2025
Publication and data sharing of completed NCI cooperative group trials.
Cueto L, Huang S, Ghali F, Abgafe V, Ubachukwu T, Winer E, Ross J, Gross C. Publication and data sharing of completed NCI cooperative group trials. Journal Of Clinical Oncology 2025, 43: 11023-11023. DOI: 10.1200/jco.2025.43.16_suppl.11023.Peer-Reviewed Original ResearchCooperative group trialsIndividual patient dataPhase III trialsYear of study completionPrimary outcomeIII trialsGroup trialAvailability of individual patient dataEastern Cooperative Oncology GroupStudy completionAnalysis of phase III trialsCooperative Oncology GroupClinical trial dataPatient dataCooperative groupsPrimary outcome dataPhase IIOncology GroupNRG OncologySubgroup analysisOnline archivesNIH trialData sharingPrimary outcome findingsOutcome dataTransarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim J, Zhao H, Li C, Madoff D, Ghobrial R, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry A, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel A, Finn R, Llovet J, investigators L. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. The Lancet 2025, 405: 203-215. PMID: 39798578, DOI: 10.1016/s0140-6736(24)02575-3.Peer-Reviewed Original ResearchConceptsEastern Cooperative Oncology GroupNon-metastatic hepatocellular carcinomaProgression-free survivalTreatment-related adverse eventsPembrolizumab groupPhase 3 studyTransarterial chemoembolisationPlacebo groupHepatocellular carcinomaIntention-to-treatOverall survivalDouble-blindPerformance statusAdverse eventsFollow-upEastern Cooperative Oncology Group performance statusChild-Pugh class A diseaseMedian progression-free survivalSolid Tumors version 1.1Blinded independent central reviewA-fetoprotein levelAlbumin-bilirubin gradeResponse Evaluation CriteriaAs-treated populationMedian follow-up
2024
Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study
Iyer S, Sica R, Ho P, Prica A, Zain J, Foss F, Hu B, Beitinjaneh A, Weng W, Kim Y, Khodadoust M, Huen A, Williams L, Ma A, Huang E, Ganpule A, Nagar S, Sripakdeevong P, Cullingford E, Karnik S, Dequeant M, Patel J, He X, Li Z, He Q, Mendonez J, Keegan A, Horwitz S. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. The Lancet Oncology 2024, 26: 110-122. PMID: 39617017, DOI: 10.1016/s1470-2045(24)00508-4.Peer-Reviewed Original ResearchT-cell lymphomaPeripheral T-cell lymphomaCutaneous T-cell lymphomaRefractory T-cell lymphomaEastern Cooperative Oncology GroupChimeric antigen receptorCytokine release syndromeCAR+ T cellsSerious adverse eventsAdverse eventsT cellsOpen-labelRefractory peripheral T-cell lymphomaAllogeneic chimeric antigen receptorHealthy donor T cellsRefractory T-cell malignanciesCAR-T cell therapyMedian patient follow-upIncidence of adverse eventsDonor T cellsObjective response rateSystemic therapy linesDose-limiting toxicityT-cell therapyDose-escalation studyFeasibility of Multi-Modal Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma
Paludo J, Dueck A, Bhatnagar V, Brown A, Cathcart-Rake E, Copley D, Diamond M, Faust L, Fiero M, Huntington S, Jeffery M, Jones L, Noble B, Power B, Ritchie J, Ross J, Ruddy K, Schellhorn S, Tarver M, Torre L, Wood W, Gross C, Kluetz P, Thanarajasingam G. Feasibility of Multi-Modal Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma. Blood 2024, 144: 387-387. DOI: 10.1182/blood-2024-194607.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupPhysical functionPatient reportsTreatment toleranceCompletion ratesBaseline 6MWTExit surveyInterquartile rangeAssess treatment tolerancePost-treatment follow-upAssessment of PFCooperative Oncology GroupMedian wear timeUnique implementation challengesWearable sensor dataWalk testCytotoxic chemotherapyNon-Hispanic/LatinoNo standard approachOncology GroupAlaska NativesPerformance statusPF measuresFull-time employmentMedian timeTrial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205)
Zeidan A, Tong H, Xiao Z, Baratam P, Abboud R, Benton C, Zeidner J, Borate U, Chai-Ho W, Lu Y, Yang J, Hu M, Li B, Xia M, Sallman D. Trial in Progress: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination with Azacitidine in Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes (AK117-205). Blood 2024, 144: 6705-6705. DOI: 10.1182/blood-2024-200541.Peer-Reviewed Original ResearchAllogeneic hematopoietic stem cell transplantationHematopoietic stem cell transplantationEastern Cooperative Oncology GroupIPSS-R scoreEvent-free survivalStem cell transplantationAcute myeloid leukemiaOverall survivalIPSS-RTransfusion independenceComplete responseCR rateDouble-blindCell transplantationHR-MDSMyeloproliferative neoplasmsAdverse eventsChimeric antigen receptor T cellsTransformation to acute myeloid leukemiaAnemia ratesMulticenter phase 2 studyTreated with hypomethylating agentsHigher-risk myelodysplastic syndromesSeverity of adverse eventsAdequate organ functionEligibility and Endpoints for Clinical Trials in Trimodality Therapy for Bladder Cancer
Singh P, Ballas L, Sonpavde G, Chen R, Bangs R, Bauman B, Nagar H, Delacroix S, Lerner S, Efstathiou J. Eligibility and Endpoints for Clinical Trials in Trimodality Therapy for Bladder Cancer. Bladder Cancer 2024, 10: 199-213. PMID: 39493817, PMCID: PMC11530036, DOI: 10.3233/blc-240036.Peer-Reviewed Original ResearchBladder cancer treatmentTransurethral resection of bladder tumorEastern Cooperative Oncology GroupTrimodality therapyLong-term outcomesClinical trialsCancer treatmentRadical cystectomySystemic therapyEligibility criteriaSecondary endpointsTrial eligibility criteriaBladder cancerMaximal transurethral resection of bladder tumorEndpoint definitionsAlternative to radical cystectomyResection of bladder tumorCo-primary end pointsConcurrent systemic therapyMaximal transurethral resectionPhase II/III clinical trialsLocalized bladder cancerEvent-free survivalCooperative Oncology GroupBladder cancer researchA first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.
Weiss D, Dinardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Carraway H, Frankel S, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. Journal Of Clinical Oncology 2024, 42: tps6590-tps6590. DOI: 10.1200/jco.2024.42.16_suppl.tps6590.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupCell line-derived xenograftsDose-escalation studyMaximum tolerated dosePatient-derived xenograftsHigh riskEscalation studyTreatment armsEffects of CYP3A4 inhibitionRecommended phase 2 doseRelapsed/refractory acute myeloid leukemiaPhase 2 doseAccelerated titration designMinichromosome maintenance protein 2Preliminary antitumor activityCooperative Oncology GroupFirst-in-humanAcute myeloid leukemiaGrade 2 eventsTreated patient populationTolerated dose levelsAML cell linesAnti-tumor activityInhibition of Cdc7Cancer cell death
2023
E7820, an Anti-Cancer Sulfonamide, in Combination with Venetoclax in Patients with Splicing Factor Mutant Myeloid Malignancies: A Phase II Clinical Trial
Bewersdorf J, Chandhok N, Watts J, Derkach A, Abdel-Wahab O, Stein E, Taylor J. E7820, an Anti-Cancer Sulfonamide, in Combination with Venetoclax in Patients with Splicing Factor Mutant Myeloid Malignancies: A Phase II Clinical Trial. Blood 2023, 142: 1547. DOI: 10.1182/blood-2023-182369.Peer-Reviewed Original ResearchAcute myeloid leukemiaEastern Cooperative Oncology GroupPhase II clinical trialChronic myelomonocytic leukemiaMyelodysplastic syndromePatient-derived xenograftsII clinical trialsPreclinical dataSplicing factor genesMyeloid malignanciesClinical trialsAdequate end-organ functionContext of combination therapyDay 1Safety run-in phaseRefractory acute myeloid leukemiaSimon 2-stage designResponse rateDynamic BH3 profilingCycles of therapyNegative prognostic impactEvent-free survivalMyelodysplastic syndrome patientsHuman acute myeloid leukemiaPhase II trial
2022
An international analysis evaluating frontline bendamustine with rituximab in extranodal marginal zone lymphoma
Alderuccio J, Arcaini L, Watkins M, Beaven A, Shouse G, Epperla N, Spina M, Stefanovic A, Sandoval-Sus J, Torka P, Alpert A, Olszewski A, Kim S, Hess B, Gaballa S, Ayyappan S, Castillo J, Argnani L, Voorhees T, Saba R, Chowdhury S, Vargas F, Reis I, Kwon D, Alexander J, Zhao W, Edwards D, Martin P, Cencini E, Kamdar M, Link B, Logothetis C, Herrera A, Friedberg J, Kahl B, Luminari S, Zinzani P, Lossos I. An international analysis evaluating frontline bendamustine with rituximab in extranodal marginal zone lymphoma. Blood Advances 2022, 6: 2035-2044. PMID: 35196377, PMCID: PMC9006265, DOI: 10.1182/bloodadvances.2021006844.Peer-Reviewed Original ResearchConceptsProgression-free survivalEastern Cooperative Oncology GroupMALT-IPIRituximab maintenanceOverall survivalHerpes zosterAssociated with longer progression-free survivalPerformance status 0 to 1Associated with shorter progression-free survivalHeterogeneous non-Hodgkin lymphomasPresence of B symptomsLonger progression-free survivalShorter progression-free survivalExtranodal marginal zone lymphomaOccurrence of herpes zosterMarginal zone lymphomaInternational Prognosis IndexNon-Hodgkin's lymphomaAdvanced-stage diseaseCooperative Oncology GroupStandard-of-careAdverse prognosis factorsAssociated with occurrenceImpact OSUpfront regimens
2018
Wide Variation in Use and Interpretation of Gene Mutation Profiling Panels Among Health Care Providers of Patients with Myelodysplastic Syndromes (MDS): Results of a Large Web-Based Survey
Pine A, Chokr N, Stahl M, Steensma D, Sekeres M, Litzow M, Luger S, Stone R, Greenberg P, Bejar R, Gore S, Zeidan A. Wide Variation in Use and Interpretation of Gene Mutation Profiling Panels Among Health Care Providers of Patients with Myelodysplastic Syndromes (MDS): Results of a Large Web-Based Survey. Blood 2018, 132: 1825. DOI: 10.1182/blood-2018-99-113888.Peer-Reviewed Original ResearchGene mutation profilingSouthwest Oncology GroupMyelodysplastic syndromeRisk stratificationHealth care providersMutation profilingOncology GroupMDS patientsClinical trialsCare providersWeb-based surveyConsensus evidence-based guidelinesInternational Prognostic Scoring SystemEastern Cooperative Oncology GroupGene panelAdvisory CommitteeConventional prognostic modelsThird of respondersHigh-risk patientsCooperative Oncology GroupPrognostic scoring systemRisk stratification toolManagement of patientsStem cell transplantEvidence-based guidelines
2015
North American Cooperative Group Members' Patterns of Blood Products Transfusion for Patients with Acute Leukemia
Pine A, Lee E, Sekeres M, Steensma D, Prebet T, DeZern A, Komrokji R, Litzow M, Luger S, Stone R, Erba H, Garcia-Manero G, Lee A, Podoltsev N, Barbarotta L, Hendrickson J, Gore S, Zeidan A. North American Cooperative Group Members' Patterns of Blood Products Transfusion for Patients with Acute Leukemia. Blood 2015, 126: 1138. DOI: 10.1182/blood.v126.23.1138.1138.Peer-Reviewed Original ResearchRed blood cell transfusionNon-bleeding patientsBlood cell transfusionBone marrow biopsyBlood product transfusionSouthwest Oncology GroupPlatelet transfusionsOutpatient settingAcute leukemiaPlatelet levelsCell transfusionHemoglobin levelsTransfusion practiceLumbar punctureFibrinogen levelsProduct transfusionHospitalized patientsOncology GroupClinical trialsPlatelet thresholdMost respondersConsensus evidence-based guidelinesMost providersEastern Cooperative Oncology GroupStable hospitalized patients
2011
Phase II Study of S-1 Plus Either Irinotecan or Docetaxel for Non-small Cell Lung Cancer Patients Treated with More Than Three Lines of Treatment
Kim D, Lee D, Jang S, Kim S, Suh C, Lee J. Phase II Study of S-1 Plus Either Irinotecan or Docetaxel for Non-small Cell Lung Cancer Patients Treated with More Than Three Lines of Treatment. Cancer Research And Treatment 2011, 43: 212-216. PMID: 22247705, PMCID: PMC3253862, DOI: 10.4143/crt.2011.43.4.212.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupNon-small cell lung cancer patientsCell lung cancer patientsPhase II studyLung cancer patientsII studyCancer patientsEpidermal growth factor receptor tyrosine kinase inhibitor therapyMetastatic non-small cell lung cancer patientsProspective single-center phase II studySingle-center phase II studyTyrosine kinase inhibitor therapyCooperative Oncology GroupPlatinum-based chemotherapyMedian survival timeSquamous cell carcinomaKinase inhibitor therapyLine of treatmentEligible patientsMedian followStable diseaseSalvage treatmentUnacceptable toxicityOncology GroupInhibitor therapy
2009
A phase III randomized, placebo-controlled trial of docetaxel (D) with or without gefitinib (G) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): A trial of the Eastern Cooperative Oncology Group (ECOG)
Argiris A, Ghebremichael M, Gilbert J, Burtness B, Forastiere A. A phase III randomized, placebo-controlled trial of docetaxel (D) with or without gefitinib (G) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): A trial of the Eastern Cooperative Oncology Group (ECOG). Journal Of Clinical Oncology 2009, 27: 6011-6011. DOI: 10.1200/jco.2009.27.15_suppl.6011.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupMedian overall survivalArm AM SCCHNPrior chemotherapyAdverse eventsOverall survivalArm BCommon grade 3/4 adverse eventsEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsECOG performance status 2Grade 3/4 adverse eventsGrade 5 adverse eventsMetastatic squamous cell carcinomaModest single-agent activityReceptor tyrosine kinase inhibitorsECOG PS 0Objective response ratePerformance status 2Phase III randomizedPlacebo-controlled trialTime of progressionCooperative Oncology GroupSingle-agent activityPhase II randomized trial of bortezomib (B) plus irinotecan (I) or B with addition of I at progression in recurrent (R) or metastatic (M) squamous cell carcinoma of the head and neck (SCCHN) (E1304): A trial of the Eastern Cooperative Oncology Group
Gilbert J, Lee J, Argiris A, Feldman L, Haigentz M, Burtness B, Forastiere A. Phase II randomized trial of bortezomib (B) plus irinotecan (I) or B with addition of I at progression in recurrent (R) or metastatic (M) squamous cell carcinoma of the head and neck (SCCHN) (E1304): A trial of the Eastern Cooperative Oncology Group. Journal Of Clinical Oncology 2009, 27: 6020-6020. DOI: 10.1200/jco.2009.27.15_suppl.6020.Peer-Reviewed Original ResearchGrade 5 toxicityArm 2Response rateArm 1Metastatic squamous cell carcinomaEastern Cooperative Oncology GroupCycles of therapyECOG PS 0ECOG PS 1Cooperative Oncology GroupTime of progressionSquamous cell carcinomaSCCHN cell linesPrior chemoPrimary endpointStable diseaseToxic regimenActive therapyOncology GroupPS 0Cell carcinomaNF-κβTumor sensitivityTherapyInhibits growth
2002
Epidermal growth factor receptors as a target for cancer treatment: The emerging role of IMC-C225 in the treatment of lung and head and neck cancers
Herbst RS, Langer CJ. Epidermal growth factor receptors as a target for cancer treatment: The emerging role of IMC-C225 in the treatment of lung and head and neck cancers. Seminars In Oncology 2002, 29: 27-36. PMID: 11894011, DOI: 10.1053/sonc.2002.31525.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCombined Modality TherapyErbB ReceptorsGene Expression Regulation, NeoplasticHalf-LifeHead and Neck NeoplasmsHumansNeoplasm MetastasisNeoplasm Recurrence, LocalRadiation-Sensitizing AgentsRandomized Controlled Trials as TopicSalvage TherapyConceptsSquamous cell carcinomaEpidermal growth factor receptorIMC-C225Phase II trialGrowth factor receptorCell carcinomaII trialFactor receptorRadiation therapyNon-small cell lung cancer xenograftsNon-small cell lung cancerGemcitabine/carboplatin combinationSeparate phase II trialsAdvanced squamous cell carcinomaCell lung cancer xenograftsOngoing phase II trialEastern Cooperative Oncology GroupPhase III registration trialPhase I pharmacokinetic studyCultured human squamous cell carcinomasHuman squamous cell carcinomaPaclitaxel/carboplatinSecond-line settingStandard salvage regimensTreatment-naive patients
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