2017
Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045.
De Wit R, Bajorin D, Bellmunt J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Li H, Perini R, Vaughn D. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045. Journal Of Clinical Oncology 2017, 35: 4530-4530. DOI: 10.1200/jco.2017.35.15_suppl.4530.Peer-Reviewed Original ResearchAdvanced urothelial cancerGlobal health status/QoL scoreUrothelial cancerKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testHRQOL end pointsSecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisStudy treatmentPembroHazards modelInvestigator's choiceRate of improvementLongitudinal data analysis modelEnd pointHealth-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer.
Vaughn D, Bellmunt J, De Wit R, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Li H, Perini R, Bajorin D. Health-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer. Journal Of Clinical Oncology 2017, 35: 282-282. DOI: 10.1200/jco.2017.35.6_suppl.282.Peer-Reviewed Original ResearchGlobal health status/QoL scoreAdvanced UCKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testAdvanced urothelial cancerHRQOL end pointsInvestigator-choice chemotherapySecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisUrothelial cancerStudy treatmentPembroHazards modelInvestigator's choiceRate of improvement
2012
Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy.
Pond G, Sonpavde G, Choueiri T, Qu A, Vaughn D, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Beer T, Stadler W, O'Donnell P, Sternberg C, Rosenberg J, Molins J. Time from prior chemotherapy (TFPC) as a prognostic factor in advanced urothelial carcinoma (UC) receiving second-line systemic therapy. Journal Of Clinical Oncology 2012, 30: 4522-4522. DOI: 10.1200/jco.2012.30.15_suppl.4522.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaMedian overall survivalOverall survivalPrior chemotherapyUrothelial carcinomaLiver metastasesPerformance statusPrognostic factorsSecond-line systemic therapyOptimal cutpointSignificant negative prognostic impactECOG performance statusFirst study treatmentSecond-line chemotherapyPhase II trialKaplan-Meier methodNegative prognostic impactProportional hazards regressionLikelihood ratio χBaseline HbII trialMetastatic diseaseOS independentPrognostic impactCorrelation of progression-free survival at 6 months (PFS6) with overall survival at 12 months (OS12) in an analysis of 10 trials of second-line therapy for advanced urothelial carcinoma (UC).
Maughan B, Boucher K, Agarwal N, Choueiri T, Qu A, Vogelzang N, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Vaishampayan U, Beer T, Sternberg C, Rosenberg J, Molins J, Sonpavde G. Correlation of progression-free survival at 6 months (PFS6) with overall survival at 12 months (OS12) in an analysis of 10 trials of second-line therapy for advanced urothelial carcinoma (UC). Journal Of Clinical Oncology 2012, 30: 4525-4525. DOI: 10.1200/jco.2012.30.15_suppl.4525.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaPhase II trialUrothelial carcinomaIndividual-level agreementResponse rateII trialIndividual patient progressionProgression-free survivalAssociation of responsePearson's chi-square testDuration of benefitSignificant unmet needRandom-effects modelChi-square testPearson correlationPrimary endpointVisceral metastasesOverall survivalPerformance statusMedian ageYates' continuity correctionPatient progressionIntermediate endpointsPFS6