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Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies
DC Field | Value | Language |
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dc.contributor.author | Takahashi, Shunji | - |
dc.contributor.author | Bando, Hideaki | - |
dc.contributor.author | Kinoshita, Ichiro | - |
dc.contributor.author | Modi, Shanu | - |
dc.contributor.author | Tsurutani, Junji | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Sato, Yuta | - |
dc.contributor.author | Nakatani, Shunsuke | - |
dc.contributor.author | Lee, Caleb | - |
dc.contributor.author | Sugihara, Masahiro | - |
dc.contributor.author | Okuda, Yasuyuki | - |
dc.contributor.author | Iwata, Hiroji | - |
dc.date.accessioned | 2024-02-07T06:11:58Z | - |
dc.date.available | 2024-02-07T06:11:58Z | - |
dc.date.created | 2024-02-05 | - |
dc.date.created | 2024-02-05 | - |
dc.date.issued | 2024-04 | - |
dc.identifier.citation | Japanese Journal of Clinical Oncology, Vol.54 No.4, pp.434-443 | - |
dc.identifier.issn | 0368-2811 | - |
dc.identifier.uri | https://hdl.handle.net/10371/198988 | - |
dc.description.abstract | 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. | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies | - |
dc.type | Article | - |
dc.identifier.doi | 10.1093/jjco/hyad181 | - |
dc.citation.journaltitle | Japanese Journal of Clinical Oncology | - |
dc.identifier.wosid | 001143357400001 | - |
dc.citation.endpage | 443 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 434 | - |
dc.citation.volume | 54 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | ANTIBODY-DRUG CONJUGATE | - |
dc.subject.keywordPlus | PHASE-II | - |
dc.subject.keywordPlus | AMERICAN-PATHOLOGISTS | - |
dc.subject.keywordPlus | ADVERSE EVENTS | - |
dc.subject.keywordPlus | CISPLATIN | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | RECURRENT | - |
dc.subject.keywordPlus | GUIDELINE | - |
dc.subject.keywordPlus | CYCLOPHOSPHAMIDE | - |
dc.subject.keywordAuthor | DS8201-A-J101 | - |
dc.subject.keywordAuthor | DS8201-A-A104 | - |
dc.subject.keywordAuthor | human epidermal growth factor receptor 2 | - |
dc.subject.keywordAuthor | salivary gland carcinoma | - |
dc.subject.keywordAuthor | trastuzumab deruxtecan | - |
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