grade >= 3 treatment-emergent adverse events were decreased neutrophil count and anemia. Adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8 patients (9.3%). These findings support the continued exploration of T-DXd in HER2-positive mCRC. |
| نوع الوثيقة: |
article in journal/newspaper |
| وصف الملف: |
application/pdf |
| اللغة: |
English |
| العلاقة: |
https://pubmed.ncbi.nlm.nih.gov/37286557Test/; https://hdl.handle.net/10171/67553Test |
| الإتاحة: |
https://hdl.handle.net/10171/67553Test |
| حقوق: |
info:eu-repo/semantics/openAccess |
| رقم الانضمام: |
edsbas.2A207742 |
| قاعدة البيانات: |
BASE |
