2021
TrilynX: A phase 3 trial of xevinapant and concurrent chemoradiation for locally advanced head and neck cancer.
Bourhis J, Burtness B, Licitra L, Nutting C, Schoenfeld J, Sarkouh R, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen E. TrilynX: A phase 3 trial of xevinapant and concurrent chemoradiation for locally advanced head and neck cancer. Journal Of Clinical Oncology 2021, 39: tps6091-tps6091. DOI: 10.1200/jco.2021.39.15_suppl.tps6091.Peer-Reviewed Original ResearchEvent-free survivalEFS eventsConcurrent chemoradiationAdvanced squamous cell carcinomaRandomized phase 2 studyECOG PS 0T cell-dependent pathwayLocoregional control ratePhase 2 studyPhase 3 trialPlatinum-based chemotherapySquamous cell carcinomaBiomarkers of responseStandard of careThree-year followIntensity-modulated radiotherapyExposure-response relationship× ULNBackbone therapyDefinitive chemoradiationEligible patientsLA-SCCHNMonotherapy periodX ULNConcurrent chemoradiotherapy
2019
Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.
Argiris A, Li S, Savvides P, Ohr JP, Gilbert J, Levine MA, Chakravarti A, Haigentz M, Saba NF, Ikpeazu CV, Schneider CJ, Pinto HA, Forastiere AA, Burtness B. Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2019, 37: 3266-3274. PMID: 31618129, PMCID: PMC6980834, DOI: 10.1200/jco.19.00555.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease ProgressionDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansMaleNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckTime FactorsUnited StatesConceptsAddition of bevacizumabProgression-free survivalOverall survivalResponse rateMedian progression-free survivalMetastatic squamous cell carcinomaPlatinum-based chemotherapy doubletsTreatment-related grade 3Phase III randomized trialsTreatment-related deathsMedian overall survivalPlatinum-based chemotherapySquamous cell carcinomaBetter toxicity profileBiomarker-driven studiesOverall response rateHumanized monoclonal antibodyVascular endothelial growth factorEndothelial growth factorChemotherapy doubletsMedian OSMetastatic SCCHNOS ratesEligible patientsMetastatic head1127P Brachytherapy and non-cancer mortality in patients with oral cavity and oropharynx SCCs
Yu J, Tsay C, Sasaki C, Son Y, Decker R, Mehra S, Burtness B. 1127P Brachytherapy and non-cancer mortality in patients with oral cavity and oropharynx SCCs. Annals Of Oncology 2019, 30: v457. DOI: 10.1093/annonc/mdz252.019.Peer-Reviewed Original ResearchNon-cancer mortalityExternal beam radiationOverall survivalCancer mortalityOral cavityOropharyngeal squamous cell cancerBrachytherapy-treated patientsGenentech/RocheImpact of brachytherapyReceipt of brachytherapySecond primary cancerEffect of comorbiditySquamous cell cancerProportional hazards regressionSingle-institution studyHigher cancer mortalityBeam radiationElectronic medical recordsGlaxo Smith KlineBristol-Myers SquibbEligible patientsOropharynx SCCHPV statusPrimary malignancySecondary outcomesAlliance A091404: A phase II study of enzalutamide (NSC# 766085) for patients with androgen receptor-positive salivary cancers.
Ho A, Foster N, Zoroufy A, Worden F, Price K, Adkins D, Bowles D, Kang H, Burtness B, Sherman E, Morton R, Katabi N, Munster P, Schwartz G. Alliance A091404: A phase II study of enzalutamide (NSC# 766085) for patients with androgen receptor-positive salivary cancers. Journal Of Clinical Oncology 2019, 37: 6020-6020. DOI: 10.1200/jco.2019.37.15_suppl.6020.Peer-Reviewed Original ResearchProgression-free survivalSalivary gland cancerProgression of diseaseAndrogen receptorOverall survivalStable diseaseMedian progression-free survivalGood responsePhase II studyFirst prospective trialPhase II trialEligible patientsPrior therapyRECIST v1.1Salivary cancerUnconfirmed PRHormonal therapyII trialPrimary endpointSecondary endpointsII studyProspective trialGland cancerClinical activityConfirmatory scan
2016
Randomized Phase II Trial of Irinotecan/Docetaxel or Irinotecan/Docetaxel Plus Cetuximab for Metastatic Pancreatic Cancer
Burtness B, Powell M, Catalano P, Berlin J, Liles DK, Chapman AE, Mitchell E, Benson AB. Randomized Phase II Trial of Irinotecan/Docetaxel or Irinotecan/Docetaxel Plus Cetuximab for Metastatic Pancreatic Cancer. American Journal Of Clinical Oncology 2016, 39: 340-345. PMID: 24685886, PMCID: PMC4177955, DOI: 10.1097/coc.0000000000000068.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAgedAnticoagulantsAntineoplastic Combined Chemotherapy ProtocolsCA-19-9 AntigenCamptothecinCetuximabDiarrheaDisease-Free SurvivalDocetaxelEnoxaparinFemaleHumansIrinotecanMaleMiddle AgedPancreatic NeoplasmsResponse Evaluation Criteria in Solid TumorsSurvival RateTaxoidsThromboembolismConceptsProgression-free survivalMetastatic pancreatic cancerAddition of cetuximabGrade 3/4 toxicitiesOverall survivalArm APancreatic cancerResponse rateArm B.Arm B. Median progression-free survivalMedian progression-free survivalPrincipal grade 3/4 toxicitiesRandomized phase II trialIrinotecan/docetaxelPhase II trialEligible patientsII trialPrimary endpointSecondary endpointsThromboembolic eventsDocetaxel combinationIrinotecan combinationObjective responseIrinotecan therapyMetastatic adenocarcinoma
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 9Cetuximab
2013
Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial
Argiris A, Ghebremichael M, Gilbert J, Lee JW, Sachidanandam K, Kolesar JM, Burtness B, Forastiere AA. Phase III Randomized, Placebo-Controlled Trial of Docetaxel With or Without Gefitinib in Recurrent or Metastatic Head and Neck Cancer: An Eastern Cooperative Oncology Group Trial. Journal Of Clinical Oncology 2013, 31: 1405-1414. PMID: 23460714, PMCID: PMC3612594, DOI: 10.1200/jco.2012.45.4272.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellDiarrheaDocetaxelDrug Administration ScheduleErbB ReceptorsFatigueFemaleGefitinibGenotypeHead and Neck NeoplasmsHumansKaplan-Meier EstimateLeukopeniaMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProto-Oncogene ProteinsProto-Oncogene Proteins c-metProto-Oncogene Proteins p21(ras)QuinazolinesRas ProteinsTaxoidsTreatment OutcomeConceptsAddition of gefitinibPerformance statusArm ADisease progressionEastern Cooperative Oncology Group performance statusEastern Cooperative Oncology Group trialEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsReceptor tyrosine kinase inhibitorsGrade 3/4 diarrheaPhase III randomizedSingle-agent gefitinibTrials of docetaxelUnplanned subset analysisECOG performance statusGrade 3/4 toxicitiesMedian overall survivalTime of progressionSquamous cell carcinomaTyrosine kinase inhibitorsEligible patientsMetastatic SCCHNWeekly docetaxelMetastatic headOverall survival
2009
Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer
Burtness B, Gibson M, Egleston B, Mehra R, Thomas L, Sipples R, Quintanilla M, Lacy J, Watkins S, Murren JR, Forastiere AA. Phase II trial of docetaxel–irinotecan combination in advanced esophageal cancer. Annals Of Oncology 2009, 20: 1242-1248. PMID: 19429872, PMCID: PMC2699385, DOI: 10.1093/annonc/mdn787.Peer-Reviewed Original ResearchConceptsAdvanced esophageal cancerPartial responseComplete responseEligible patientsEsophageal cancerEastern Cooperative Oncology Group performance statusMetastatic squamous cell carcinomaSafety of docetaxelPhase II trialSquamous cell carcinomaPrincipal toxic effectsAssessable patientsEsophagogastric cancerMeasurable diseaseToxic deathsII trialCN patientsMedian survivalPerformance statusNormal bilirubinPreclinical evidenceMedian timeCell carcinomaMyocardial infarctionTumor assessment
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 Weekly Docetaxel/Irinotecan Combination in Advanced Pancreatic Cancer
Burtness B, Thomas L, Sipples R, McGurk M, Salikooti S, Christoforou M, Mirto G, Salem R, Sosa J, Kloss R, Rahman Z, Chung G, Lacy J, Murren JR. Phase II Trial of Weekly Docetaxel/Irinotecan Combination in Advanced Pancreatic Cancer. The Cancer Journal 2007, 13: 257-262. PMID: 17762761, DOI: 10.1097/ppo.0b013e31813c1174.Peer-Reviewed Original ResearchConceptsAdvanced pancreatic cancerPancreatic cancerEligible patientsIrinotecan combinationPartial responseComplete responseEastern Cooperative Oncology Group performance status 0Principal grade 3/4 toxicitiesWorld Health Organization criteriaSafety of docetaxelGrade 3/4 toxicitiesObjective response ratePerformance status 0One-year survivalPhase II trialCombination of docetaxelNormal bilirubin levelsEvaluable patientsFebrile neutropeniaMeasurable diseaseStatus 0Toxic deathsUnresectable diseaseII trialRecurrent disease
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 nodesNeoadjuvant dose-dense (DD) concurrent doxorubicin (A) and docetaxel (T) for stage III breast cancer (BC)
Abu-Khalaf M, Kim R, Cohenuram M, Chung G, Digiovanna M, Haffty B, Carter D, Horvath L, Tavassoli F, Burtness B. Neoadjuvant dose-dense (DD) concurrent doxorubicin (A) and docetaxel (T) for stage III breast cancer (BC). Journal Of Clinical Oncology 2006, 24: 10721-10721. DOI: 10.1200/jco.2006.24.18_suppl.10721.Peer-Reviewed Original ResearchPathologic complete response rateStage III breast cancerDisease-free survivalBreast cancerOverall survivalResponse rateImproved disease-free survivalAddition of taxanesComplete response rateGrade 4 neutropeniaPathologic response rateAcute renal failureAdvanced breast cancerAdjuvant CMFAdjuvant settingDD chemotherapyDose CNeutropenic feverEligible patientsNeoadjuvant settingPrimary endpointRenal failureEjection fractionMedian ageTreatment cessationPostchemotherapy MRI Overestimates Residual Disease Compared with Histopathology in Responders to Neoadjuvant Therapy for Locally Advanced Breast Cancer
Kwong MS, Chung GG, Horvath LJ, Ward BA, Hsu AD, Carter D, Tavassoli F, Haffty B, Burtness BA. Postchemotherapy MRI Overestimates Residual Disease Compared with Histopathology in Responders to Neoadjuvant Therapy for Locally Advanced Breast Cancer. The Cancer Journal 2006, 12: 212-221. PMID: 16803680, DOI: 10.1097/00130404-200605000-00010.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDocetaxelDoxorubicinFemaleGranulocyte Colony-Stimulating FactorHumansMagnetic Resonance ImagingMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm InvasivenessNeoplasm, ResidualPrognosisSurvival RateTaxoidsTreatment OutcomeConceptsAdvanced breast cancerPathologic complete responseMagnetic resonance imagingComplete responseBreast cancerResonance imagingNeoadjuvant chemotherapyPreoperative magnetic resonance imagingResidual invasive carcinomaBreast magnetic resonance imagingResidual tumor sizeSerial magnetic resonanceBreast magnetic resonanceMagnetic resonanceEligible patientsPrimary chemotherapyNeoadjuvant therapyResidual cancerAxillary lesionsPathologic evaluationStable patientsAdditional patientsPosttreatment examinationResidual diseaseTumor sizePhase II, parallel-design study of preoperative combined modality therapy and the matrix metalloprotease (mmp) inhibitor prinomastat in patients with esophageal adenocarcinoma
Heath EI, Burtness BA, Kleinberg L, Salem RR, Yang SC, Heitmiller RF, Canto MI, Knisely JP, Topazian M, Montgomery E, Tsottles N, Pithavala Y, Rohmiller B, Collier M, Forastiere AA. Phase II, parallel-design study of preoperative combined modality therapy and the matrix metalloprotease (mmp) inhibitor prinomastat in patients with esophageal adenocarcinoma. Investigational New Drugs 2006, 24: 135-140. PMID: 16502351, DOI: 10.1007/s10637-006-5934-5.Peer-Reviewed Original ResearchConceptsPathologic complete response rateThrombo-embolic eventsParallel design studyModality therapyResponse rateAdvanced esophageal cancer patientsRandomized phase IIComplete response rateEvidence of diseaseProgression-free survivalEsophageal cancer patientsOverall response ratePhase IIAdjuvant paclitaxelConcurrent radiotherapyEligible patientsPreoperative treatmentMusculoskeletal toxicityOverall survivalResectable adenocarcinomaDisease relapsePreoperative stagingTreatment armsDisease improvementContinuous infusion
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
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
1998
High-dose chemotherapy followed by reinfusion of selected CD34+ peripheral blood cells in patients with poor-prognosis breast cancer: a randomized multicentre study
Chabannon C, Cornetta K, Lotz J, Rosenfeld C, Shlomchik M, Yanovitch S, Marolleau J, Sledge G, Novakovitch G, Srour E, Burtness B, Camerlo J, Gravis G, Lee-Fischer J, Faucher C, Chabbert I, Krause D, Maraninchi D, Mills B, Kunkel L, Oldham F, Blaise D, Viens P. High-dose chemotherapy followed by reinfusion of selected CD34+ peripheral blood cells in patients with poor-prognosis breast cancer: a randomized multicentre study. British Journal Of Cancer 1998, 78: 913-921. PMID: 9764583, PMCID: PMC2063121, DOI: 10.1038/bjc.1998.601.Peer-Reviewed Original ResearchConceptsPoor prognosis breast cancerHigh-dose chemotherapyHaematopoietic recoveryBreast cancerRecombinant human granulocyte colony-stimulating factorBlood cellsRandomized multicentre studyGranulocyte colony-stimulating factorHuman granulocyte colony-stimulating factorPeripheral blood cellsPeripheral blood CD34Peripheral blood progenitorsColony-stimulating factorMobilized blood cellsEpithelial tumor cellsEligible patientsStudy armsMulticentre studyPeripheral bloodConventional chemotherapyStudy groupPatientsChemotherapyBlood CD34CD34