2023
Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma
Wong S, Torres-Saavedra P, Saba N, Shenouda G, Bumpous J, Wallace R, Chung C, El-Naggar A, Gwede C, Burtness B, Tennant P, Dunlap N, Redman R, Stokes W, Rudra S, Mell L, Sacco A, Spencer S, Nabell L, Yao M, Cury F, Mitchell D, Jones C, Firat S, Contessa J, Galloway T, Currey A, Harris J, Curran W, Le Q. Radiotherapy Plus Cisplatin With or Without Lapatinib for Non–Human Papillomavirus Head and Neck Carcinoma. JAMA Oncology 2023, 9: 1565-1573. PMID: 37768670, PMCID: PMC10540060, DOI: 10.1001/jamaoncol.2023.3809.Peer-Reviewed Original ResearchConceptsProgression-free survivalAdverse event ratesOverall survivalStage IIIClinical trialsAcute adverse event ratesProgression-free survival ratesEnd pointEvent ratesAnti-epidermal growth factor receptor (EGFR) antibodiesBenefit of chemoradiotherapyZubrod performance statusPrimary end pointSecondary end pointsCycles of cisplatinAddition of lapatinibEGFR antibody therapyGrowth factor receptor antibodyLog-rank testDual EGFRPlus CisplatinFrontline therapyPerformance statusAntibody therapyNeck carcinoma
2020
High Dose Cisplatin: Still the One?
Husain ZA, Burtness BA. High Dose Cisplatin: Still the One? International Journal Of Radiation Oncology • Biology • Physics 2020, 107: 615-616. PMID: 32589986, DOI: 10.1016/j.ijrobp.2019.09.026.Peer-Reviewed Original Research
2018
Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial
Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. The Lancet 2018, 393: 40-50. PMID: 30449625, PMCID: PMC6541928, DOI: 10.1016/s0140-6736(18)32779-x.Peer-Reviewed Original ResearchConceptsHPV-positive oropharyngeal carcinomaProgression-free survivalOverall survivalNon-inferiority trialCisplatin groupCetuximab groupOropharyngeal carcinomaSevere toxicityEligibility criteriaPositive oropharyngeal squamous cell carcinomaHuman papillomavirus-positive oropharyngeal cancerNational Cancer Institute-USAZubrod performance status 0Oropharyngeal squamous cell carcinomaAdequate bone marrowPerformance status 0Replacement of cisplatinZubrod performance statusInferior overall survivalTobacco smoking historyAmerican Joint CommitteeNon-inferiority criteriaSquamous cell carcinomaStandard of careNon-inferiority margin
2016
CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers
Enzinger PC, Burtness BA, Niedzwiecki D, Ye X, Douglas K, Ilson DH, Villaflor VM, Cohen SJ, Mayer RJ, Venook A, Benson AB, Goldberg RM. CALGB 80403 (Alliance)/E1206: A Randomized Phase II Study of Three Chemotherapy Regimens Plus Cetuximab in Metastatic Esophageal and Gastroesophageal Junction Cancers. Journal Of Clinical Oncology 2016, 34: 2736-2742. PMID: 27382098, PMCID: PMC5019745, DOI: 10.1200/jco.2015.65.5092.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionDisease-Free SurvivalEpirubicinEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsSurvival RateTime FactorsTreatment FailureConceptsGastroesophageal junction cancerProgression-free survivalMetastatic esophagealJunction cancerOverall survivalTreatment failureResponse rateMedian progression-free survivalRandomized phase II studyContinuous infusion fluorouracilOptimal chemotherapy backboneTreatment-related deathsMedian overall survivalPhase II studyPrimary end pointCooperative group studiesPromising preclinical dataChemotherapy backboneChemotherapy regimensAdverse eventsII studySecondary outcomesMedian timeTreatment armsPreclinical data
2015
A Phase I Study of CUDC-101, a Multitarget Inhibitor of HDACs, EGFR, and HER2, in Combination with Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma
Galloway TJ, Wirth LJ, Colevas AD, Gilbert J, Bauman JE, Saba NF, Raben D, Mehra R, W. A, Atoyan R, Wang J, Burtness B, Jimeno A. A Phase I Study of CUDC-101, a Multitarget Inhibitor of HDACs, EGFR, and HER2, in Combination with Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma. Clinical Cancer Research 2015, 21: 1566-1573. PMID: 25573383, PMCID: PMC6607903, DOI: 10.1158/1078-0432.ccr-14-2820.Peer-Reviewed Original ResearchConceptsHuman growth factor receptor 2Peripheral blood mononuclear cellsEpidermal growth factor receptorDose-limiting toxicityAdverse eventsCUDC-101Tumor biopsiesHistone deacetylaseNeck squamous cell cancerNeck squamous cell carcinomaHigh-risk HNSCCGrowth factor receptor 2Squamous cell cancerSquamous cell carcinomaBlood mononuclear cellsExternal beam radiationTreatment of HNSCCRoute of administrationOne-week runFactor receptor 2Concurrent cisplatinGrowth factor receptorRisk patientsCell cancerCell carcinoma
2014
Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303
Egloff AM, Lee JW, Langer CJ, Quon H, Vaezi A, Grandis JR, Seethala RR, Wang L, Shin DM, Argiris A, Yang D, Mehra R, Ridge JA, Patel UA, Burtness BA, Forastiere AA. Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303. Clinical Cancer Research 2014, 20: 5041-5051. PMID: 25107914, PMCID: PMC4184913, DOI: 10.1158/1078-0432.ccr-14-0051.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingRadiotherapyRisk FactorsSquamous Cell Carcinoma of Head and NeckTreatment OutcomeConceptsProgression-free survivalOverall survivalLA-SCCHNMaintenance cetuximabAdvanced squamous cell headMedian progression-free survivalTwo-year overall survivalNeck squamous cell carcinomaTumor human papillomavirus (HPV) statusGrade 5 toxicityMedian overall survivalMedian radiotherapy doseMost common gradeCycles of cisplatinHuman papillomavirus (HPV) statusPhase II studySquamous cell headTumor HPV statusLonger overall survivalSquamous cell carcinomaOropharyngeal primaryHPV statusII studyPrimary endpointProtocol treatmentA 3′-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3′-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Annals Of Oncology 2014, 25: 2230-2236. PMID: 25081901, PMCID: PMC4207729, DOI: 10.1093/annonc/mdu367.Peer-Reviewed Original ResearchMeSH Keywords3' Untranslated RegionsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCarcinoma, Squamous CellCetuximabCisplatinCyclin-Dependent Kinase Inhibitor p16Disease-Free SurvivalDrug Resistance, NeoplasmFemaleGene Expression Regulation, NeoplasticGenotypeHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPrognosisProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)Ras ProteinsSquamous Cell Carcinoma of Head and NeckConceptsNeck squamous cell carcinomaSquamous cell carcinomaKRAS-variantMetastatic headCell carcinomaPatient outcomesP16 expressionRecurrent/metastatic headPoor progression-free survivalCell linesM HNSCC patientsPlatinum-based regimenProgression-free survivalPotential predictive biomarkersHNSCC tumor samplesHNSCC cell linesTG/GGDrug resistance/sensitivityHNSCC patientsOropharynx tumorsClinical findingsRetrospective studyPredictive biomarkersClinical trialsPlatinum response
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 rashCetuximab and Cisplatin for Chemotherapy-Refractory Squamous Cell Cancer of the Head and Neck
Burtness B. Cetuximab and Cisplatin for Chemotherapy-Refractory Squamous Cell Cancer of the Head and Neck. Journal Of Clinical Oncology 2005, 23: 5440-5442. PMID: 16009959, DOI: 10.1200/jco.2005.02.002.Peer-Reviewed Original Research
2004
Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up
Psyrri A, Kwong M, DiStasio S, Lekakis L, Kassar M, Sasaki C, Wilson LD, Haffty BG, Son YH, Ross DA, Weinberger PM, Chung GG, Zelterman D, Burtness BA, Cooper DL. Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up. Journal Of Clinical Oncology 2004, 22: 3061-3069. PMID: 15284256, DOI: 10.1200/jco.2004.01.108.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrachytherapyCarcinoma, Squamous CellCisplatinCombined Modality TherapyDrug Administration ScheduleFemaleFluorouracilFollow-Up StudiesHead and Neck NeoplasmsHumansLeucovorinMaleMiddle AgedQuality of LifeRemission InductionSurvival RateTreatment OutcomeConceptsConcurrent cisplatin chemoradiotherapyComplete response rateInduction chemotherapyCisplatin chemoradiotherapyOrgan preservationResponse rateAdvanced headGrade 3Survival rateProgression-free survival ratesNeck squamous cell carcinomaCommon grade 3Courses of cisplatinPartial response ratePhase II studyOverall survival ratePoor functional outcomeSquamous cell carcinomaExternal beam radiotherapyExcellent PFSResectable HNSCCAdvanced diseaseConcurrent chemoradiotherapyPersistent dysphagiaII study
2003
Epidermal growth factor receptor, p53 mutation, and pathological response predict survival in patients with locally advanced esophageal cancer treated with preoperative chemoradiotherapy.
Gibson MK, Abraham SC, Wu TT, Burtness B, Heitmiller RF, Heath E, Forastiere A. Epidermal growth factor receptor, p53 mutation, and pathological response predict survival in patients with locally advanced esophageal cancer treated with preoperative chemoradiotherapy. Clinical Cancer Research 2003, 9: 6461-8. PMID: 14695149.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAgedBcl-2-Associated X ProteinCisplatinCombined Modality TherapyDisease-Free SurvivalDNA Mutational AnalysisErbB ReceptorsEsophageal NeoplasmsFemaleFluorouracilGenes, p53HumansImmunohistochemistryMaleMiddle AgedMutationProportional Hazards ModelsProto-Oncogene ProteinsProto-Oncogene Proteins c-bcl-2Regression AnalysisTime FactorsTreatment OutcomeConceptsAdvanced esophageal cancerOverall survivalComplete responseEsophageal cancerEpidermal growth factor receptorP53 mutationsGrowth factor receptorClinical covariatesCellular markersBetter tumor differentiationPathological complete responseFactor receptorEGF-R expressionBcl-2 expressionInfusional cisplatinDaily radiotherapyMost patientsPoor OSPreoperative chemoradiotherapyPatient agePretreatment tumorOutcome predictorsPredictive factorsBarrett's metaplasiaTumor locationMature survival results with preoperative cisplatin, protracted infusion 5-fluorouracil, and 44-Gy radiotherapy for esophageal cancer
Kleinberg L, Knisely JP, Heitmiller R, Zahurak M, Salem R, Burtness B, Heath EI, Forastiere AA. Mature survival results with preoperative cisplatin, protracted infusion 5-fluorouracil, and 44-Gy radiotherapy for esophageal cancer. International Journal Of Radiation Oncology • Biology • Physics 2003, 56: 328-334. PMID: 12738305, DOI: 10.1016/s0360-3016(02)04598-4.Peer-Reviewed Original ResearchConceptsTime of surgeryEsophageal cancerDay 1Survival rateNeoadjuvant therapyPreoperative therapyMedian survivalComplete responseVenous infusionSurvival resultsResponse rateDisease-specific survival ratesLong-term survival resultsPathologic complete response rateCycles of paclitaxelPathologic stage IIAComplete response ratePathologic complete responsePathologic stage IRemainder of patientsDisease-specific survivalOverall cure rateSquamous cell carcinomaIsolated local failureCancer-related death
2000
Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin.
Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D’Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. Journal Of Clinical Oncology 2000, 18: 904-14. PMID: 10673534, DOI: 10.1200/jco.2000.18.4.904.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsArea Under CurveCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCetuximabCisplatinDose-Response Relationship, DrugDrug Administration ScheduleErbB ReceptorsFemaleGene Expression Regulation, NeoplasticHead and Neck NeoplasmsHumansInfusions, IntravenousLung NeoplasmsMaleNeoplasms, Glandular and EpithelialRecombinant Fusion ProteinsRemission InductionSafetyConceptsAntibody dosesMultiple doseSystemic clearancePhase I clinical trialWeeks of therapyDose-dependent pharmacokineticsCell lung cancerChimeric monoclonal antibodyCoadministration of cisplatinEpidermal growth factor receptorMurine chimeric monoclonal antibodyGrowth factor receptorDisease stabilizationPartial responseAdvanced tumorsSingle doseLung cancerClinical trialsDisease progressionEpithelial tumorsNonlinear pharmacokineticsPatientsDose levelsAntibody C225Relevant dosesPhase 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