2017
Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma
Sznol M, Ferrucci PF, Hogg D, Atkins MB, Wolter P, Guidoboni M, Lebbé C, Kirkwood JM, Schachter J, Daniels GA, Hassel J, Cebon J, Gerritsen W, Atkinson V, Thomas L, McCaffrey J, Power D, Walker D, Bhore R, Jiang J, Hodi FS, Wolchok JD. Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma. Journal Of Clinical Oncology 2017, 35: jco.2016.72.116. PMID: 28915085, DOI: 10.1200/jco.2016.72.1167.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansIpilimumabMaleMaximum Tolerated DoseMelanomaMiddle AgedNeoplasm InvasivenessNeoplasm StagingNivolumabPatient SafetyPrognosisRandomized Controlled Trials as TopicRetrospective StudiesSkin NeoplasmsSurvival AnalysisConceptsTreatment-related adverse eventsTreatment-related select adverse eventsSelect adverse eventsAdverse eventsImmune-modulating agentsAdvanced melanomaMedian timeSafety profileResolution rateGrade 3/4 treatment-related adverse eventsTreatment-related grade 3/4 adverse eventsGrade 3/4 adverse eventsDose of nivolumabIpilimumab combination therapyProgression-free survivalEndocrine adverse eventsAddition of nivolumabGrade 3/4AE managementMedian durationUnacceptable toxicityAntitumor responseCombination therapyStudy deathsDisease progression
2016
Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma
Weber JS, Hodi FS, Wolchok JD, Topalian SL, Schadendorf D, Larkin J, Sznol M, Long GV, Li H, Waxman IM, Jiang J, Robert C. Safety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma. Journal Of Clinical Oncology 2016, 35: jco.2015.66.138. PMID: 28068177, DOI: 10.1200/jco.2015.66.1389.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsSelect adverse eventsObjective response rateImmune-modulating agentsTreatment-related select adverse eventsAdverse eventsNivolumab monotherapyAdvanced melanomaSafety profileGrade 3Grade treatment-related adverse eventsProgression-free survival benefitHigher objective response rateRenal adverse eventsPhase III trialsDrug-related deathsNumber of dosesIII trialsSurvival benefitMedian timePooled analysisSafety guidelinesRetrospective analysisSafety dataPatients