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A phase I/II and pharmacogenomic study of pemetrexed and cisplatin in patients with unresectable, advanced gastric carcinoma

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dc.contributor.authorChen, Jen-Shi-
dc.contributor.authorChao, Yee-
dc.contributor.authorBang, Yung-Jue-
dc.contributor.authorRoca, Enrique-
dc.contributor.authorChung, Hyun C.-
dc.contributor.authorPalazzo, Felipe-
dc.contributor.authorKim, Yeul H.-
dc.contributor.authorMyrand, Scott P.-
dc.contributor.authorMullaney, Brian P.-
dc.contributor.authorShen, Li J.-
dc.contributor.authorLinn, Carlos-
dc.date.accessioned2021-01-31T11:00:43Z-
dc.date.available2021-01-31T11:00:43Z-
dc.date.created2020-12-23-
dc.date.issued2010-09-
dc.identifier.citationAnti-Cancer Drugs, Vol.21 No.8, pp.777-784-
dc.identifier.issn0959-4973-
dc.identifier.other119694-
dc.identifier.urihttps://hdl.handle.net/10371/172961-
dc.description.abstractThis phase I/II study was conducted to determine the maximum recommended dose of pemetrexed when given in combination with a fixed dose of cisplatin, and the efficacy, toxicity and association of 5,10-methylenetetrahydrofolate reductase (MTHFR) variants with this pemetrexed-cisplatin combination, in patients with unresectable, advanced gastric carcinoma. Patients 18-70 years of age, with stage IV disease or post-surgery recurrence, no earlier palliative chemotherapy, 0 or 1 Eastern Cooperative Oncology Group performance status, were included. The cisplatin dose was 75mg/m(2). In phase I, the initial dose of pemetrexed was 600mg/m(2), escalated in 100mg/m(2) increments. In phase II, efficacy, including overall response rate, overall survival, as well as toxicity and MTHFR pharmacogenetics were investigated. Phase I enrolled 16 patients; 700mg/m(2) was defined as pemetrexed recommended dose. Thirteen serious adverse events were reported; the most common grade 3/4 toxicities were haematologic (10 of 13, 76.9%). Phase II enrolled 73 patients, 69 qualified for safety and 68 for efficacy analysis; 65 for pharmacogenomic analysis. Overall response rate was 23.5% (14.1%, 35.4%), disease control rate 55.9%, median overall survival 11.8 months (95% confidence interval, 7.2-18.5 months), progression-free survival 4.9 months (95% confidence interval, 2.8-7.1 months), and median response duration 5.4 months. Patients with MTHFR A1298C variants had median overall survival of 6.6 months, significantly shorter than patients with the wild type (median 18.5 months, P = 0.001). The pemetrexed-cisplatin combination in patients with advanced gastric cancer generates modest efficacy and a manageable toxicity profile. The reduced overall survival in patients with MTHFR A1298C polymorphism variants deserves further investigation. Anti-Cancer Drugs 21: 777-784 (C) 2010 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.-
dc.language영어-
dc.publisherLippincott Williams & Wilkins Ltd.-
dc.titleA phase I/II and pharmacogenomic study of pemetrexed and cisplatin in patients with unresectable, advanced gastric carcinoma-
dc.typeArticle-
dc.contributor.AlternativeAuthor방영주-
dc.identifier.doi10.1097/CAD.0b013e32833cfbca-
dc.citation.journaltitleAnti-Cancer Drugs-
dc.identifier.wosid000280448800007-
dc.identifier.scopusid2-s2.0-77955231880-
dc.citation.endpage784-
dc.citation.number8-
dc.citation.startpage777-
dc.citation.volume21-
dc.identifier.sci000280448800007-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorBang, Yung-Jue-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusMETHYLENETETRAHYDROFOLATE REDUCTASE GENE-
dc.subject.keywordPlusHIGH-DOSE METHOTREXATE-
dc.subject.keywordPlus1ST-LINE THERAPY-
dc.subject.keywordPlusPALLIATIVE CHEMOTHERAPY-
dc.subject.keywordPlusEUROPEAN-ORGANIZATION-
dc.subject.keywordPlusCOOPERATIVE GROUP-
dc.subject.keywordPlusIII TRIAL-
dc.subject.keywordPlusCANCER-
dc.subject.keywordPlusFLUOROURACIL-
dc.subject.keywordPlusPOLYMORPHISMS-
dc.subject.keywordAuthoradvanced gastric carcinoma-
dc.subject.keywordAuthorcisplatin-
dc.subject.keywordAuthorMTHFR-
dc.subject.keywordAuthorpharmacogenetics-
dc.subject.keywordAuthorphase I/II clinical trials-
dc.subject.keywordAuthorpemetrexed-
dc.subject.keywordAuthorunresectable-
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