2024
Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer
Cecchini M, Salem R, Robert M, Czerniak S, Blaha O, Zelterman D, Rajaei M, Townsend J, Cai G, Chowdhury S, Yugawa D, Tseng R, Arbelaez C, Jiao J, Shroyer K, Thumar J, Kortmansky J, Zaheer W, Fischbach N, Persico J, Stein S, Khan S, Cha C, Billingsley K, Kunstman J, Johung K, Wiess C, Muzumdar M, Spickard E, Aushev V, Laliotis G, Jurdi A, Liu M, Escobar-Hoyos L, Lacy J. Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer. JAMA Oncology 2024, 10: 1027-1035. PMID: 38900452, PMCID: PMC11190830, DOI: 10.1001/jamaoncol.2024.1575.Peer-Reviewed Original ResearchProgression-free survivalPancreatic ductal adenocarcinomaOverall survivalCtDNA levelsPhase 2 nonrandomized controlled trialAnalysis of circulating tumor DNAMedian progression-free survivalResectable pancreatic ductal adenocarcinomaControlled trialsAssess surgical candidacyBaseline ctDNA levelModified 5-fluorouracilResectable pancreatic cancerPancreatic protocol computed tomographyAssociated with recurrenceTumor molecular featuresAggressive malignant tumorKaplan-Meier estimatesRandomized clinical trialsStandard of careCtDNA-positivePreoperative cyclesNonrandomized controlled trialsUnresectable diseaseModified FOLFIRINOXImpact of semaglutide and tirzepatide administration on weight in women with stage I-III breast cancer.
Fischbach N, Zhou B, Deng Y, Parsons K, Shelton A, Lustberg M. Impact of semaglutide and tirzepatide administration on weight in women with stage I-III breast cancer. Journal Of Clinical Oncology 2024, 42: e24140-e24140. DOI: 10.1200/jco.2024.42.16_suppl.e24140.Peer-Reviewed Original ResearchStage I-III breast cancerI-III breast cancerAdverse breast cancer outcomesBreast cancerMaximal weight lossMean weight lossBreast cancer survivorsDistant breast cancer recurrenceGLP-1 agonistsBreast cancer outcomesStage distributionClinically meaningful weight lossBreast cancer recurrenceWeight loss maintenanceUntreated patientsCancer survivorsMeasures regression analysisIncidence of diabetesWeight lossTreated patientsRetrospective analysisHealth NetworkMental healthCancer outcomesGLP-1Using an AI trial screening tool to assess language as a barrier for enrollment of underrepresented minorities in cancer clinical trials.
Corvese L, Weiss C, Huie S, Zhou B, Deng Y, Gong G, Kunz P, Fischbach N. Using an AI trial screening tool to assess language as a barrier for enrollment of underrepresented minorities in cancer clinical trials. Journal Of Clinical Oncology 2024, 42: e13586-e13586. DOI: 10.1200/jco.2024.42.16_suppl.e13586.Peer-Reviewed Original ResearchClinical trialsCancer clinical trialsTrial enrollmentPercentage of patientsYale Cancer CenterClinical trial enrollmentLimitations of clinical trialsTreating providersEnrolling patientsCancer CenterUnique patientsBreast programPatientsPatient-matchedEnrollment ratesStudy-related activitiesScreening toolTrial participantsTrialsCancerOffice staffClinicEnrollmentLanguage barriersNon-English
2023
Prognostic impact of reduced HER2 protein expression in post-neoadjuvant therapy resection specimens: A single institution experience and review of the literature
Mogica J, Tang H, Liang Y, Zhong M, Hui P, Harigopal M, Krishnamurti U, Fischbach N, Zhan H. Prognostic impact of reduced HER2 protein expression in post-neoadjuvant therapy resection specimens: A single institution experience and review of the literature. The Breast 2023, 72: 103586. PMID: 37812963, PMCID: PMC10568274, DOI: 10.1016/j.breast.2023.103586.Peer-Reviewed Original ResearchConceptsHER2 IHC 3Human epidermal growth factor receptor 2Kaplan-Meier survival analysisHER2-IHC expressionPathologic complete responseResidual diseaseIHC 3Breast cancerIHC expressionSurvival analysisSuperior disease-free survivalEpidermal growth factor receptor 2Intensive adjuvant therapyPost-therapy surveillanceYale Cancer CenterDisease-free survivalGrowth factor receptor 2Recurrence-free survivalSingle institution experienceLow recurrence rateFactor receptor 2HER2 protein expressionAdjuvant trialsNeoadjuvant treatmentAdjuvant therapyMetastatic breast cancer (MBC) with ultra-high tumor mutational burden (UHTMB): A comprehensive genomic profiling (CGP) study.
Fanucci K, Lustberg M, Fischbach N, Pelletier M, Sivapiragasam A, Ashok Kumar P, Kallem M, Danziger N, Sokol E, Sivakumar S, Pavlick D, Ross J, Pusztai L. Metastatic breast cancer (MBC) with ultra-high tumor mutational burden (UHTMB): A comprehensive genomic profiling (CGP) study. Journal Of Clinical Oncology 2023, 41: 1036-1036. DOI: 10.1200/jco.2023.41.16_suppl.1036.Peer-Reviewed Original ResearchMetastatic breast cancerLobular histologyBreast cancerHER2 IHCGenomic alterationsComprehensive genomic profiling studyPD-L1 gene amplificationImmune checkpoint inhibitor treatmentMicrosatellite instabilityAxillary LN metastasisMetastatic site biopsySubset of ptsStage IV diseaseCheckpoint inhibitor treatmentPD-L1 expressionTumor mutational burdenMutations/MbMSI-high statusHER2 IHC resultsGenomic profiling studiesSite biopsiesSP142 assayLN metastasisMetastatic diseaseHigh TMBDecreased HER2 expression in residual disease following neoadjuvant therapy in patients with HER2-positive breast cancer.
Paredes Mogica J, Tang H, Fischbach N, Zhan H. Decreased HER2 expression in residual disease following neoadjuvant therapy in patients with HER2-positive breast cancer. Journal Of Clinical Oncology 2023, 41: e12621-e12621. DOI: 10.1200/jco.2023.41.16_suppl.e12621.Peer-Reviewed Original ResearchNeo-adjuvant therapyKaplan-Meier survival analysisHER2 IHC 3Pathologic complete responseResidual diseaseBreast cancerHER2 expressionAdjuvant therapyNeoadjuvant therapyEpidermal growth factor receptor 2 overexpressionHuman epidermal growth factor receptor 2 (HER2) overexpressionSurvival analysisHER2-positive breast cancerAggressive adjuvant therapyHER2-IHC expressionPost-therapy surveillanceResidual invasive tumorTrastuzumab/pertuzumabYale Cancer CenterRecurrence-free survivalBreast cancer outcomesAdo-trastuzumab emtansineLow recurrence rateStandard of careAssociation of pre
2022
Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC.
Foldi J, Kahn A, Silber A, Qing T, Reisenbichler E, Fischbach N, Persico J, Adelson K, Katoch A, Chagpar A, Park T, Blanchard A, Blenman K, Rimm DL, Pusztai L. Clinical Outcomes and Immune Markers by Race in a Phase I/II Clinical Trial of Durvalumab Concomitant with Neoadjuvant Chemotherapy in Early-Stage TNBC. Clinical Cancer Research 2022, 28: 3720-3728. PMID: 35903931, PMCID: PMC9444984, DOI: 10.1158/1078-0432.ccr-22-0862.Peer-Reviewed Original ResearchConceptsImmune-related adverse eventsTriple-negative breast cancerNon-AA patientsEvent-free survivalPhase I/II clinical trialsClinical trialsNeoadjuvant chemotherapyOverall survivalAA patientsEarly-stage triple-negative breast cancerIncidence of irAEsPathologic complete response rateSignificant associationMultivariate logistic regression analysisTumor-infiltrating lymphocyte countsComplete response ratePrimary efficacy endpointPD-L1 statusProportional hazards modelLogistic regression analysisAfrican American womenEFS ratesNeoadjuvant immunotherapyEfficacy endpointAdverse eventsThe mutational profile of ER-, PR+, HER2- metastatic breast cancer.
Fischbach N, Huang R, Lustberg M, Pelletier M, Pusztai L, Sivakumar S, Sokol E, Ross J, Levy M. The mutational profile of ER-, PR+, HER2- metastatic breast cancer. Journal Of Clinical Oncology 2022, 40: 1025-1025. DOI: 10.1200/jco.2022.40.16_suppl.1025.Peer-Reviewed Original ResearchTriple-negative breast cancerComprehensive genomic profilingMetastatic breast cancerBreast cancerClinical trialsPathology reportsMutational profileHER2- metastatic breast cancerConsecutive breast cancersAnti-estrogen therapyNegative breast cancerPD-L1 IHCPotential therapeutic implicationsHigh rateEndocrine therapyEstrogen therapyPatient ageFoundation MedicineKRAS alterationsRare subtypeHER2 expressionClinical behaviorReceptor phenotypeBreast carcinomaTreatment strategiesClinical outcomes and immune markers by race in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage TNBC.
Foldi J, Kahn A, Silber A, Qing T, Reisenbichler E, Fischbach N, Persico J, Adelson K, Katoch A, Chagpar A, Park T, Blanchard A, Blenman K, Rimm D, Pusztai L. Clinical outcomes and immune markers by race in a phase I/II clinical trial of durvalumab concomitant with neoadjuvant chemotherapy in early-stage TNBC. Journal Of Clinical Oncology 2022, 40: 516-516. DOI: 10.1200/jco.2022.40.16_suppl.516.Peer-Reviewed Original ResearchImmune-related adverse eventsTriple-negative breast cancerMultivariate logistic regression analysisPD-L1 statusLogistic regression analysisAA raceOverall survivalPathologic responseClinical trialsBreast cancerEarly-stage triple-negative breast cancerIncidence of irAEsPhase I/II trialPathologic complete response rateSignificant associationPhase I/II clinical trialsBaseline body mass indexSafety of immunotherapyWeekly nab-paclitaxelCharlson Comorbidity IndexComplete response ratePrimary efficacy endpointPD-L1 expressionBody mass indexBreast cancer recurrenceAuthor Correction: Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer
Foldi J, Silber A, Reisenbichler E, Singh K, Fischbach N, Persico J, Adelson K, Katoch A, Horowitz N, Lannin D, Chagpar A, Park T, Marczyk M, Frederick C, Burrello T, Ibrahim E, Qing T, Bai Y, Blenman K, Rimm DL, Pusztai L. Author Correction: Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer. Npj Breast Cancer 2022, 8: 17. PMID: 35115541, PMCID: PMC8814070, DOI: 10.1038/s41523-022-00392-3.Peer-Reviewed Original Research
2021
Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer
Foldi J, Silber A, Reisenbichler E, Singh K, Fischbach N, Persico J, Adelson K, Katoch A, Horowitz N, Lannin D, Chagpar A, Park T, Marczyk M, Frederick C, Burrello T, Ibrahim E, Qing T, Bai Y, Blenman K, Rimm DL, Pusztai L. Neoadjuvant durvalumab plus weekly nab-paclitaxel and dose-dense doxorubicin/cyclophosphamide in triple-negative breast cancer. Npj Breast Cancer 2021, 7: 9. PMID: 33558513, PMCID: PMC7870853, DOI: 10.1038/s41523-021-00219-7.Peer-Reviewed Original ResearchStromal tumor-infiltrating lymphocytesWeekly nab-paclitaxelTriple-negative breast cancerPD-L1Nab-paclitaxelAdverse eventsBreast cancerGrade 3/4 treatment-related adverse eventsPhase I/II trialGrade 3/4 adverse eventsTreatment-related adverse eventsDoxorubicin/cyclophosphamidePhase II studyGuillain-Barre syndromeMononuclear inflammatory cellsPathologic complete responseTumor-infiltrating lymphocytesTumor cell stainingEvaluable patientsNeoadjuvant durvalumabSP263 antibodyII trialNeoadjuvant chemotherapyNeoadjuvant therapyPrimary endpoint
2020
A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer
Cecchini M, Kortmansky JS, Cui C, Wei W, Thumar JR, Uboha NV, Hafez N, Lacy J, Fischbach NA, Sabbath KD, Gomez CM, Sporn JR, Stein S, Hochster HS. A phase 1b expansion study of TAS‐102 with oxaliplatin for refractory metastatic colorectal cancer. Cancer 2020, 127: 1417-1424. PMID: 33351187, PMCID: PMC8085021, DOI: 10.1002/cncr.33379.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDrug Administration ScheduleDrug CombinationsDrug Resistance, NeoplasmFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinProgression-Free SurvivalPyrrolidinesResponse Evaluation Criteria in Solid TumorsThymineTrifluridineConceptsMetastatic colorectal cancerOverall response rateRefractory metastatic colorectal cancerProgression-free survivalTAS-102Colorectal cancerDay 1Primary endpointOverall survivalDose escalationDay 5Median progression-free survivalPhase 1b studyMedian overall survivalResponse Evaluation CriteriaTreat populationDose expansionPartial responseStandard dosesUnexpected side effectsStudy treatmentTumor shrinkageUnexpected toxicitiesSide effectsNovel antimetabolite
2019
A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC).
Cecchini M, Kortmansky J, Lacy J, Fischbach N, Thumar J, Sabbath K, Gomez C, Sporn J, Stein S, Hochster H. A phase I study of TAS-102 in combination with oxaliplatin (TAS-OX) for refractory metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2019, 37: 630-630. DOI: 10.1200/jco.2019.37.4_suppl.630.Peer-Reviewed Original ResearchDisease control rateMetastatic colorectal cancerTAS-102Progressive diseaseDay 1Thymidine phosphorylase inhibitorRefractory metastatic colorectal cancerDose-escalating studyECOG PS 0Phase II doseEfficacy of oxaliplatinUsual laboratory parametersEligible patientsEvaluable patientsMeasurable diseaseUnexpected AEsStarting doseTreatment discontinuationPS 0Improved survivalLaboratory parametersOral combinationColorectal cancerPatient populationControl rate
2018
Bullous disorders associated with anti–PD-1 and anti–PD-L1 therapy: A retrospective analysis evaluating the clinical and histopathologic features, frequency, and impact on cancer therapy
Siegel J, Totonchy M, Damsky W, Berk-Krauss J, Castiglione F, Sznol M, Petrylak DP, Fischbach N, Goldberg SB, Decker RH, Stamatouli AM, Hafez N, Glusac EJ, Tomayko MM, Leventhal JS. Bullous disorders associated with anti–PD-1 and anti–PD-L1 therapy: A retrospective analysis evaluating the clinical and histopathologic features, frequency, and impact on cancer therapy. Journal Of The American Academy Of Dermatology 2018, 79: 1081-1088. PMID: 30025829, DOI: 10.1016/j.jaad.2018.07.008.Peer-Reviewed Original ResearchMeSH KeywordsAdrenal Cortex HormonesAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenDrug EruptionsFemaleHumansLichenoid EruptionsMaleMiddle AgedNeoplasm ProteinsNeoplasmsNivolumabPemphigoid, BullousProgrammed Cell Death 1 ReceptorRetrospective StudiesSkin Diseases, VesiculobullousTertiary Care CentersTreatment OutcomeConceptsPD-L1 therapyAnti-PD-1/PD-L1 therapyBullous disordersBullous eruptionPD-1/PD-L1 therapyCell death ligand-1 therapyAnti-programmed cell death 1Cancer therapyDeath ligand 1 therapySingle tertiary care centerLinear IgA bullous dermatosisYale-New Haven HospitalDistinct therapeutic challengesInterruption of immunotherapyPositive tumor responseSteroid-sparing agentTertiary care centerIgA bullous dermatosisCell death 1New Haven HospitalStable diseaseSystemic corticosteroidsSystemic steroidsMaintenance therapyL1 therapy
2017
Pathologic complete response (pCR) rates after neoadjuvant pertuzumab (P) and trastuzumab (H) administered concomitantly with weekly paclitaxel (T) and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) chemotherapy for clinical stage I-III HER2-positive breast cancer.
Foldi J, Mougalian S, Silber A, Lannin D, Killelea B, Chagpar A, Horowitz N, Frederick C, Rispoli L, Abu-Khalaf M, Sabbath K, Sanft T, Fischbach N, Brandt D, Hofstatter E, DiGiovanna M, Pusztai L. Pathologic complete response (pCR) rates after neoadjuvant pertuzumab (P) and trastuzumab (H) administered concomitantly with weekly paclitaxel (T) and 5-fluorouracil/epirubicin/cyclophosphamide (FEC) chemotherapy for clinical stage I-III HER2-positive breast cancer. Journal Of Clinical Oncology 2017, 35: 577-577. DOI: 10.1200/jco.2017.35.15_suppl.577.Peer-Reviewed Original ResearchPathologic complete response rateHER2-positive breast cancerDual HER2 blockadeComplete response ratePCR rateEstrogen receptorHER2 blockadeBreast cancerStage IResponse rateGrade 3/4 adverse eventsSymptomatic congestive heart failureClinical stage ICompletion of chemotherapyPhase II studyTaxane-based chemotherapyCongestive heart failureEfficacy of anthracyclinesPositive breast cancerNormal cardiac functionEntire treatment durationER cohortER- cancersNeoadjuvant pertuzumabWeekly paclitaxelPhase II Study of Modified FOLFOX6 With Bevacizumab in Metastatic Gastroesophageal Adenocarcinoma
Li J, Yao X, Kortmansky JS, Fischbach NA, Stein S, Deng Y, Zhang Y, Doddamane I, Karimeddini D, Hochster HS, Lacy J. Phase II Study of Modified FOLFOX6 With Bevacizumab in Metastatic Gastroesophageal Adenocarcinoma. American Journal Of Clinical Oncology 2017, 40: 146-151. PMID: 25144267, DOI: 10.1097/coc.0000000000000114.Peer-Reviewed Original ResearchConceptsMetastatic gastroesophageal adenocarcinomaProgression-free survivalGastroesophageal adenocarcinomaOverall survivalTreatment-related grade 3/4 toxicityResponse rateMedian progression-free survivalProspective phase II trialLonger progression-free survivalCisplatin-based regimensConfirmed response rateEfficacy of bevacizumabFirst-line bevacizumabOxaliplatin-based regimenUntreated metastatic adenocarcinomaGrade 3/4 toxicitiesMedian overall survivalAddition of bevacizumabPhase II studyPhase II trialModified FOLFOX6GI perforationHemorrhagic eventsII trialII study
2015
Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC).
James E, Cong X, Yao X, Hahn C, Kaley K, Li J, Kortmansky J, Fischbach N, Cha C, Salem R, Stein S, Hochster H, Lacy J. Final analysis of a phase II study of Yale-modified FOLFIRINOX (mFOLFIRINOX) in metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2015, 33: 395-395. DOI: 10.1200/jco.2015.33.3_suppl.395.Peer-Reviewed Original ResearchMetastatic pancreatic cancerResponse rateProphylactic pegfilgrastimEntire cohortPhase II open-label studyFinal analysisECOG PS 0ECOG PS 0/1Grade 3/4 toxicitiesOpen-label studyPhase II studyBolus 5FUPS 0/1Febrile neutropeniaLAPC patientsPeritoneal diseaseII studyPS 0Surgical resectionUnacceptable toxicityImproved tolerabilityPeripheral neuropathyMetastatic sitesPancreatic cancerFOLFIRINOX
2014
Safety and Effectiveness of Bevacizumab-Containing Treatment for Non–Small-Cell Lung Cancer: Final Results of the ARIES Observational Cohort Study
Lynch TJ, Spigel DR, Brahmer J, Fischbach N, Garst J, Jahanzeb M, Kumar P, Vidaver RM, Wozniak AJ, Fish S, Flick ED, Leon L, Hazard SJ, Kosty MP, Investigators O. Safety and Effectiveness of Bevacizumab-Containing Treatment for Non–Small-Cell Lung Cancer: Final Results of the ARIES Observational Cohort Study. Journal Of Thoracic Oncology 2014, 9: 1332-1339. PMID: 25122429, DOI: 10.1097/jto.0000000000000257.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDrug Therapy, CombinationEuropeFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedProspective StudiesSurvival RateTime FactorsTreatment OutcomeUnited StatesVascular Endothelial Growth Factor AConceptsTrial of bevacizumabObservational cohort studyCell lung cancerCohort studyLung cancerARIES observational cohort studyBevacizumab-associated adverse eventsMedian progression-free survivalProspective observational cohort studyReal-world patient populationRecombinant humanized monoclonal antibodyFirst-line bevacizumabProtocol-defined treatmentMedian overall survivalProgression-free survivalEffectiveness of bevacizumabCommunity-based populationHumanized monoclonal antibodyVascular endothelial growth factorEndothelial growth factorSquamous histologyAdvanced NSCLCChemotherapy regimenMetastatic NSCLCAdverse eventsAre Amended Surgical Pathology Reports Getting to the Correct Responsible Care Provider?
Parkash V, Domfeh A, Cohen P, Fischbach N, Pronovost M, Haines GK, Gershkovich P. Are Amended Surgical Pathology Reports Getting to the Correct Responsible Care Provider? American Journal Of Clinical Pathology 2014, 142: 58-63. PMID: 24926086, DOI: 10.1309/ajcpy55evinjclgx.Peer-Reviewed Original ResearchConceptsCare providersTumor board discussionChart reviewPatient chartsPhysician chartsElectronic health record systemsPatient referralMalignant diagnosisErroneous managementSurgical pathologyHealth record systemsClinical teamOriginal diagnosisDiagnostic changesPhysiciansNew physiciansReport reviewPatientsRecord systemReferralDiagnosisEMR systemBoard discussionsDelivery systemReviewInterim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC).
James E, Yao X, Cong X, Li J, Hahn C, Kaley K, Kortmansky J, Fischbach N, Chang B, Salem R, Cha C, Stein S, Hochster H, Lacy J. Interim analysis of a phase II study of dose-modified FOLFIRINOX (mFOLFIRINOX) in locally advanced (LAPC) and metastatic pancreatic cancer (MPC). Journal Of Clinical Oncology 2014, 32: e15226-e15226. DOI: 10.1200/jco.2014.32.15_suppl.e15226.Peer-Reviewed Original Research