Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer results of a randomized phase III study

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1、ComparisonofOralCapecitabineVersusIntravenousFluorouracilPlusLeucovorinasFirst-LineTreatmentin605PatientsWithMetastaticColorectalCancer:ResultsofaRandomizedPhaseIIIStudyByPauloM.Hoff,RafatAnsari,GeraldBatist,JohnCox,WalterKocha,MarioKuperminc,JeanMaroun,DavidWalde,CharlesWe

2、aver,EvelynHarrison,HansU.Burger,BrunoOsterwalder,AlfredO.Wong,andRalfWongPurpose:Tocomparetheresponserate,ef®cacypa-producedasigni®cantlylowerincidence(P<.0002)oframeters,andtoxicitypro®leoforalcapecitabinewithdiarrhea,stomatitis,nausea,andalopecia.Patientsbolusintravenous

3、(IV)¯uorouracilplusleucovorin(5-treatedwithcapecitabinealsodisplayedlowerinci-FU/LV)as®rst-linetreatmentinpatientswithmetastaticdencesofgrade3/4stomatitisandgrade3/4neutro-colorectalcancer.penia(P<.0001)leadingtosigni®cantlylessneutro-PatientsandMethods:Weprospectivelyrando

4、mizedpenicfever/sepsis.Grade3hand-footsyndrome(P<605patientstotreatmentwithoralcapecitabinefor14.00001)andgrade3/4hyperbilirubinemiawerethedaysevery3weeksor5-FU/LVbyrapidIVinjectiondailyonlytoxicitiesmorefrequentlyassociatedwithcapecit-for5daysin4-weekcycles.abinethanwith5-

5、FU/LVtreatment.Results:TheoverallobjectivetumorresponserateConclusion:Oralcapecitabinewasmoreactivethanamongallrandomizedpatientswassigni®cantly5-FU/LVintheinductionofobjectivetumorresponses.higherinthecapecitabinegroup(24.8%)thanintheTimetodiseaseprogressionandsurvivalwere

6、atleast5-FU/LVgroup(15.5%;P5.005).Inthecapecitabineequivalentforcapecitabinecomparedwiththe5-FU/LVand5-FU/LVgroups,mediantimestodiseaseprogres-arm.Capecitabinealsodemonstratedclinicallymean-sionwere4.3and4.7months(log-rankP5.72),ingfulbene®tsoverbolus5-FU/LVintermsofmediant

7、imestotreatmentfailurewere4.1and3.1tolerability.months(P5.19),andmedianoverallsurvivaltimesJClinOncol19:2282-2292.©2001byAmericanwere12.5and13.3months(P5.974),respectively.SocietyofClinicalOncology.Capecitabine,comparedwithbolus5-FU/LVtreatment,4,5COLORECTALCANCERisthethird

8、mostcommonlymetastaticdisease,andapproximately50%to60%even-diagnosedmalignancy,acc