2025
Ciltacabtagene Autoleucel (Cilta-cel) Vs Standard of Care (SoC) in Patients with Lenalidomide (Len)-Refractory Multiple Myeloma (MM) after 1–3 Lines of Therapy: Minimal Residual Disease (MRD) Negativity in the Phase 3 Cartitude-4 Trial
Popat R, Oriol A, Cavo M, Karlin L, Avivi I, Roeloffzen W, Kim S, Lipe B, Bar N, Horvath N, Spencer A, Min C, Chen D, Li Q, Li K, Slaughter A, Lonardi C, Benachour N, Ghosh A, Vogel M, Lendvai N, Lengil T, Patel N, Filho O, Florendo E, Lin Y. Ciltacabtagene Autoleucel (Cilta-cel) Vs Standard of Care (SoC) in Patients with Lenalidomide (Len)-Refractory Multiple Myeloma (MM) after 1–3 Lines of Therapy: Minimal Residual Disease (MRD) Negativity in the Phase 3 Cartitude-4 Trial. Transplantation And Cellular Therapy 2025, 31: s35. DOI: 10.1016/j.jtct.2025.01.047.Peer-Reviewed Original ResearchMinimal residual disease negativityMRD-negativity ratesMinimal residual diseaseProgression-free survivalCilta-cel infusionSustained MRD negativityCilta-celMRD negativityOverall survivalMultiple myelomaSOC armMinimal residual disease positivityMedian progression-free survivalInterim analysisStandard of careMedian OSComplete responseMRD evaluationResidual diseaseCiltacabtagene autoleucelBridging therapyPost-infusionNext-generation sequencingTherapyInfusionIdentifying the optimal post-surgical timing of molecular residual disease (MRD) detection in colorectal cancer (CRC) using an ultra-sensitive assay: Interim results from the VICTORI study.
Solar Vasconcelos J, Titmuss E, Navarro F, Abbott C, Chia B, Topham J, Ladua G, Krishnan T, Hegebarth D, Lim H, Gill K, Gill S, Brown C, Ghuman A, Meneghetti A, Renouf D, Schaeffer D, Chen R, Boyle S, Loree J. Identifying the optimal post-surgical timing of molecular residual disease (MRD) detection in colorectal cancer (CRC) using an ultra-sensitive assay: Interim results from the VICTORI study. Journal Of Clinical Oncology 2025, 43: 275-275. DOI: 10.1200/jco.2025.43.4_suppl.275.Peer-Reviewed Original ResearchMolecular residual diseaseColorectal cancerCtDNA detectionDetection of molecular residual diseaseWeek 8Week 4Resectable colorectal cancerYear of surgeryTime of surgerySingle nucleotide variantsYear follow-upPost-surgical timesNeoadjuvant therapyResidual diseaseCurative intentMRD assaysResidual cancerClinical relapseDisease recurrenceCtDNA concentrationRecurrent cancerClinical outcomesCfDNA concentrationFollow-upRecurrence
2024
Ultra-sensitive molecular residual disease detection through whole genome sequencing with single-read error correction
Li X, Liu T, Bacchiocchi A, Li M, Cheng W, Wittkop T, Mendez F, Wang Y, Tang P, Yao Q, Bosenberg M, Sznol M, Yan Q, Faham M, Weng L, Halaban R, Jin H, Hu Z. Ultra-sensitive molecular residual disease detection through whole genome sequencing with single-read error correction. EMBO Molecular Medicine 2024, 16: 2188-2209. PMID: 39164471, PMCID: PMC11393307, DOI: 10.1038/s44321-024-00115-0.Peer-Reviewed Original ResearchMolecular residual diseaseCirculating tumor DNAWhole-genome sequencingCell-free DNAGenome sequenceDetection of molecular residual diseaseCirculating tumor DNA detectionResidual disease detectionConsistent with clinical outcomesVariant allele frequencyResidual diseaseMelanoma patientsMonitoring immunotherapyTumor DNAEsophageal cancerClinical outcomesColorectal cancerWGS technologiesAllele frequenciesCancerDNAAnalytical sensitivitySequenceImmunotherapyRelapseAssociation of personalized and tumor-informed ctDNA with patient survival outcomes in pancreatic adenocarcinoma
Botta G, Abdelrahim M, Drengler R, Aushev V, Esmail A, Laliotis G, Brewer C, George G, Abbate S, Chandana S, Tejani M, Malla M, Bansal D, Rivero-Hinojosa S, Spickard E, McCormick N, Cecchini M, Lacy J, Fei N, Kasi P, Kasi A, Dayyani F, Hanna D, Sharma S, Malhotra M, Aleshin A, Liu M, Jurdi A. Association of personalized and tumor-informed ctDNA with patient survival outcomes in pancreatic adenocarcinoma. The Oncologist 2024, 29: 859-869. PMID: 39022993, PMCID: PMC11449101, DOI: 10.1093/oncolo/oyae155.Peer-Reviewed Original ResearchMolecular residual diseasePancreatic ductal adenocarcinomaPatient survival outcomesCtDNA detectionSurvival outcomesStage I–III pancreatic ductal adenocarcinomaAssociated with shorter DFSMedian follow-up timeFollow-up timeCtDNA levelsResidual diseaseShorter DFSPrognostic factorsPancreatic adenocarcinomaAssociated with patient survival outcomesDuctal adenocarcinomaRetrospective analysisDiagnosed patientsMultivariate analysisSurveillance periodPatientsPlasma samplesTumor informationWhole exomeSurveillance windowTranslation of Epigenetics in Cell-Free DNA Liquid Biopsy Technology and Precision Oncology
Tan W, Nagabhyrava S, Ang-Olson O, Das P, Ladel L, Sailo B, He L, Sharma A, Ahuja N. Translation of Epigenetics in Cell-Free DNA Liquid Biopsy Technology and Precision Oncology. Current Issues In Molecular Biology 2024, 46: 6533-6565. PMID: 39057032, PMCID: PMC11276574, DOI: 10.3390/cimb46070390.Peer-Reviewed Original ResearchCell-free DNA liquid biopsyCell-free DNALiquid biopsy technologiesLiquid biopsyBiopsy technologyEarly cancer detectionClinical applicationCfDNA-based liquid biopsyMonitoring residual diseaseEarly detection testsCancer detectionPotential of epigeneticsPersonalized cancer treatmentImprove cancer outcomesTissue of originFragmentation pattern analysisResidual diseaseDNA methylationMulti-cancer early detection testTreatment responseBiopsyCancer outcomesCancer preventionEpigeneticsPrecision oncologyCirculating Tumor DNA in Genitourinary Cancers: Detection, Prognostics, and Therapeutic Implications
Gerke M, Jansen C, Bilen M. Circulating Tumor DNA in Genitourinary Cancers: Detection, Prognostics, and Therapeutic Implications. Cancers 2024, 16: 2280. PMID: 38927984, PMCID: PMC11201475, DOI: 10.3390/cancers16122280.Peer-Reviewed Original ResearchRenal cell carcinomaGU cancersProstate cancerBladder cancerGenitourinary (GU) cancersUtilization of liquid biopsyCastration-resistant prostate cancerDetect residual diseaseCirculating tumor DNATherapeutic response predictionCtDNA assaysResidual diseaseCtDNA analysisCell carcinomaTumor DNAGenitourinary cancersPrognostic informationClinical detection methodsTreatment responseGenomic alterationsLiquid biopsyClinical trialsTherapeutic implicationsCancerCtDNAPrevalence and dynamics of circulating tumor DNA (ctDNA) among patients (pts) with HER2+ breast cancer (BC) receiving neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) in the DAPHNe trial.
Waks A, Tarantino P, Li T, Ogayo E, Rahman T, DiLullo M, El-Refai S, Abbott C, Boyle S, Chen R, Desai N, Spring L, Tung N, King T, Krop I, Tayob N, Mittendorf E, Tolaney S, Winer E, Parsons H. Prevalence and dynamics of circulating tumor DNA (ctDNA) among patients (pts) with HER2+ breast cancer (BC) receiving neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) in the DAPHNe trial. Journal Of Clinical Oncology 2024, 42: 588-588. DOI: 10.1200/jco.2024.42.16_suppl.588.Peer-Reviewed Original ResearchMinimal residual diseaseResidual cancer burdenBreast cancerResidual diseaseDynamics of circulating tumor DNAMinimal residual disease dataRCB 0RCB IIResidual cancer burden-IDetect minimal residual diseaseQuantify minimal residual diseaseResidual cancer burden scoreHER2+ breast cancerAdjuvant systemic therapyClinical stage IINode-negative tumorsHER2 + BCMedian follow-upPlasma samplesBreast cancer recurrenceImmediately post-operativelyLong-term outcomesAssociated with elevated riskCtDNA-positiveT3/T4 tumorsCirculating tumor DNA (ctDNA) kinetics in colorectal cancer (CRC) treated with curative intent in the VICTORI study with an ultrasensitive MRD assay.
Solar Vasconcelos J, Titmuss E, Navarro F, Abbott C, Chia B, Topham J, Ladua G, Krishnan T, Hegebarth D, Lim H, Gill K, Gill S, Brown C, Ghuman A, Meneghetti A, Renouf D, Schaeffer D, Chen R, Boyle S, Loree J. Circulating tumor DNA (ctDNA) kinetics in colorectal cancer (CRC) treated with curative intent in the VICTORI study with an ultrasensitive MRD assay. Journal Of Clinical Oncology 2024, 42: e15625-e15625. DOI: 10.1200/jco.2024.42.16_suppl.e15625.Peer-Reviewed Original ResearchMolecular residual diseaseCirculating tumor DNARecurrence-free survivalColorectal cancerMRD assaysDetection of molecular residual diseaseLevels of circulating tumor DNAPoor recurrence-free survivalTreated with curative intentDetect circulating tumor DNAProspective cohort of patientsCurative interventionsCurative-intent treatmentCohort of patientsSingle nucleotide variantsStage I-IIISeparation of patientsMRD- patientsMRD testingNeoadjuvant treatmentResidual diseaseClinical recurrenceCurative intentRectal cancerTumor DNAUltra-sensitive ctDNA mutation tracking to identify molecular residual disease and predict relapse in patients with early breast cancer.
Garcia-Murillas I, Cutts R, Abbott C, Boyle S, Pugh J, Chen R, Dunne K, Bunce C, Johnston S, Ring A, Russell S, Evans A, Skene A, Wheatley D, Smith I, Turner N. Ultra-sensitive ctDNA mutation tracking to identify molecular residual disease and predict relapse in patients with early breast cancer. Journal Of Clinical Oncology 2024, 42: 1010-1010. DOI: 10.1200/jco.2024.42.16_suppl.1010.Peer-Reviewed Original ResearchMolecular residual diseaseCirculating tumor DNAEarly breast cancerBreast cancer patientsFollow-upNeoadjuvant chemotherapyResidual diseaseClinical relapseCtDNA detectionClinical outcomesBreast cancerAssociated with relapse free survivalDetection of molecular residual diseaseCancer patientsCirculating tumor DNA levelsLevels of circulating tumor DNAHigh risk of relapseHigh riskCirculating tumor DNA detectionMedian lead-timeRelapse free survivalDe-escalation studiesBreast cancer relapseShortened overall survivalBaseline prior to treatmentMolecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).
John T, Grohe C, Goldman J, Kato T, Laktionov K, Bonanno L, Tiseo M, Majem M, Domine M, Ahn M, Perol M, Hartmaier R, Robichaux J, Bhetariya P, Markovets A, Rukazenkov Y, Muldoon C, Herbst R, Tsuboi M, Wu Y. Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2024, 42: 8005-8005. DOI: 10.1200/jco.2024.42.16_suppl.8005.Peer-Reviewed Original ResearchDisease-free survivalMolecular residual diseaseNon-small cell lung cancerDisease-free survival eventsDisease recurrenceEGFR-mutantOverall survivalStage IB-IIIA non-small cell lung cancerEGFR T790M resistance mutationT790M resistance mutationMedian follow-up timeEGFR-TKI sensitivityResected tumor tissueCell lung cancerTumor-specific variantsMedian lead timeWhole-exome sequencingDetection of ctDNAADAURA studyADAURA trialInvestigator-assessedMolecular recurrenceEGFR-TKIsResidual diseaseEligible ptsA phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation.
Al Malki M, Keyzner A, Suh H, Popat U, Gill S, Chen Y, Solh M, Gowda L, Buonomo E, Wang Y, Murray J, MacBeath G, Barton D, Chattopadhyay S, Reshef R. A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation. Journal Of Clinical Oncology 2024, 42: tps2678-tps2678. DOI: 10.1200/jco.2024.42.16_suppl.tps2678.Peer-Reviewed Original ResearchHematopoietic cell transplantationMinimal residual diseaseEngineered T cell therapiesPatient hematopoietic cellsT-cell therapyMinor histocompatibility antigensHematopoietic cellsHLA-A*02:01Residual diseaseCell transplantationHematologic malignanciesPost-HCTT cellsHistocompatibility antigensTreatment armsCAR-T cell therapyAllogeneic hematopoietic cell transplantationHematopoietic cell transplant patientsPrevent disease relapseRelapse post-HCTDose-limiting toxicityDisease-free survivalEngineered T cellsHaploidentical donor transplantationSurrogate of efficacyChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology
Wierda W, Brown J, Abramson J, Awan F, Bilgrami S, Bociek G, Brander D, Cortese M, Cripe L, Davis R, Eradat H, Fakhri B, Fletcher C, Gaballa S, Hamid M, Hill B, Kaesberg P, Kahl B, Kamdar M, Kipps T, Ma S, Mosse C, Nakhoda S, Parikh S, Schorr A, Schuster S, Seshadri M, Siddiqi T, Stephens D, Thompson M, Ujjani C, Valdez R, Wagner-Johnston N, Woyach J, Sundar H, Dwyer M. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology. Journal Of The National Comprehensive Cancer Network 2024, 22: 175-204. PMID: 38626800, DOI: 10.6004/jnccn.2024.0018.Peer-Reviewed Original ResearchConceptsSmall lymphocytic lymphomaChronic lymphocytic leukemiaPredictor of improved survivalUndetectable minimal residual diseaseImmunoglobulin heavy chain variable region mutational statusMinimal residual diseaseManagement of patientsSelection of treatmentRelapsed/refractory CLL/SLLLymphocytic lymphomaResidual diseaseCombination regimensTP53 mutationsMutation statusPerformance statusLymphocytic leukemiaNCCN GuidelinesPatient agePrognostic implicationsToxicity profileDisease stageComorbid conditionsPatientsCLL/SLLCytogenetic variabilityEvent-free survival by residual cancer burden with pembrolizumab in early-stage TNBC: exploratory analysis from KEYNOTE-522☆
Pusztai L, Denkert C, O’Shaughnessy J, Cortes J, Dent R, McArthur H, Kümmel S, Bergh J, Park Y, Hui R, Harbeck N, Takahashi M, Untch M, Fasching P, Cardoso F, Zhu Y, Pan W, Tryfonidis K, Schmid P. Event-free survival by residual cancer burden with pembrolizumab in early-stage TNBC: exploratory analysis from KEYNOTE-522☆. Annals Of Oncology 2024, 35: 429-436. PMID: 38369015, DOI: 10.1016/j.annonc.2024.02.002.Peer-Reviewed Original ResearchTriple-negative breast cancerEvent-free survivalPathological complete responseResidual cancer burdenEarly-stage triple-negative breast cancerEvent-free survival eventsPembrolizumab groupRCB-2KEYNOTE-522Neoadjuvant pembrolizumabRCB-0Central nervous system recurrenceCancer burdenCycles of paclitaxelIncreased pCR ratePembrolizumab to chemotherapyCycles of doxorubicinCox regression modelsRCB-1Adjuvant pembrolizumabDistant recurrencePCR rateResidual diseaseSystemic recurrenceComplete responseASCL1 Drives Tolerance to Osimertinib in EGFR Mutant Lung Cancer in Permissive Cellular Contexts.
Hu B, Wiesehöfer M, de Miguel F, Liu Z, Chan L, Choi J, Melnick M, Arnal Estape A, Walther Z, Zhao D, Lopez-Giraldez F, Wurtz A, Cai G, Fan R, Gettinger S, Xiao A, Yan Q, Homer R, Nguyen D, Politi K. ASCL1 Drives Tolerance to Osimertinib in EGFR Mutant Lung Cancer in Permissive Cellular Contexts. Cancer Research 2024, 84: 1303-1319. PMID: 38359163, DOI: 10.1158/0008-5472.can-23-0438.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsPatient-derived xenograftsEGFR mutant lung cancerMutant lung cancerPre-treatment tumorsResidual diseaseDrug toleranceLung cancerResidual tumor cells in vivoEGFR mutant lung adenocarcinomaTyrosine kinase inhibitor osimertinibEGFR tyrosine kinase inhibitorsTyrosine kinase inhibitor treatmentTumor cells in vivoMutant lung adenocarcinomaMaximal tumor regressionTranscription factor Ascl1Drug-tolerant cellsTime of maximal responseEvidence of cellsCells in vivoOsimertinib treatmentTumor regressionSingle cell transcriptional profilingTumor cells
2023
Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials
Rediti M, Fernandez-Martinez A, Venet D, Rothé F, Hoadley K, Parker J, Singh B, Campbell J, Ballman K, Hillman D, Winer E, El-Abed S, Piccart M, Di Cosimo S, Symmans W, Krop I, Salgado R, Loi S, Pusztai L, Perou C, Carey L, Sotiriou C. Immunological and clinicopathological features predict HER2-positive breast cancer prognosis in the neoadjuvant NeoALTTO and CALGB 40601 randomized trials. Nature Communications 2023, 14: 7053. PMID: 37923752, PMCID: PMC10624889, DOI: 10.1038/s41467-023-42635-2.Peer-Reviewed Original ResearchConceptsEvent-free survivalHER2-positive breast cancerPathological complete responseCALGB 40601Breast cancerBreast pathological complete responseStromal tumor-infiltrating lymphocytesHormone receptor statusPhase III trialsClinical nodal statusIndependent prognostic factorTumor-infiltrating lymphocytesIdentification of patientsBreast cancer prognosisT cell receptorNeoadjuvant paclitaxelNeoadjuvant therapyIII trialsNodal statusComplete responsePrognostic factorsPrognostic scoreReceptor statusClinicopathological featuresResidual diseasePrognostic impact of reduced HER2 protein expression in post-neoadjuvant therapy resection specimens: A single institution experience and review of the literature
Mogica J, Tang H, Liang Y, Zhong M, Hui P, Harigopal M, Krishnamurti U, Fischbach N, Zhan H. Prognostic impact of reduced HER2 protein expression in post-neoadjuvant therapy resection specimens: A single institution experience and review of the literature. The Breast 2023, 72: 103586. PMID: 37812963, PMCID: PMC10568274, DOI: 10.1016/j.breast.2023.103586.Peer-Reviewed Original ResearchConceptsHER2 IHC 3Human epidermal growth factor receptor 2Kaplan-Meier survival analysisHER2-IHC expressionPathologic complete responseResidual diseaseIHC 3Breast cancerIHC expressionSurvival analysisSuperior disease-free survivalEpidermal growth factor receptor 2Intensive adjuvant therapyPost-therapy surveillanceYale Cancer CenterDisease-free survivalGrowth factor receptor 2Recurrence-free survivalSingle institution experienceLow recurrence rateFactor receptor 2HER2 protein expressionAdjuvant trialsNeoadjuvant treatmentAdjuvant therapyTreatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials?
Chehayeb R, Kahn A, Pusztai L. Treatment efficacy score: a better surrogate for arm-level survival differences in neoadjuvant breast cancer trials? Future Oncology 2023, 19: 1945-1951. PMID: 37767612, DOI: 10.2217/fon-2022-1203.Peer-Reviewed Original ResearchExcellent long-term survivalNeoadjuvant breast cancer trialsResidual cancer burden scorePathologic complete responseBreast cancer trialsLong-term survivalNeoadjuvant chemotherapyPathologic responseComplete responseSurvival improvementBurden scoreResidual diseaseTrial armsSurvival differencesCancer trialsBreast cancerTreatment efficacyStage IIGood surrogateEfficacy scoresTrialsSurvivalScoresRate differencesChemotherapyctDNA and Lung Cancer
Cheng J, Hu Y, Wong D, Patel A. ctDNA and Lung Cancer. Current Cancer Research 2023, 511-537. DOI: 10.1007/978-3-031-22903-9_20.ChaptersCell-free DNALung cancerNon-small cell lung cancerCell lung cancerMinimal residual diseaseResidual diseasePleural fluidImportant clinical applicationsClinical utilityTreatment selectionEarly cancer detectionPhysiologic underpinningsClinical modelTherapy monitoringClinical applicationCancerCancer detectionAlpha-1 Adrenergic Antagonists Sensitize Neuroblastoma to Therapeutic Differentiation.
Broso F, Gatto P, Sidarovich V, Ambrosini C, De Sanctis V, Bertorelli R, Zaccheroni E, Ricci B, Destefanis E, Longhi S, Sebastiani E, Tebaldi T, Adami V, Quattrone A. Alpha-1 Adrenergic Antagonists Sensitize Neuroblastoma to Therapeutic Differentiation. Cancer Research 2023, 83: 2733-2749. PMID: 37289021, DOI: 10.1158/0008-5472.can-22-1913.Peer-Reviewed Original ResearchConceptsResidual diseaseAdrenergic antagonistsAdrenergic receptorsAlpha-1 adrenergic antagonistAdministration of doxazosinPost-consolidation therapyOverall survival probabilityPrevention of relapseHigh-risk casesMultimodal therapeutic approachPost-consolidation phaseDifferentiation of neuroblastomaNB cell viabilityAggressive childhood tumorRetinoids isotretinoinPediatric patientsΑ1B-adrenergic receptorPrevent relapseChildhood tumorsTherapeutic approachesSpecific blockadeNB cellsPharmacologic targetNeuroblastomaTumor growthDecreased HER2 expression in residual disease following neoadjuvant therapy in patients with HER2-positive breast cancer.
Paredes Mogica J, Tang H, Fischbach N, Zhan H. Decreased HER2 expression in residual disease following neoadjuvant therapy in patients with HER2-positive breast cancer. Journal Of Clinical Oncology 2023, 41: e12621-e12621. DOI: 10.1200/jco.2023.41.16_suppl.e12621.Peer-Reviewed Original ResearchNeo-adjuvant therapyKaplan-Meier survival analysisHER2 IHC 3Pathologic complete responseResidual diseaseBreast cancerHER2 expressionAdjuvant therapyNeoadjuvant therapyEpidermal growth factor receptor 2 overexpressionHuman epidermal growth factor receptor 2 (HER2) overexpressionSurvival analysisHER2-positive breast cancerAggressive adjuvant therapyHER2-IHC expressionPost-therapy surveillanceResidual invasive tumorTrastuzumab/pertuzumabYale Cancer CenterRecurrence-free survivalBreast cancer outcomesAdo-trastuzumab emtansineLow recurrence rateStandard of careAssociation of pre
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