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
Induction Therapy for Locally Advanced, Resectable Esophagogastric Cancer
Boland PM, Meyer JE, Berger AC, Cohen SJ, Neuman T, Cooper HS, Olszanski AJ, Davey M, Cheng JD, Lebenthal A, Burtness BA, Scott WJ, Astsaturov IA. Induction Therapy for Locally Advanced, Resectable Esophagogastric Cancer. American Journal Of Clinical Oncology 2017, 40: 393-398. PMID: 26986978, PMCID: PMC5026539, DOI: 10.1097/coc.0000000000000171.Peer-Reviewed Original ResearchConceptsGastroesophageal junction carcinomaPreoperative chemoradiationPreoperative chemotherapyAdditional patientsSmall molecule receptor tyrosine kinase inhibitorGrade 4 nonhematologic toxicityReceptor tyrosine kinase inhibitorsPhase ICommon acute toxicitiesLocalized esophageal cancerResectable esophagogastric cancerTolerability of vandetanibMedian overall survivalMicroscopic residual diseasePathologic complete responseLocalized esophageal carcinomaTyrosine kinase inhibitorsEsophagogastric cancerInduction therapyNonhematologic toxicityPrior therapyDaily radiotherapyLate complicationsOverall survivalSurgical candidates
2014
Induction cetuximab, paclitaxel, and carboplatin followed by chemoradiation with cetuximab, paclitaxel, and carboplatin for stage III/IV head and neck squamous cancer: a phase II ECOG-ACRIN trial (E2303)
Wanebo HJ, Lee J, Burtness BA, Ridge JA, Ghebremichael M, Spencer SA, Psyrri D, Pectasides E, Rimm D, Rosen FR, Hancock MR, Tolba KA, Forastiere AA. Induction cetuximab, paclitaxel, and carboplatin followed by chemoradiation with cetuximab, paclitaxel, and carboplatin for stage III/IV head and neck squamous cancer: a phase II ECOG-ACRIN trial (E2303). Annals Of Oncology 2014, 25: 2036-2041. PMID: 25009013, PMCID: PMC4176450, DOI: 10.1093/annonc/mdu248.Peer-Reviewed Original ResearchConceptsEvent-free survivalStage III/IV headResponse/survivalInduction therapyComplete responseStage III/IV HNSCCNeck squamous cell carcinomaPrimary site biopsiesTreatment-related deathsPathologic complete responseNeck squamous cancerSquamous cell carcinomaProtein expression statusEligible patientsSite biopsiesOverall survivalCell carcinomaPromising survivalSquamous cancerDisease progressionChemoradiationRadiation therapyPatientsWeek 9CetuximabPrognostic Biomarkers in Phase II Trial of Cetuximab-Containing Induction and Chemoradiation in Resectable HNSCC: Eastern Cooperative Oncology Group E2303
Psyrri A, Lee JW, Pectasides E, Vassilakopoulou M, Kosmidis EK, Burtness BA, Rimm DL, Wanebo HJ, Forastiere AA. Prognostic Biomarkers in Phase II Trial of Cetuximab-Containing Induction and Chemoradiation in Resectable HNSCC: Eastern Cooperative Oncology Group E2303. Clinical Cancer Research 2014, 20: 3023-3032. PMID: 24700741, PMCID: PMC4049169, DOI: 10.1158/1078-0432.ccr-14-0113.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCarcinoma, Squamous CellCetuximabChemoradiotherapyDisease-Free SurvivalDrug Resistance, NeoplasmFemaleFluorescent Antibody TechniqueHead and Neck NeoplasmsHumansInduction ChemotherapyKaplan-Meier EstimateMaleMiddle AgedMitogen-Activated Protein Kinase KinasesPaclitaxelPhosphatidylinositol 3-KinasesPrognosisProportional Hazards ModelsProto-Oncogene Proteins c-aktRas ProteinsSignal TransductionSquamous Cell Carcinoma of Head and NeckTissue Array AnalysisConceptsProgression-free survivalEvent-free survivalPhase II trialOverall survivalII trialTissue microarrayStage III/IV headMultivariable Cox proportional hazards modelsMultivariable Cox regression analysisNeck squamous cell cancerRAS/MAPK/ERKCox proportional hazards modelInsulin-like growth factor 1 receptorLarge prospective studiesCox regression analysisInferior overall survivalKaplan-Meier methodSquamous cell cancerLog-rank testGrowth factor 1 receptorProportional hazards modelPI3K/Akt pathwayFactor 1 receptorPI3K/AktEGF receptor
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
2006
Long-term assessment of cardiac function after dose-dense and -intense sequential doxorubicin (A), paclitaxel (T), and cyclophosphamide (C) as adjuvant therapy for high risk breast cancer
Abu-Khalaf MM, Juneja V, Chung GG, DiGiovanna MP, Sipples R, McGurk M, Zelterman D, Haffty B, Reiss M, Wackers FJ, Lee FA, Burtness BA. Long-term assessment of cardiac function after dose-dense and -intense sequential doxorubicin (A), paclitaxel (T), and cyclophosphamide (C) as adjuvant therapy for high risk breast cancer. Breast Cancer Research And Treatment 2006, 104: 341-349. PMID: 17051423, DOI: 10.1007/s10549-006-9413-7.Peer-Reviewed Original ResearchConceptsLeft ventricular ejection fractionEnd of chemotherapyEquilibrium radionuclide angiographyBreast cancerAdjuvant therapySequential doxorubicinCardiac functionIpsilateral axillary lymph nodesHigh-risk breast cancerRisk breast cancerClinical heart failureInitiation of chemotherapyAxillary lymph nodesVentricular ejection fractionEnd of therapyLong-term cardiotoxicityMedian absolute changeEligible patientsFilgrastim supportLate cardiotoxicityAxillary nodesAsymptomatic declineEjection fractionHeart failureLymph nodes
2005
Five-Year Update of an Expanded Phase II Study of Dose-Dense and -Intense Doxorubicin, Paclitaxel and Cyclophosphamide (ATC) in High-Risk Breast Cancer
Abu-Khalaf MM, Windsor S, Ebisu K, Salikooti S, Ananthanarayanan G, Chung GG, DiGiovanna MP, Haffty BG, Abrams M, Farber LR, Hsu AD, Reiss M, Zelterman D, Burtness BA. Five-Year Update of an Expanded Phase II Study of Dose-Dense and -Intense Doxorubicin, Paclitaxel and Cyclophosphamide (ATC) in High-Risk Breast Cancer. Oncology 2005, 69: 372-383. PMID: 16319508, DOI: 10.1159/000089991.Peer-Reviewed Original ResearchConceptsHigh-risk breast cancerBreast cancerAdjuvant therapyLymph nodesCommon grade 3 toxicitiesIpsilateral axillary lymph nodesGrade 3 toxicityGrade 3/4 neutropeniaPhase II studyAxillary lymph nodesPalmar-plantar erythrodysesthesiaDose-denseEligible patientsFeasible regimenFilgrastim supportNeutropenic feverDistant diseaseAxillary nodesDose intensityII studyBC surgerySequential doxorubicinAcute leukemiaMetastatic cancerMedian number
2003
Sequential High‐Dose Alkylating Therapy and Stem Cell Support for High‐Risk Stage III Breast Cancer
Bou‐Khalil J, Rose M, Psyrri A, D’Andrea E, Medoff E, Staugaard‐Hahn C, Holtkamp C, Gran S, Pezzimente J, Snyder E, Cooper D, Haffty B, Reiss M, Burtness B. Sequential High‐Dose Alkylating Therapy and Stem Cell Support for High‐Risk Stage III Breast Cancer. The Breast Journal 2003, 9: 472-477. PMID: 14616941, DOI: 10.1046/j.1524-4741.2003.09604.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsConnecticutCyclophosphamideFemaleGranulocyte Colony-Stimulating FactorHumansMedical RecordsMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPaclitaxelPalliative CareRetrospective StudiesStem Cell TransplantationSurvival AnalysisTreatment OutcomeConceptsStem cell rescueAdvanced breast cancerBreast cancerCell rescueLymph nodesHormone receptor-positive tumorsIpsilateral axillary lymph nodesStandard-dose adjuvant chemotherapyWhite blood cell toxicityStage III breast cancerAnthracycline-containing chemotherapyPositive lymph nodesTreatment-related complicationsAxillary lymph nodesHigh-dose chemotherapyStem cell supportReceptor-positive tumorsGranulocyte colony-stimulating factorMajority of cancersColony-stimulating factorAdjuvant chemotherapyNeutropenic feverNeoadjuvant chemotherapyStage IIIBMedian time
2002
Phase I Dose Escalation Trial of Weekly Docetaxel Plus Irinotecan in Patients with Advanced Cancer
Bleickardt E, Argiris A, Rich R, Blum K, McKeon A, Tara H, Zelterman D, Burtness B, Davies MJ, Murren JR. Phase I Dose Escalation Trial of Weekly Docetaxel Plus Irinotecan in Patients with Advanced Cancer. Cancer Biology & Therapy 2002, 1: 646-651. PMID: 12642688, DOI: 10.4161/cbt.314.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityWeek of restWeekly docetaxelPancreatic cancerDose levelsSolid tumorsPredominant dose-limiting toxicityCommon dose-limiting toxicityNon-small cell lungPhase II dosesNausea/vomitingAdvanced solid tumorsMaximum-tolerated dosePhase II trialPhase I trialNonhematologic toxicityEligible patientsEscalation trialII trialPartial responseSevere neutropeniaWeekly administrationI trialAdvanced cancerCell lung
2001
Use of paclitaxel in patients with pre‐existing cardiomyopathy: A review of our experience
Gollerkeri A, Harrold L, Rose M, Jain D, Burtness B. Use of paclitaxel in patients with pre‐existing cardiomyopathy: A review of our experience. International Journal Of Cancer 2001, 93: 139-141. PMID: 11391633, DOI: 10.1002/ijc.1295.Peer-Reviewed Original ResearchConceptsLeft ventricular ejection fractionYale Cancer CenterPaclitaxel therapyClinic recordsDecreased LVEFCompletion of paclitaxelPre-existing cardiomyopathyPrior cardiac diseasePrior doxorubicin therapySecond-line agentsCongestive heart failureVentricular ejection fractionUse of paclitaxelEffect of paclitaxelEjection fractionHeart failureCardiac dysfunctionClinical evidenceOutpatient clinicCancer CenterCardiac toxicityDoxorubicin therapyCardiac functionRetrospective analysisMean change
2000
The feasibility of high-dose chemotherapy in breast cancer patients with impaired left ventricular function
Rose M, Lee F, Gollerkeri A, D'Andrea E, Psyrri A, Bdolah-Abram T, Burtness B. The feasibility of high-dose chemotherapy in breast cancer patients with impaired left ventricular function. Bone Marrow Transplantation 2000, 26: 133-139. PMID: 10918422, DOI: 10.1038/sj.bmt.1702449.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCombined Modality TherapyCyclophosphamideDoxorubicinFemaleFollow-Up StudiesHematopoietic Stem Cell MobilizationHematopoietic Stem Cell TransplantationHumansMiddle AgedNeutropeniaPaclitaxelStroke VolumeSurvival RateVentricular Dysfunction, LeftConceptsLeft ventricular ejection fractionHigh-dose chemotherapyBreast cancer patientsMean absolute decreaseCancer patientsAbsolute decreaseLV functionCell rescueImpaired left ventricular functionHigh-dose thiotepaImpaired LV functionHigh-dose melphalanStem cell rescueSymptomatic heart failureCourses of chemotherapyVentricular ejection fractionLeft ventricular functionSequential paclitaxelMetastatic diseaseCardiac deathCardiac symptomsEjection fractionHeart failureVentricular functionCardiac toxicityDose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer
Murren J, Peccerillo K, DiStasio S, Li X, Leffert J, Pizzorno G, Burtness B, McKeon A, Cheng Y. Dose escalation and pharmacokinetic study of irinotecan in combination with paclitaxel in patients with advanced cancer. Cancer Chemotherapy And Pharmacology 2000, 46: 43-50. PMID: 10912577, DOI: 10.1007/s002800000115.Peer-Reviewed Original ResearchConceptsDose of irinotecanElimination of irinotecanDrug AdministrationAdvanced cancerFirst cycle patientsChemotherapy-related toxicityDose of paclitaxelClinical side effectsSequence of administrationBlood cell elementsNonhematologic toxicityReversible neutropeniaFirst doseMost patientsPartial responseCycle patientsDose escalationMild diarrheaPreclinical dataPlasma concentrationsSide effectsIrinotecanPatientsPharmacokinetic parametersWeekly schedulePhase II evaluation of preoperative chemoradiation and postoperative adjuvant chemotherapy for squamous cell and adenocarcinoma of the esophagus.
Heath E, Burtness B, Heitmiller R, Salem R, Kleinberg L, Knisely J, Yang S, Talamini M, Kaufman H, Canto M, Topazian M, Wu T, Olukayode K, Forastiere A. Phase II evaluation of preoperative chemoradiation and postoperative adjuvant chemotherapy for squamous cell and adenocarcinoma of the esophagus. Journal Of Clinical Oncology 2000, 18: 868-76. PMID: 10673530, DOI: 10.1200/jco.2000.18.4.868.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAntimetabolites, AntineoplasticAntineoplastic AgentsAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemotherapy, AdjuvantCisplatinEsophageal NeoplasmsEsophagectomyFeasibility StudiesFemaleFluorouracilFollow-Up StudiesHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm StagingPaclitaxelRadiotherapy DosageRemission InductionSurvival RateTreatment OutcomeConceptsSurvival rateAdjuvant chemotherapyPreoperative chemoradiationComplete responseComplete pathologic response rateCompletion of chemoradiotherapyContinuous infusion cisplatinPathologic response ratePostoperative adjuvant chemotherapyPostoperative adjuvant therapyPathologic complete responsePhase II trialPhase II evaluationComplete tumor resectionContinuous intravenous infusionMedian survival timePathologic complete respondersExcellent survival ratesGy of radiationPatterns of failurePreoperative treatment planPreoperative cisplatinComplete respondersPreoperative treatmentResectable cancer
1999
A phase I study of paclitaxel for mobilization of peripheral blood progenitor cells
Burtness B, Psyrri A, Rose M, D’Andrea E, Staugaard-Hahn C, Henderson-Bakas M, Clark M, Mechanic S, Krause D, Snyder E, Cooper R, Abrantes J, Corringham R, Deisseroth A, Cooper D. A phase I study of paclitaxel for mobilization of peripheral blood progenitor cells. Bone Marrow Transplantation 1999, 23: 311-315. PMID: 10100573, DOI: 10.1038/sj.bmt.1701589.Peer-Reviewed Original ResearchConceptsSchedule of paclitaxelDose escalationH infusionPeripheral blood progenitor cellsDose of paclitaxelPhase I trialBlood progenitor cellsStem cell yieldStem cellsTolerable toxicityI trialInfusion scheduleDose levelsPhase IPaclitaxelDoseProgenitor cellsCells/NeuropathyFilgrastimInfusionEscalationAdjuvant sequential dose-dense doxorubicin, paclitaxel, and cyclophosphamide (ATC) for high-risk breast cancer is feasible in the community setting.
Burtness B, Windsor S, Holston B, DiStasio S, Staugaard-Hahn C, Abrantes J, Kneuper-Hall R, Farber L, Orell J, Bober-Sorcinelli K, Haffty BG, Reiss M. Adjuvant sequential dose-dense doxorubicin, paclitaxel, and cyclophosphamide (ATC) for high-risk breast cancer is feasible in the community setting. The Cancer Journal 1999, 5: 224-9. PMID: 10439168.Peer-Reviewed Original ResearchConceptsBreast cancerDefinitive breast cancer surgeryMetastatic axillary lymph nodesHigh-risk breast cancerMore axillary nodesMyalgia/arthralgiaGrade 3 toxicityNausea/vomitingPercent of patientsAxillary lymph nodesHigh-risk patientsBreast cancer surgeryPreliminary efficacy dataFilgrastim supportNeutropenic feverAcceptable toxicityAdjuvant therapyAxillary nodesDose intensityStandard therapyBone scanLymph nodesCancer surgeryDistant metastasisAcute leukemia