2022
Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study
Harrington KJ, Burtness B, Greil R, Soulières D, Tahara M, de Castro G, Psyrri A, Brana I, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal Of Clinical Oncology 2022, 41: 790-802. PMID: 36219809, PMCID: PMC9902012, DOI: 10.1200/jco.21.02508.Peer-Reviewed Original ResearchConceptsPD-L1 CPSNeck squamous cell carcinomaSquamous cell carcinomaRecurrent/metastatic headMetastatic headCell carcinomaOverall survivalNext-line therapyObjective response ratePembrolizumab-based therapyProgression-free survivalDeath ligand 1Long-term efficacyKEYNOTE-048Data cutoffSurvival benefitTotal populationMedian studyPembrolizumabResponse rateCarcinomaPositive scoreLigand 1Subsequent treatmentEfficacy
2020
Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer
Emancipator K, Huang L, Aurora-Garg D, Bal T, Cohen EEW, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Swaby R. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Modern Pathology 2020, 34: 532-541. PMID: 33239737, DOI: 10.1038/s41379-020-00710-9.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyClinical Decision-MakingClinical Trials, Phase III as TopicDecision Support TechniquesDisease ProgressionHead and Neck NeoplasmsHumansImmunohistochemistryPredictive Value of TestsProgression-Free SurvivalRandomized Controlled Trials as TopicRetrospective StudiesSquamous Cell Carcinoma of Head and NeckTime FactorsConceptsTumor proportion scoreObjective response ratePD-L1 expression statusDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaImmune checkpoint inhibitorsLigand 1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaKEYNOTE-040Pembrolizumab efficacyCheckpoint inhibitorsOverall survivalMetastatic HNSCCCell carcinomaNeck cancerClinical trialsProportion scoreInvestigator's choiceResponse rateExpression statusYouden indexHNSCCPatients
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 head
2017
Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial.
Argiris A, Li S, Savvides P, Ohr J, Gilbert J, Levine M, Haigentz M, Saba N, Chakravarti A, Ikpeazu C, Schneider C, Pinto H, Forastiere A, Burtness B. Phase III randomized trial of chemotherapy with or without bevacizumab (B) in patients (pts) with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Survival analysis of E1305, an ECOG-ACRIN Cancer Research Group trial. Journal Of Clinical Oncology 2017, 35: 6000-6000. DOI: 10.1200/jco.2017.35.15_suppl.6000.Peer-Reviewed Original ResearchMedian overall survivalOverall survivalArm BM SCCHNAUC 6Hazard ratioArm AResponse rateMetastatic squamous cell carcinomaAnti-VEGF monoclonal antibodyCarboplatin AUC 6Objective response ratePerformance status 0Trial of chemotherapyFirst-line treatmentSquamous cell carcinomaImproved response ratesA vs BEligible ptsMedian PFSOropharyngeal primaryPlatinum doubletsStatus 0Primary endpointProphylactic antibioticsIDO1 as a mechanism of adaptive immune resistance to anti-PD1 monotherapy in HNSCC.
Wirth L, Burtness B, Mehra R, Bauman J, Lee J, Smith N, Lefranc-Torres A, Westra W, Bishop J, Faquin W, Lin D, Pai S. IDO1 as a mechanism of adaptive immune resistance to anti-PD1 monotherapy in HNSCC. Journal Of Clinical Oncology 2017, 35: 6053-6053. DOI: 10.1200/jco.2017.35.15_suppl.6053.Peer-Reviewed Original ResearchHPV- HNSCCsPD-L1Clinical responseHNSCC patientsResponse rateAnti-PD-1 monotherapyAnti-PD-1 therapyHuman papillomavirus-associated headAnti-PD-1 blockadeNeck squamous cell carcinomaAdaptive immune resistanceAnti-PD1 monotherapyHPV(-) HNSCC patientsImmunogenic viral antigensImmune checkpoint moleculesPost-treatment biopsiesT cell activityImmune checkpoint pathwaysSquamous cell carcinomaQuantitative PCRImproved response ratesImmune-related genesCheckpoint moleculesPD-1IDO1 expressionPhase II trial of ribociclib and everolimus in p16 low anaplastic thyroid cancer (ATC).
Tawfik B, Gerber D, Burtness B, Hughes R, Myers L, Sumer B, Truelson J, Strom T, Kurian P, Saleem S, Pearson J, Zhu H, Khan S. Phase II trial of ribociclib and everolimus in p16 low anaplastic thyroid cancer (ATC). Journal Of Clinical Oncology 2017, 35: tps6098-tps6098. DOI: 10.1200/jco.2017.35.15_suppl.tps6098.Peer-Reviewed Original ResearchAnaplastic thyroid cancerThyroid cancerCell cycle progressionII trialCycle progressionResponse ratePhase I/II trialOpen-label trialRare thyroid cancerPhase II trialAggressive clinical courseCDK 4/6 inhibitorsEffective treatment optionOverall response rateMTOR inhibitor everolimusATC cell linesRapid cell cycle progressionMedian OSATC patientsPrimary endpointSecondary endpointsMetastatic diseaseTrue response rateAdditional patientsClinical course
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 dataRandomized 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
2015
Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort.
Seiwert T, Haddad R, Gupta S, Mehra R, Tahara M, Berger R, Lee S, Burtness B, Le D, Heath K, Blum A, Dolled-Filhart M, Emancipator K, Pathiraja K, Cheng J, Chow L. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort. Journal Of Clinical Oncology 2015, 33: lba6008-lba6008. DOI: 10.1200/jco.2015.33.18_suppl.lba6008.Peer-Reviewed Original ResearchRecurrent/metastatic SCCHNOverall response rateDrug-related adverse eventsProgression-free survivalAdverse eventsMetastatic SCCHNPD-L1KEYNOTE-012Expansion cohortOverall survivalCommon drug-related adverse eventsTumor-specific effector T cellsResponse rateAdvanced squamous cell carcinomaDrug-related gradePost-baseline scanSafety of pembrolizumabPrimary end pointLines of therapyPD-L1 expressionEffector T cellsSquamous cell carcinomaHumanized monoclonal antibodyPreliminary efficacy analysisAdvanced SCCHN
2014
Increased Time From Neoadjuvant Chemoradiation to Surgery Is Associated With Higher Pathologic Complete Response Rates in Esophageal Cancer
Shaikh T, Ruth K, Scott WJ, Burtness BA, Cohen SJ, Konski AA, Cooper HS, Astsaturov I, Meyer JE. Increased Time From Neoadjuvant Chemoradiation to Surgery Is Associated With Higher Pathologic Complete Response Rates in Esophageal Cancer. The Annals Of Thoracic Surgery 2014, 99: 270-276. PMID: 25440267, PMCID: PMC4284823, DOI: 10.1016/j.athoracsur.2014.08.033.Peer-Reviewed Original ResearchConceptsPathologic complete response rateComplete response rateHigher pathologic complete response rateNeoadjuvant chemoradiationResponse rateEsophageal cancerNeoadjuvant chemoradiation treatmentCompletion of chemoradiationTiming of surgeryLength of stayOperative stayChemoradiation treatmentBlood lossPathologic responseSurgery intervalSurgical morbidityCancer sitesChemoradiationMorbidity dataSurgeryPatientsInterval groupTreatment factorsEsophagectomyStay
2013
Novel targets in HPV-negative head and neck cancer: overcoming resistance to EGFR inhibition
Burtness B, Bauman JE, Galloway T. Novel targets in HPV-negative head and neck cancer: overcoming resistance to EGFR inhibition. The Lancet Oncology 2013, 14: e302-e309. PMID: 23816296, DOI: 10.1016/s1470-2045(13)70085-8.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCetuximabDrug DesignDrug Resistance, NeoplasmErbB ReceptorsHead and Neck NeoplasmsHistone Deacetylase InhibitorsHumansMolecular Targeted TherapyPapillomaviridaeProtein Kinase InhibitorsProto-Oncogene Proteins c-metReceptor, ErbB-2Signal TransductionTreatment OutcomeConceptsHPV-negative headNeck cancerHuman papillomavirusEGFR inhibitionSingle-agent cetuximabLow cure rateMonoclonal antibody cetuximabActive therapyCytotoxic chemotherapyDisease survivalCure rateMechanisms of resistanceAntibody cetuximabResponse rateCetuximabEGFRNovel targetReceptor tyrosine kinasesCancerTherapyHistone deacetylaseChemotherapyHabitual exposureModest effectNuclear functionsAnalysis of HPV and ERCC1 in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
Mehra R, Egloff A, Li S, Yang D, Wang L, Zhu F, Forastiere A, Burtness B, Argiris A. Analysis of HPV and ERCC1 in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Journal Of Clinical Oncology 2013, 31: 6006-6006. DOI: 10.1200/jco.2013.31.15_suppl.6006.Peer-Reviewed Original ResearchCisplatin/paclitaxelHazard ratioHuman papillomavirusCisplatin/5-FUResponse rateM SCCHNOdds ratioExact testAnalysis of HPVMetastatic squamous cell carcinomaDocetaxel/irinotecanTumor p16 statusObjective response ratePhase II trialSquamous cell carcinomaCox regression modelLog-rank testPotential confounding factorsFisher's exact testHPV-/p16Better OSII trialHPV DNAClinical outcomesCell carcinoma
2012
A Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab with or Without Bevacizumab as Frontline Therapy for Metastatic Colorectal Cancer. A Fox Chase Extramural Research Study
Dotan E, Meropol NJ, Burtness B, Denlinger CS, Lee J, Mintzer D, Zhu F, Ruth K, Tuttle H, Sylvester J, Cohen SJ. A Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab with or Without Bevacizumab as Frontline Therapy for Metastatic Colorectal Cancer. A Fox Chase Extramural Research Study. Journal Of Gastrointestinal Cancer 2012, 43: 562-569. PMID: 22294255, PMCID: PMC3400721, DOI: 10.1007/s12029-012-9368-3.Peer-Reviewed Original ResearchConceptsVascular endothelial growth factorMetastatic colorectal cancerPhase II studyEpidermal growth factor receptorDay 1Arm B.II studyOverall survivalArm AColorectal cancerResponse rateMetastatic colorectal cancer patientsDual antibody therapySafety of capecitabineResultsTwenty-three patientsFirst-line treatmentColorectal cancer patientsOverall response rateKRAS mutation statusEndothelial growth factorBevacizumab 7.5Capecitabine 850Cetuximab 400Growth factor receptorOxaliplatin 130
2011
Significance of Pathologic Response to Preoperative Therapy in Pancreatic Cancer
Chun YS, Cooper HS, Cohen SJ, Konski A, Burtness B, Denlinger CS, Astsaturov I, Hall MJ, Hoffman JP. Significance of Pathologic Response to Preoperative Therapy in Pancreatic Cancer. Annals Of Surgical Oncology 2011, 18: 3601-3607. PMID: 21947697, DOI: 10.1245/s10434-011-2086-4.Peer-Reviewed Original ResearchConceptsPathologic response ratePathologic responsePreoperative therapyPancreatic adenocarcinomaResponse rateComplete pathologic response rateMajor pathologic response rateMajor pathologic responseNegative lymph nodesImportant prognostic factorMinority of patientsSmaller tumor sizeMedian survival rateR0 resectionConsecutive patientsPancreatic headPartial responsePrognostic factorsImproved survivalLymph nodesTumor sizeHistopathologic examinationMinor responsePancreatic cancerTherapy occurs
2009
Phase II randomized trial of bortezomib (B) plus irinotecan (I) or B with addition of I at progression in recurrent (R) or metastatic (M) squamous cell carcinoma of the head and neck (SCCHN) (E1304): A trial of the Eastern Cooperative Oncology Group
Gilbert J, Lee J, Argiris A, Feldman L, Haigentz M, Burtness B, Forastiere A. Phase II randomized trial of bortezomib (B) plus irinotecan (I) or B with addition of I at progression in recurrent (R) or metastatic (M) squamous cell carcinoma of the head and neck (SCCHN) (E1304): A trial of the Eastern Cooperative Oncology Group. Journal Of Clinical Oncology 2009, 27: 6020-6020. DOI: 10.1200/jco.2009.27.15_suppl.6020.Peer-Reviewed Original ResearchGrade 5 toxicityArm 2Response rateArm 1Metastatic squamous cell carcinomaEastern Cooperative Oncology GroupCycles of therapyECOG PS 0ECOG PS 1Cooperative Oncology GroupTime of progressionSquamous cell carcinomaSCCHN cell linesPrior chemoPrimary endpointStable diseaseToxic regimenActive therapyOncology GroupPS 0Cell carcinomaNF-κβTumor sensitivityTherapyInhibits growthPhase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN)
Mehra R, Sherman E, Ruth K, Litwin S, Sylvester J, Tuttle H, Burtness B, Cohen R, Langer C. Phase II study of pemetrexed (P) and gemcitabine (G) in patients with advanced head and neck cancer (SCCHN). Journal Of Clinical Oncology 2009, 27: 6052-6052. DOI: 10.1200/jco.2009.27.15_suppl.6052.Peer-Reviewed Original ResearchPhase II studyResponse rateII studyOverall survivalMetastatic squamous cell cancerRecurrent/metastatic SCCHNRecurrent/metastatic diseaseStage 1Adequate bone marrowGrade 4 anemiaGrade 3 toxicityMedian overall survivalSquamous cell cancerLack of efficacyAdvanced HNSCCKarnofsky PSLA-SCCHNMetastatic SCCHNPrior therapyUnconfirmed PRAlternative regimenDefinitive therapyPrimary endpointRecurrent diseaseSecondary endpoints
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 cessationPhase 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
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 rash
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