Phase II Trial of Irinotecan plus Nedaplatin (INP) in Treating Patients with Extensive Stage Small Cell Lung Cancer

Phase II Trial of Irinotecan plus Nedaplatin (INP) in Treating Patients with Extensive Stage Small Cell Lung Cancer

AbstractPurpose:WeconductedaphaseIIstudyofcombinationchemotherapywithirinotecan(CPT-11)andnedaplatin(NDP),(INPregimen),todeterminetheeffectsandtoxicitiesinpatientswithextensivestagesmallcelllungcancer(SCLC).Methods:FromMarch2005toDecember2010,60patientswithhistologicallyorcytologicallyconfirmedextensiveSCLCwereenrolledintothisstudy.AllreceivedtreatmentCPT-11atadoseof60mg/m2ondays1and8,andNDP20mg/m2ondays1-5,every3-4weeksasacycle.Patientsweretreateduntiltumorprogressionorunacceptabletoxicity.Results:Maintoxicitiesincluded:myelosuppression,nauseaorvomiting,diarrhea,elevationofalanineaminotransferase,andbilirubin.Notreatmentrelateddeathoccurredinthisstudy.Thirteenpatientshadcompleteresponse,forty-twohadpartialresponse,threeremainedstable,andtwohadprogressivedisease.Medianprogression-freesurvivalwas13months(95%confidenceinterval:9-17)andmedianoverallsurvivalwas22months(95%confidenceinterval:19-25).Conclusion:INPisaneffectiveandwelltoleratedregimenfortreatmentofextensivestagedSCLC.