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
2019
Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201.
Iqbal S, McDonough S, Lenz HJ, Ilson D, Burtness B, Nangia CS, Barzi A, Schneider CJ, Liu JJ, Dotan E, Guthrie KA, Hochster HS. Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201. Journal Of Clinical Oncology 2019, 38: 472-479. PMID: 31815582, PMCID: PMC7007287, DOI: 10.1200/jco.19.00925.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDNA-Binding ProteinsEndonucleasesEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilGene ExpressionHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsOxaliplatinPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesStomach NeoplasmsYoung AdultConceptsProgression-free survivalAdvanced esophagogastric cancerPhase II studyPlatinum-based therapyOverall survivalII studySuperior median progression-free survivalMedian progression-free survivalMRNA expressionRegimen of irinotecanUpper GI tumorsZubrod performance statusPercent of patientsOccurrence of gradeStandard of careMetastatic esophagealEsophagogastric cancerPerformance statusUntreated patientsGastroesophageal cancerGI tumorsTreatment armsFOLFOXPlatinum sensitivityPatients
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
2014
E2208: Randomized phase II study of paclitaxel with or without the anti-IGF-IR antibody cixutumumab (IMC-A12) as second-line treatment for patients with metastatic esophageal or GE junction cancer.
Cohen S, Feng Y, Catalano P, Mitchell E, O'Dwyer P, Lubner S, Fisher G, Mulcahy M, Burtness B, Benson A. E2208: Randomized phase II study of paclitaxel with or without the anti-IGF-IR antibody cixutumumab (IMC-A12) as second-line treatment for patients with metastatic esophageal or GE junction cancer. Journal Of Clinical Oncology 2014, 32: 4020-4020. DOI: 10.1200/jco.2014.32.15_suppl.4020.Peer-Reviewed Original Research
2010
CALGB 80403/ECOG 1206: A randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer.
Enzinger P, Burtness B, Hollis D, Niedzwiecki D, Ilson D, Benson A, Mayer R, Goldberg R. CALGB 80403/ECOG 1206: A randomized phase II study of three standard chemotherapy regimens (ECF, IC, FOLFOX) plus cetuximab in metastatic esophageal and GE junction cancer. Journal Of Clinical Oncology 2010, 28: 4006-4006. DOI: 10.1200/jco.2010.28.15_suppl.4006.Peer-Reviewed Original Research