Combination of Docetaxel Plus Savolitinib in Refractory Cancer Patients: A Report on Phase I Trial
DC Field | Value | Language |
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dc.contributor.author | Kim, S.T.[Kim, S.T.] | - |
dc.contributor.author | Lee, S.[Lee, S.] | - |
dc.contributor.author | Park, M.[Park, M.] | - |
dc.contributor.author | Park, S.H.[Park, S.H.] | - |
dc.contributor.author | Park, J.O.[Park, J.O.] | - |
dc.contributor.author | Lim, H.Y.[Lim, H.Y.] | - |
dc.contributor.author | Park, Y.S.[Park, Y.S.] | - |
dc.contributor.author | Kang, W.K.[Kang, W.K.] | - |
dc.contributor.author | Gangolli, E.A.[Gangolli, E.A.] | - |
dc.contributor.author | Shin, H.[Shin, H.] | - |
dc.contributor.author | Kim, K.-M.[Kim, K.-M.] | - |
dc.contributor.author | Hollingsworth, S.J.[Hollingsworth, S.J.] | - |
dc.contributor.author | Mortimer, P.G.S.[Mortimer, P.G.S.] | - |
dc.contributor.author | Lee, J.[Lee, J.] | - |
dc.date.accessioned | 2021-07-29T05:45:19Z | - |
dc.date.available | 2021-07-29T05:45:19Z | - |
dc.date.created | 2019-11-29 | - |
dc.date.issued | 2019-04 | - |
dc.identifier.issn | 1936-5233 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/15886 | - |
dc.description.abstract | MET amplification is a frequently observed genomic aberration in solid tumors. We conducted a phase I trial to evaluate dose-limiting toxicity (DLT) and recommended phase II dose (RP2D) for the combination therapy. The following dose levels were tested in this single-arm phase I study: docetaxel as an intravenous infusion over 1 hour at 60 mg/m2 once every 3 weeks of a 21-day schedule plus savolitinib (level 1, 200 mg qd; level 2, 400 mg qd; level 3, 600 mg qd; level 4800 mg qd). In total, there were 17 patients enrolled on to this study [7 gastric cancer (GC) patients, 5 melanoma patients, 3 sarcoma patients, and 2 rectal cancer patients]. Most of the patients (14 of 17) were heavily pretreated (≥third line or greater lines of treatment). For the first 3 cohorts (200 mg savolitinib + docetaxel 60 mg/m2, 400 mg savolitinib + docetaxel 60 mg/m2, 600 mg savolitinib + docetaxel 60 mg/m2), there were no DLTs. In the fourth dose cohort (800 mg savolitinib + docetaxel 60 mg/m2), one DLT occurred with generalized edema grade 3 that required intensive management. One GC patient with both MET overexpression (3+) and MET amplification (MET/CEP7 ratio, 7.3) achieved a durable partial response for 297 days, and another MET-amplified GC patient (MET/CEP7 ratio, 7.6) achieved stable disease for 86 days. Due to the higher incidence of G4 neutropenia in cohort 4 (800 mg), we recommend savolitinib 600 mg qd in combination with docetaxel 60 mg/m2 as the RP2D for phase II trial. The combination therapy demonstrated a very promising antitumor activity with durable responses in MET amplified GC patients. © 2019 The Authors | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | Neoplasia Press, Inc. | - |
dc.title | Combination of Docetaxel Plus Savolitinib in Refractory Cancer Patients: A Report on Phase I Trial | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, S.T.[Kim, S.T.] | - |
dc.contributor.affiliatedAuthor | Park, S.H.[Park, S.H.] | - |
dc.contributor.affiliatedAuthor | Park, J.O.[Park, J.O.] | - |
dc.contributor.affiliatedAuthor | Lim, H.Y.[Lim, H.Y.] | - |
dc.contributor.affiliatedAuthor | Park, Y.S.[Park, Y.S.] | - |
dc.contributor.affiliatedAuthor | Kang, W.K.[Kang, W.K.] | - |
dc.contributor.affiliatedAuthor | Kim, K.-M.[Kim, K.-M.] | - |
dc.contributor.affiliatedAuthor | Lee, J.[Lee, J.] | - |
dc.identifier.doi | 10.1016/j.tranon.2018.12.009 | - |
dc.identifier.scopusid | 2-s2.0-85060467156 | - |
dc.identifier.wosid | 000460917400001 | - |
dc.identifier.bibliographicCitation | Translational Oncology, v.12, no.4, pp.597 - 601 | - |
dc.relation.isPartOf | Translational Oncology | - |
dc.citation.title | Translational Oncology | - |
dc.citation.volume | 12 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 597 | - |
dc.citation.endPage | 601 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.isOpenAccess | Y | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | GASTRIC-CANCER | - |
dc.subject.keywordPlus | MET | - |
dc.subject.keywordPlus | OVEREXPRESSION | - |
dc.subject.keywordPlus | AMPLIFICATION | - |
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