2023
Real-World Outcomes of Latinx Versus Non-Latinx Patients Treated With First-Line Immunotherapy for Metastatic Renal-Cell Carcinoma
Chehrazi-Raffle A, Leong S, Ali S, Kim T, Melamed S, Li X, Zengin Z, Meza L, Chawla N, Govindarajan A, Castro D, Mercier B, Ebrahimi H, Dizman N, Tripathi N, Sayegh N, Rock A, Yeh J, Pal S, Onyshchenko M. Real-World Outcomes of Latinx Versus Non-Latinx Patients Treated With First-Line Immunotherapy for Metastatic Renal-Cell Carcinoma. The Oncologist 2023, 28: 1079-1084. PMID: 37432304, PMCID: PMC10712704, DOI: 10.1093/oncolo/oyad190.Peer-Reviewed Original ResearchConceptsMetastatic renal cell carcinomaProgression-free survivalComprehensive cancer centerNivolumab/ipilimumabShorter progression-free survivalOverall survivalRenal cell carcinomaLatinx patientsMultivariate Cox proportional hazards regressionCox proportional hazards regressionSafety-net healthcare systemHope Comprehensive Cancer CenterFirst-line immunotherapyTertiary oncology centerImmune checkpoint inhibitorsLos Angeles County DepartmentMedian overall survivalKaplan-Meier methodProportional hazards regressionDifferent healthcare settingsReal-world outcomesCheckpoint inhibitorsData cutoffClinical outcomesHazards regressionAssociation 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 significanceOutcomesCarcinomaInfusionAssessment of short-chain fatty acid (SCFA) and circulating cytokine trends in a clinical trial of nivolumab/ipilimumab and CBM588 in metastatic renal cell carcinoma (mRCC).
Dizman N, Pathak K, Alcantara M, Meza L, Bergerot P, Willey M, Dorff T, Hsu J, Zengin Z, Castro D, Ebrahimi H, Chehrazi-Raffle A, Tripathi A, Trent J, Takahashi M, Oka K, Higashi S, Kortylewski M, Pirrotte P, Pal S. Assessment of short-chain fatty acid (SCFA) and circulating cytokine trends in a clinical trial of nivolumab/ipilimumab and CBM588 in metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2023, 41: 4556-4556. DOI: 10.1200/jco.2023.41.16_suppl.4556.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaNivolumab/ipilimumabObjective response rateShort-chain fatty acidsPlasma short-chain fatty acidsImmune checkpoint blockadeCheckpoint blockadeCytokine levelsSCFA levelsClinical trialsRandomized phase I clinical trialSarcomatoid Metastatic Renal Cell CarcinomaPhase I clinical trialStool SCFA levelsAcid levelsTreatment-naïve patientsAltered amino acid metabolismRenal cell carcinomaIpilimumab armNaïve patientsButyric acid levelsSerum cytokinesClinical outcomesCell carcinomaBiologic rationaleAssociation between intra-tumoral microbiome and clinical benefit (CB) from immunotherapy (IO) in patients with metastatic renal cell carcinoma (mRCC).
Meza L, Choi Y, Zhang J, Dizman N, Zengin Z, Ebrahimi H, Barragan-Carrillo R, Hsu J, Chawla N, Chehrazi-Raffle A, Tripathi A, Castro D, Mercier B, Govindarajan A, Chan A, Schork N, Byron S, Pal S. Association between intra-tumoral microbiome and clinical benefit (CB) from immunotherapy (IO) in patients with metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2023, 41: 4561-4561. DOI: 10.1200/jco.2023.41.16_suppl.4561.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaClinical benefitLine immunotherapyMicrobial diversityNivolumab/ipilimumabStart of immunotherapyBacterial diversityClear cell histologyPD-L1 expressionRenal cell carcinomaRelative abundanceAvailable RNA sequencing dataRelative microbial abundanceParaffin-embedded samplesRNA sequencing dataRNA-seq readsCell histologyCommon regimenMedian ageLine treatmentCell carcinomaPoor riskShannon diversity indexRCC tumorsImmunotherapyPrevalence of dietary modification and supplement use in patients with metastatic renal cell carcinoma (mRCC).
Ebrahimi H, Battle D, Zengin Z, Dizman N, Meza L, Castro D, Govindarajan A, Mercier B, Chawla N, Chehrazi-Raffle A, Tripathi A, Liu S, Vaishampayan U, Staehler M, Pal S. Prevalence of dietary modification and supplement use in patients with metastatic renal cell carcinoma (mRCC). Journal Of Clinical Oncology 2023, 41: 662-662. DOI: 10.1200/jco.2023.41.6_suppl.662.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaRenal cell carcinomaDietary modificationSupplement useCell carcinomaSupplement intakeKetogenic dietSupplement usageActive systemic therapyNivolumab/ipilimumabFirst-line treatmentMajority of patientsT-testPatient advocacy groupsChi-square testStudent's t-testClinical trial candidatesOnly patientsSystemic therapyMedian ageAntineoplastic treatmentProspective studyPotential confoundersInclusion criteriaMediterranean diet
2022
Characterization of the microbial resistome in a prospective trial of CBM588 in metastatic renal cell carcinoma (mRCC) offers mechanism for interplay between antibiotic (abx) use and immune checkpoint inhibitor (ICI) activity.
Dizman N, Meza L, Bergerot P, Dorff T, Lyou Y, Frankel P, Llamas M, Hsu J, Zengin Z, Malhotra J, Govindarajan A, Castro D, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Highlander S, Pal S. Characterization of the microbial resistome in a prospective trial of CBM588 in metastatic renal cell carcinoma (mRCC) offers mechanism for interplay between antibiotic (abx) use and immune checkpoint inhibitor (ICI) activity. Journal Of Clinical Oncology 2022, 40: 4510-4510. DOI: 10.1200/jco.2022.40.16_suppl.4510.Peer-Reviewed Original ResearchNivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: A randomized phase Ib study and the evolution of the functionality of microbial communities with treatment.
Dizman N, Meza L, Bergerot P, Alcantara M, Dorff T, Lyou Y, Frankel P, Llamas M, Hsu J, Zengin Z, Malhotra J, Gillece J, Reining L, Trent J, Takahashi M, Oka K, Higashi S, Highlander S, Pal S. Nivolumab/ipilimumab with or without CBM588 in metastatic renal cell carcinoma: A randomized phase Ib study and the evolution of the functionality of microbial communities with treatment. Journal Of Clinical Oncology 2022, 40: 371-371. DOI: 10.1200/jco.2022.40.6_suppl.371.Peer-Reviewed Original ResearchMetastatic renal cell carcinomaNivolumab/ipilimumabRenal cell carcinomaClinical outcomesIpilimumab armCell carcinomaTissue next-generation sequencingPhase Ib studyProtocol-based therapyHigh-risk diseaseGut microbial compositionGut microbiome functionalityGut microbiome functionPrior nephrectomyObjective responseSarcomatoid featuresMedian ageRisk diseaseWeek 12Body of evidenceIpilimumabStool samplesClear cellsTreatment responseIb study
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 age