A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer
DC Field | Value | Language |
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dc.contributor.author | Kim, Tae-Yong | - |
dc.contributor.author | Han, Hye Sook | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Zang, Dae Young | - |
dc.contributor.author | Rha, Sun Young | - |
dc.contributor.author | Park, Young Lee | - |
dc.contributor.author | Kim, Jin-Soo | - |
dc.contributor.author | Lee, Kyung-Hun | - |
dc.contributor.author | Park, Se Hoon | - |
dc.contributor.author | Song, Eun-Kee | - |
dc.contributor.author | Jung, Soo-A | - |
dc.contributor.author | Lee, NaMi | - |
dc.contributor.author | Kim, Yeul Hong | - |
dc.contributor.author | Cho, Jae Yong | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.date.available | 2020-11-02T06:29:17Z | - |
dc.date.issued | 2019-11 | - |
dc.identifier.issn | 1436-3291 | - |
dc.identifier.issn | 1436-3305 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/1457 | - |
dc.description.abstract | Background Poziotinib (HM781-36B) is an irreversible pan-HER tyrosine kinase inhibitor which targets EGFR, HER2, and HER4. This prospective, multicenter, open-label, phase I/II study determined the maximum tolerated dose (MTD) and evaluated the safety and efficacy of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer (GC). Methods Patients with HER2-positive GC previously treated with one line of chemotherapy received oral poziotinib (8 mg or 12 mg) once daily for 14 days, followed by 7 days off. Paclitaxel (175 mg/m2 infusion) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg infusion) were administered concomitantly with poziotinib on day 1 every 3 weeks. Results In the phase I part, 12 patients were enrolled (7 at dose level 1, 5 at dose level 2). One patient receiving poziotinib 8 mg and 2 receiving poziotinib 12 mg had dose-limiting toxicities (DLTs); all DLTs were grade 4 neutropenia, one with fever. The most common poziotinib-related adverse events were diarrhea, rash, stomatitis, pruritus and loss of appetite. The MTD of poziotinib was determined to be 8 mg/day and this was used in the phase II part which enrolled 32 patients. Two patients (6.3%) had complete responses and 5 (15.6%) had partial responses (objective response rate 21.9%). Median progression-free survival and overall survival were 13.0 weeks (95% CI 9.8–21.9) and 29.5 weeks (95% CI 17.9–59.2), respectively. Conclusions The MTD of poziotinib combined with paclitaxel and trastuzumab was 8 mg/day. This combination yielded promising anti-tumor efficacy with manageable toxicity in previously treated patients with HER2-positive GC. | - |
dc.format.extent | 9 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Springer Verlag | - |
dc.title | A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer | - |
dc.type | Article | - |
dc.publisher.location | 미국 | - |
dc.identifier.doi | 10.1007/s10120-019-00958-4 | - |
dc.identifier.scopusid | 2-s2.0-85064233072 | - |
dc.identifier.wosid | 000492168800013 | - |
dc.identifier.bibliographicCitation | Gastric Cancer, v.22, no.6, pp 1206 - 1214 | - |
dc.citation.title | Gastric Cancer | - |
dc.citation.volume | 22 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 1206 | - |
dc.citation.endPage | 1214 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | EARLY BREAST-CANCER | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | PLUS TRASTUZUMAB | - |
dc.subject.keywordPlus | LAPATINIB | - |
dc.subject.keywordPlus | HER2 | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | PERTUZUMAB | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | CAPECITABINE | - |
dc.subject.keywordAuthor | Chemotherapy | - |
dc.subject.keywordAuthor | Gastric cancer | - |
dc.subject.keywordAuthor | HER2 | - |
dc.subject.keywordAuthor | Poziotinib | - |
dc.subject.keywordAuthor | Trastuzumab | - |
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