2023
Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial
Stockton S, Catalano P, Cohen S, Burtness B, Mitchell E, Dotan E, Lubner S, Kumar P, Mulcahy M, Fisher G, Crandall T, Benson A. Paclitaxel With or Without Cixutumumab as Second-Line Treatment of Metastatic Esophageal or Gastroesophageal Junction Cancer: A Randomized Phase II ECOG-ACRIN Trial. The Oncologist 2023, 28: 827-e822. PMID: 37104870, PMCID: PMC10485278, DOI: 10.1093/oncolo/oyad096.Peer-Reviewed Original ResearchConceptsProgression-free survivalSecond-line therapyGastroesophageal junction cancerArm AMetastatic esophagealJunction cancerArm BMedian progression-free survivalRandomized phase II trialMedian overall survivalObjective response rateSecond-line treatmentAdvanced esophageal cancerInsulin-like growth factor 1 receptorPhase II trialStandard of careGrowth factor 1 receptorFactor 1 receptorStable diseaseII trialMetastatic settingPrimary endpointOverall survivalPreclinical evidenceClinical outcomesScreening for extranodal extension in HPV-associated oropharyngeal carcinoma: evaluation of a CT-based deep learning algorithm in patient data from a multicentre, randomised de-escalation trial
Kann B, Likitlersuang J, Bontempi D, Ye Z, Aneja S, Bakst R, Kelly H, Juliano A, Payabvash S, Guenette J, Uppaluri R, Margalit D, Schoenfeld J, Tishler R, Haddad R, Aerts H, Garcia J, Flamand Y, Subramaniam R, Burtness B, Ferris R. Screening for extranodal extension in HPV-associated oropharyngeal carcinoma: evaluation of a CT-based deep learning algorithm in patient data from a multicentre, randomised de-escalation trial. The Lancet Digital Health 2023, 5: e360-e369. PMID: 37087370, PMCID: PMC10245380, DOI: 10.1016/s2589-7500(23)00046-8.Peer-Reviewed Original ResearchConceptsExtranodal extensionOropharyngeal carcinomaShort-axis diameterChallenging cohortPathology reportsECOG-ACRIN Cancer Research GroupDe-escalation trialsCancer Research GroupDe-escalation strategiesSurgical pathology reportsNational Cancer InstituteInter-reader agreementLargest short-axis diameterPostoperative chemoradiationProtocol exclusionsConcurrent chemoradiationPrimary endpointMulticentre trialPretreatment CTAdjuvant strategiesHuman papillomavirusTreatment selection toolUS National InstitutesPretreatment identificationStudy protocol
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
TRYHARD, a randomized phase II trial (RTOG Foundation 3501) of concurrent accelerated radiation plus cisplatin (cis) with or without lapatinib (Lap) for stage III- IV Non-HPV head and neck carcinoma (HNC).
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, Mell L, Spencer S, Stokes W, Yao M, Mitchell D, Harris J, Curran W, Le Q. TRYHARD, a randomized phase II trial (RTOG Foundation 3501) of concurrent accelerated radiation plus cisplatin (cis) with or without lapatinib (Lap) for stage III- IV Non-HPV head and neck carcinoma (HNC). Journal Of Clinical Oncology 2021, 39: 6014-6014. DOI: 10.1200/jco.2021.39.15_suppl.6014.Peer-Reviewed Original ResearchProgression-free survivalPhase II trialOverall survivalStage IIIII trialArm AGrade 3Treatment-related grade 3Randomized phase II trialFinal analysisEffects of chemoradiationBaseline patient characteristicsDays of therapyAdverse event ratesSurvival of patientsCycles of CDDPLog-rank testDual EGFRA vs BMucositis ratesRash ratesPFS ratePrimary endpointSecondary endpointsFrontline therapyRandomized 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 0Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis
Petit C, Lacas B, Pignon J, Le Q, Grégoire V, Grau C, Hackshaw A, Zackrisson B, Parmar M, Lee J, Ghi M, Sanguineti G, Temam S, Cheugoua-Zanetsie M, O'Sullivan B, Posner M, Vokes E, Hernandez J, Szutkowski Z, Lartigau E, Budach V, Suwiński R, Poulsen M, Kumar S, Laskar S, Mazeron J, Jeremic B, Simes J, Zhong L, Overgaard J, Fortpied C, Torres-Saavedra P, Bourhis J, Aupérin A, Blanchard P, Groups M, Adelstein D, Agarwal J, Alfonsi M, Argiris A, Aupérin A, Bacigalupo A, Bar-Ad V, Bartelink H, Beadle B, Belkacemi Y, Bensadoun R, Bernier J, Blanchard P, Bourhis J, Bratland Å, Brizel D, Budach V, Budach W, Burtness B, Calais G, Campbell B, Caudell J, Chabaud S, Chamorey E, Chaukar D, Cheugoua-Zanetsie M, Cho K, Choussy O, Hernandez J, Denham J, Dobrowsky W, Dominello M, Driessen C, Fallai C, Forastiere A, Fortpied C, Fountzilas G, Garaud P, Garden A, Gery B, Ghadjar P, Ghi M, Laskar S, Graff-Cailleaud P, Grau C, Gregoire V, Hackshaw A, Haddad E, Haffty B, Hansen A, Hay J, Hayoz S, Horiot J, Hitt R, Jeremic B, Johansen J, Jones C, Julieron M, Kristensen C, Kumar S, Lacas B, Langendijk J, Lapeyre M, Lartigau E, Licitra L, Le Q, Lee J, Lee P, Lewin F, Li Y, Lopes A, Lotayef M, Maciejewski B, Mazeron J, Mehta S, Michalski W, Moon J, Moon S, Moyal E, Nankivell M, Nilsson P, Olmi P, Orecchia R, O'Sullivan B, Overgaard J, Parmar M, Petit C, Pignon J, Pointreau Y, Posner M, Poulsen M, Quon H, Racadot S, Rosenthal D, Rovea P, Redda M, Sanguineti G, Shenouda G, Simes J, Sharma A, Simon C, Sire C, Skladowski K, Spencer S, Staar S, Strojan P, Stromberger C, Suwinski R, Szutkowski Z, Takácsi-Nagy Z, Tao Y, Temam S, Thomson D, Tobias J, Torres-Saavedra P, Torri V, Tripcony L, Trotti A, Tseroni V, van Herpen C, van Tinteren H, Vermorken J, Viegas C, Vokes E, Waldron J, Wernecke K, Widder J, Wolf G, Wong S, Wu J, Yamazaki H, Zaktonik B, Zackrisson B, Zhong L. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis. The Lancet Oncology 2021, 22: 727-736. PMID: 33862002, DOI: 10.1016/s1470-2045(21)00076-0.Peer-Reviewed Original ResearchConceptsOverall survivalLocoregional therapyAdvanced headNeck cancerConcomitant chemotherapyConcomitant chemoradiotherapyIndividual patient data networkNeck squamous cell cancerAltered fractionation radiotherapyNon-metastatic headRole of chemotherapyPlatinum-based chemotherapySquamous cell cancerModalities of treatmentLog-rank testIndividual patient dataCochran's Q statisticInstitut National du CancerP scoreInduction chemotherapyFractionation radiotherapyPrimary endpointHazard ratioHyperfractionated radiotherapySurvival benefit
2020
Transoral robotic surgical resection followed by randomization to low- or standard-dose IMRT in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN Cancer Research Group (E3311).
Ferris R, Flamand Y, Weinstein G, Li S, Quon H, Mehra R, Garcia J, Chung C, Gillison M, Duvvuri U, O'malley B, Ozer E, Thomas G, Koch W, Kupferman M, Bell R, Saba N, Lango M, Mendez E, Burtness B. Transoral robotic surgical resection followed by randomization to low- or standard-dose IMRT in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN Cancer Research Group (E3311). Journal Of Clinical Oncology 2020, 38: 6500-6500. DOI: 10.1200/jco.2020.38.15_suppl.6500.Peer-Reviewed Original ResearchProgression-free survivalExtranodal extensionOropharynx cancerTransoral resectionPrimary endpointArm BArm AECOG-ACRIN Cancer Research GroupAdvanced oropharynx cancerTreatment-related deathsUninvolved surgical marginsArm DIntermediate-risk patientsLow-risk diseasePhase III trialsNon-surgical therapyGood oncologic outcomesPost-operative managementCancer Research GroupPost-operative therapyLow-dose radiationPostoperative RTDistant recurrenceFree survivalIII trials
2019
Alliance 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
2018
Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study
Cohen EEW, Soulières D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ, investigators K, Acosta-Rivera M, Adkins D, Aghmesheh M, Ahn M, Airoldi M, Aleknavicius E, Al-Farhat Y, Algazi A, Almokadem S, Alyasova A, Bauman J, Benasso M, Berrocal A, Bray V, Burtness B, Caponigro F, Castro A, Cescon T, Chan K, Chaudhry A, Chauffert B, Cohen E, Csoszi T, De Boer J, Delord J, Dietz A, Dinis J, Dupuis C, Digue L, Erfan J, Alvarez Y, Evans M, Fidler M, Forster M, Friesland S, Ganti A, Geoffrois L, Grant C, Gruenwald V, Harrington K, Hoffmann T, Horvai G, Inciura A, Jang R, Jankowska P, Jimeno A, Joseph M, Ramiro A, Karaszewska B, Kawecki A, Keilholz U, Keller U, Kim S, Kocsis J, Kotecki N, Kozloff M, Lambea J, Landherr L, Lantsukhay Y, Lazarev S, Lee L, Le Tourneau C, Licitra L, Lifirenko I, Mach N, Martincic D, Matorin O, McGrath M, Machiels J, Mehra R, Misiukiewicz K, Morris J, Mufazalov F, Niu J, Srinivasan D, Segura P, Rauch D, Ribeiro M, Rodriguez C, Rolland F, Russo A, Ruzsa A, Sanches F, Shin S, Shtiveland M, Soulieres D, Soria A, Specenier P, Szekanecz E, Szota J, van Herpen C, Velez-Cortes H, Walsh W, Wilop S, Winterhalder R, Wojtukiewicz M, Wong D, Zandberg D. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. The Lancet 2018, 393: 156-167. PMID: 30509740, DOI: 10.1016/s0140-6736(18)31999-8.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease ProgressionDocetaxelDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansKaplan-Meier EstimateMaleMethotrexateMiddle AgedNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckConceptsNeck squamous cell carcinomaSquamous cell carcinomaStandard of careTreatment-related adverse eventsCell carcinomaMetastatic headOverall survivalTreat populationAdverse eventsCommon treatment-related adverse eventsWorse treatment-related adverse eventsPlatinum-containing treatmentTreatment-related deathsMedian overall survivalWeb response systemEffective treatment optionFavorable safety profileEarly phase trialsTreatment of headSubsidiary of MerckManageable toxicityMeaningful prolongationAdvanced diseasePrimary endpointMetastatic disease
2017
Phase 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 coursePhase 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 antibioticsLUX-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
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
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 treatmentE1308: Reduced-dose IMRT in human papilloma virus (HPV)-associated resectable oropharyngeal squamous carcinomas (OPSCC) after clinical complete response (cCR) to induction chemotherapy (IC).
Cmelak A, Li S, Marur S, Zhao W, Westra W, Chung C, Gillison M, Gilbert J, Bauman J, Wagner L, Ferris R, Trevarthen D, Colevas A, Jahagirdar B, Burtness B. E1308: Reduced-dose IMRT in human papilloma virus (HPV)-associated resectable oropharyngeal squamous carcinomas (OPSCC) after clinical complete response (cCR) to induction chemotherapy (IC). Journal Of Clinical Oncology 2014, 32: lba6006-lba6006. DOI: 10.1200/jco.2014.32.18_suppl.lba6006.Peer-Reviewed Original ResearchClinical complete responseOropharyngeal squamous carcinomaLate grade 3 toxicityPost-treatment neck dissectionStage III/IVAHigh tumor control ratesGrade 3 toxicityWeek x 3Tumor control rateHuman papilloma virusLate toxicityPrimary endpointCurrent smokersComplete responseNeck dissectionNodal stageSquamous carcinomaControl ratePapilloma virusC-IMRTT1-3Weekly schedulePFSInvolved nodesDose
2013
E 1308: A phase II trial of induction chemotherapy (IC) followed by cetuximab with low dose versus standard dose IMRT in patients with human papilloma virus (HPV)-associated resectable squamous cell carcinoma of the oropharynx (OPSCC).
Marur S, Li S, Cmelak A, Gillison M, Ferris R, Bauman J, Zhao W, Westra W, Chung C, Wagner L, Trevarthen D, Jahagirdar B, Colevas A, Burtness B. E 1308: A phase II trial of induction chemotherapy (IC) followed by cetuximab with low dose versus standard dose IMRT in patients with human papilloma virus (HPV)-associated resectable squamous cell carcinoma of the oropharynx (OPSCC). Journal Of Clinical Oncology 2013, 31: 6005-6005. DOI: 10.1200/jco.2013.31.15_suppl.6005.Peer-Reviewed Original ResearchClinical complete responseGrade 3/4 toxicitiesInduction chemotherapyLow doseBetter overall clinical responseCycles of ICPost-treatment neck dissectionResectable squamous cell carcinomaStage III/IVAOverall clinical responseWeek x 3Phase II trialSquamous cell carcinomaHuman papilloma virusPost-baseline measurementRadiation dose reductionEligible ptsHPV-OPSCCYear PFSOPSCC patientsPrimary endpointSecondary endpointsClinical responseCurrent smokersII trial
2009
Phase 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 endpointsPhase 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 growth
2007
Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology
Burtness B, Powell M, Berlin J, Liles D, Chapman A, Mitchell E, Benson A. Phase II trial of irinotecan/docetaxel for advanced pancreatic cancer with randomization between irinotecan/docetaxel and irinotecan/docetaxel plus C225, a monoclonal antibody to the epidermal growth factor receptor (EGF-r) : Eastern Cooperative Oncology. Journal Of Clinical Oncology 2007, 25: 4519-4519. DOI: 10.1200/jco.2007.25.18_suppl.4519.Peer-Reviewed Original ResearchPhase II trialArm AII trialPS 0Arm BPancreatic cancerMedian survivalOverall survivalRandomized phase II trialECOG PS 0Treatment-related deathsMedian overall survivalMetastatic pancreatic cancerTherapeutic anticoagulationDocetaxel chemotherapyMetastatic patientsPrimary endpointBiologic agentsDistant metastasisHistologic confirmationNormal bilirubinSame therapyYear survivalMedian numberArm 2
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