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
2021
Updated report of a phase II randomized trial of transoral surgical resection followed by low-dose or standard postoperative therapy in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN cancer research group (E3311).
Ferris R, Flamand Y, Weinstein G, Li S, Quon H, Mehra R, Garcia J, Ringash J, Lewin J, Duvvuri U, O'Malley B, Ozer E, Thomas G, Koch W, Kupferman M, Bell R, Saba N, Lango M, Wagner L, Burtness B. Updated report of a phase II randomized trial of transoral surgical resection followed by low-dose or standard postoperative therapy in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN cancer research group (E3311). Journal Of Clinical Oncology 2021, 39: 6010-6010. DOI: 10.1200/jco.2021.39.15_suppl.6010.Peer-Reviewed Original ResearchPrimary transoral surgeryOropharynx cancerArm BPatient-reported outcomesPostoperative RTTransoral surgeryArm AHuman papillomavirus-associated oropharynx cancerECOG-ACRIN Cancer Research GroupAdvanced oropharynx cancerArm DStandard postoperative therapyPhase II trialProportion of patientsCancer Research GroupNeck cancer-specific qualityPre-specified endpointsTransoral surgical resectionDeintensification strategiesFavorable QOLIneligible patientsPathologic riskPostoperative chemoradiationAdjuvant therapyII trial
2020
Transoral robotic surgical resection followed by randomization to low- or standard-dose IMRT in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN Cancer Research Group (E3311).
Ferris R, Flamand Y, Weinstein G, Li S, Quon H, Mehra R, Garcia J, Chung C, Gillison M, Duvvuri U, O'malley B, Ozer E, Thomas G, Koch W, Kupferman M, Bell R, Saba N, Lango M, Mendez E, Burtness B. Transoral robotic surgical resection followed by randomization to low- or standard-dose IMRT in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN Cancer Research Group (E3311). Journal Of Clinical Oncology 2020, 38: 6500-6500. DOI: 10.1200/jco.2020.38.15_suppl.6500.Peer-Reviewed Original ResearchProgression-free survivalExtranodal extensionOropharynx cancerTransoral resectionPrimary endpointArm BArm AECOG-ACRIN Cancer Research GroupAdvanced oropharynx cancerTreatment-related deathsUninvolved surgical marginsArm DIntermediate-risk patientsLow-risk diseasePhase III trialsNon-surgical therapyGood oncologic outcomesPost-operative managementCancer Research GroupPost-operative therapyLow-dose radiationPostoperative RTDistant recurrenceFree survivalIII trials
2017
Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial.
Argiris A, Li S, Savvides P, Ohr J, Gilbert J, Levine M, Haigentz M, Saba N, Chakravarti A, Ikpeazu C, Schneider C, Pinto H, Forastiere A, Burtness B. Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial. Journal Of Clinical Oncology 2017, 35: 6000-6000. DOI: 10.1200/jco.2017.35.15_suppl.6000.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalArm BM SCCHNAUC 6Hazard ratioArm AResponse rateMetastatic squamous cell carcinomaAnti-VEGF monoclonal antibodyCarboplatin AUC 6Objective response ratePerformance status 0Trial of chemotherapyFirst-line treatmentSquamous cell carcinomaImproved response ratesA vs BEligible ptsMedian PFSOropharyngeal primaryPlatinum doubletsStatus 0Primary endpointProphylactic antibiotics
2011
Phase II and Coagulation Cascade Biomarker Study of Bevacizumab With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
Astsaturov IA, Meropol NJ, Alpaugh RK, Burtness BA, Cheng JD, McLaughlin S, Rogatko A, Xu Z, Watson JC, Weiner LM, Cohen SJ. Phase II and Coagulation Cascade Biomarker Study of Bevacizumab With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma. American Journal Of Clinical Oncology 2011, 34: 70-75. PMID: 20458210, PMCID: PMC3030655, DOI: 10.1097/coc.0b013e3181d2734a.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkersBlood Coagulation FactorsDeoxycytidineFemaleGemcitabineHumansLiver NeoplasmsLymphatic MetastasisMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPancreatic NeoplasmsPeritoneal NeoplasmsSurvival RateTreatment OutcomeConceptsMetastatic pancreatic cancerPancreatic cancerArm BArm AAnti-vascular endothelial growth factor antibody bevacizumabCommon grade 3/4 nonhematologic toxicitiesGemcitabine-refractory metastatic pancreatic cancerElevated D-dimer levelsGrade 3/4 nonhematologic toxicitiesMedian progression-free survivalThrombin-antithrombin complex levelsVascular endothelial growth factor (VEGF) pathwayEndothelial growth factor pathwayConfirmed objective responsesGemcitabine-containing regimenAntitumor activityModest antitumor activitySecond-line treatmentD-dimer levelsMetastatic pancreatic adenocarcinomaProgression-free survivalThrombin-antithrombin complexGrowth factor pathwaysNonhematologic toxicityObjective response
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 activity
2008
A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study
Burtness BA, Manola J, Axelrod R, Argiris A, Forastiere AA. A randomized phase II study of ixabepilone (BMS-247550) given daily × 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study. Annals Of Oncology 2008, 19: 977-983. PMID: 18296423, DOI: 10.1093/annonc/mdm591.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCombined Modality TherapyDisease-Free SurvivalDocetaxelDrug Administration ScheduleDrug Resistance, NeoplasmEpothilonesFemaleHead and Neck NeoplasmsHematologic DiseasesHumansInfusions, IntravenousMaleMiddle AgedPaclitaxelPeripheral Nervous System DiseasesRecurrenceSalvage TherapySurvival AnalysisTaxoidsConceptsTaxane-naive patientsArm BEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group StudyRecurrent squamous cell cancerSensory/motor neuropathyRandomized phase II studyMetastatic/recurrent diseaseCommon grade 3Grade 3 neuropathyPhase II studyPrimary end pointSquamous cell cancerSquamous cell carcinomaEligible patientsPrior regimensWeekly ixabepiloneRecurrent diseaseII studyMedian survivalPartial responsePerformance statusMotor neuropathyCell cancerCell carcinoma
2007
Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology
Burtness B, Powell M, Berlin J, Liles D, Chapman A, Mitchell E, Benson A. Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. Journal Of Clinical Oncology 2007, 25: 4519-4519. DOI: 10.1200/jco.2007.25.18_suppl.4519.Peer-Reviewed Original ResearchPhase II trialArm AII trialPS 0Arm BPancreatic cancerMedian survivalOverall survivalRandomized phase II trialECOG PS 0Treatment-related deathsMedian overall survivalMetastatic pancreatic cancerTherapeutic anticoagulationDocetaxel chemotherapyMetastatic patientsPrimary endpointBiologic agentsDistant metastasisHistologic confirmationNormal bilirubinSame therapyYear survivalMedian numberArm 2
2006
A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck
Burtness B, Goldwasser M, Axelrod R, Argiris A, Forastiere A. A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. Journal Of Clinical Oncology 2006, 24: 5532-5532. DOI: 10.1200/jco.2006.24.18_suppl.5532.Peer-Reviewed Original ResearchArm BEligible ptsArm A.Recurrent squamous cell cancerRandomized phase II studyMetastatic/recurrent diseaseECOG PS 0Grade 3/4 anemiaPhase II studySquamous cell cancerDiphenhydramine premedicationMales 69Prior regimensRecurrent SCCHNTaxane exposurePrimary endpointII studyMedian survivalPartial responseProgressive diseasePS 0Recurrent diseaseMotor neuropathyArm ACell cancer
2005
Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study. Journal Of Clinical Oncology 2005, 23: 8646-8654. PMID: 16314626, DOI: 10.1200/jco.2005.02.4646.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinCross-Over StudiesDose-Response Relationship, DrugDrug HypersensitivityErbB ReceptorsFemaleFollow-Up StudiesHead and Neck NeoplasmsHematologic DiseasesHumansImmunohistochemistryMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalSeverity of Illness IndexSkin DiseasesSurvival AnalysisTime FactorsTreatment OutcomeConceptsProgression-free survivalAddition of cetuximabRecurrent/metastatic squamous cell carcinomaMedian progression-free survivalMetastatic squamous cell carcinomaEpidermal growth factor receptorSquamous cell carcinomaOverall survivalArm BArm AResponse rateEnd pointHazard ratioCell carcinomaCorrelation of EGFREastern Cooperative Oncology Group StudyMetastatic/recurrent headPhase III randomized trialsCetuximab-treated patientsMedian overall survivalObjective response ratePrimary end pointSecondary end pointsClinical end pointsDevelopment of rash