Cited 5 times in
Phase 1b Open-Label Trial of Afatinib Plus Xentuzumab (BI 836845) in Patients With EGFR Mutation-Positive NSCLC After Progression on EGFR Tyrosine Kinase Inhibitors
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2022-02-23T01:18:08Z | - |
dc.date.available | 2022-02-23T01:18:08Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/187623 | - |
dc.description.abstract | Introduction: Insulin-like growth factor signaling has been implicated in acquired resistance to EGFR tyrosine kinase inhibitors (TKIs) in NSCLC. This phase 1 trial (NCT02191891) investigated the combination of xentuzumab (an insulin-like growth factor-ligand neutralizing monoclonal antibody) and afatinib (an EGFR TKI) in patients with previously treated EGFR mutation-positive NSCLC. Methods: The trial comprised dose escalation (part A) and expansion (part B). Patients had advanced or metastatic NSCLC that had progressed on EGFR TKI monotherapy or platinum-based chemotherapy (nonadenocarcinoma only, part A) or irreversible EGFR TKI monotherapy (part B). Absence of EGFR T790M mutation was required in part B. Part A used a 3 + 3 design, with a starting dose of xentuzumab 1000 mg/wk (intravenous) and afatinib 30 mg/d (oral). Primary endpoints were the maximum tolerated dose of the combination (part A) and objective response (part B). Results: A total of 16 patients each were treated in parts A and B. Maximum tolerated dose was xentuzumab 1000 mg/wk plus afatinib 40 mg/d. No patients in part B had an objective response, but 10 had stable disease (median [range] duration of disease control: 2.3 [0.8-10.9] mo). The most common drug-related adverse events were diarrhea (75 %), paronychia (69 %), and rash (69 %) in part A and diarrhea (31 %), rash (19 %), paronychia (19 %), and fatigue (19 %) in part B. Conclusions: There were no new safety issues; xentuzumab and afatinib could be safely coadministered. Nevertheless, the combination revealed only modest activity in patients with EGFR mutation-positive, T790M-negative NSCLC after progression on afatinib. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier Inc. | - |
dc.relation.isPartOf | JTO Clinical and Research Reports | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Phase 1b Open-Label Trial of Afatinib Plus Xentuzumab (BI 836845) in Patients With EGFR Mutation-Positive NSCLC After Progression on EGFR Tyrosine Kinase Inhibitors | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Keunchil Park | - |
dc.contributor.googleauthor | Daniel Shao Weng Tan | - |
dc.contributor.googleauthor | Wu-Chou Su | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Ki Hyeong Lee | - |
dc.contributor.googleauthor | Chin-Chou Wang | - |
dc.contributor.googleauthor | Takashi Seto | - |
dc.contributor.googleauthor | Dennis Chin-Lun Huang | - |
dc.contributor.googleauthor | Helen Hayoun Jung | - |
dc.contributor.googleauthor | Ming-Chi Hsu | - |
dc.contributor.googleauthor | Thomas Bogenrieder | - |
dc.contributor.googleauthor | Chia-Chi Lin | - |
dc.identifier.doi | 10.1016/j.jtocrr.2021.100206 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J04164 | - |
dc.identifier.eissn | 2666-3643 | - |
dc.identifier.pmid | 34590052 | - |
dc.subject.keyword | Afatinib | - |
dc.subject.keyword | EGFR tyrosine kinase inhibitor | - |
dc.subject.keyword | IGF | - |
dc.subject.keyword | NSCLC | - |
dc.subject.keyword | Xentuzumab | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 2 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 100206 | - |
dc.identifier.bibliographicCitation | JTO Clinical and Research Reports, Vol.2(9) : 100206, 2021-07 | - |
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