2023
Association Between Time-of-Day of Immune Checkpoint Blockade Administration and Outcomes in Metastatic Renal Cell Carcinoma
Dizman N, Govindarajan A, Zengin Z, Meza L, Tripathi N, Sayegh N, Castro D, Chan E, Lee K, Prajapati S, Feng M, Loo V, Pace M, O'Brien S, Bailey E, Barragan-Carrillo R, Chehrazi-Raffle A, Hsu J, Li X, Agarwal N, Pal S. Association Between Time-of-Day of Immune Checkpoint Blockade Administration and Outcomes in Metastatic Renal Cell Carcinoma. Clinical Genitourinary Cancer 2023, 21: 530-536. PMID: 37495481, DOI: 10.1016/j.clgc.2023.06.004.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaObjective response rateTreatment failureRenal cell carcinomaHazard ratioOverall survivalCell carcinomaMultivariate analysisHigh Cut-OffNivolumab/ipilimumabProspective Randomized StudyBaseline characteristicsRandomized studyClinical outcomesMedian timePreclinical evidenceUnivariate analysisPatientsResponse rateImmune systemInfusion timeStatistical significanceOutcomesCarcinomaInfusion
2022
Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3
Meza L, McDermott D, Escudier B, Hutson T, Porta C, Verzoni E, Atkins M, Kasturi V, Pal S, Rini B. Tivozanib in Patients with Advanced Renal Cell Carcinoma Previously Treated With Axitinib: Subgroup Analysis from TIVO-3. The Oncologist 2022, 28: e167-e170. PMID: 36576430, PMCID: PMC10020797, DOI: 10.1093/oncolo/oyac255.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaProgression-free survivalRenal cell carcinomaTIVO-3Cell carcinomaResponse rateEvaluate PFSAdvanced renal cell carcinomaTreated with axitinibTreatment of patientsClinical efficacyIdentified patientsSubgroup analysisTivozanibAxitinibPatientsCarcinomaSorafenibTreatmentMonthsSubgroupsTrialsTherapySurvivalDrugCharacterization of Patients With Metastatic Renal Cell Carcinoma Experiencing Complete Response to First-line Therapies: Results From the International Metastatic Renal Cell Carcinoma Database Consortium
Takemura K, Navani V, Ernst M, Wells J, Meza L, Pal S, Lee J, Li H, Agarwal N, Alva A, Hansen A, Basappa N, Szabados B, Powles T, Tran B, Hocking C, Beuselinck B, Yuasa T, Choueiri T, Heng D. Characterization of Patients With Metastatic Renal Cell Carcinoma Experiencing Complete Response to First-line Therapies: Results From the International Metastatic Renal Cell Carcinoma Database Consortium. Journal Of Urology 2022, 209: 701-709. PMID: 36573926, DOI: 10.1097/ju.0000000000003132.Peer-Reviewed Original ResearchConceptsTKI cohortInternational Metastatic Renal Cell Carcinoma Database ConsortiumComplete responseFirst-line therapyOverall survivalCombination therapyTKI armsTyrosine kinase inhibitor therapyMetastatic renal cell carcinomaNon-clear cell histologyMultiple sites of metastasesTyrosine kinase inhibitor monotherapyBaseline characteristics of patientsResponse rateComplete response rateKinase inhibitor therapyOverall survival benefitSite of metastasisFavorable overall survivalRenal cell carcinomaAdverse clinicopathological featuresCharacterization of patientsReal-world patientsCharacteristics of patientsClinical trial populationsCABOSEQ: The Effectiveness of Cabozantinib in Patients With Treatment Refractory Advanced Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Navani V, Wells J, Boyne D, Cheung W, Brenner D, McGregor B, Labaki C, Schmidt A, McKay R, Meza L, Pal S, Donskov F, Beuselinck B, Otiato M, Ludwig L, Powles T, Szabados B, Choueiri T, Heng D. CABOSEQ: The Effectiveness of Cabozantinib in Patients With Treatment Refractory Advanced Renal Cell Carcinoma: Results From the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Clinical Genitourinary Cancer 2022, 21: 106.e1-106.e8. PMID: 35945133, DOI: 10.1016/j.clgc.2022.07.008.Peer-Reviewed Original ResearchConceptsInternational Metastatic Renal Cell Carcinoma Database ConsortiumIpilimumab-nivolumabOverall survivalTreatment failureAdvanced renal cell carcinomaActivity of cabozantinibClinically meaningful activityMedian TTFEffects of cabozantinibGrowth factor inhibitorsRenal cell carcinomaMultivariate Cox regressionMedian OSRetrospective observational naturePoor riskCell carcinomaFactor inhibitorsCabozantinibCox regressionResponse ratePatientsOverall populationObservational natureVEGFiMonthsNivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial
Dizman N, Meza L, Bergerot P, Alcantara M, Dorff T, Lyou Y, Frankel P, Cui Y, Mira V, Llamas M, Hsu J, Zengin Z, Salgia N, Salgia S, Malhotra J, Chawla N, Chehrazi-Raffle A, Muddasani R, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Kortylewski M, Highlander SK, Pal SK. Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial. Nature Medicine 2022, 28: 704-712. PMID: 35228755, PMCID: PMC9018425, DOI: 10.1038/s41591-022-01694-6.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaProgression-free survivalRenal cell carcinomaCell carcinomaCheckpoint inhibitorsResponse rateGut microbiomePoor-risk diseaseTreatment-naive patientsSingle-center studyPhase 1 trialRandomized phase 1 trialSignificant differencesBifidobacterium sppMechanism of actionNivolumab-ipilimumabSarcomatoid histologyPrimary endpointSecondary endpointsImmune compartmentStudy armsClinical outcomesClear cellsClinical observationsPatientsCABOSEQ: The efficacy of cabozantinib post up-front immuno-oncology combinations in patients with advanced renal cell carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC).
Navani V, Wells C, Boyne D, Cheung W, Brenner D, McGregor B, Labaki C, Schmidt A, McKay R, Pal S, Meza L, Donskov F, Beuselinck B, Ernst M, Otiato M, Ludwig L, Powles T, Szabados B, Choueiri T, Heng D. CABOSEQ: The efficacy of cabozantinib post up-front immuno-oncology combinations in patients with advanced renal cell carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC). Journal Of Clinical Oncology 2022, 40: 318-318. DOI: 10.1200/jco.2022.40.6_suppl.318.Peer-Reviewed Original ResearchInternational Metastatic Renal Cell Carcinoma Database ConsortiumIpilimumab-nivolumabTreatment failureOverall survivalInternational Metastatic Renal Cell Carcinoma Database Consortium criteriaInternational Metastatic Renal Cell Carcinoma Database Consortium risk groupAdvanced renal cell carcinomaResponse rateActivity of cabozantinibClinically meaningful activityRenal cell carcinomaEndothelial growth factorCell histologySarcomatoid componentBone metastasesVEGF inhibitorsPoor riskCell carcinomaCabozantinibHazard ratioRisk groupsPatientsGrowth factorTherapyEarly lines
2021
First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM-588 in patients with metastatic renal cell carcinoma.
Meza L, Dizman N, Bergerot P, Dorff T, Lyou Y, Frankel P, Mira V, Llamas M, Hsu J, Zengin Z, Salgia N, Salgia S, Malhotra J, Chawla N, Chehrazi-Raffle A, Gillece J, Reining L, Trent J, Highlander S, Pal S. First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM-588 in patients with metastatic renal cell carcinoma. Journal Of Clinical Oncology 2021, 39: 4513-4513. DOI: 10.1200/jco.2021.39.15_suppl.4513.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaProgression-free survivalNivolumab/ipilimumabRenal cell carcinomaCBM 588Response rateClinical outcomesWeek 12Cell carcinomaSarcomatoid Metastatic Renal Cell CarcinomaMedian progression-free survivalGut microbiomeGrade 3/4 toxicitiesPhase Ib studyKey eligibility criteriaDiagnosis of sarcomaIMDC criteriaEvaluable patientsPrimary endpointSecondary endpointsICI responseMetastatic diseaseSarcomatoid featuresIntermediate riskMedian ageThe impact of antibiotic (Ab) exposure on clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors (ICI) or VEGF targeted therapy (VEGF-TT).
Ernst M, Alaiwi S, Dizman N, Labaki C, Nuzzo P, Adib E, Schmidt A, Meza L, Gan C, Wells J, Bakouny Z, Pal S, Choueiri T, Heng D, Dudani S. The impact of antibiotic (Ab) exposure on clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) treated with immune checkpoint inhibitors (ICI) or VEGF targeted therapy (VEGF-TT). Journal Of Clinical Oncology 2021, 39: 4552-4552. DOI: 10.1200/jco.2021.39.15_suppl.4552.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaImmune checkpoint inhibitorsOverall survivalABS exposureClinical outcomesTreatment failureResponse rateMultivariable analysisIndependent associationRisk factorsAdministration of AbFourth-line settingIMDC risk factorsIMDC risk scoresPoor-risk diseaseTreatment linesMultivariable Cox regressionInferior clinical outcomesInferior overall survivalIndependent prognostic markerRenal cell carcinomaSignificant independent associationOutcomes of interestIMDC criteriaCheckpoint inhibitors