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Phase I/II study of weekly Oraxol for the second-line treatment of patients with metastatic or recurrent gastric cancer

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dc.contributor.authorLee, Keun-Wook-
dc.contributor.authorLee, Kyung Hee-
dc.contributor.authorZang, Dae Young-
dc.contributor.authorPark, Young Iee-
dc.contributor.authorShin, Dong Bok-
dc.contributor.authorKim, Jin Won-
dc.contributor.authorIm, Seock-Ah-
dc.contributor.authorKoh, Sung Ae-
dc.contributor.authorYu, Kyung-Sang-
dc.contributor.authorCho, Joo-Youn-
dc.contributor.authorJung, Jin-A-
dc.contributor.authorBang, Yung-Jue-
dc.date.accessioned2021-01-31T12:01:46Z-
dc.date.available2021-01-31T12:01:46Z-
dc.date.issued2015-08-
dc.identifier.citationOncologist, Vol.20 No.8, pp.896-897-
dc.identifier.issn1083-7159-
dc.identifier.other63448-
dc.identifier.urihttps://hdl.handle.net/10371/173219-
dc.description.abstractBackground. 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.titlePhase I/II study of weekly Oraxol for the second-line treatment of patients with metastatic or recurrent gastric cancer-
dc.typeArticle-
dc.contributor.AlternativeAuthor임석아-
dc.identifier.doi10.1634/theoncologist.2015-0202-
dc.citation.journaltitleOncologist-
dc.identifier.scopusid2-s2.0-84940037954-
dc.citation.endpage897-
dc.citation.number8-
dc.citation.startpage896-
dc.citation.volume20-
dc.identifier.urlhttp://theoncologist.alphamedpress.org/content/20/8/896-
dc.identifier.rimsid63448-
dc.identifier.sci000360973500013-
dc.contributor.affiliatedAuthorIm, Seock-Ah-
dc.contributor.affiliatedAuthorBang, Yung-Jue-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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