2024
A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors.
Long G, Haddad R, Robert C, Mortier L, Schadendorf D, Uppaluri R, Svane I, Saiag P, Lim A, Soria Rivas A, Scolyer R, Chaney M, Abildgaard C, Ahmad Q, Ringeisen F, McDowell D, Burtness B. A randomized phase 2 trial of the IO102-IO103 (IDO and PD-L1) cancer vaccine plus pembrolizumab as neoadjuvant/adjuvant treatment of patients with solid tumors. Journal Of Clinical Oncology 2024, 42: tps2701-tps2701. DOI: 10.1200/jco.2024.42.16_suppl.tps2701.Peer-Reviewed Original ResearchEvent-free survivalAdjuvant pembrolizumabNeoadjuvant pembrolizumabCancer vaccinesAdjuvant treatmentCohort CCohort APD-L1-positive cellsRandomized phase 2 trialExpansion of T cellsPost-treatment tumor tissuesPotential anti-tumor activityImmune checkpoint inhibitorsResponse to pembrolizumabLocally advanced diseasePathologic tumor responseTherapeutic cancer vaccinesImmune-suppressive cellsPhase 1/2 trialDisease-free survivalNeo-adjuvant treatmentPhase 2 trialTreatment of multiple tumor typesSquamous cell carcinomaHead and neck
2019
Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck. JAMA Oncology 2019, 5: 1170-1180. PMID: 31194247, PMCID: PMC6567846, DOI: 10.1001/jamaoncol.2019.1146.Peer-Reviewed Original ResearchDisease-free survivalAdverse eventsEastern Cooperative Oncology Group performance statusMedian disease-free survivalDrug-related adverse effectsEnd pointNeck squamous cell cancerIndependent data monitoring committeeErbB family blocker afatinibCommon grade 3More adverse eventsPrimary end pointSecondary end pointsUnacceptable adverse eventsDate of randomizationHealth-related qualitySquamous cell cancerRisk of recurrenceSquamous cell carcinomaSecondary primary tumorsInterim futility analysisData monitoring committeeAcneiform rashAfatinib groupDefinitive chemoradiotherapy
2017
LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).
Burtness B, Haddad R, Dinis J, Trigo Perez J, Yokota T, Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Segalla J, Psyrri A, Vasilevskaya I, Nangia C, Chaves-Conde M, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen E. LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts). Journal Of Clinical Oncology 2017, 35: 6001-6001. DOI: 10.1200/jco.2017.35.15_suppl.6001.Peer-Reviewed Original ResearchDisease-free survivalPhase III trialsIII trialsEGFR inhibitionMedian disease-free survivalRecurrent/metastatic diseaseErbB family blocker afatinibPre-planned interim analysisECOG PS 0Median treatment durationSquamous cell cancerDefinitive chemoradiationECOG PSEligible ptsAdvanced HNSCCConcurrent cisplatinN2 diseasePrimary endpointAdjuvant therapyMetastatic diseasePS 0Complete responseDisease recurrenceMedian ageNodal stage
2014
Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial
Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen E. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials 2014, 15: 469. PMID: 25432788, PMCID: PMC4289298, DOI: 10.1186/1745-6215-15-469.Peer-Reviewed Original ResearchMeSH KeywordsAfatinibAntineoplastic AgentsCarcinoma, Squamous CellChemoradiotherapyChemotherapy, AdjuvantClinical ProtocolsDisease-Free SurvivalDouble-Blind MethodErbB ReceptorsHead and Neck NeoplasmsHumansMolecular Targeted TherapyNeoplasm Recurrence, LocalNeoplasm StagingProtein Kinase InhibitorsQuality of LifeQuinazolinesResearch DesignRisk FactorsSquamous Cell Carcinoma of Head and NeckTime FactorsTreatment OutcomeConceptsEpidermal growth factor receptorDisease-free survivalErbB family membersAdvanced diseaseOropharynx cancerOverall survivalEndpoint measuresUnfavourable riskPrimary siteHigh-risk HNSCC patientsHPV-positive oropharynx cancerIrreversible ErbB family blockerDisease-free survival ratesRandomized phase II trialNeck squamous cell carcinomaErbB family blockerHigh-risk headHigh-risk HNSCCPrimary endpoint measureGood clinical conditionEvidence of diseaseLymph node involvementPhase II trialPhase III studyUnacceptable adverse events
2013
Dysplasia at the margin? Investigating the case for subsequent therapy in ‘Low-Risk’ squamous cell carcinoma of the oral tongue
Sopka DM, Li T, Lango MN, Mehra R, Liu JC, Burtness B, Flieder DB, Ridge JA, Galloway TJ. Dysplasia at the margin? Investigating the case for subsequent therapy in ‘Low-Risk’ squamous cell carcinoma of the oral tongue. Oral Oncology 2013, 49: 1083-1087. PMID: 24054332, PMCID: PMC4037753, DOI: 10.1016/j.oraloncology.2013.08.001.Peer-Reviewed Original ResearchConceptsDisease-free survivalFox Chase Cancer CenterModerate dysplasiaOverall survivalLocal controlOral tongueSevere dysplasiaMild dysplasiaActuarial local controlInferior local controlKaplan-Meier methodOral tongue cancerWorse local controlSquamous cell carcinomaEarly-stage cancerAdditional therapyMeier methodResection marginsSubsequent therapyEntire cohortTongue cancerCancer CenterCell carcinomaPathology reportsFinal margins
2012
LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.
Burtness B, Bourhis J, Vermorken J, Dai L, Lind C, Ehrnrooth E, Cohen E. LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients. Journal Of Clinical Oncology 2012, 30: tps5599-tps5599. DOI: 10.1200/jco.2012.30.15_suppl.tps5599.Peer-Reviewed Original ResearchDisease-free survivalNeck dissectionPO QDAdvanced squamous cell cancerIrreversible ErbB family blockerAdequate bone marrowErbB family blockerStudy of afatinibSubsequent neck dissectionCompletion of chemoradiationEvidence of diseaseHigh-risk patientsSecond primary tumorsHealth-related qualityBase of tongueSquamous cell cancerRisk of recurrenceNeck cancer patientsPlatinum-based chemoradiationSalivary gland cancerConcurrent cisplatinCurative intentDefinitive chemoradiationPrior therapyStudy medication
2006
Neoadjuvant 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 cessation
2005
Remarkably High Frequency of EGFR Expression in Breast Carcinomas with Squamous Differentiation
Bossuyt V, Fadare O, Martel M, Ocal IT, Burtness B, Moinfar F, Leibl S, Tavassoli FA. Remarkably High Frequency of EGFR Expression in Breast Carcinomas with Squamous Differentiation. International Journal Of Surgical Pathology 2005, 13: 319-327. PMID: 16273187, DOI: 10.1177/106689690501300403.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedBone NeoplasmsBreast NeoplasmsCarcinoma, AdenosquamousCarcinoma, Squamous CellCarcinosarcomaCell DifferentiationErbB ReceptorsFollow-Up StudiesHumansImmunohistochemistryKeratinsLung NeoplasmsLymph NodesLymphatic MetastasisMiddle AgedNeoplasm StagingReceptor, ErbB-2Receptors, EstrogenConceptsEpidermal growth factor receptorDisease-free survivalSquamous differentiationBreast carcinomaEstrogen receptorLymph nodesHER2 statusTissue microarrayEGFR expressionFull axillary lymph node dissectionAxillary lymph node dissectionLymph node positive breast carcinomaNode-positive breast carcinomaHuman epidermal growth factor receptorEGFR-negative tumorsLymph node dissectionPositive lymph nodesLymph node statusPositive breast carcinomaEGFR-positive tumorsEGFR-positive tumor cellsGrowth factor receptorNode dissectionEGFR positivityDistant metastasisQuantitative Determination of Nuclear and Cytoplasmic Epidermal Growth Factor Receptor Expression in Oropharyngeal Squamous Cell Cancer by Using Automated Quantitative Analysis
Psyrri A, Yu Z, Weinberger PM, Sasaki C, Haffty B, Camp R, Rimm D, Burtness BA. Quantitative Determination of Nuclear and Cytoplasmic Epidermal Growth Factor Receptor Expression in Oropharyngeal Squamous Cell Cancer by Using Automated Quantitative Analysis. Clinical Cancer Research 2005, 11: 5856-5862. PMID: 16115926, DOI: 10.1158/1078-0432.ccr-05-0420.Peer-Reviewed Original ResearchConceptsEpidermal growth factor receptorOropharyngeal squamous cell cancerLocal recurrence rateSquamous cell cancerEGFR expression levelsEGFR expressionCell cancerRecurrence rateEGFR levelsHigh tumorInferior disease-free survivalExpression levelsNeck squamous cell carcinomaEpidermal growth factor receptor expressionTumor EGFR levelsGrowth factor receptor expressionProtein expressionDisease-free survivalOropharyngeal cancer casesSquamous cell carcinomaFactor receptor expressionMedian expression levelCy5-conjugated antibodiesEGFR protein expressionNuclear EGFR levels
2004
Improved method for the detection of cytokeratin 19-positive cells in the peripheral blood of breast cancer patients
Alvero AB, Burtness BA, Ercan AG, Sapi E. Improved method for the detection of cytokeratin 19-positive cells in the peripheral blood of breast cancer patients. Laboratory Investigation 2004, 84: 658-661. PMID: 15105816, DOI: 10.1038/labinvest.3700086.Peer-Reviewed Original ResearchConceptsBreast cancer patientsQuantitative real-time reverse transcription-polymerase chain reactionCancer patientsDisease-free survivalReal-time reverse transcription-polymerase chain reactionReverse transcription-polymerase chain reactionDetection of cytokeratinClinical parametersPeripheral bloodPolymerase chain reactionCytokeratin 19PatientsTumor cellsChain reactionImproved assayAssaysCellsTherapyCytokeratinBlood