2023
Pre-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
2021
A 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
DKN-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 1.1
2017
SWOG S1310: Randomized phase II trial of single agent MEK inhibitor trametinib vs. 5-fluorouracil or capecitabine in refractory advanced biliary cancer.
Kim R, McDonough S, El-Khoueiry A, Bekaii-Saab T, Stein S, Sahai V, Keogh G, Kim E, Baron A, Siegel A, Barzi A, Guthrie K, Javle M, Hochster H. SWOG S1310: Randomized phase II trial of single agent MEK inhibitor trametinib vs. 5-fluorouracil or capecitabine in refractory advanced biliary cancer. Journal Of Clinical Oncology 2017, 35: 4016-4016. DOI: 10.1200/jco.2017.35.15_suppl.4016.Peer-Reviewed Original ResearchProgression-free survivalGrade 3 toxicityMedian overall survivalOverall survivalArm BResponse rateArm ATreatment-related grade 3 toxicitiesMedian progression-free survivalAdvanced biliary cancerGemcitabine/platinumSecond-line treatmentPhase II trialHigh-grade toxicityStandard treatment optionMEK inhibitor trametinibOverall response rateInterim futility analysisEarly promising resultsLack of responseEligible patientsInfusional 5FUStable diseaseII trialPrimary endpoint
2011
P1-17-07: Phase II Trial of RAD001 Plus Carboplatin in Patients with Triple-Negative Metastatic Breast Cancer.
Singh J, Stein S, Volm M, Smith J, Novik Y, Speyer J, Adams S, Meyers M, Muggia F, Schneider R, Formenti S, Omene C, Choi H, Davis S, Goldberg J, Tiersten A. P1-17-07: Phase II Trial of RAD001 Plus Carboplatin in Patients with Triple-Negative Metastatic Breast Cancer. Cancer Research 2011, 71: p1-17-07-p1-17-07. DOI: 10.1158/0008-5472.sabcs11-p1-17-07.Peer-Reviewed Original ResearchTriple-negative metastatic breast cancerGrade 3 neutropeniaMetastatic breast cancerBreast cancerClinical benefitGrade 3Platinum agentsNon-hematological grade 3Negative metastatic breast cancerTriple-negative breast cancerGrade 3 thrombocytopeniaPrior chemotherapy regimensSingle-agent carboplatinDose of carboplatinPhase II trialProgression-free survivalOral mTOR inhibitorTriple-negative breast cancer cellsDifferent breast cancer cell linesPhosphorylation site-specific antibodiesNegative breast cancer cellsBreast cancer cell linesBreast cancer cellsAkt-mTOR pathwayAssessable patients