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 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 FOLFIRINOXA single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer
Verma N, Johung K, Kortmansky J, Zaheer W, Lacy J, Cecchini M, Stein S, Cheng Y, Lam W, Liu S, Reddy V, Hochster H, Higgins S. A single arm phase 2 clinical trial of YIV-906 with neoadjuvant concurrent chemo-radiation therapy in patients with locally advanced rectal cancer. Journal Of Gastrointestinal Oncology 2024, 15: 1050-1059. PMID: 38989411, PMCID: PMC11231844, DOI: 10.21037/jgo-24-23.Peer-Reviewed Original ResearchCombining antivascular endothelial growth factor and anti-epidermal growth factor receptor antibodies: randomized phase II study of irinotecan and cetuximab with/without ramucirumab in second-line colorectal cancer (ECOG-ACRIN E7208)
Hochster H, Catalano P, Weitz M, Mitchell E, Cohen D, O’Dwyer P, Faller B, Kortmansky J, O’Hara M, Kricher S, Lacy J, Lenz H, Verma U, Benson A. Combining antivascular endothelial growth factor and anti-epidermal growth factor receptor antibodies: randomized phase II study of irinotecan and cetuximab with/without ramucirumab in second-line colorectal cancer (ECOG-ACRIN E7208). Journal Of The National Cancer Institute 2024, djae114. PMID: 38775718, DOI: 10.1093/jnci/djae114.Peer-Reviewed Original ResearchProgression-free survivalDisease-control ratePhase 3 trialColorectal cancerAnti-VEGFAnti-VEGFRAnti-EGFRKRAS-wild type colorectal cancerPhase II study of irinotecanKRAS wild-type colorectal cancerMedian progression-free survivalRandomized phase II studyKRAS wild-type tumorsWild-type colorectal cancerAnti-VEGFR antibodiesAnti-VEGF drugsTreated with ICSecond-line treatmentStudy of irinotecanWild-type tumorsAdvanced colorectal cancerPhase 2 studyAnti-EGFR antibodiesAnti-VEGF antibodyECOG PSPembrolizumab Plus Binimetinib With or Without Chemotherapy for MSS/pMMR Metastatic Colorectal Cancer: Outcomes From KEYNOTE-651 Cohorts A, C, and E
Chen E, Kavan P, Tehfe M, Kortmansky J, Sawyer M, Chiorean E, Lieu C, Polite B, Wong L, Fakih M, Spencer K, Chaves J, Li C, Leconte P, Adelberg D, Kim R. Pembrolizumab Plus Binimetinib With or Without Chemotherapy for MSS/pMMR Metastatic Colorectal Cancer: Outcomes From KEYNOTE-651 Cohorts A, C, and E. Clinical Colorectal Cancer 2024, 23: 183-193. PMID: 38653648, DOI: 10.1016/j.clcc.2024.03.002.Peer-Reviewed Original ResearchObjective response rateMetastatic colorectal cancerCohort ACohort CCohort EDose escalationInvestigator-assessed objective response rateColorectal cancerResponse rateModified toxicity probability interval designDose reductionSafety findingsPrimary endpointPembrolizumabBinimetinibLeucovorinE. CONCLUSIONSChemotherapyPatientsCohortIrinotecanOxaliplatinCancerInterval designWeeksPembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Leconte P, Adelberg D, Chiorean E. Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D. Clinical Colorectal Cancer 2024, 23: 118-127.e6. PMID: 38762348, DOI: 10.1016/j.clcc.2024.03.001.Peer-Reviewed Original ResearchMetastatic colorectal cancerObjective response rateCohort BCohort DAdverse eventsColorectal cancerT-cell-inflamed gene expression profileInvestigator-assessed objective response ratePD-L1 combined positive scoreTreatment-related adverse eventsResponse rateCombined positive scoreDose-limiting toxicityMedian follow-upTumor mutational burdenDecreased neutrophil countPrimary end pointMismatch repair-proficientStandard of careBiomarker analysisMethods PatientsRECIST v1.1PD-L1HER2 expressionMutational burdenSystemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline Update
Gordan J, Kennedy E, Abou-Alfa G, Beal E, Finn R, Gade T, Goff L, Gupta S, Guy J, Hoang H, Iyer R, Jaiyesimi I, Jhawer M, Karippot A, Kaseb A, Kelley R, Kortmansky J, Leaf A, Remak W, Sohal D, Taddei T, Wilson Woods A, Yarchoan M, Rose M. Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline Update. Journal Of Clinical Oncology 2024, 42: 1830-1850. PMID: 38502889, DOI: 10.1200/jco.23.02745.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsAdvanced hepatocellular carcinomaSecond-line therapyFirst-line treatmentRandomized controlled trialsHepatocellular carcinomaSystemic therapyFirst-lineChild-Pugh class A liver diseaseEastern Cooperative Oncology Group performance status 0Child-Pugh class A patientsSecond-line therapy optionsFirst-line settingPerformance status 0Third-line therapyFirst-line therapyClass A patientsEvidence-based guidelinesTolerated sorafenibStatus 0A patientsMechanism of actionTherapy optionsClinical decision-makingGuideline update
2023
NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma
Cecchini M, Cleary J, Shyr Y, Chao J, Uboha N, Cho M, Shields A, Pant S, Goff L, Spencer K, Kim E, Stein S, Kortmansky J, Canosa S, Sklar J, Swisher E, Radke M, Ivy P, Boerner S, Durecki D, Hsu C, LoRusso P, Lacy J. NCI10066: a Phase 1/2 study of olaparib in combination with ramucirumab in previously treated metastatic gastric and gastroesophageal junction adenocarcinoma. British Journal Of Cancer 2023, 130: 476-482. PMID: 38135713, PMCID: PMC10844282, DOI: 10.1038/s41416-023-02534-1.Peer-Reviewed Original ResearchQuantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer
Cecchini M, Zhang J, Wei W, Sklar J, Lacy J, Zhong M, Kong Y, Zhao H, DiPalermo J, Devine L, Stein S, Kortmansky J, Johung K, Bindra R, LoRusso P, Schalper K. Quantitative DNA Repair Biomarkers and Immune Profiling for Temozolomide and Olaparib in Metastatic Colorectal Cancer. Cancer Research Communications 2023, 3: 1132-1139. PMID: 37387791, PMCID: PMC10305782, DOI: 10.1158/2767-9764.crc-23-0045.Peer-Reviewed Original ResearchConceptsWhole-exome sequencingMGMT protein expressionColorectal cancerStable diseaseQuantitative immunofluorescenceT cellsProtein expressionPromoter hypermethylationLow MGMT protein expressionPARP inhibitorsRadiographic tumor regressionMetastatic colorectal cancerAdvanced colorectal cancerPretreatment tumor biopsiesEffector T cellsTumor-infiltrating lymphocytesMGMT proteinDNA repair biomarkersBaseline CD8Eligible patientsIncreased CD8Methylguanine-DNA methyltransferaseObjective responseProgressive diseaseImmune markersPre-operative chemoradiotherapy with or without induction chemotherapy for operable locally-advanced esophageal cancer
Peters G, Talcott W, Peters N, Dhanasopan A, Lacy J, Cecchini M, Kortmansky J, Stein S, Lattanzi S, Park H, Boffa D, Johung K, Jethwa K. Pre-operative chemoradiotherapy with or without induction chemotherapy for operable locally-advanced esophageal cancer. Journal Of Gastrointestinal Oncology 2023, 14: 1181-1192. PMID: 37435226, PMCID: PMC10331751, DOI: 10.21037/jgo-22-1005.Peer-Reviewed Original ResearchProgression-free survivalMedian progression-free survivalOverall survivalIC-CRTInduction chemotherapySingle-institution retrospective cohort studyPre-operative chemoradiotherapyAdvanced esophageal cancerAdvanced esophageal carcinomaPathologic complete responseRetrospective cohort studyKaplan-Meier methodSubset of patientsProportional hazards regressionCycles of inductionAdenocarcinoma histologyCRT cohortCohort studyComplete responsePathologic responseTreatment cohortsDistant metastasisHazards regressionEsophageal cancerEsophageal carcinoma
2022
Pembrolizumab (pembro) plus binimetinib (bini) with or without chemotherapy (chemo) for metastatic colorectal cancer (mCRC): Results from KEYNOTE-651 cohorts A, C, and E.
Chen E, Kavan P, Tehfe M, Kortmansky J, Sawyer M, Chiorean E, Lieu C, Polite B, Wong L, Fakih M, Spencer K, Chaves J, Li C, Carpenter D, Leconte P, Kim R. Pembrolizumab (pembro) plus binimetinib (bini) with or without chemotherapy (chemo) for metastatic colorectal cancer (mCRC): Results from KEYNOTE-651 cohorts A, C, and E. Journal Of Clinical Oncology 2022, 40: 3573-3573. DOI: 10.1200/jco.2022.40.16_suppl.3573.Peer-Reviewed Original ResearchMetastatic colorectal cancerDose-limiting toxicityCohort ACohort ECohort CEvaluable ptsMicrosatellite stableDose levelsEnd pointDose-finding phasePrimary end pointSecondary end pointsKRAS mutation statusTotal PtCohort A.RECIST v1.1Data cutoffMulticenter trialDose escalationColorectal cancerMedian studyPembroDose reductionLimited efficacyTRAEsPembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI for metastatic colorectal cancer (CRC) in KEYNOTE-651: Long-term follow-up of cohorts B and D.
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Carpenter D, Leconte P, Chiorean E. Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI for metastatic colorectal cancer (CRC) in KEYNOTE-651: Long-term follow-up of cohorts B and D. Journal Of Clinical Oncology 2022, 40: 3521-3521. DOI: 10.1200/jco.2022.40.16_suppl.3521.Peer-Reviewed Original ResearchCohort BColorectal cancerCohort DPMMR colorectal cancerRECIST v1.1End pointExploratory end pointsPD-L1 dataSingle-arm cohortAntitumor activityManageable safety profileMetastatic colorectal cancerPrimary end pointSecondary end pointsNew safety signalsAntitumor immune responseCombination of chemotherapyKRAS mutation statusGreater antitumor activityData cutoffStarting doseNeutrophil countPrior linesInvestigator reviewSafety profile
2021
Implementing the cancer and aging research group (CARG) tool in the ambulatory oncology setting to drive informed treatment selection.
Mbewe A, Pike P, Lewis R, Kortmansky J, Chiang A, Kanowitz J. Implementing the cancer and aging research group (CARG) tool in the ambulatory oncology setting to drive informed treatment selection. Journal Of Clinical Oncology 2021, 39: 209-209. DOI: 10.1200/jco.2020.39.28_suppl.209.Peer-Reviewed Original ResearchInformed treatment selectionCARG ScoreOlder patientsGeriatric patientsTreatment selectionSolid tumorsCommunity-based oncology clinicGeriatric Oncology (SIOG) guidelinesNew chemotherapy regimenSmilow Cancer HospitalSupportive care referralsComprehensive geriatric assessmentGuideline-based careDifferent treatment regimenUnique clinical challengesQuality improvement initiativesChemotherapy toxicity riskChemotherapy riskChemotherapy startASCO guidelinesChemotherapy regimenMultiple comorbiditiesCare referralED visitsGeriatric assessmentTandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias
Branagan AR, Duffy E, Gan G, Li F, Foster C, Verma R, Zhang L, Parker TL, Seropian S, Cooper DL, Brandt D, Kortmansky J, Witt D, Ferencz TM, Dhodapkar KM, Dhodapkar MV. Tandem high-dose influenza vaccination is associated with more durable serologic immunity in patients with plasma cell dyscrasias. Blood Advances 2021, 5: 1535-1539. PMID: 33683337, PMCID: PMC7948269, DOI: 10.1182/bloodadvances.2020003880.Peer-Reviewed Original ResearchConceptsHigh-dose influenza vaccinationPlasma cell dyscrasiaInfluenza vaccinationProtective immunityCell dyscrasiaPCD patientsPlacebo-controlled clinical trialHigh-dose vaccinationHigh-dose vaccineInfluenza-specific immunityBurden of influenzaSaline placebo injectionsAge-based vaccinationHigher seroprotectionSerologic immunityPlacebo injectionsVaccine strategiesTiter responseClinical trialsFlu seasonPatientsVaccinationImmunityNovel coronavirusSeroprotection
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 antimetaboliteMargin negative resection and pathologic downstaging with multiagent chemotherapy with or without radiotherapy in patients with localized pancreas cancer: A national cancer database analysis
Miccio JA, Talcott WJ, Patel T, Park HS, Cecchini M, Salem RR, Khan SA, Stein S, Kortmansky JS, Lacy J, Narang A, Herman J, Jabbour SK, Hallemeier CL, Johung K, Jethwa KR. Margin negative resection and pathologic downstaging with multiagent chemotherapy with or without radiotherapy in patients with localized pancreas cancer: A national cancer database analysis. Clinical And Translational Radiation Oncology 2020, 27: 15-23. PMID: 33392398, PMCID: PMC7772693, DOI: 10.1016/j.ctro.2020.12.003.Peer-Reviewed Original ResearchPancreatic ductal adenocarcinomaCT3-4 diseaseMargin-negative resectionR0 resectionNon-metastatic pancreatic ductal adenocarcinomaLocalized Pancreatic Ductal AdenocarcinomaNational Cancer Database AnalysisPre-operative RTMulti-agent chemotherapyNational Cancer DatabasePathologic complete responsePre-operative radiotherapyKaplan-Meier methodCox regression analysisMultivariable associateMultiagent chemotherapyNegative resectionPathologic responseComplete responseMeier methodCurative treatmentPancreas cancerFemale sexCancer DatabaseDuctal adenocarcinomaSystemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline.
Gordan JD, Kennedy EB, Abou-Alfa GK, Beg MS, Brower ST, Gade TP, Goff L, Gupta S, Guy J, Harris WP, Iyer R, Jaiyesimi I, Jhawer M, Karippot A, Kaseb AO, Kelley RK, Knox JJ, Kortmansky J, Leaf A, Remak WM, Shroff RT, Sohal DPS, Taddei TH, Venepalli NK, Wilson A, Zhu AX, Rose MG. Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline. Journal Of Clinical Oncology 2020, 38: 4317-4345. PMID: 33197225, DOI: 10.1200/jco.20.02672.Peer-Reviewed Original ResearchConceptsAdvanced hepatocellular carcinomaFirst-line treatmentSecond-line therapyChild-Pugh classFirst-line therapyHepatocellular carcinomaSystemic therapyLiver diseaseTherapy optionsEastern Cooperative Oncology Group performance status 0Evidence-based clinical practice guidelinesSecond-line therapy optionsTyrosine kinase inhibitor sorafenibECOG PS 0Performance status 0Third-line therapyPhase IIIClinical practice guidelinesKinase inhibitor sorafenibTyrosine kinase inhibitorsAppropriate candidatesStatus 0ASCO guidelinesMost patientsPS 0259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC
Manji G, Bahary N, Chung V, Dalenc F, Ducreux M, Gomez-Roca C, Im S, Kortmansky J, Lacy J, Segal N, Tredan O, Cirovic O, DuPree K, Lenain C, Lu D, Robert L, Xu J, Zhang X, Kim S. 259 Phase Ib/II open-label, randomized evaluation of atezolizumab (atezo) + selicrelumab (seli) + gemcitabine+nab-paclitaxel (gem+nabP) or bevacizumab (bev) vs control in MORPHEUS-PDAC, -TNBC and -CRC. 2020, a157-a158. DOI: 10.1136/jitc-2020-sitc2020.0259.Peer-Reviewed Original ResearchAssociation of Neoadjuvant Treatment Modality with Negative Margin and Pathologic Downstaging in Patients Undergoing Pancreatic Cancer Resection: A National Cancer Database Analysis
Miccio J, Mokhtech M, Jabbour S, Anker C, Patel T, Park H, Cecchini M, Salem R, Kuntsman J, Stein S, Kortmansky J, Lacy J, Narang A, Herman J, Haddock M, Hallemeier C, Johung K, Jethwa K. Association of Neoadjuvant Treatment Modality with Negative Margin and Pathologic Downstaging in Patients Undergoing Pancreatic Cancer Resection: A National Cancer Database Analysis. International Journal Of Radiation Oncology • Biology • Physics 2020, 108: e662. DOI: 10.1016/j.ijrobp.2020.07.1980.Peer-Reviewed Original ResearchThe Utility of Neoadjuvant Radiotherapy after Neoadjuvant Multiagent Chemotherapy in Patients with Localized Pancreatic Cancer
Miccio J, Talcott W, Patel T, Park H, Cecchini M, Salem R, Stein S, Kortmansky J, Lacy J, Johung K, Jethwa K. The Utility of Neoadjuvant Radiotherapy after Neoadjuvant Multiagent Chemotherapy in Patients with Localized Pancreatic Cancer. International Journal Of Radiation Oncology • Biology • Physics 2020, 108: e31-e32. DOI: 10.1016/j.ijrobp.2020.02.538.Peer-Reviewed Original ResearchMulticenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome
Shah MA, Enzinger P, Ko AH, Ocean AJ, Philip PA, Thakkar PV, Cleveland K, Lu Y, Kortmansky J, Christos PJ, Zhang C, Kaur N, Elmonshed D, Galletti G, Sarkar S, Bhinder B, Pittman ME, Plotnikova OM, Kotlov N, Frenkel F, Bagaev A, Elemento O, Betel D, Giannakakou P, Lenz HJ. Multicenter Phase II Study of Cabazitaxel in Advanced Gastroesophageal Cancer: Association of HER2 Expression and M2-Like Tumor-Associated Macrophages with Patient Outcome. Clinical Cancer Research 2020, 26: 4756-4766. PMID: 32641434, PMCID: PMC8209413, DOI: 10.1158/1078-0432.ccr-19-3920.Peer-Reviewed Original ResearchMeSH KeywordsAdenocarcinomaAdultAgedAged, 80 and overEsophageal NeoplasmsEsophagogastric JunctionFemaleGene AmplificationGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMaleMiddle AgedProgression-Free SurvivalReceptor, ErbB-2Response Evaluation Criteria in Solid TumorsStomach NeoplasmsTaxoidsTumor-Associated MacrophagesConceptsProgression-free survivalMulticenter phase II studyPhase II studyPFS ratesII studyMacrophage signatureHER2 amplificationGastric cancerEfficacy targetAdvanced gastroesophageal cancerM2 macrophage signaturePrior taxane therapyCommon adverse eventsAdvanced gastric cancerMetastatic gastric cancerM2-like tumorImproved disease controlPrior therapyRECIST 1.1Taxane efficacyPrimary endpointTaxane therapyAdverse eventsGastroesophageal cancerMetastatic disease