2025
Long-Term Follow-Up of E3311, an ECOG-ACRIN Cancer Research Group Phase II Trial of Transoral Surgery and Risk-Based Adjuvant Treatment in Human Papillomavirus-Initiated Oropharynx Cancer.
Burtness B, Flamand Y, Quon H, Weinstein G, Mehra R, Garcia J, Kim S, O'Malley B, Ozer E, Ikpeazu C, Koch W, Gross N, Bell R, Patel M, Lango M, Morris L, Smith R, Karakla D, Richmon J, Holsinger F, Ferris R. Long-Term Follow-Up of E3311, an ECOG-ACRIN Cancer Research Group Phase II Trial of Transoral Surgery and Risk-Based Adjuvant Treatment in Human Papillomavirus-Initiated Oropharynx Cancer. Journal Of Clinical Oncology 2025, jco2402550. PMID: 40493877, DOI: 10.1200/jco-24-02550.Peer-Reviewed Original ResearchExtranodal extensionOverall survivalOropharynx cancerTransoral surgeryRisk of late recurrenceLong-term follow-upFavorable pathologic characteristicsPhase II trialECOG-ACRINWeekly cisplatinN1 diseaseNeck dissectionProgression-FreeLate recurrenceNeck nodesArm AAdjuvant treatmentSmoking historyPostoperative managementPathological characteristicsPrimary sitePFSPatientsSurgeryCancerQuANTUM-Wild: A phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3 -ITD–negative acute myeloid leukemia (AML).
Montesinos P, Cheong J, Daver N, Fathi A, Levis M, Luger S, Miyamoto T, Oliva E, Perl A, Recher C, Schlenk R, Wang J, Zeidan A, Liu L, Duong Y, Imadalou K, Alexis K, Nahar A, Burns K, Erba H. QuANTUM-Wild: A phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3 -ITD–negative acute myeloid leukemia (AML). Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps6580.Peer-Reviewed Original ResearchAcute myeloid leukemiaRelapse-free survivalEvent-free survivalArm AOverall survivalComplete remissionDouble-blindArm CCases of acute myeloid leukemiaAcute myeloid leukemia blastsAcute myeloid leukemia casesFLT3-ITD-negativeHigh-dose cytarabineFLT3 gene mutationsType II FLT3 inhibitorsPlacebo-controlled trialProlonged overall survivalAllele frequency <5%Leukemic cell survivalArm BStandard chemotherapyEligible ptsInduction/consolidation chemotherapyPrimary endpointSecondary endpointsNeoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163.
Saba N, Flamand Y, Lin D, Chung C, McDonald M, Flampouri S, Khan S, Snyderman C, Hanna E, El-Sayed I, Solares C, Le C, Ghaly M, Hwang P, Shin D, Axelrod R, Ikpeazu C, Adkins D, Duan F, Cohen M, Samuels M, Swiecicki P, Subramaniam R, Chakravarthy A, Burtness B. Neoadjuvant Chemotherapy and Surgery versus Surgery for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma: ECOG-ACRIN EA3163. Clinical Cancer Research 2025, 31: 2339-2346. PMID: 40227186, PMCID: PMC12165817, DOI: 10.1158/1078-0432.ccr-24-4085.Peer-Reviewed Original ResearchConceptsSinus squamous cell carcinomaNeoadjuvant chemotherapySquamous cell carcinomaOverall survivalArm BOne-sided alphaArm ACell carcinomaRandomized studyArm A versus BSP ratesGrade 5 eventsCo-primary objectivesSingle-institution studyA versus BLog-rank testFisher's exact testPreservation rateExact testChemotherapyOrgan preservationSurgeryPatientsT3/T4aCarcinomaA Phase 1/1B Trial of Pembrolizumab and Trametinib in Advanced NSCLC Enriched for KRAS Mutations
Riess J, Lara M, Luxardi G, de Rodas M, Shimoda M, Kelly K, Lara P, Beckett L, Monjazeb A, Schalper K, Maverakis E, Gandara D. A Phase 1/1B Trial of Pembrolizumab and Trametinib in Advanced NSCLC Enriched for KRAS Mutations. JTO Clinical And Research Reports 2025, 6: 100806. PMID: 40486486, PMCID: PMC12145753, DOI: 10.1016/j.jtocrr.2025.100806.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerMEK inhibitionAdverse eventsProgressive diseaseKRAS mutationsMyeloid-derived suppressor cellsTrametinib 2 mgDose-escalation studyPlatinum-based chemotherapyImmune cell alterationsTumor immune microenvironmentPhase 1 studyCell lung cancerHigh-parameter flow cytometryArm BEscalation studyPartial responseArm ASuppressor cellsImmune microenvironmentPembrolizumabTrametinibQuantitative immunofluorescenceLung cancer
2024
Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia
Montesinos P, Cheong J, Daver N, Fathi A, Levis M, Luger S, Miyamoto T, Oliva E, Perl A, Récher C, Schlenk R, Wang J, Zeidan A, Liu L, Duong Y, Imadalou K, Alexis K, Nahar A, Burns K, Erba H. Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia. Blood 2024, 144: 1504.3-1504.3. DOI: 10.1182/blood-2024-205101.Peer-Reviewed Original ResearchFMS-like tyrosine kinase 3Acute myeloid leukemiaRelapse-free survivalEvent-free survivalArm AOverall survivalEligible ptsFLT3-ITDMonotherapy maintenanceAllo-HSCTDouble-blindFLT3 mutationsArm CMyeloid leukemiaAssociated with significantly prolonged overall survivalFLT3 activationFms-like tyrosine kinase 3 ligandFMS-like tyrosine kinase 3-internal tandem duplicationAllogeneic hematopoietic stem cell transplantationFms-like tyrosine kinase 3-mutatedRelapsed/Refractory Acute Myeloid LeukemiaBone marrow blast countFms-like tyrosine kinase 3 expressionCases of acute myeloid leukemiaHematopoietic stem cell transplantationSequencing of Checkpoint or BRAF/MEK Inhibitors on Brain Metastases in Melanoma.
Ascierto P, Mandalà M, Ferrucci P, Guidoboni M, Rutkowski P, Ferraresi V, Arance A, Guida M, Maiello E, Gogas H, Richtig E, Quaglino P, Lebbé C, Helgadottir H, Queirolo P, Spagnolo F, Tucci M, Del Vecchio M, Gonzalez-Cao M, Minisini A, De Placido S, Sanmamed M, Casula M, Bulgarelli J, Pisano M, Piccinini C, Piccin L, Cossu A, Mallardo D, Paone M, Vitale M, Melero I, Grimaldi A, Giannarelli D, Palmieri G, Dummer R, Sileni V. Sequencing of Checkpoint or BRAF/MEK Inhibitors on Brain Metastases in Melanoma. NEJM Evidence 2024, 3: evidoa2400087. PMID: 39315864, DOI: 10.1056/evidoa2400087.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitionBrain metastasesBRAF/MEK inhibitorsArm BArm AProgressive diseaseCheckpoint inhibitionBrain metastases-free survivalImmune checkpoint inhibitor ipilimumabMetastases-free survival ratesDevelopment of brain metastasesCheckpoint inhibitor ipilimumabMetastases-free survivalUnresectable metastatic melanomaV600-mutant melanomaCheckpoint inhibitorsInhibitor ipilimumabMetastatic melanomaBRAF/MEK inhibitionArm CReviewed patientsBRAF/MEKThree-arm trialEncorafenibFollow-upPhase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A
Gettinger S, Song Z, Reckamp K, Moscow J, Gray R, Wang V, McShane L, Rubinstein L, Patton D, Williams P, Hamilton S, Kong X, Tricoli J, Conley B, Arteaga C, Harris L, O'Dwyer P, Chen A, Flaherty K. Phase II Trial of Afatinib in Patients With EGFR-Mutated Solid Tumors Excluding Lung Cancer: Results From NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol A. JCO Precision Oncology 2024, 8: e2300725. PMID: 38986051, DOI: 10.1200/po.23.00725.Peer-Reviewed Original ResearchConceptsProgression-free survivalTyrosine kinase inhibitorsEGFR tyrosine kinase inhibitorsNCI-MATCHLung cancerGlioblastoma multiformeOverall survivalAdvanced non-small cell lung cancerNational Cancer Institute-Molecular AnalysisNon-small cell lung cancerEnd pointsTumor genomic testingTrial primary end pointPhase 2 trialPhase II trialSecondary end pointsPrimary end pointCell lung cancerCohort of patientsMedian OSStable diseaseAdenosquamous carcinomaProtocol therapyPartial responseArm ASACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer.
Garrido-Castro A, Kim S, Desrosiers J, Nanda R, Carey L, Clark A, Sacks R, O'Connor T, Sinclair N, Lo K, Thomas A, Wrabel E, O'Meara T, Lin N, Burstein H, He M, Rimm D, Mittendorf E, Tayob N, Tolaney S. SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer. Journal Of Clinical Oncology 2024, 42: lba1004-lba1004. DOI: 10.1200/jco.2024.42.17_suppl.lba1004.Peer-Reviewed Original ResearchProgression-free survivalMetastatic breast cancerHR+/HER2- metastatic breast cancerPD-L1 expressionSacituzumab govitecanAntibody drug conjugatesOverall survivalArm BPD-L1Arm ASN-38Study therapyBreast cancerHormone receptor-positive/HER2-negative breast cancerOpen-label phase 2 studyFollow-upDeplete regulatory T cellsFrequent treatment-related toxicitiesHormone receptor-positive/HER2-negativeImproving progression-free survivalTopoisomerase I inhibitor payloadMedian progression-free survivalRandomized phase II trialUpregulated MHC class IT cell effector functionSafety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KT-253, a targeted protein degrader of MDM2, in patients with relapsed/refractory (R/R) solid tumors, lymphoma, high grade myeloid malignancies and acute lymphoblastic leukemia (ALL).
Khawaja M, Naqash A, Schneider R, Shastri A, Stahl M, Moser J, Abdel Karim N, Madanat Y, Jonas B, Stein E, Gadgeel S, McCloskey J, Gollerkeri A, Perea R, Chutake Y, Agarwal S, Henrick P, Shi K, Daver N. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KT-253, a targeted protein degrader of MDM2, in patients with relapsed/refractory (R/R) solid tumors, lymphoma, high grade myeloid malignancies and acute lymphoblastic leukemia (ALL). Journal Of Clinical Oncology 2024, 42: 3084-3084. DOI: 10.1200/jco.2024.42.16_suppl.3084.Peer-Reviewed Original ResearchAcute lymphoblastic leukemiaMouse double minute 2Arm BArm AAdverse eventsSolid tumorsOpen-label phase 1 studyMouse double minute 2 inhibitorUpregulated p53 activityDecreased oral intakeMerkel cell carcinomaAdenoid cystic carcinomaPhase 1 studySolid tumor typesAcute apoptotic responseDose-dependent increaseGDF-15 proteinPreclinical PDX modelsWild-type p53Anti-tumor activityDouble minute 2Upregulation of CDKN1AR/R AMLDose escalationTumor regressionAdvanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587).
Serzan M, Jegede O, Alter R, Bilen M, Braun D, Einstein D, Haas N, Herchenhorn D, King J, Runcie K, Sosman J, Sternberg C, Yang Y, Signoretti S, CHOUEIRI T, Atkins M. Advanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587). Journal Of Clinical Oncology 2024, 42: tps4614-tps4614. DOI: 10.1200/jco.2024.42.16_suppl.tps4614.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsArm BArm APrimary endpointRate of immune-related adverse eventsMetastatic clear cell renal cell carcinomaImmune-related adverse eventsMolecular predictors of responseVEGF receptor tyrosine kinase inhibitorReceptor tyrosine kinase inhibitorsEnhance T cell primingOne-sided significance levelClear cell renal cell carcinomaAnti-PD1 inhibitorsIMDC risk groupsTreatment free intervalProgression-free survivalT cell primingTreatment-free survivalCell renal cell carcinomaSubpopulations of TregsFirst-line treatmentRenal cell carcinomaPredictors of responseAssociated with increased presenceRandomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147)
Sheth S, Oh J, Bellone S, Siegel E, Greenman M, Mutlu L, McNamara B, Pathy S, Clark M, Azodi M, Altwerger G, Andikyan V, Huang G, Ratner E, Kim D, Iwasaki A, Levi A, Buza N, Hui P, Flaherty S, Schwartz P, Santin A. Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147). Clinical Cancer Research 2024, 30: of1-of10. PMID: 38592381, DOI: 10.1158/1078-0432.ccr-23-3639.Peer-Reviewed Original ResearchConceptsRandomized phase II trialCD4/CD8 T cellsT cellsHPV clearanceArm BNo significant differenceClinical surveillanceRate of HPV clearanceSecondary outcomesPre-neoplastic cervical lesionsCervical intraepithelial neoplasiaT cell infiltrationT cell responsesSignificant differenceCIN3 patientsIntraepithelial neoplasiaArm ACervical lesionsImiquimod groupSurveillance armVaginal suppositoriesProspective trialsArm CHPV vaccinationImiquimodA phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients
Lee V, Parkinson R, Zahurak M, Cope L, Cercek A, Verheul H, Gootjes E, Lenz H, Iqbal S, Jones P, Baylin S, Rami V, Ahuja N, Khoueiry A, Azad N. A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients. International Journal Of Cancer 2024, 154: 1794-1801. PMID: 38312102, DOI: 10.1002/ijc.34845.Peer-Reviewed Original ResearchRefractory to irinotecanArm ATAS-102DNA methyltransferase inhibitorArm BRates of progression free survivalB. Median overall survivalEvidence of target modulationMetastatic colorectal cancer patientsResistant to systemic therapyTreatment related adverse eventsProgression free survivalPhase II studyPhase II trialKaplan-Meier ratesRelated adverse eventsColorectal cancer patientsFree survivalOverall survivalSystemic therapyAdverse eventsIrinotecanRegorafenibCancer patientsGuadecitabineAdvanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587).
Serzan M, Jegede O, Bilen M, Braun D, Einstein D, Haas N, Hammers H, King J, Runcie K, Sosman J, Sternberg C, Yang Y, Choueiri T, Signoretti S, Atkins M. Advanced renal cell cancer combination immunotherapy clinical trial (ARCITECT; HCRN GU 22-587). Journal Of Clinical Oncology 2024, 42: tps492-tps492. DOI: 10.1200/jco.2024.42.4_suppl.tps492.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsArm BArm APrimary endpointRate of immune-related adverse eventsMetastatic clear cell renal cell carcinomaImmune-related adverse eventsMolecular predictors of responseVEGF receptor tyrosine kinase inhibitorReceptor tyrosine kinase inhibitorsEnhance T cell primingOne-sided significance levelClear cell renal cell carcinomaAnti-PD1 inhibitorsIMDC risk groupsTreatment free intervalProgression-free survivalT cell primingTreatment-free survivalCell renal cell carcinomaSubpopulations of TregsFirst-line treatmentRenal cell carcinomaPredictors of responseAnti-tumor activity
2023
A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer
Mayer E, Tayob N, Ren S, Savoie J, Spigel D, Burris H, Ryan P, Harris L, Winer E, Burstein H. A randomized phase II study of metronomic cyclophosphamide and methotrexate (CM) with or without bevacizumab in patients with advanced breast cancer. Breast Cancer Research And Treatment 2023, 204: 123-132. PMID: 38019444, DOI: 10.1007/s10549-023-07167-9.Peer-Reviewed Original ResearchObjective response rateProgression-free survivalAdvanced breast cancerPhase II studyMetastatic breast cancerOverall survivalArm ABreast cancerArm BII studyMetronomic chemotherapyRandomized phase II studyGrade adverse eventsMetronomic oral cyclophosphamideOral metronomic chemotherapyMedian overall survivalStandard-dose chemotherapyFurther clinical evaluationMetronomic cyclophosphamideOral cyclophosphamideArm B.Primary endpointSecondary endpointsAdverse eventsDose chemotherapyCTNI-41. PHASE II AND PHASE 0 RESULTS OF ABTC 1801: A MULTI-ARM CLINICAL TRIAL OF THE PARP INHIBITOR PAMIPARIB WITH VERY LOW DOSE METRONOMIC TEMOZOLOMIDE IN RECURRENT IDH MUTANT GLIOMAS
Schiff D, Bindra R, Li J, Ye X, Ellingson B, Walbert T, Campian J, Nabors B, Lieberman F, Ozer B, Desai A, Omuro A, Wen P, Desideri S, Danda N, Grossman S. CTNI-41. PHASE II AND PHASE 0 RESULTS OF ABTC 1801: A MULTI-ARM CLINICAL TRIAL OF THE PARP INHIBITOR PAMIPARIB WITH VERY LOW DOSE METRONOMIC TEMOZOLOMIDE IN RECURRENT IDH MUTANT GLIOMAS. Neuro-Oncology 2023, 25: v84-v84. PMCID: PMC10639307, DOI: 10.1093/neuonc/noad179.0323.Peer-Reviewed Original ResearchObjective response rateArm AMetronomic temozolomideArm BGrade 3Non-enhancing tumorMeaningful objective response rateTumor/plasma ratioCumulative hematologic toxicityGrade 3 anemiaGrade 3 thrombocytopeniaGrade 4 neutropeniaPhase II componentArm clinical trialPhase IIKPS 90Median PFSHematologic toxicityPrimary endpointAlkylator therapyProgressive diseaseARM patientsMedian ageBRCAness phenotypeClinical trialsPaclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial
Stockton S, Catalano P, Cohen S, Burtness B, Mitchell E, Dotan E, Lubner S, Kumar P, Mulcahy M, Fisher G, Crandall T, Benson A. Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial. The Oncologist 2023, 28: 827-e822. PMID: 37104870, PMCID: PMC10485278, DOI: 10.1093/oncolo/oyad096.Peer-Reviewed Original ResearchConceptsProgression-free survivalSecond-line therapyGastroesophageal junction cancerArm AMetastatic esophagealJunction cancerArm BMedian progression-free survivalRandomized phase II trialMedian overall survivalObjective response rateSecond-line treatmentAdvanced esophageal cancerInsulin-like growth factor 1 receptorPhase II trialStandard of careGrowth factor 1 receptorFactor 1 receptorStable diseaseII trialMetastatic settingPrimary endpointOverall survivalPreclinical evidenceClinical outcomes
2022
Randomized Trial of Olaparib With or Without Cediranib for Metastatic Castration-Resistant Prostate Cancer: The Results From National Cancer Institute 9984
Kim JW, McKay RR, Radke MR, Zhao S, Taplin ME, Davis NB, Monk P, Appleman LJ, Lara PN, Vaishampayan UN, Zhang J, Paul AK, Bubley G, Van Allen EM, Unlu S, Huang Y, Loda M, Shapiro GI, Glazer PM, LoRusso PM, Ivy SP, Shyr Y, Swisher EM, Petrylak DP. Randomized Trial of Olaparib With or Without Cediranib for Metastatic Castration-Resistant Prostate Cancer: The Results From National Cancer Institute 9984. Journal Of Clinical Oncology 2022, 41: 871-880. PMID: 36256912, PMCID: PMC9901975, DOI: 10.1200/jco.21.02947.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerRadiographic progression-free survivalMedian radiographic progression-free survivalCastration-resistant prostate cancerArm AProstate cancerAdverse eventsGrade 3Progressive metastatic castration-resistant prostate cancerEndothelial growth factor receptor inhibitorEnd pointHomologous recombination repair genesGrowth factor receptor inhibitorsPrimary end pointSecondary end pointsProgression-free survivalRecombination repair genesPoly (ADP-ribose) polymerase inhibitionTreat setTreat patientsClinical outcomesRandomized trialsPreclinical modelsReceptor inhibitorsCediranibLong-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials
Gettinger SN, Huber RM, Kim DW, Bazhenova L, Hansen KH, Tiseo M, Langer CJ, Rodríguez L, West HL, Reckamp KL, Weiss GJ, Smit EF, Hochmair MJ, Kim SW, Ahn MJ, Kim ES, Groen HJM, Pye J, Liu Y, Zhang P, Vranceanu F, Camidge DR. Long-Term Efficacy and Safety of Brigatinib in Crizotinib-Refractory ALK+ NSCLC: Final Results of the Phase 1/2 and Randomized Phase 2 (ALTA) Trials. JTO Clinical And Research Reports 2022, 3: 100385. PMID: 36065449, PMCID: PMC9440305, DOI: 10.1016/j.jtocrr.2022.100385.Peer-Reviewed Original ResearchProgression-free survivalPhase 1/2 studyMedian investigator-assessed progression-free survivalInvestigator-assessed progression-free survivalMedian overall survivalPhase 2 trialLong-term efficacyOverall survivalPhase 1/2Arm AStudy endMedian intracranial progression-free survivalIntracranial progression-free survivalRandomized phase 2 trialNew safety signalsIndependent review committeeArm B.Advanced malignanciesBrain metastasesManageable safetyArm BPositive NSCLCSafety signalsNSCLCPatientsRandomized phase II study of platinum and etoposide (EP) versus temozolomide and capecitabine (CAPTEM) in patients (pts) with advanced G3 non-small cell gastroenteropancreatic neuroendocrine neoplasms (GEPNENs): ECOG-ACRIN EA2142.
Eads J, Catalano P, Fisher G, Rubin D, Iagaru A, Klimstra D, Konda B, Kwong M, Chan J, De Jesus-Acosta A, Halfdanarson T, Shaib W, Soares H, Hong S, Wong T, O'Dwyer P. Randomized phase II study of platinum and etoposide (EP) versus temozolomide and capecitabine (CAPTEM) in patients (pts) with advanced G3 non-small cell gastroenteropancreatic neuroendocrine neoplasms (GEPNENs): ECOG-ACRIN EA2142. Journal Of Clinical Oncology 2022, 40: 4020-4020. DOI: 10.1200/jco.2022.40.16_suppl.4020.Peer-Reviewed Original ResearchProgression free survivalDay 1EP chemotherapyArm AEligible ptsKi-67Treatment cyclesRandomized phase II studyOne-sided significance levelG3 neuroendocrine carcinomaMean Ki-67Favorable toxicity profileGastroenteropancreatic neuroendocrine neoplasmsPrimary tumor siteFront-line treatmentHeterogeneous disease entityGrade (GG3 NENG3 NETsRestaging scansAUC 5ECOG PSFebrile neutropeniaArm BFree survivalA Randomized Phase 2 Trial of Azacitidine ± Durvalumab as First-line Therapy for Higher-Risk Myelodysplastic Syndromes
Zeidan AM, Boss I, Beach C, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O’Connor T, Previtali A, Rose S, Garcia-Manero G. A Randomized Phase 2 Trial of Azacitidine ± Durvalumab as First-line Therapy for Higher-Risk Myelodysplastic Syndromes. Blood Advances 2022, 6: 2207-2218. PMID: 34972214, PMCID: PMC9006291, DOI: 10.1182/bloodadvances.2021005487.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeAdverse eventsArm BArm ASubcutaneous azacitidineMyelodysplastic syndromeTreatment cyclesRandomized phase 2 trialInhibitory immune checkpoint moleculesHematologic adverse eventsMedian overall survivalFirst-line therapyFirst-line treatmentPhase 2 studyPhase 2 trialImmune checkpoint moleculesOverall response rateBone marrow granulocytesAzacitidine monotherapyIntravenous durvalumabCheckpoint moleculesOverall survivalClinical outcomesMarrow granulocytesGrade 3
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