Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Lee, Kyung Hee | - |
dc.contributor.author | Zang, Dae Young | - |
dc.contributor.author | Park, Young Iee | - |
dc.contributor.author | Shin, Dong Bok | - |
dc.contributor.author | Kim, Jin Won | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Koh, Sung Ae | - |
dc.contributor.author | Yu, Kyung-Sang | - |
dc.contributor.author | Cho, Joo-Youn | - |
dc.contributor.author | Jung, Jin-A | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.date.available | 2020-02-28T08:44:32Z | - |
dc.date.created | 2020-02-06 | - |
dc.date.issued | 2015-08 | - |
dc.identifier.issn | 1083-7159 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/10268 | - |
dc.description.abstract | Background. Oraxol consists of paclitaxel and HM30181A, a P-glycoprotein inhibitor, to increase the oral bioavailability of paclitaxel. This phase I/II study (HM-OXL-201) was conducted to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Oraxol. In addition, we investigated the efficacy and safety of Oraxol as second-line chemotherapy for metastatic or recurrent gastric cancer (GC). Methods. In the phase I component, paclitaxel was orally administered at escalating doses (90, 120, or 150 mg/m(2) per day) with a fixed dose (15 mg/day) of HM30181A. Oraxol was administrated 6 times per cycle (days 1, 2, 8, 9, 15, and 16) every 4 weeks. In the phase II component, the efficacy and safety of Oraxol were evaluated. Results. In the phase I component, the MTD could not be determined. Based on toxicity and pharmacokinetic data, the RP2D of oral paclitaxel was determined to be 150 mg/m(2). In the phase II component, 4 of 43 patients (9.3%) achieved partial responses. Median progression-free survival and overall survival were 2.6 and 10.7 months, respectively. Toxicity profiles were favorable, and the most common drug-related adverse events (grade >= 3) were neutropenia and diarrhea. Conclusion. Oraxol exhibited modest efficacy and favorable toxicity profiles as second-line chemotherapy for GC. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.relation.isPartOf | ONCOLOGIST | - |
dc.subject | P-GLYCOPROTEIN INHIBITOR | - |
dc.subject | LOW-DOSE PACLITAXEL | - |
dc.subject | ORAL BIOAVAILABILITY | - |
dc.subject | PLUS PACLITAXEL | - |
dc.subject | SUPPORTIVE CARE | - |
dc.subject | OPEN-LABEL | - |
dc.subject | CHEMOTHERAPY | - |
dc.subject | TRIAL | - |
dc.subject | CISPLATIN | - |
dc.subject | IRINOTECAN | - |
dc.title | Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000360973500013 | - |
dc.identifier.doi | 10.1634/theoncologist.2015-0202 | - |
dc.identifier.bibliographicCitation | ONCOLOGIST, v.20, no.8, pp.896 - 897 | - |
dc.identifier.scopusid | 2-s2.0-84940037954 | - |
dc.citation.endPage | 897 | - |
dc.citation.startPage | 896 | - |
dc.citation.title | ONCOLOGIST | - |
dc.citation.volume | 20 | - |
dc.citation.number | 8 | - |
dc.contributor.affiliatedAuthor | Shin, Dong Bok | - |
dc.type.docType | Article | - |
dc.subject.keywordPlus | P-GLYCOPROTEIN INHIBITOR | - |
dc.subject.keywordPlus | LOW-DOSE PACLITAXEL | - |
dc.subject.keywordPlus | ORAL BIOAVAILABILITY | - |
dc.subject.keywordPlus | PLUS PACLITAXEL | - |
dc.subject.keywordPlus | SUPPORTIVE CARE | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | CISPLATIN | - |
dc.subject.keywordPlus | IRINOTECAN | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
1342, Seongnam-daero, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea(13120)031-750-5114
COPYRIGHT 2020 Gachon University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.