Academic Journal
Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies
| العنوان: | Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies |
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| المؤلفون: | Takahashi, Shunji, Bando, Hideaki, Kinoshita, Ichiro, Modi, Shanu, Tsurutani, Junji, Bang, Yung-Jue, Sato, Yuta, Nakatani, Shunsuke, Lee, Caleb, Sugihara, Masahiro, Okuda, Yasuyuki, Iwata, Hiroji |
| المساهمون: | Bang, Yung-Jue |
| بيانات النشر: | Oxford University Press |
| سنة النشر: | 2024 |
| المجموعة: | Seoul National University: S-Space |
| مصطلحات موضوعية: | ANTIBODY-DRUG CONJUGATE, PHASE-II, AMERICAN-PATHOLOGISTS, ADVERSE EVENTS, CISPLATIN, CANCER, TRIAL, RECURRENT, GUIDELINE, CYCLOPHOSPHAMIDE, DS8201-A-J101, DS8201-A-A104, human epidermal growth factor receptor 2, salivary gland carcinoma, trastuzumab deruxtecan |
| الوصف: | Background: HER2-expressing salivary gland carcinoma (SGC) is associated with poor prognosis. Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies. This study aimed to present the efficacy and safety of T-DXd in patients with HER2-expressing SGC from a pooled analysis. Methods: Patients with HER2-expressing SGC were pooled from two phase I, open-label studies of T-DXd: a two-phase, multiple-dose, first-in-human study (NCT02564900) and a single-sequence crossover drug-drug interaction study (NCT03383692). Endpoints included efficacy (objective response rate [ORR], duration of response [DoR] and progression-free survival [PFS]) and safety. Results: This pooled analysis included 17 patients with SGC (median age: 57 years; male: 88.2%); median (range) follow-up duration was 12.0 (2.3-34.8) months. Among these patients, 14 had received prior HER2-targeted agents and 13 had undergone prior radiotherapy. The investigator-assessed confirmed ORR was 58.8% (95% confidence interval [CI], 32.9-81.6). The median (95% CI) DoR and PFS were 17.6 months (4.0 to not evaluable [NE]) and 20.5 months (11.1-NE), respectively. All 17 patients reported treatment-emergent adverse events (TEAEs); 76.5% reported TEAEs of grade >= 3. The most common TEAEs were decreased appetite (94.1%), nausea (88.2%) and neutrophil count decreased (76.5%). Of the 17 patients, five (29.4%) reported adjudicated drug-related interstitial lung disease (grade 1, n = 3; grade 2, n =1; grade 3, n = 1). Conclusion: The results of this pooled analysis provide evidence that clinical benefit is achievable with T-DXd in patients with HER2-expressing SGC. ; N ; 1 |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| ردمك: | 978-0-01-143357-8 0-01-143357-4 |
| تدمد: | 0368-2811 |
| Relation: | Japanese Journal of Clinical Oncology, Vol.54 No.4, pp.434-443; https://hdl.handle.net/10371/198988; 001143357400001; 2-s2.0-85190313311; 204918 |
| DOI: | 10.1093/jjco/hyad181 |
| الاتاحة: | https://hdl.handle.net/10371/198988 https://doi.org/10.1093/jjco/hyad181 |
| رقم الانضمام: | edsbas.48FEFBDE |
| قاعدة البيانات: | BASE |
Full Text Finder | ردمك: | 9780011433578 0011433574 |
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| تدمد: | 03682811 |
| DOI: | 10.1093/jjco/hyad181 |