2024
690TiP HERTHENA-PanTumor01: A global phase II trial of HER3-DXd in metastatic solid tumors
Powles T, Bhatia A, Burtness B, Kogawa T, Nishina T, Nakayama I, Fountzilas C, Castillo D, Mckean M, Meric-Bernstam F, Colombo N, Smithy J, Fayette J, Chandra S, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Kudchadkar R, Hayashi H. 690TiP HERTHENA-PanTumor01: A global phase II trial of HER3-DXd in metastatic solid tumors. Annals Of Oncology 2024, 35: s534-s535. DOI: 10.1016/j.annonc.2024.08.2161.Peer-Reviewed Original ResearchHERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors.
Bhatia A, Hayashi H, Kogawa T, Nishina T, Fountzilas C, Castillo D, McKean M, Colombo N, Smithy J, Fayette J, Chandra S, Powles T, Kudchadkar R, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Burtness B. HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps3164-tps3164. DOI: 10.1200/jco.2024.42.16_suppl.tps3164.Peer-Reviewed Original ResearchHead and neck squamous cell cancerHuman epidermal growth factor receptor 3Platinum-based chemotherapyHER3-DXdPhase 2 trialAntibody-drug conjugatesSolid tumorsHuman anti-HER3 monoclonal antibodyAnti-HER3 monoclonal antibodyAnti-PD-(L)1 therapyGastric cancerHER2-negative gastric cancerTopoisomerase I inhibitor payloadAssociated with poor clinical outcomesEpidermal growth factor receptor 3Anti-HER3 antibodiesGastroesophageal junction cancerHER2+ cancersMetastatic solid tumorsMetastatic breast cancerSquamous cell cancerBRAF wild-typePoor clinical outcomesMultiple tumor typesAcral subtype
2023
Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Klein R, Saboda K, Obara S, Chung C. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2023, 41: 3851-3862. PMID: 36977289, DOI: 10.1200/jco.22.01994.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response rateRecurrent/metastatic headCMET overexpressionMetastatic headCombination armAntiepidermal growth factor receptor monoclonal antibodyNoncomparative phase II studyRecurrent/metastatic HNSCCRandomized phase II trialEnd pointNeck squamous cell carcinomaHPV negative subgroupPhase II studyPrimary end pointSecondary end pointsHPV-positive diseaseHuman papillomavirus (HPV) statusMajor prognostic factorPhase II trialKey eligibility criteriaSquamous cell carcinomaReceptor monoclonal antibodyHPV-negative HNSCCTreating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update
Bhatia A, Burtness B. Treating Head and Neck Cancer in the Age of Immunotherapy: A 2023 Update. Drugs 2023, 83: 217-248. PMID: 36645621, DOI: 10.1007/s40265-023-01835-2.Commentaries, Editorials and LettersConceptsNeck cancerRecurrent/metastatic settingImmune checkpoint inhibitor nivolumabNeck squamous cell carcinomaAge of immunotherapyLate stage HNSCCImmune checkpoint inhibitionPlatinum-containing chemotherapyFirst-line treatmentGrowth factor receptor overexpressionCheckpoint inhibitor nivolumabSquamous cell carcinomaEpidermal growth factor receptor (EGFR) overexpressionPathogenesis of HNSCCTreatment of patientsTreatment of HNSCCManagement of headMonoclonal antibody cetuximabCurative intentPalliative chemotherapyAdvanced diseaseInhibitor nivolumabLocoregional failureMetastatic settingMultimodality therapy
2022
A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202.
Bhatia A, Flamand Y, Johnson J, Ishizuka J, Duan F, Tang M, Karivedu V, Subramaniam R, Burtness B. A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202. Journal Of Clinical Oncology 2022, 40: tps6098-tps6098. DOI: 10.1200/jco.2022.40.16_suppl.tps6098.Peer-Reviewed Original ResearchProgression-free survivalVascular endothelial growth factorM HNSCCOverall survivalPrimary endpointExperimental armControl armHigher treatment-related adverse eventsPhase II/III trialsOne-sided alpha levelRecurrent/metastatic headTreatment-related adverse eventsEffector T cell responsesMyeloid-derived suppressor cellsPhase II/IIIPhase IIStratified log-rank testEfficacy of atezolizumabPlatinum-doublet chemotherapyImmune checkpoint inhibitionFirst-line pembrolizumabAnti-tumor immunityPhase IIIDendritic cell maturationPhase III evaluation
2021
Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC).
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Saboda K, Obara S, Chung C. Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2021, 39: 6015-6015. DOI: 10.1200/jco.2021.39.15_suppl.6015.Peer-Reviewed Original ResearchMedian progression-free survivalOverall response rateHepatocyte growth factorAdvanced HNSCCPartial responsePrimary endpointEvaluable subjectsHPV statusRecurrent/metastatic HNSCCAnti-EGFR monoclonal antibodiesNeck squamous cell carcinomaMajor prognostic variablesPerformance status 0Phase II trialProgression-free survivalNon-comparative trialsSquamous cell carcinomaConfidence intervalsPhase III investigationFC combinationDual pathway inhibitionLFT elevationsPFS endpointPrior cetuximabStatus 0Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer in elderly or frail patients.
Forman R, Bhatia A, Burtness B. Efficacy and toxicity of weekly paclitaxel, carboplatin, and cetuximab as induction chemotherapy or in cases of metastases or relapse for head and neck cancer in elderly or frail patients. Journal Of Clinical Oncology 2021, 39: 6042-6042. DOI: 10.1200/jco.2021.39.15_suppl.6042.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalInduction chemotherapyFrail patientsAdverse effectsMean progression-free survivalNeck squamous cell carcinomaP16-positive diseasePrimary end pointRECIST response rateCommon adverse effectsMean overall survivalRetrospective observational studyCommon tumor siteCommon reason patientsSquamous cell carcinomaCases of metastasisDose interruptionWeekly paclitaxelAdvanced diseaseGastrointestinal symptomsMetastatic headPrior radiationChart reviewElderly patients
2020
Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Bauman J, Roe D, Saba N, Bauman J, Kaczmar J, Burtness B, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Bhatia A, Giri A, Caulin C, Stabile L, Centuori S, Chung C. Randomized, phase II study of ficlatuzumab with or without cetuximab in patients with pan-refractory, recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6594-tps6594. DOI: 10.1200/jco.2020.38.15_suppl.tps6594.Peer-Reviewed Original ResearchProgression-free survivalOverall response rateM HNSCCPhase II trialHepatocyte growth factorII trialCetuximab resistanceMulticenter phase II trialRecurrent/metastatic headTotal peripheral T cellsRandomized phase II trialExpression of HGFPoor progression-free survivalNeck squamous cell carcinomaPeripheral immune profileKey secondary endpointPhase II studyKey eligibility criteriaSquamous cell carcinomaPeripheral T cellsPI3K/AktIgG1 monoclonal antibodyTwo-arm designECOG 0EGFR monotherapyAdjuvant external beam radiotherapy for surgically resected, nonmetastatic anaplastic thyroid cancer
Saeed NA, Kelly JR, Deshpande HA, Bhatia AK, Burtness BA, Judson BL, Mehra S, Edwards HA, Yarbrough WG, Peter PR, Holt EH, Decker RH, Husain ZA, Park HS. Adjuvant external beam radiotherapy for surgically resected, nonmetastatic anaplastic thyroid cancer. Head & Neck 2020, 42: 1031-1044. PMID: 32011055, DOI: 10.1002/hed.26086.Peer-Reviewed Original ResearchConceptsAnaplastic thyroid cancerLonger OSAdjuvant EBRTThyroid cancerAdjuvant external beam radiotherapyNational Cancer DatabaseExternal beam radiotherapyConcurrent chemoradiationConcurrent chemotherapyImproved survivalMedian ageCancer DatabaseRetrospective analysisBeam radiotherapyEBRTChemotherapyPatientsCancerUVAChemoradiationResectionRadiotherapy
2019
Clinical Outcomes of Head and Neck Cancer Patients Who Undergo Resection, But Forgo Adjuvant Therapy
LOGANADANE G, KANN BH, PARK HS, JOHNSON SB, MEHRA S, JUDSON BL, BHATIA A, BELKACEMI Y, YARBROUGH WG, BURTNESS B, HUSAIN ZA. Clinical Outcomes of Head and Neck Cancer Patients Who Undergo Resection, But Forgo Adjuvant Therapy. Anticancer Research 2019, 39: 4885-4890. PMID: 31519591, DOI: 10.21873/anticanres.13674.Peer-Reviewed Original ResearchConceptsLocoregional recurrence-free survivalAdjuvant therapyNeck squamous cell carcinomaOutcomes of patientsRecurrence-free survivalSquamous cell carcinomaNeck cancer patientsHNSCC patientsClinical outcomesRecurrence rateCell carcinomaMean TTPCancer patientsPatientsTherapyResectionMonthsOutcomesHNSCCSurgeryCarcinomaHeadIncidenceProgressionClinical Outcomes of Head and Neck Cancer Patients who Undergo Resection, but Forgo Adjuvant Therapy
Loganadane G, Kann B, Park H, Johnson S, Mehra S, Judson B, Bhatia A, Belkacemi Y, Yarbrough W, Burtness B, Husain Z. Clinical Outcomes of Head and Neck Cancer Patients who Undergo Resection, but Forgo Adjuvant Therapy. International Journal Of Radiation Oncology • Biology • Physics 2019, 105: e375-e376. DOI: 10.1016/j.ijrobp.2019.06.1628.Peer-Reviewed Original Research
2018
Adjuvant therapy in major salivary gland cancers: Analysis of 8580 patients in the National Cancer Database
Cheraghlou S, Kuo P, Mehra S, Agogo GO, Bhatia A, Husain ZA, Yarbrough WG, Burtness BA, Judson BL. Adjuvant therapy in major salivary gland cancers: Analysis of 8580 patients in the National Cancer Database. Head & Neck 2018, 40: 1343-1355. PMID: 29756412, DOI: 10.1002/hed.24984.Peer-Reviewed Original ResearchConceptsNational Cancer Data BaseLate-stage diseaseAdjuvant treatmentSalivary gland cancerAdverse featuresAdjuvant radiotherapyImproved survivalGland cancerMajor salivary gland cancerAddition of chemotherapyNational Cancer DatabaseAdjuvant therapySurvival benefitRetrospective studyCancer DatabaseImproved outcomesCancer casesPatientsChemotherapyDiseaseTreatmentRadiotherapySurvivalCancerTherapyPostoperative Chemoradiation in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
Bhatia AK, Burtness BA, Decker RH. Postoperative Chemoradiation in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck. Journal Of Clinical Oncology 2018, 36: jco.2018.77.798. PMID: 29547345, DOI: 10.1200/jco.2018.77.7987.Peer-Reviewed Original Research
2017
Demethylation Therapy as a Targeted Treatment for Human Papillomavirus–Associated Head and Neck Cancer
Biktasova A, Hajek M, Sewell A, Gary C, Bellinger G, Deshpande HA, Bhatia A, Burtness B, Judson B, Mehra S, Yarbrough WG, Issaeva N. Demethylation Therapy as a Targeted Treatment for Human Papillomavirus–Associated Head and Neck Cancer. Clinical Cancer Research 2017, 23: 7276-7287. PMID: 28916527, DOI: 10.1158/1078-0432.ccr-17-1438.Peer-Reviewed Original ResearchConceptsClinical trialsHNSCC cellsMatrix metalloproteinasesHuman papillomavirus-associated headNeck squamous cell carcinomaSquamous cell carcinomaAbility of HPVClin Cancer ResTumor cell proliferationNeck cancer cellsWindow trialsCell carcinomaEffective therapyPreclinical modelsHPVHPV oncogenesMouse modelMouse blood vesselsDNA demethylating agentHNSCCXenografted tumorsHPV genesIFN responseTherapyTumor samplesNovel Molecular Targets for Chemoprevention in Malignancies of the Head and Neck
Bhatia A, Burtness B. Novel Molecular Targets for Chemoprevention in Malignancies of the Head and Neck. Cancers 2017, 9: 113. PMID: 28858212, PMCID: PMC5615328, DOI: 10.3390/cancers9090113.Peer-Reviewed Original ResearchNeck cancerSecond primary tumorsExtensive clinical researchCancer-related mortalityNovel molecular targetsWhole-exome sequencingBiologic agentsOral leukoplakiaInvasive cancerPrimary tumorClinical trialsPrecursor lesionsNovel molecular pathwaysPrimary headMucosal fieldTumor specimensNeck regionCare optionsClinical researchCancerDriver mutationsExome sequencingMolecular targetsGenetic mutationsMolecular pathwaysDouble‐blind, randomized phase 3 trial of low‐dose 13‐cis retinoic acid in the prevention of second primaries in head and neck cancer: Long‐term follow‐up of a trial of the Eastern Cooperative Oncology Group‐ACRIN Cancer Research Group (C0590)
Bhatia AK, Lee J, Pinto HA, Jacobs CD, Limburg PJ, Rubin P, Arusell RM, Dunphy EP, Khandekar JD, Reiner SA, Baez‐Diaz L, Celano P, Li S, Li Y, Burtness BA, Adams GL, Pandya KJ. Double‐blind, randomized phase 3 trial of low‐dose 13‐cis retinoic acid in the prevention of second primaries in head and neck cancer: Long‐term follow‐up of a trial of the Eastern Cooperative Oncology Group‐ACRIN Cancer Research Group (C0590). Cancer 2017, 123: 4653-4662. PMID: 28786105, PMCID: PMC5693641, DOI: 10.1002/cncr.30920.Peer-Reviewed Original ResearchConceptsSecond primary tumorsOverall survivalFormer smokersDevelopment of SPTsIncidence of SPTsEarly-stage SCCHNFuture prevention trialsImproved overall survivalClinical risk factorsSquamous cell cancerLog-rank testLong-term resultsPotential survival advantageCompeting-risk approachCumulative incidenceIndex tumorCell cancerPrevention trialsPrimary tumorRisk factorsSubset analysisDry skinSurvival advantagePatientsTargeted interventionsTreatment guidelines and patterns of care in oral cavity squamous cell carcinoma: Primary surgical resection vs. nonsurgical treatment
Fujiwara RJT, Burtness B, Husain ZA, Judson BL, Bhatia A, Sasaki CT, Yarbrough WG, Mehra S. Treatment guidelines and patterns of care in oral cavity squamous cell carcinoma: Primary surgical resection vs. nonsurgical treatment. Oral Oncology 2017, 71: 129-137. PMID: 28688680, DOI: 10.1016/j.oraloncology.2017.06.013.Peer-Reviewed Original ResearchConceptsOral cavity squamous cell carcinomaNational Cancer Data BaseLate-stage diseasePrimary nonsurgical treatmentOral cavity malignancyNonsurgical treatmentSquamous cell carcinomaOverall survivalSurgical resectionCell carcinomaTreatment modalitiesNational Comprehensive Cancer Network Clinical Practice GuidelinesAcademic/research programMultimodality clinical trialsDefinitive radiation therapyImproved overall survivalDecreased overall survivalPrimary surgical resectionOral cavity cancerNon-randomized natureClinical practice guidelinesPatterns of careNon-white raceProportional hazards modelBinary logistic regression
2016
Double blind phase III trial of effects of low dose 13-cisretinoic acid on prevention of second primaries in stages I-II head and neck cancer: A trial of the ECOG-ACRIN Cancer Research Group (C0590).
Bhatia A, Lee J, Pinto H, Jacobs C, Limburg P, Arusell R, Dunphy E, Khandekar J, Reiner S, Baez-Diaz L, Celano P, Li S, Li Y, Burtness B, Pandya K. Double blind phase III trial of effects of low dose 13-cisretinoic acid on prevention of second primaries in stages I-II head and neck cancer: A trial of the ECOG-ACRIN Cancer Research Group (C0590). Journal Of Clinical Oncology 2016, 34: 1507-1507. DOI: 10.1200/jco.2016.34.15_suppl.1507.Peer-Reviewed Original ResearchPhase II trial of carboplatin/paclitaxel and cetuximab, followed by carboplatin/paclitaxel/cetuximab and erlotinib, in metastatic or recurrent squamous cell carcinoma of the head and neck.
Bhatia A, Mehra R, Khan S, Egleston B, Alpaugh R, Lango M, Ridge J, Burtness B. Phase II trial of carboplatin/paclitaxel and cetuximab, followed by carboplatin/paclitaxel/cetuximab and erlotinib, in metastatic or recurrent squamous cell carcinoma of the head and neck. Journal Of Clinical Oncology 2016, 34: 6027-6027. DOI: 10.1200/jco.2016.34.15_suppl.6027.Peer-Reviewed Original Research
2015
Human Papillomavirus–Associated Oropharyngeal Cancer: Defining Risk Groups and Clinical Trials
Bhatia A, Burtness B. Human Papillomavirus–Associated Oropharyngeal Cancer: Defining Risk Groups and Clinical Trials. Journal Of Clinical Oncology 2015, 33: 3243-3250. PMID: 26351343, PMCID: PMC5814107, DOI: 10.1200/jco.2015.61.2358.Peer-Reviewed Original ResearchConceptsClinical trialsRisk groupsHuman papillomavirus-associated oropharynx cancerHPV-negative OPCPoor-risk subsetTreatment-related morbidityDe-escalation trialsPrognostic risk groupsClinical trial optionsYounger median ageNew treatment strategiesIdeal patient groupNovel therapeutic targetInvasive surgical techniquesDeintensification trialsTreatment deintensificationOropharynx cancerSmoking exposureMetastatic diseaseModality therapyFavorable prognosisMedian ageBetter prognosisSuperior prognosisIntense therapy