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