2019
Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M, de Castro G, Psyrri A, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesía R, Ngamphaiboon N, Rordorf T, Ishak W, Hong RL, Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D, Investigators K, Lerzo G, Tatangelo M, Varela M, Zarba J, Boyer M, Gan H, Gao B, Hughes B, Mallesara G, Rischin D, Taylor A, Burian M, Fuereder T, Greil R, Barrios C, de Castro D, Castro G, Franke F, Girotto G, Lima I, Nicolau U, Pinto G, Santos L, Victorino A, Chua N, Couture F, Gregg R, Hansen A, Hilton J, McCarthy J, Soulieres D, Ascui R, Gonzalez P, Villanueva L, Torregroza M, Zambrano A, Holeckova P, Kral Z, Melichar B, Prausova J, Vosmik M, Andersen M, Gyldenkerne N, Jurgens H, Putnik K, Reinikainen P, Gruenwald V, Laban S, Aravantinos G, Boukovinas I, Georgoulias V, Psyrri A, Kwong D, Al-Farhat Y, Csoszi T, Erfan J, Horvai G, Landherr L, Remenar E, Ruzsa A, Szota J, Billan S, Gluck I, Gutfeld O, Popovtzer A, Benasso M, Bui S, Ferrari V, Licitra L, Nole F, Fujii T, Fujimoto Y, Hanai N, Hara H, Matsumoto K, Mitsugi K, Monden N, Nakayama M, Okami K, Oridate N, Shiga K, Shimizu Y, Sugasawa M, Tahara M, Takahashi M, Takahashi S, Tanaka K, Ueda T, Yamaguchi H, Yamazaki T, Yasumatsu R, Yokota T, Yoshizaki T, Kudaba I, Stara Z, Ishak W, Cheah S, Ponce J, Mendoza R, Hernandez C, Soto F, Buter J, Hoeben A, Oosting S, Suijkerbuijk K, Bratland A, Brydoey M, Alvarez R, Mas L, Caguioa P, Querol J, Regala E, Tamayo M, Villegas E, Kawecki A, Karpenko A, Klochikhin A, Smolin A, Zarubenkov O, Goh B, Cohen G, du Toit J, Jordaan C, Landers G, Ruff P, Szpak W, Tabane N, Brana I, Docampo L, Lavernia J, Mesia R, Abel E, Muratidu V, Nielsen N, Cristina V, Rordorf T, Rothschild S, Hong R, Wang H, Yang M, Yeh S, Yen C, Ngamphaiboon N, Soparattanapaisarn N, Sriuranpong V, Aksoy S, Cicin I, Ekenel M, Harputluoglu H, Ozyilkan O, Harrington K, Agarwala S, Ali H, Alter R, Anderson D, Bruce J, Burtness B, Campbell N, Conde M, Deeken J, Edenfield W, Feldman L, Gaughan E, Goueli B, Halmos B, Hegde U, Hunis B, Jotte R, Karnad A, Khan S, Laudi N, Laux D, Martincic D, McCune S, McGaughey D, Misiukiewicz K, Mulford D, Nadler E, Neupane P, Nunnink J, Ohr J, O'Malley M, Patson B, Paul D, Popa E, Powell S, Redman R, Rella V, Lima C, Sivapiragasam A, Su Y, Sukari A, Wong S, Yilmaz E, Yorio J. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. The Lancet 2019, 394: 1915-1928. PMID: 31679945, DOI: 10.1016/s0140-6736(19)32591-7.Peer-Reviewed Original ResearchConceptsCombined positive scoreSecond interim analysisProgression-free survivalPD-L1 combined positive scoreAppropriate first-line treatmentFirst-line treatmentOverall survivalSquamous cell carcinomaChemotherapy groupMetastatic HNSCCInterim analysisAdverse eventsAlone groupCell carcinomaFinal analysisCell death ligand 1 (PD-L1) expressionDeath ligand 1 (PD-L1) expressionMetastatic squamous cell carcinomaNeck squamous cell carcinomaCause adverse eventsPD-L1 positivityLigand 1 expressionPD-L1 expressionTotal populationIncurable recurrent
2017
Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer
Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Krämer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels J. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Annals Of Oncology 2017, 28: 2526-2532. PMID: 28961833, PMCID: PMC5834024, DOI: 10.1093/annonc/mdx344.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, IntravenousAdministration, OralAfatinibAntimetabolites, AntineoplasticBiomarkers, TumorBiopsyCarcinoma, Squamous CellDisease-Free SurvivalHead and Neck NeoplasmsHumansMethotrexateNeoplasm MetastasisNeoplasm Recurrence, LocalPredictive Value of TestsQuinazolinesSquamous Cell Carcinoma of Head and NeckConceptsProgression-free survivalMetastatic headEfficacy outcomesMedian progression-free survivalRecurrent/metastatic headNeck squamous cell carcinomaTumor biomarkersNeck 1 trialP16-positive diseaseSecond-line afatinibOverall study populationSubset of patientsP16-negative tumorsSquamous cell carcinomaEnhanced clinical outcomesBiomarker analysisM HNSCCTherapy-naïveBaseline characteristicsStudy entryClinical outcomesHNSCC patientsPlatinum therapyCell carcinomaNeck cancer
2007
Her signaling in pancreatic cancer
Burtness B. Her signaling in pancreatic cancer. Expert Opinion On Biological Therapy 2007, 7: 823-829. PMID: 17555368, DOI: 10.1517/14712598.7.6.823.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntimetabolites, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCetuximabDeoxycytidineEpidermal Growth FactorErlotinib HydrochlorideGemcitabineHumansLapatinibOrganoplatinum CompoundsOxaliplatinPancreatic NeoplasmsProtein Kinase InhibitorsQuinazolinesReceptor, ErbB-2Signal TransductionTreatment OutcomeConceptsPhase II trialPhase III trialsPancreatic cancerEpidermal growth factor receptorII trialIII trialsRandomized phase II trialTreatment-refractory cancerManagement of patientsPhase I trialEGFR antibody cetuximabAddition of erlotinibGrowth factor receptorGemcitabine chemotherapyMedian survivalStandard therapyI trialPatient selectionSignificant prolongationMetastatic cancerAntibody cetuximabTherapeutic targetGemcitabineEGFR/Cancer
2000
Phase 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
1998
Cytosine Deaminase Adenoviral Vector and 5-Fluorocytosine Selectively Reduce Breast Cancer Cells 1 Million-Fold When They Contaminate Hematopoietic Cells: A Potential Purging Method for Autologous Transplantation
Garcia-Sanchez F, Pizzorno G, Fu SQ, Nanakorn T, Krause DS, Liang J, Adams E, Leffert JJ, Yin LH, Cooperberg MR, Hanania E, Wang WL, Won JH, Peng XY, Cote R, Brown R, Burtness B, Giles R, Crystal R, Deisseroth AB. Cytosine Deaminase Adenoviral Vector and 5-Fluorocytosine Selectively Reduce Breast Cancer Cells 1 Million-Fold When They Contaminate Hematopoietic Cells: A Potential Purging Method for Autologous Transplantation. Blood 1998, 92: 672-682. PMID: 9657770, DOI: 10.1182/blood.v92.2.672.Peer-Reviewed Original ResearchMeSH KeywordsAdenoviridaeAnimalsAntimetabolites, AntineoplasticBreast NeoplasmsCell DeathCytosine DeaminaseFemaleFlucytosineFluorouracilGene Transfer TechniquesGenetic VectorsHematopoietic Stem Cell MobilizationHematopoietic Stem Cell TransplantationHematopoietic Stem CellsHumansMaleMiceNucleoside DeaminasesProdrugsTransplantation, AutologousTumor Cells, CulturedConceptsBreast cancer cellsPeripheral blood mononuclear cellsBreast cancer patientsCancer patientsCytosine deaminase geneHuman mammary epithelial cellsAdenoviral vectorCancer cellsHours of exposureHematopoietic cellsAutologous stem cell productsMarrow cellsEscherichia coli cytosine deaminase geneReplication-incompetent adenoviral vectorEpithelial cellsChemotherapy-induced myelosuppressionBreast cancer cell line MCF-7Blood mononuclear cellsEarly hematopoietic precursor cellsMale donor miceCancer cell line MCF-7Fluorescence-activated cell sorting (FACS) analysisMCF-7 breast cancer cellsNormal human mammary epithelial cellsMDA-MB-453