2020
A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials
Amiri-Kordestani L, Xie D, Tolaney SM, Bloomquist E, Tang S, Ibrahim A, Goldberg KB, Theoret MR, Pazdur R, Sridhara R, Winer EP, Beaver JA. A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials. Annals Of Oncology 2020, 31: 1704-1708. PMID: 32866625, DOI: 10.1016/j.annonc.2020.08.2106.Peer-Reviewed Original ResearchConceptsInvasive disease-free survivalEarly breast cancerHER2-positive early breast cancerTH armOverall survivalAdjuvant paclitaxelTrastuzumab trialsReceptor statusLow-risk early breast cancerHuman epidermal growth factor receptor 2Positive early breast cancerPropensity scoreEpidermal growth factor receptor 2De-escalate therapyDisease-free survivalGrowth factor receptor 2Progesterone receptor statusSingle-arm studyEstrogen receptor statusSingle-arm trialPatient-level dataFactor receptor 2Drug Administration analysisCovariates of ageHistorical clinical trials
2013
Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction
Kansal KJ, Dominici LS, Tolaney SM, Isakoff SJ, Smith BL, Jiang W, Brock JE, Winer EP, Krop IE, Golshan M. Neoadjuvant bevacizumab: surgical complications of mastectomy with and without reconstruction. Breast Cancer Research And Treatment 2013, 141: 255-259. PMID: 24026859, DOI: 10.1007/s10549-013-2682-z.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsFemaleHumansMammaplastyMastectomyMiddle AgedNeoadjuvant TherapyNeoplasm StagingPostoperative ComplicationsTreatment OutcomeYoung AdultConceptsSurgical complicationsAC/TPostoperative complicationsComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerOverall complication rateRate of complicationsThird of patientsCohort of patientsSame healthcare systemSingle-arm trialFisher's exact testUse of BevTerms of demographicsNeoadjuvant bevacizumabNeoadjuvant therapyImplant reconstructionMastectomyNeoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction.
Kansal K, Dominici L, Tolaney S, Isakoff S, Krop I, Smith B, Jiang W, Potler H, Brock J, Winer E, Golshan M. Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction. Journal Of Clinical Oncology 2013, 31: 1100-1100. DOI: 10.1200/jco.2013.31.15_suppl.1100.Peer-Reviewed Original ResearchSurgical complicationsAC/TNeoadjuvant bevacizumabNeoadjuvant therapyComplication rateCohort 2Cohort 1Breast cancerExact testImmediate expander/implant reconstructionHER2-negative breast cancerExpander/implant reconstructionOperable breast cancerUse of bevacizumabOverall complication rateRate of complicationsThird of patientsCohort of patientsSingle-arm trialSame healthcare systemFisher's exact testTerms of demographicsNon-randomized dataPostoperative complicationsImplant reconstruction
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 surgeryComplicationsPatients
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 setting