2024
A 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 Research
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
Multiagent Chemotherapy Followed by Stereotactic Body Radiotherapy Versus Conventional Radiotherapy for Resected Pancreas Cancer
Mokhtech M, Miccio JA, Johung K, Cecchini M, Stein S, Narang AK, Herman JM, Kunstman J, Haddock MG, Anker CJ, Jabbour S, Hallemeier CL, Jethwa KR. Multiagent Chemotherapy Followed by Stereotactic Body Radiotherapy Versus Conventional Radiotherapy for Resected Pancreas Cancer. American Journal Of Clinical Oncology 2022, 45: 450-457. PMID: 36318696, DOI: 10.1097/coc.0000000000000947.Peer-Reviewed Original ResearchConceptsPancreatic ductal adenocarcinomaMultiagent chemotherapyPathologic complete responseStereotactic body radiotherapyOverall survivalComplete responseNonmetastatic pancreatic ductal adenocarcinomaNeoadjuvant multiagent chemotherapyMedian overall survivalNational Cancer DatabaseMargin-negative resectionTreatment of choiceDose/fractionSimilar ratesRegional lymphatic diseaseGy/5 fxNeoadjuvant radiotherapyCox analysisSurgical candidacyProspective evaluationPathologic outcomesBody radiotherapyPancreas cancerCancer DatabaseDuctal adenocarcinoma
2021
Emerging Role of Immune Therapy in HCC
Stein S. Emerging Role of Immune Therapy in HCC. Digestive Disease Interventions 2021, 05: 277-282. DOI: 10.1055/s-0041-1722932.Peer-Reviewed Original ResearchTyrosine kinase inhibitorsHepatocellular carcinomaImmune therapySingle-agent PD-1 inhibitionVascular endothelial growth factor inhibitionMultiple tyrosine kinase inhibitorAbstract Hepatocellular carcinomaPrevalent cancer diagnosesUnprecedented response ratesPD-1 inhibitionAdvanced hepatocellular carcinomaGrowth factor inhibitionAdvanced diseaseDurable responsesPD-1Combination therapyTreatment optionsFactor inhibitionResponse rateTherapy drugsPatientsKinase inhibitorsTherapyCancer diagnosisModest improvementA phase II study of atezolizumab (ATEZO) and bevacizumab (Bev) in combination with Y90 TARE in patients (Pts) with hepatocellular carcinoma (HCC).
He A, Kim A, Toskich B, Mody K, Kim K, Stein S, Goyal L, Abrams T, Brown D, Goff L, Kim R, Parikh N, Sandow T, Johnson D, Iyer R, Petroziello M, Krishnamurthi S, Martin C, Jiang Y, Akhter N. A phase II study of atezolizumab (ATEZO) and bevacizumab (Bev) in combination with Y90 TARE in patients (Pts) with hepatocellular carcinoma (HCC). Journal Of Clinical Oncology 2021, 39: tps358-tps358. DOI: 10.1200/jco.2021.39.3_suppl.tps358.Peer-Reviewed Original ResearchPhase II studyProgression-free survivalHepatocellular carcinomaII studyArm BTARE treatmentBCLC stage B hepatocellular carcinomaAntitumor T-cell activityStage B hepatocellular carcinomaRandomized phase II studyMyeloid-derived suppressor cellsPD-L1 expression levelsIntermediate-stage hepatocellular carcinomaT cell receptor repertoireB hepatocellular carcinomaIntermediate-stage HCCMain secondary objectivesFirst-line treatmentPretreatment liver biopsyRegulatory T cellsT cell infiltrationAdvanced hepatocellular carcinomaDendritic cell maturationT cell activityPatient-reported outcomes
2020
Association 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 ResearchP-324 Advanced hepatocellular cancer: Current systemic treatment sequencing and outcomes in the United States
Uhlig J, Stein S, Kim H. P-324 Advanced hepatocellular cancer: Current systemic treatment sequencing and outcomes in the United States. Annals Of Oncology 2020, 31: s195. DOI: 10.1016/j.annonc.2020.04.406.Peer-Reviewed Original ResearchMicrosatellite instability and KRAS mutation in stage 4 CRC: Prevalence, geographic discrepancies and outcomes from the National Cancer Database.
Uhlig J, Cecchini M, Stein S, Lacy J, Kim K. Microsatellite instability and KRAS mutation in stage 4 CRC: Prevalence, geographic discrepancies and outcomes from the National Cancer Database. Journal Of Clinical Oncology 2020, 38: e16052-e16052. DOI: 10.1200/jco.2020.38.15_suppl.e16052.Peer-Reviewed Original ResearchNational Cancer DatabaseOverall survivalKRAS statusKRAS mutationsMicrosatellite instabilityMicrosatellite statusCancer DatabaseCRC siteStage IV colorectal adenocarcinomaStage IV CRC patientsUnited States National Cancer DatabaseCox proportional hazards modelStage IV CRCKRAS mutation rateRight-sided CRCProportional hazards modelDistinct prognostic profilesStatistical interaction testsKRAS wildtypePatient demographicsCRC patientsMetastatic burdenCRC treatmentMultivariable analysisPrognostic profilePD-1 targeted immunotherapy for advanced hepatocellular cancer: Current utilization and outcomes in the United States.
Uhlig J, Stein S, Kim K. PD-1 targeted immunotherapy for advanced hepatocellular cancer: Current utilization and outcomes in the United States. Journal Of Clinical Oncology 2020, 38: e16647-e16647. DOI: 10.1200/jco.2020.38.15_suppl.e16647.Peer-Reviewed Original ResearchAdvanced hepatocellular carcinomaHepatocellular carcinomaOverall survivalPD-1Multivariable analysisLiver disease risk factorsCox proportional hazards modelBilirubin resultsAdvanced hepatocellular cancerClinical performance statusLiver disease complicationsOverall survival benefitDisease risk factorsDeath protein 1Longer overall survivalOncological treatment strategiesProportional hazards modelDe-identified databaseSystemic sorafenibAdult patientsHCC resectionPatient demographicsPerformance statusSurvival benefitIndependent prognosticator3:09 PM Abstract No. 33 Comparison of radiofrequency ablation and stereotactic radiotherapy for primary treatment of intrahepatic cholangiocellular carcinoma: results from the National Cancer Database
Uhlig J, Nie J, Stein S, Cha C, Kim K. 3:09 PM Abstract No. 33 Comparison of radiofrequency ablation and stereotactic radiotherapy for primary treatment of intrahepatic cholangiocellular carcinoma: results from the National Cancer Database. Journal Of Vascular And Interventional Radiology 2020, 31: s19. DOI: 10.1016/j.jvir.2019.12.055.Peer-Reviewed Original ResearchAssociation of real-world agreement between HER2 expression and ERBB2 amplification with trastuzumab therapy benefit in advanced gastric/esophageal (adv GE) cancer patients (pts).
Stein S, Snider J, McCusker M, Miksad R, Alexander B, Castellanos E, Backenroth D, Schrock A, Madison R, Carson K, Ali S. Association of real-world agreement between HER2 expression and ERBB2 amplification with trastuzumab therapy benefit in advanced gastric/esophageal (adv GE) cancer patients (pts). Journal Of Clinical Oncology 2020, 38: 310-310. DOI: 10.1200/jco.2020.38.4_suppl.310.Peer-Reviewed Original ResearchComprehensive genomic profilingAdjusted hazard ratioGE cancersOverall survivalERBB2 copy numberERBB2 amplificationClinical outcomesUnadjusted Kaplan-Meier analysisCox proportional hazards modelMedian overall survivalKaplan-Meier analysisEsophageal cancer patientsProportional hazards modelLonger OSHazard ratioMedian ageCancer patientsHER2 expressionHER2 statusTherapy benefitHazards modelHER2Median TTDClinical databaseDiscordant testsNeuroendocrine and carcinoid tumors of the gastrointestinal tract: Epidemiology and outcomes from the National Cancer Database.
Uhlig J, Nie J, Stein S, Cecchini M, Lacy J, Kim H. Neuroendocrine and carcinoid tumors of the gastrointestinal tract: Epidemiology and outcomes from the National Cancer Database. Journal Of Clinical Oncology 2020, 38: 609-609. DOI: 10.1200/jco.2020.38.4_suppl.609.Peer-Reviewed Original ResearchNational Cancer DatabaseNeuroendocrine tumorsOverall survivalSmall intestineSurgical resectionYounger patientsCancer DatabaseGastrointestinal tractImproved overall survivalPrimary disease siteLonger overall survivalPrimary cancer siteProportional hazards modelAfrican AmericansLower stageConcurrent chemotherapyMultivariable adjustmentAdult patientsMost metastasesPatient agePatient demographicsIndependent prognosticatorCarcinoid tumorsHepatic metastasesTumor sizeDKN-01 in combination with pembrolizumab in patients with advanced gastroesophageal adenocarcinoma (GEA): Tumoral DKK1 expression as a predictor of response and survival.
Klempner S, Bendell J, Villaflor V, Tenner L, Stein S, Naik G, Sirard C, Kagey M, Chaney M, Strickler J. DKN-01 in combination with pembrolizumab in patients with advanced gastroesophageal adenocarcinoma (GEA): Tumoral DKK1 expression as a predictor of response and survival. Journal Of Clinical Oncology 2020, 38: 357-357. DOI: 10.1200/jco.2020.38.4_suppl.357.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateObjective response ratePD-L1 expressionAdvanced gastroesophageal adenocarcinomaGastroesophageal adenocarcinomaDKN-01Overall survivalDKK1 expressionGEA patientsMedian progression-free survivalImmune-suppressive tumor microenvironmentPhase 1b/2a studyKaplan-Meier methodSuppressive tumor microenvironmentPotential predictive biomarkersPredictors of responseDKK1 mRNA expressionDKK1 antibodyMedian OSFree survivalClinical benefitSurvival outcomesControl ratePredictive biomarkers
2019
LBA7 Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC)
Hsu C, Lee M, Lee K, Numata K, Stein S, Verret W, Hack S, Spahn J, Liu B, Huang C, He R, Ryoo B. LBA7 Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC). Annals Of Oncology 2019, 30: ix187. DOI: 10.1093/annonc/mdz446.006.Peer-Reviewed Original ResearchUnresectable hepatocellular carcinomaHepatocellular carcinomaMedian PFSPrimary endpointArm AF. Hoffmann-La RocheHoffmann-La RocheOno PharmaceuticalGenentech/RocheIndependent review facilityObjective response rateTolerable safety profileProgression-free survivalRoche/GenentechGr 3CI 3.6Improved PFSMedian DoRMedian followRECIST 1.1Checkpoint inhibitorsDurable responsesFree survivalUnacceptable toxicityAdverse eventsLBA39 Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC)
Lee M, Ryoo B, Hsu C, Numata K, Stein S, Verret W, Hack S, Spahn J, Liu B, Abdullah H, He R, Lee K. LBA39 Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC). Annals Of Oncology 2019, 30: v875. DOI: 10.1093/annonc/mdz394.030.Peer-Reviewed Original ResearchGenentech/RocheUnresectable hepatocellular carcinomaHepatocellular carcinomaMedian PFSPrimary endpointArm AF. Hoffmann-La RocheComplete responsePartial responseHoffmann-La RocheOno PharmaceuticalDisease control rateIndependent review facilityObjective response rateTolerable safety profileProgression-free survivalDuration of responseEli LillyMedical writing assistanceGr 3Bristol-Myers SquibbEisai Inc.Improved PFSMedian DoRRECIST 1.1KRAS mutation and microsatellite instability in colorectal cancer: Screening pattern and mutational landscape across the US.
Uhlig J, Stein S, Lacy J, Kim H. KRAS mutation and microsatellite instability in colorectal cancer: Screening pattern and mutational landscape across the US. Journal Of Clinical Oncology 2019, 37: e15138-e15138. DOI: 10.1200/jco.2019.37.15_suppl.e15138.Peer-Reviewed Original ResearchOverall survivalColorectal cancerKRAS mutationsMicrosatellite instabilityNon-metastatic colorectal cancerPropensity scoreCox proportional hazards modelMetastatic colorectal cancerNational Cancer DatabasePatients' overall survivalProportional hazards modelMutational screeningDistinct mutational patternsPatient ageYounger patientsMutational prevalenceCancer DatabaseCancer factorsCRC siteFemale African AmericansHazards modelAcademic centersEast South CentralPatientsFemale Caucasians03:36 PM Abstract No. 320 Survival analysis of patients with hepatitis c and hepatocellular carcinoma receiving interventional oncology therapies and direct-acting antivirals with 12-week sustained viral response
Kamp W, Sellers C, Stein S, Lim J, Kim H. 03:36 PM Abstract No. 320 Survival analysis of patients with hepatitis c and hepatocellular carcinoma receiving interventional oncology therapies and direct-acting antivirals with 12-week sustained viral response. Journal Of Vascular And Interventional Radiology 2019, 30: s141-s142. DOI: 10.1016/j.jvir.2018.12.388.Peer-Reviewed Original Research