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
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