2023
Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Johnson D, Fehrenbacher L, Novotny W, Herbst R, Nemunaitis J, Jablons D, Langer C, DeVore R, Gaudreault J, Damico L, Holmgren E, Kabbinavar F. Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer. Journal Of Clinical Oncology 2023, 41: 2305-2312. PMID: 37126944, DOI: 10.1200/jco.22.02543.Peer-Reviewed Original ResearchCell lung cancerSingle-agent bevacizumabLung cancerMajor hemoptysisCell histologyControl armResponse ratePrimary efficacy end pointNonsquamous cell histologyProminent adverse eventSafety of bevacizumabEfficacy end pointDistinct clinical patternsPhase II trialSquamous cell histologyLonger median timeHigh response rateMajor blood vesselsPreviously UntreatedStable diseaseII trialAdverse eventsControl patientsClinical patternMedian time
2013
Treatment of Stage IV Non-small Cell Lung Cancer Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines
Socinski MA, Evans T, Gettinger S, Hensing TA, Sequist L, Ireland B, Stinchcombe TE. Treatment of Stage IV Non-small Cell Lung Cancer Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST Journal 2013, 143: e341s-e368s. PMID: 23649446, PMCID: PMC4694611, DOI: 10.1378/chest.12-2361.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Non-Small-Cell LungCetuximabErlotinib HydrochlorideGlutamatesGuanineHumansLung NeoplasmsNeoplasm StagingPatient SelectionPemetrexedPlatinum CompoundsProtein Kinase InhibitorsQuinazolinesConceptsStage IV non-small cell lung cancerNon-small cell lung cancerFirst-line therapyPerformance statusNonsquamous histologyLung cancerAmerican CollegeChest Physicians Evidence-Based Clinical Practice GuidelinesEastern Cooperative Oncology Group (ECOG) PSChest Physicians Lung Cancer GuidelinesEvidence-based clinical practice guidelinesNon-small cell lung cancer diagnosisEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsCell lung cancer diagnosisReceptor tyrosine kinase inhibitorsClinical patient characteristicsLung cancer guidelinesRole of cetuximabSafety of bevacizumabThird-line settingECOG performance statusGood performance statusPlatinum-based regimensPoor performance status
2012
Safety of bevacizumab in metastatic breast cancer patients undergoing surgery Cortés J, Caralt M, Delaloge S, et al (Vall d'Hebron Univ Hosp, Barcelona, Spain; Institut Gustave Roussy, Villejuif Cedex, France; et al) Eur J Cancer 48:475-481, 2012§
Dominici L, Golshan M. Safety of bevacizumab in metastatic breast cancer patients undergoing surgery Cortés J, Caralt M, Delaloge S, et al (Vall d'Hebron Univ Hosp, Barcelona, Spain; Institut Gustave Roussy, Villejuif Cedex, France; et al) Eur J Cancer 48:475-481, 2012§. Breast Diseases A Year Book Quarterly 2012, 23: 351-352. DOI: 10.1016/j.breastdis.2012.09.015.Peer-Reviewed Original ResearchMetastatic breast cancer patientsSafety of bevacizumabBreast cancer patientsCancer patientsBevacizumab
2010
Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery?
Golshan M, Garber JE, Gelman R, Tung N, Smith BL, Troyan S, Greenberg CC, Winer EP, Ryan P. Does Neoadjuvant Bevacizumab Increase Surgical Complications in Breast Surgery? Annals Of Surgical Oncology 2010, 18: 733-737. PMID: 20882415, DOI: 10.1245/s10434-010-1366-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsChemotherapy, AdjuvantCisplatinCombined Modality TherapyFemaleHumansMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm StagingPostoperative ComplicationsReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneSentinel Lymph Node BiopsySurvival RateTreatment OutcomeConceptsTriple-negative breast cancerSingle-arm trialNeoadjuvant cisplatinPostoperative complicationsBreast cancerTwo-sided Fisher's exact testExpander/implantsSafety of bevacizumabOperable breast cancerDefinitive local therapyBreast cancer surgeryNegative breast cancerFisher's exact testBackgroundNeoadjuvant chemotherapyNeoadjuvant settingNeoadjuvant therapyProtocol therapySurgical complicationsLocal therapyRelated complicationsCancer surgeryCisplatin therapyBreast surgeryComplicationsPatientsEfficacy and safety of bevacizumab in active brain metastases from non-small cell lung cancer
De Braganca KC, Janjigian YY, Azzoli CG, Kris MG, Pietanza MC, Nolan CP, Omuro AM, Holodny AI, Lassman AB. Efficacy and safety of bevacizumab in active brain metastases from non-small cell lung cancer. Journal Of Neuro-Oncology 2010, 100: 443-447. PMID: 20440540, PMCID: PMC3246379, DOI: 10.1007/s11060-010-0200-2.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerActive brain metastasesInitiation of bevacizumabSafety of bevacizumabProgression-free survivalBrain metastasesCell lung cancerCNS metastasisOverall survivalLung cancerCentral nervous system metastasesMedian progression-free survivalAccelerated FDA approvalActive CNS metastasesParenchymal brain metastasesProgressive brain metastasesMedian overall survivalNervous system metastasesAdditional safety dataPrimary brain tumorsHigh response rateIntra-tumoral hemorrhageBevacizumab safetyConcurrent anticoagulationCorticosteroid requirements
2009
Surgical Complications and the Use of Neoadjuvant Bevacizumab.
Golshan M, Garber J, Gelman R, Tung N, Smith B, Troyan S, Greenberg C, Winer E, Ryan P. Surgical Complications and the Use of Neoadjuvant Bevacizumab. Cancer Research 2009, 69: 43-43. DOI: 10.1158/0008-5472.sabcs-09-43.Peer-Reviewed Original ResearchTriple-negative breast cancerDefinitive local therapyPhase II trialPostoperative complicationsNeoadjuvant cisplatinDefinitive surgeryII trialWound breakdownLocal therapyMedian ageBreast cancerSingle-arm phase II trialArm phase II trialTwo-sided Fisher's exact testClinical stage IIDose-dense ACSafety of bevacizumabOperable breast cancerBreast cancer surgerySingle-arm trialNegative breast cancerFisher's exact testCycles cisplatinNeoadjuvant bevacizumabNeoadjuvant setting9006 Safety of bevacizumab (BV) combined with chemotherapy (CTX) in patients (pts) with non-small cell lung cancer (NSCLC): interim results from the ARIES Lung observational cohort study (OCS)
Jahanzeb M, Fischbach N, Kosty M, Kumar P, Spigel D, Wozniak A, Teng S, Wang L, Sing A, Lynch T. 9006 Safety of bevacizumab (BV) combined with chemotherapy (CTX) in patients (pts) with non-small cell lung cancer (NSCLC): interim results from the ARIES Lung observational cohort study (OCS). European Journal Of Cancer Supplements 2009, 7: 507. DOI: 10.1016/s1359-6349(09)71719-7.Peer-Reviewed Original ResearchPreliminary safety and effectiveness of bevacizumab (BV) based treatment in subpopulations of patients (pts) with non-small cell lung cancer (NSCLC) from the ARIES study: A bevacizumab (BV) treatment observational cohort study (OCS)
Fischbach N, Spigel D, Brahmer J, Garst J, Robles R, Chung C, Wang L, Sing A, Lynch T. Preliminary safety and effectiveness of bevacizumab (BV) based treatment in subpopulations of patients (pts) with non-small cell lung cancer (NSCLC) from the ARIES study: A bevacizumab (BV) treatment observational cohort study (OCS). Journal Of Clinical Oncology 2009, 27: 8040-8040. DOI: 10.1200/jco.2009.27.15_suppl.8040.Peer-Reviewed Original ResearchNon-small cell lung cancerObservational cohort studyAdverse eventsClinical outcomesNSCLC ptsAdvanced non-small cell lung cancerARIES observational cohort studyMedian f/uAnti-VEGF monoclonal antibodyKey safety outcomeProtocol-specified treatmentSafety of bevacizumabCarboplatin/paclitaxelSerious adverse eventsPhase III trialsEffectiveness of bevacizumabCell lung cancerSubpopulation of patientsCohort sizePoor PSBrain metastasesChemotherapy regimenBaseline characteristicsCohort studyIII trialsSafety of bevacizumab (B) and erlotinib (E) therapy in patients (pts) with treated brain metastases (mets) in the phase III, placebo (P)-controlled, randomized BeTa trial for pts with advanced non-small cell lung cancer (NSCLC) after failure of standard first-line chemotherapy
Otterson G, O’Connor P, Lin M, Herbst R. Safety of bevacizumab (B) and erlotinib (E) therapy in patients (pts) with treated brain metastases (mets) in the phase III, placebo (P)-controlled, randomized BeTa trial for pts with advanced non-small cell lung cancer (NSCLC) after failure of standard first-line chemotherapy. Journal Of Clinical Oncology 2009, 27: e19025-e19025. DOI: 10.1200/jco.2009.27.15_suppl.e19025.Peer-Reviewed Original ResearchNon-small cell lung cancerBrain metsBrain metastasesAdverse eventsTreatment durationAdvanced non-small cell lung cancerAdvanced stage non-small cell lung cancerStage non-small cell lung cancerEpidermal growth factor receptor-targeted therapyLung StudyNervous system adverse eventsStandard first-line chemotherapyWhole-brain radiation therapySafety of bevacizumabSubset of ptsCarboplatin/paclitaxelFirst-line chemotherapyMedian treatment durationAcceptable safety profileAdvanced NSCLC patientsBrain radiation therapyFirst-line treatmentNew safety signalsSubset of patientsReceptor-targeted therapy
2007
Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Chemotherapy or Erlotinib Compared With Chemotherapy Alone for Treatment of Recurrent or Refractory Non–Small-Cell Lung Cancer
Herbst RS, O'Neill VJ, Fehrenbacher L, Belani CP, Bonomi PD, Hart L, Melnyk O, Ramies D, Lin M, Sandler A. Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Chemotherapy or Erlotinib Compared With Chemotherapy Alone for Treatment of Recurrent or Refractory Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2007, 25: 4743-4750. PMID: 17909199, DOI: 10.1200/jco.2007.12.3026.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdenocarcinoma, Bronchiolo-AlveolarAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarcinoma, Large CellCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDocetaxelErlotinib HydrochlorideFemaleGlutamatesGuanineHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPemetrexedQuinazolinesSurvival RateTaxoidsTreatment OutcomeConceptsProgression-free survivalAdverse eventsLung cancerHumanized anti-vascular endothelial growth factor monoclonal antibodyRefractory non-small cell lung cancerAnti-vascular endothelial growth factor monoclonal antibodyEpidermal growth factor receptor tyrosine kinase inhibitorsGrowth factor receptor tyrosine kinase inhibitorsNon-small cell lung cancerSingle-arm phase IRandomized phase II trialOne-year survival rateReceptor tyrosine kinase inhibitorsFatal pulmonary hemorrhagePlatinum-based regimenSafety of bevacizumabStudies of bevacizumabUnexpected safety signalsPhase II studySecond-line settingPhase II trialTreatment of recurrentCell lung cancerFactor monoclonal antibodyFavorable safety profile
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
Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F. Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer. Journal Of Clinical Oncology 2004, 22: 2184-2191. PMID: 15169807, DOI: 10.1200/jco.2004.11.022.Peer-Reviewed Original ResearchConceptsCell lung cancerSingle-agent bevacizumabLung cancerMajor hemoptysisCell histologyControl armResponse ratePrimary efficacy end pointNonsquamous cell histologyProminent adverse eventSafety of bevacizumabEfficacy end pointDistinct clinical patternsPhase II trialSquamous cell histologyLonger median timeHigh response rateMajor blood vesselsPreviously UntreatedStable diseaseII trialAdverse eventsControl patientsClinical patternMedian time
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