2024
HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors.
Bhatia A, Hayashi H, Kogawa T, Nishina T, Fountzilas C, Castillo D, McKean M, Colombo N, Smithy J, Fayette J, Chandra S, Powles T, Kudchadkar R, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Burtness B. HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps3164-tps3164. DOI: 10.1200/jco.2024.42.16_suppl.tps3164.Peer-Reviewed Original ResearchHead and neck squamous cell cancerHuman epidermal growth factor receptor 3Platinum-based chemotherapyHER3-DXdPhase 2 trialAntibody-drug conjugatesSolid tumorsHuman anti-HER3 monoclonal antibodyAnti-HER3 monoclonal antibodyAnti-PD-(L)1 therapyGastric cancerHER2-negative gastric cancerTopoisomerase I inhibitor payloadAssociated with poor clinical outcomesEpidermal growth factor receptor 3Anti-HER3 antibodiesGastroesophageal junction cancerHER2+ cancersMetastatic solid tumorsMetastatic breast cancerSquamous cell cancerBRAF wild-typePoor clinical outcomesMultiple tumor typesAcral subtype
2023
Paclitaxel 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
2017
A randomized phase II pilot study prospectively evaluating treatment for patients based on ERCC1 for advanced/ metastatic esophageal, gastric, or gastroesophageal junction cancer: SWOG S1201.
Iqbal S, McDonough S, Lenz H, Ilson D, Burtness B, Nangia C, Barzi A, Schneider C, Liu J, Dotan E, Guthrie K, Hochster H. A randomized phase II pilot study prospectively evaluating treatment for patients based on ERCC1 for advanced/ metastatic esophageal, gastric, or gastroesophageal junction cancer: SWOG S1201. Journal Of Clinical Oncology 2017, 35: 4009-4009. DOI: 10.1200/jco.2017.35.15_suppl.4009.Peer-Reviewed Original ResearchAdvanced esophagogastric cancerERCC1 levelsRandomized phase II pilot studyRandomized phase II studyPhase II pilot studyHigh ERCC1 levelsPhase II studyHER2-negative patientsGastroesophageal junction cancerDifferential treatment effectsMetastatic esophagealEsophagogastric cancerII studyJunction cancerNegative patientsPS 0Superior PFSERCC1 expressionTx groupFOLFOXPlatinum sensitivityRetrospective dataPFSHigh subgroupPilot study
2016
CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers
Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. Journal Of Clinical Oncology 2016, 34: 2736-2742. PMID: 27382098, PMCID: PMC5019745, DOI: 10.1200/jco.2015.65.5092.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionDisease-Free SurvivalEpirubicinEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsSurvival RateTime FactorsTreatment FailureConceptsGastroesophageal junction cancerProgression-free survivalMetastatic esophagealJunction cancerOverall survivalTreatment failureResponse rateMedian progression-free survivalRandomized phase II studyContinuous infusion fluorouracilOptimal chemotherapy backboneTreatment-related deathsMedian overall survivalPhase II studyPrimary end pointCooperative group studiesPromising preclinical dataChemotherapy backboneChemotherapy regimensAdverse eventsII studySecondary outcomesMedian timeTreatment armsPreclinical data