Phase II trial with S-1 in chemotherapy-naive patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)

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dc.contributor.authorChollet, P.en
dc.contributor.authorSchoffski, P.en
dc.contributor.authorWeigang-Kohler, K.en
dc.contributor.authorSchellens, J. H.en
dc.contributor.authorCure, H.en
dc.contributor.authorPavlidis, N.en
dc.contributor.authorGrunwald, V.en
dc.contributor.authorDe Boer, R.en
dc.contributor.authorWanders, J.en
dc.contributor.authorFumoleau, P.en
dc.date.accessioned2015-11-24T18:58:50Z
dc.date.available2015-11-24T18:58:50Z
dc.identifier.issn0959-8049-
dc.identifier.urihttps://olympias.lib.uoi.gr/jspui/handle/123456789/19315
dc.rightsDefault Licence-
dc.subjectAdulten
dc.subjectAgeden
dc.subjectAntimetabolites, Antineoplastic/*administration & dosage/adverse effectsen
dc.subjectCohort Studiesen
dc.subjectDrug Combinationsen
dc.subjectFemaleen
dc.subjectHumansen
dc.subjectMaleen
dc.subjectMiddle Ageden
dc.subjectOxonic Acid/*administration & dosage/adverse effectsen
dc.subjectPyridines/*administration & dosage/adverse effectsen
dc.subjectStomach Neoplasms/*drug therapyen
dc.subjectTegafur/*administration & dosage/adverse effectsen
dc.subjectTreatment Outcomeen
dc.titlePhase II trial with S-1 in chemotherapy-naive patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG)en
heal.abstractS-1 is a new oral fluorinated pyrimidine derivate, in which the oral 5-fluorouracil (5-FU) prodrug, tegafur, was combined with two 5-FU-modulating substances, 5-chloro-2,4-dihydroxypyridine (gimeracil), and potassium oxonate (oteracil), at a molar ratio of 1:0.4:1. The final mechanism of action is exerted by 5-FU. The present study is the first European phase II trial of S-1 in gastric cancer. The primary study objectives were the safety, toxicity and activity of S-1 in non-pretreated patients with gastric cancer. The secondary objective was the duration of response. Patients had to have histologically- or cytologically-verified metastatic or locally advanced, unresectable gastric cancer; S-1 was administered orally twice daily at 40, then 35 mg/m(2) for 28 days every 5 weeks. The starting dose of 40 mg/m(2) was found to be intolerable due to significant non-haematological toxicity, and this dose was rapidly reduced to 35 mg/m(2) twice daily. Of the 7 patients enrolled at the 40 mg/m(2) level, only 3 were evaluable. At 35 mg/m(2), a response rate of 26.1% (95% Confidence Interval (CI) 12.0-45.1%) in 23 enrolled patients, and 31.6% (C.I. 14.7-53.0%) in 19 evaluable patients according to an independent radiology review, was found. The median duration of response at 35 mg/m(2) (6 patients) was 223 days (range, 108-828 days), and of stable disease was 111 days (range 68-411 days). S-1 can be administered with an acceptable safety and toxicity in European patients at a dose of 35 mg/m(2) days 1 - 28 every 5 weeks and is associated with a moderate response rate similar to the results achieved with other fluoropyrimidines.en
heal.accesscampus-
heal.fullTextAvailabilityTRUE-
heal.identifier.secondaryhttp://www.ncbi.nlm.nih.gov/pubmed/12763215-
heal.identifier.secondaryhttp://ac.els-cdn.com/S0959804903002375/1-s2.0-S0959804903002375-main.pdf?_tid=7b046b7a08281e239de9dd6f90363c5d&acdnat=1333610886_65346a474687ae0a0922e74db168396c-
heal.journalNameEur J Canceren
heal.journalTypepeer-reviewed-
heal.languageen-
heal.publicationDate2003-
heal.recordProviderΠανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικήςel
heal.typejournalArticle-
heal.type.elΆρθρο Περιοδικούel
heal.type.enJournal articleen

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