2019
Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201.
Iqbal S, McDonough S, Lenz HJ, Ilson D, Burtness B, Nangia CS, Barzi A, Schneider CJ, Liu JJ, Dotan E, Guthrie KA, Hochster HS. Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of ERCC1: SWOG S1201. Journal Of Clinical Oncology 2019, 38: 472-479. PMID: 31815582, PMCID: PMC7007287, DOI: 10.1200/jco.19.00925.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDNA-Binding ProteinsEndonucleasesEsophageal NeoplasmsEsophagogastric JunctionFemaleFluorouracilGene ExpressionHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsOxaliplatinPrognosisProgression-Free SurvivalProportional Hazards ModelsProspective StudiesStomach NeoplasmsYoung AdultConceptsProgression-free survivalAdvanced esophagogastric cancerPhase II studyPlatinum-based therapyOverall survivalII studySuperior median progression-free survivalMedian progression-free survivalMRNA expressionRegimen of irinotecanUpper GI tumorsZubrod performance statusPercent of patientsOccurrence of gradeStandard of careMetastatic esophagealEsophagogastric cancerPerformance statusUntreated patientsGastroesophageal cancerGI tumorsTreatment armsFOLFOXPlatinum sensitivityPatientsPembrolizumab 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
Induction Therapy for Locally Advanced, Resectable Esophagogastric Cancer
Boland PM, Meyer JE, Berger AC, Cohen SJ, Neuman T, Cooper HS, Olszanski AJ, Davey M, Cheng JD, Lebenthal A, Burtness BA, Scott WJ, Astsaturov IA. Induction Therapy for Locally Advanced, Resectable Esophagogastric Cancer. American Journal Of Clinical Oncology 2017, 40: 393-398. PMID: 26986978, PMCID: PMC5026539, DOI: 10.1097/coc.0000000000000171.Peer-Reviewed Original ResearchConceptsGastroesophageal junction carcinomaPreoperative chemoradiationPreoperative chemotherapyAdditional patientsSmall molecule receptor tyrosine kinase inhibitorGrade 4 nonhematologic toxicityReceptor tyrosine kinase inhibitorsPhase ICommon acute toxicitiesLocalized esophageal cancerResectable esophagogastric cancerTolerability of vandetanibMedian overall survivalMicroscopic residual diseasePathologic complete responseLocalized esophageal carcinomaTyrosine kinase inhibitorsEsophagogastric cancerInduction therapyNonhematologic toxicityPrior therapyDaily radiotherapyLate complicationsOverall survivalSurgical candidates
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
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
2005
Oxaliplatin Induces a Delayed Immune-Mediated Hemolytic Anemia: A Case Report and Review of the Literature
Noronha V, Burtness B, Murren J, Duffy TP. Oxaliplatin Induces a Delayed Immune-Mediated Hemolytic Anemia: A Case Report and Review of the Literature. Clinical Colorectal Cancer 2005, 5: 283-286. PMID: 16356307, DOI: 10.3816/ccc.2005.n.041.Peer-Reviewed Original ResearchMeSH KeywordsAnemia, HemolyticAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCecal NeoplasmsDrug HypersensitivityFemaleFluorouracilHumansHypersensitivity, DelayedIleal NeoplasmsIntestinal NeoplasmsLeucovorinMiddle AgedOrganoplatinum CompoundsOxaliplatinTreatment OutcomeConceptsHemolytic anemiaMild self-limited episodesCycles of chemotherapySelf-limited episodesImmune-mediated hemolysisMinimal side effectsBevacizumab therapyPartial remissionLaboratory featuresIleocecal regionMetastatic carcinomaCase reportFuture therapiesSide effectsAnemiaOxaliplatinTherapyRemissionChemotherapyCarcinomaSymptomsImmuneWomen
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 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