2024
20 Evaluating intermediate endpoints for overall survival in metastatic renal cell carcinoma treated with immune checkpoint inhibitors: an IMDC study
Saliby R, Xie W, Wells C, Saad E, Eid M, Semaan K, Labaki C, Ferrier E, Zarba M, Ebrahimi H, Ravi P, Suarez C, Morales J, McKay R, Powles T, Wood L, Lalani A, Pal S, de Velasco G, Takemura K, Agarwal N, Braun D, Heng D, Choueiri T. 20 Evaluating intermediate endpoints for overall survival in metastatic renal cell carcinoma treated with immune checkpoint inhibitors: an IMDC study. The Oncologist 2024, 29: s8-s9. PMCID: PMC11301915, DOI: 10.1093/oncolo/oyae181.013.Peer-Reviewed Original ResearchTime to next therapyInternational mRCC Database ConsortiumTime to treatment failureInternational mRCC Database Consortium risk groupOverall survivalObjective responseFollow-upIndividual patient dataLandmark analysisTreatment failureInternational Metastatic Renal-Cell Carcinoma Database ConsortiumMetastatic renal cell carcinoma treated with immune checkpoint inhibitorsRisk groupsEndpoint of overall survivalMonths of follow-upIntermediate endpointsICI-based regimensImmune checkpoint inhibitorsImmune-checkpoint inhibitorsMedian Follow-UpAnalysis of OSAssociated with OSAssociation of OSPost-therapy initiationFollow-up timeNivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649.
Elimova E, Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Bruges Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Nathani R, Janjigian Y. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4-year follow-up of CheckMate 649. Journal Of Clinical Oncology 2024, 42: 4040-4040. DOI: 10.1200/jco.2024.42.16_suppl.4040.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewCombined positive scoreObjective response ratePD-L1Overall survivalFollow-upCheckMate 649Clinically meaningful progression-free survivalPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Dual primary endpointsHER2+ patientsDeath-ligand 1Analysis of OSIndependent central reviewLong-term efficacyFollow-up resultsEarly Follow-upClinically Meaningful ImprovementsMedian OSOS benefitPD-1Central reviewNivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649.
Shitara K, Moehler M, Ajani J, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Cleary J, Elimova E, Bruges Maya R, Karamouzis M, Skoczylas T, Bragagnoli A, Liu T, Tehfe M, Feeney K, Wang R, Nathani R, Janjigian Y. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649. Journal Of Clinical Oncology 2024, 42: 306-306. DOI: 10.1200/jco.2024.42.3_suppl.306.Peer-Reviewed Original ResearchProgression-free survivalBlinded independent central reviewCombined positive scoreObjective response ratePD-L1Overall survivalFollow-upCheckMate 649Clinically meaningful progression-free survivalPD-L1 combined positive scoreProgression-free survival benefitProgrammed death-ligand 1Dual primary endpointsHER2+ patientsDeath-ligand 1Analysis of OSIndependent central reviewLong-term efficacyFollow-up resultsEarly Follow-upClinically Meaningful ImprovementsMedian OSOS benefitPD-1Central review
2023
Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance
Sridhar S, Powles T, Climent Durán M, Park S, Massari F, Thiery-Vuillemin A, Valderrama B, Ullén A, Tsuchiya N, Aragon-Ching J, Gupta S, Petrylak D, Bellmunt J, Wang J, Laliberte R, di Pietro A, Costa N, Grivas P, Sternberg C, Loriot Y. Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance. European Urology 2023, 85: 154-163. PMID: 37714742, DOI: 10.1016/j.eururo.2023.08.001.Peer-Reviewed Original ResearchBest supportive careProgression-free survivalAdvanced urothelial carcinomaFirst-line chemotherapyPlatinum-based chemotherapyOverall survivalFirst-line maintenanceChemotherapy durationMaintenance treatmentUrothelial carcinomaFirst-line platinum-based chemotherapyAnalysis of OSAdvanced urothelial cancerPhase 3 trialAnalysis of subgroupsAdvanced UCPrior chemotherapyProspective trialSafety findingsSupportive careHazard ratioUrothelial cancerDisease progressionChemotherapyOverall populationAvelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial
Grivas P, Park S, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullén A, Loriot Y, Sridhar S, Yamamoto Y, Petrylak D, Sternberg C, Gupta S, Huang B, Costa N, Laliberte R, di Pietro A, Valderrama B, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. European Urology 2023, 84: 95-108. PMID: 37121850, DOI: 10.1016/j.eururo.2023.03.030.Peer-Reviewed Original ResearchConceptsBest supportive careProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyOverall survivalHazard ratioUrothelial carcinomaAnalysis of OSFirst-line maintenance therapyRelevant subgroupsCox proportional hazards modelClinical subgroup analysisPhase 3 trialKaplan-Meier methodProportional hazards modelFirst-line maintenanceMetastatic UCMaintenance therapyStable diseaseSupportive careComplete responsePartial responseAdvanced cancerPD-L1Maintenance treatment
2021
Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB).
Curigliano G, Mueller V, Borges V, Hamilton E, Hurvitz S, Loi S, Murthy R, Okines A, Paplomata E, Cameron D, Carey L, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Ramos J, Zhang C, Winer E. Updated results of tucatinib versus placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB). Journal Of Clinical Oncology 2021, 39: 1043-1043. DOI: 10.1200/jco.2021.39.15_suppl.1043.Peer-Reviewed Original ResearchMetastatic breast cancerBrain metastasesOverall survivalTyrosine kinase inhibitorsBreast cancerPlacebo armAnalysis of OSOral tyrosine kinase inhibitorECOG performance statusPlacebo-controlled trialTotal study populationKaplan-Meier timeHER2CLIMB trialMeaningful prolongationMetastatic HER2Study medicationTolerability assessmentsMetastatic settingAdverse eventsDose modificationHazard ratioLast patientPerformance statusDisease progressionStudy population
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