2024
Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1
2012
ECOG 1308: A phase II trial of induction chemotherapy followed by cetuximab with low dose versus standard dose IMRT in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx (OP).
Marur S, Lee J, Cmelak A, Zhao W, Westra W, Chung C, Gillison M, Gilbert J, Bauman J, Wagner L, Ferris R, Trevarthen D, Colevas A, Jahagirdar B, Burtness B. ECOG 1308: A phase II trial of induction chemotherapy followed by cetuximab with low dose versus standard dose IMRT in patients with HPV-associated resectable squamous cell carcinoma of the oropharynx (OP). Journal Of Clinical Oncology 2012, 30: 5566-5566. DOI: 10.1200/jco.2012.30.15_suppl.5566.Peer-Reviewed Original ResearchOropharyngeal squamous cell carcinomaInduction chemotherapySquamous cell carcinomaQuality of lifeCell carcinomaDay 1Primary siteMedian age 57 yearsResectable squamous cell carcinomaPhase II clinical trialCetuximab loading doseCisplatin 75mg/Pack-years smokingStandard-dose RTTumor stage T1Age 57 yearsHuman papillomavirus infectionPhase II trialProgression-free survivalExpression of biomarkersLow-dose radiationClinical CRRT armTarget accrualToxic regimensA 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
A phase 2 trial of bortezomib followed by the addition of doxorubicin at progression in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck
Argiris A, Ghebremichael M, Burtness B, Axelrod RS, Deconti RC, Forastiere AA. A phase 2 trial of bortezomib followed by the addition of doxorubicin at progression in patients with recurrent or metastatic adenoid cystic carcinoma of the head and neck. Cancer 2011, 117: 3374-3382. PMID: 21246525, PMCID: PMC3135694, DOI: 10.1002/cncr.25852.Peer-Reviewed Original ResearchConceptsAdenoid cystic carcinomaStable diseaseEvaluable patientsObjective responseCystic carcinomaEastern Cooperative Oncology Group performance status 0Day 1Common distant metastatic siteGrade 3 sensory neuropathyMedian progression-free survivalMetastatic adenoid cystic carcinomaGrade 3 anorexiaPerformance status 0Phase 2 trialProgression-free survivalTime of progressionSingle-agent bortezomibCombination of bortezomibDistant metastatic sitesAddition of doxorubicinMeasurable diseaseStatus 0Disease stabilizationFrequent toxicitiesPrior therapy
2003
Mature 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
1997
Dose-escalation and pharmacodynamic study of topotecan in combination with cyclophosphamide in patients with refractory cancer.
Murren JR, Anderson S, Fedele J, Pizzorno G, Belliveau D, Zelterman D, Burtness BA, Tocino I, Flynn SD, Beidler D, Cheng YC. Dose-escalation and pharmacodynamic study of topotecan in combination with cyclophosphamide in patients with refractory cancer. Journal Of Clinical Oncology 1997, 15: 148-57. PMID: 8996136, DOI: 10.1200/jco.1997.15.1.148.Peer-Reviewed Original ResearchConceptsPeripheral blood mononuclear cellsMaximum-tolerated doseMg/ m2/dDose of topotecanM2/dRefractory cancerDay 1Treatment cyclesDrug-induced DNA fragmentationGrowth factor supportTransfusion of RBCsDose of cyclophosphamideFirst treatment cycleAdministration of cyclophosphamideGranulocyte colony-stimulating factorPharmacokinetics of topotecanClass of agentsColony-stimulating factorBlood cell elementsBolus scheduleNonhematologic toxicityReversible neutropeniaDNA fragmentationFactor supportCombination therapy