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Enhanced antitumor effect of binimetinib in combination with capecitabine for biliary tract cancer patients with mutations in the RAS/RAF/MEK/ERK pathway: Phase Ib study
DC Field | Value | Language |
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dc.contributor.author | Kim, Jin Won | - |
dc.contributor.author | Lee, Kyung-Hun | - |
dc.contributor.author | Kim, Ji-Won | - |
dc.contributor.author | Suh, Koung Jin | - |
dc.contributor.author | Nam, Ah-Rong | - |
dc.contributor.author | Bang, Ju-Hee | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Oh, Do-Youn | - |
dc.date.accessioned | 2021-01-31T11:04:17Z | - |
dc.date.available | 2021-01-31T11:04:17Z | - |
dc.date.created | 2019-09-27 | - |
dc.date.issued | 2019-08-13 | - |
dc.identifier.citation | British Journal of Cancer, Vol.121 No.4, pp.332-339 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.other | 84672 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173001 | - |
dc.description.abstract | BACKGROUND: A phase Ib study of binimetinib and capecitabine for gemcitabine-pretreated biliary tract cancer (BTC) patients was conducted. METHODS: Binimetinib and capecitabine were dosed twice daily on days 1-14, in 3-week cycles. In the dose-escalation (DE) part, three dose levels (DL) were tested (DL1: binimetinib/capecitabine, 15 mg/1000 mg/m(2); DL2: 30 mg/1000 mg/m(2); DL3: 30 mg/1250 mg/m(2)). RESULTS: In the DE part, nine patients were recruited and no dose-limiting toxicity was noted. Therefore, the recommended phase 2 dose was determined as DL3. In the expansion part, 25 patients were enrolled. In total, 34 patients, 25 (73.5%) and 9 patients (26.5%) were second-line and third-line settings, respectively. The 3-month progression-free survival (PFS) rate was 64.0%, and the median PFS and overall survival (OS) were 4.1 and 7.8 months. The objective response rate and disease control rate were 20.6% and 76.5%. In total, 68.4% of stable diseases were durable (> 12 weeks). Furthermore, patients with RAS/RAF/MEK/ERK pathway mutations (38.5%) showed significantly better tumour response (p = 0.028), PFS (5.4 vs. 3.5 months, p = 0.010) and OS (10.8 vs. 5.9 months, p = 0.160) than wild type. Most of the adverse events were grade 1/2 and manageable. CONCLUSIONS: A combination of binimetinib and capecitabine shows acceptable tolerability and promising antitumor efficacy for gemcitabine-pretreated BTC, especially in patients with RAS/RAF/MEK/ERK pathway mutations. | - |
dc.language | 영어 | - |
dc.publisher | Nature Publishing Group | - |
dc.title | Enhanced antitumor effect of binimetinib in combination with capecitabine for biliary tract cancer patients with mutations in the RAS/RAF/MEK/ERK pathway: Phase Ib study | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1038/s41416-019-0523-5 | - |
dc.citation.journaltitle | British Journal of Cancer | - |
dc.identifier.wosid | 000480675100007 | - |
dc.identifier.scopusid | 2-s2.0-85069053177 | - |
dc.citation.endpage | 339 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 332 | - |
dc.citation.volume | 121 | - |
dc.identifier.sci | 000480675100007 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.contributor.affiliatedAuthor | Oh, Do-Youn | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | GROWTH | - |
dc.subject.keywordPlus | MEK162 | - |
dc.subject.keywordPlus | CHOLANGIOCARCINOMA | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | KINASE | - |
dc.subject.keywordPlus | INTERLEUKIN-6 | - |
dc.subject.keywordPlus | 5-FLUOROURACIL | - |
dc.subject.keywordPlus | GEMCITABINE | - |
dc.subject.keywordPlus | SURVIVAL | - |
dc.subject.keywordPlus | CELLS | - |
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