2016
The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer
Papadimitrakopoulou V, Lee JJ, Wistuba II, Tsao AS, Fossella FV, Kalhor N, Gupta S, Byers LA, Izzo JG, Gettinger SN, Goldberg SB, Tang X, Miller VA, Skoulidis F, Gibbons DL, Shen L, Wei C, Diao L, Peng SA, Wang J, Tam AL, Coombes KR, Koo JS, Mauro DJ, Rubin EH, Heymach JV, Hong WK, Herbst RS. The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2016, 34: 3638-3647. PMID: 27480147, PMCID: PMC5065110, DOI: 10.1200/jco.2015.66.0084.Peer-Reviewed Original ResearchDisease control rateKRAS wild-type patientsMedian overall survivalProgression-free survivalWild-type patientsArm 1Overall survivalKRAS statusArm 3Lung cancerAdvanced non-small cell lung cancerNon-small cell lung cancerBiomarker-driven treatment strategiesLung Cancer Elimination (BATTLE) trialMedian progression-free survivalImproved progression-free survivalBiomarker-Integrated ApproachesReal-time biopsyPrimary end pointCell lung cancerPrior therapyUmbrella studyAdvanced NSCLCControl rateMesenchymal tumors
2012
A Multicenter Phase I Trial of PX-866, an Oral Irreversible Phosphatidylinositol 3-Kinase Inhibitor, in Patients with Advanced Solid Tumors
Hong DS, Bowles DW, Falchook GS, Messersmith WA, George GC, O'Bryant CL, Vo AC, Klucher K, Herbst RS, Eckhardt SG, Peterson S, Hausman DF, Kurzrock R, Jimeno A. A Multicenter Phase I Trial of PX-866, an Oral Irreversible Phosphatidylinositol 3-Kinase Inhibitor, in Patients with Advanced Solid Tumors. Clinical Cancer Research 2012, 18: 4173-4182. PMID: 22693357, DOI: 10.1158/1078-0432.ccr-12-0714.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overArea Under CurveDiarrheaDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleEnzyme InhibitorsFatigueFemaleGonanesHumansMaleMetabolic Clearance RateMiddle AgedMutationNauseaNeoplasmsPhosphatidylinositol 3-KinasesPhosphoinositide-3 Kinase InhibitorsTreatment OutcomeVomitingConceptsDose-limiting toxicityArm 1PX-866Stable diseaseArm 2Frequent study drug-related adverse eventsSolid tumorsStudy drug-related adverse eventsDrug-related adverse eventsMulticenter phase I trialGrade III diarrheaAdvanced solid tumorsDose-escalation studyResponse Evaluation CriteriaContinuous dosing scheduleElevated aspartate aminotransferasePhase I trialEvaluable patientsIrreversible small-molecule inhibitorAdverse eventsDosing schedulesI trialAdditional patientsGastrointestinal disordersIncurable cancer
2006
A phase II, multicenter, randomized clinical trial to evaluate the efficacy and safety of bevacizumab in combination with either chemotherapy (docetaxel or pemetrexed) or erlotinib hydrochloride compared with chemotherapy alone for treatment of recurrent or refractory non-small cell lung cancer
Fehrenbacher L, O’Neill V, Belani C, Bonomi P, Hart L, Melnyk O, Sandler A, Ramies D, Herbst R. A phase II, multicenter, randomized clinical trial to evaluate the efficacy and safety of bevacizumab in combination with either chemotherapy (docetaxel or pemetrexed) or erlotinib hydrochloride compared with chemotherapy alone for treatment of recurrent or refractory non-small cell lung cancer. Journal Of Clinical Oncology 2006, 24: 7062-7062. DOI: 10.1200/jco.2006.24.18_suppl.7062.Peer-Reviewed Original ResearchDisease progressionArm 1Single-arm phase I/II studyRefractory non-small cell lung cancerPhase I/II studyNon-small cell lung cancerRandomized phase II trialEGFR tyrosine kinase inhibitorsAnti-VEGF mAbsPlatinum-based regimenSafety of bevacizumabCombination of bevacizumabFirst-line settingNon-squamous NSCLCAdvanced stage diseaseAvailable EGFR tyrosine kinase inhibitorsPhase II trialProgression-free survivalTreatment of recurrentCell lung cancerClinical disease progressionFavorable safety profileTreatment of NSCLCTyrosine kinase inhibitorsAdenocarcinoma/
2004
Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non–small-cell lung cancer: report of a randomized comparative trial
Komaki R, Lee JS, Milas L, Lee HK, Fossella FV, Herbst RS, Allen PK, Liao Z, Stevens CW, Lu C, Zinner RG, Papadimitrakopoulou VA, Kies MS, Blumenschein GR, Pisters KM, Glisson BS, Kurie J, Kaplan B, Garza VP, Mooring D, Tucker SL, Cox JD. Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non–small-cell lung cancer: report of a randomized comparative trial. International Journal Of Radiation Oncology • Biology • Physics 2004, 58: 1369-1377. PMID: 15050312, DOI: 10.1016/j.ijrobp.2003.10.005.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAgranulocytosisAmifostineAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCisplatinCombined Modality TherapyConfidence IntervalsEtoposideFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedRadiation PneumonitisRadiation-Protective AgentsRadiotherapy DosageSurvival AnalysisTreatment OutcomeConceptsArm 2 patientsCell lung cancerArm 1 patientsLung cancerArm 1Concurrent chemotherapyNational Cancer Institute Common Toxicity CriteriaConcurrent cisplatin-based chemotherapyAbility of amifostineCommon Toxicity CriteriaCisplatin-based chemotherapyTumor-protective effectMedian survival timeEffects of amifostineAcute toxicityEsophageal toxicityNeutropenic feverOral etoposideConcurrent chemoradiotherapyHematologic toxicityMild hypotensionThoracic radiotherapyLiving patientsSevere pneumonitisTumor characteristics
2002
Randomized phase III study of chemoradiation with or without amifostine for patients with favorable performance status inoperable stage II-III non-small cell lung cancer: Preliminary results
Komaki R, Lee J, Kaplan B, Allen P, Kelly J, Liao Z, Stevens C, Fossella F, Zinner R, Papadimitrakopoulou V, Khuri F, Glisson B, Pisters K, Kurie J, Herbst R, Milas L, Ro J, Thames H, Hong W, Cox J. Randomized phase III study of chemoradiation with or without amifostine for patients with favorable performance status inoperable stage II-III non-small cell lung cancer: Preliminary results. Seminars In Radiation Oncology 2002, 12: 46-49. PMID: 11917284, DOI: 10.1053/srao.2002.31363.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerThoracic radiation therapyInoperable stage IICell lung cancerSevere esophagitisArm 2Arm 1Lung cancerDay 1Randomized phase III studyStage IIPhase III studyGy/fractionMedian survival timeLong-term efficacyOral etoposideAcute pneumonitisConcurrent chemoradiotherapyIII studyTumor characteristicsPulmonary toxicityStudy groupRadiation therapyDay 29Survival time