0000000000379084

AUTHOR

Tom M. Ganten

showing 5 related works from this author

Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study.

2016

Abstract Purpose: Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months. Experimental Design: The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014. Results: Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor s…

OncologySorafenibAdultMaleNiacinamideCancer Researchmedicine.medical_specialtyCarcinoma HepatocellularDrug-Related Side Effects and Adverse ReactionsMedizinDisease-Free Survival03 medical and health sciences0302 clinical medicineInternal medicinemedicineHumansAdverse effectProtein Kinase InhibitorsAgedNeoplasm StagingPerformance statusbusiness.industryPhenylurea CompoundsLiver NeoplasmsCancerMiddle AgedSorafenibmedicine.diseasePrognosisSurgeryClinical trialOncology030220 oncology & carcinogenesisHepatocellular carcinomaDisease Progression030211 gastroenterology & hepatologyFemaleLiver functionbusinessLiver cancermedicine.drugClinical cancer research : an official journal of the American Association for Cancer Research
researchProduct

Sirolimus Use in Liver Transplant Recipients With Hepatocellular Carcinoma: A Randomized, Multicenter, Open-Label Phase 3 Trial

2016

International audience; BACKGROUND:We investigated whether sirolimus-based immunosuppression improves outcomes in liver transplantation (LTx) candidates with hepatocellular carcinoma (HCC).METHODS:In a prospective-randomized open-label international trial, 525 LTx recipients with HCC initially receiving mammalian target of rapamycin inhibitor-free immunosuppression were randomized 4 to 6 weeks after transplantation into a group on mammalian target of rapamycin inhibitor-free immunosuppression (group A: 264 patients) or a group incorporating sirolimus (group B: 261). The primary endpoint was recurrence-free survival (RFS); intention-to-treat (ITT) analysis was conducted after 8 years. Overal…

MaleTime FactorsIntention to Treat Analysimedicine.medical_treatmentMedizinPROGRESSIONKaplan-Meier EstimateLiver transplantationGastroenterologyImmunosuppressive Agent0302 clinical medicineEVEROLIMUSRENAL-CELL CARCINOMARisk FactorsMedicine and Health SciencesClinical endpointAge FactorSirolimuProspective StudiesIMMUNOSUPPRESSIONTOR Serine-Threonine KinaseTOR Serine-Threonine KinasesHazard ratioLiver NeoplasmsAge FactorsImmunosuppressionMiddle AgedCANCER3. Good healthIntention to Treat AnalysisEuropeRAPAMYCIN INHIBITORSTreatment OutcomeTARGETLocalLiver Neoplasm030220 oncology & carcinogenesisCombinationDisease ProgressionSURVIVAL[SDV.IMM]Life Sciences [q-bio]/Immunology030211 gastroenterology & hepatologyDrug Therapy CombinationFemaleImmunosuppressive Agentsmedicine.drugHumanAdultmedicine.medical_specialtyCanadaCarcinoma HepatocellularTime Factor[SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/SurgeryRisk AssessmentDisease-Free Survival03 medical and health sciencesYoung AdultDrug TherapyInternal medicinemedicineHumansAdult; Age Factors; Aged; Australia; Canada; Carcinoma Hepatocellular; Disease Progression; Disease-Free Survival; Drug Therapy Combination; Europe; Female; Humans; Immunosuppressive Agents; Intention to Treat Analysis; Kaplan-Meier Estimate; Liver Neoplasms; Male; Middle Aged; Neoplasm Recurrence Local; Prospective Studies; Risk Assessment; Risk Factors; Sirolimus; TOR Serine-Threonine Kinases; Time Factors; Treatment Outcome; Young Adult; Liver Transplantation; TransplantationRECURRENCEMETAANALYSISAgedSirolimusTransplantationEverolimusIntention-to-treat analysisbusiness.industryRisk FactorCarcinomaAustraliaHepatocellular3126 Surgery anesthesiology intensive care radiologySurgeryLiver TransplantationTransplantationProspective StudieNeoplasm RecurrenceSirolimusNeoplasm Recurrence Localbusiness
researchProduct

Final Analysis of Overall Survival Per Subgroups of Hcc Patients in the Prospective, Non-Interventional Insight Study Treated with Sorafenib

2014

ABSTRACT Aim: INSIGHT is a prospective, non-interventional study, conducted in Germany and Austria in pts with hepatocellular carcinoma HCC. The objectives of this study are the evaluation of safety and efficacy under practice conditions in both hospitals and private practices. Enrollment into INSIGHT is not restricted to a particular tumor stage. Methods: This final analysis evaluated overall survival and safety data incluling relevant subgroups. All patients with HCC were observed for the duration of their sorafenib therapy. In addition to baseline data the performance status, tumor status (clinical and/or radiological), and overall survival time are documented. Documentation of adverse e…

Sorafenibmedicine.medical_specialtyPerformance statusbusiness.industryMedizinHematologyHepatitis CHepatitis Bmedicine.diseaseBCLC StageSurgeryOncologyPrivate practiceHepatocellular carcinomaInternal medicineMedicinebusinessAdverse effectmedicine.drugAnnals of Oncology
researchProduct

Interim Analysis of Overall Survival Per Subgroups in the Prospective, Non-Interventional Insight Study in Patients with Hepatocellular Carcinoma Tre…

2012

ABSTRACT Background The efficacy of Sorafenib in patients (pts) with hepatocellular carcinoma (HCC) has been proven in randomized, controlled trials. INSIGHT is a prospective, non-interventional study, conducted in Germany and Austria in pts with HCC. The objectives of this study are the evaluation of safety and efficacy under practice conditions in both hospitals and private practices. Enrollment into INSIGHT is not restricted to a particular tumor stage. Recruitment into the study is ongoing. Methods The second interim analysis (data cut-off 23 FEB 2012) evaluated overall survival and safety data in relevant subgroups. All patients with HCC were observed for the duration of their sorafeni…

Sorafenibmedicine.medical_specialtyCirrhosisPerformance statusbusiness.industryHematologymedicine.diseaseInterim analysisBCLC StageOncologyInternal medicineHepatocellular carcinomamedicineStage (cooking)businessAdverse effectmedicine.drugAnnals of Oncology
researchProduct

Resminostat plus sorafenib as second-line therapy of advanced hepatocellular carcinoma - The SHELTER study

2016

Background & Aims No established therapies for patients with hepatocellular carcinoma (HCC) and progression on first-line sorafenib treatment currently exist. This phase I/II trial investigated safety, pharmacokinetics and potential biomarkers of the histone deacetylase inhibitor resminostat and a combination therapy with resminostat and sorafenib. Methods Patients with HCC and radiologically confirmed progression on sorafenib were treated in an exploratory, multi-center, open-label, uncontrolled, non-randomized, parallel group phase I/II study. In the combination group (n=38) four dose levels ranged from daily 200 to 600mg resminostat plus 400 to 800mg sorafenib. The monotherapy group (n=1…

0301 basic medicineOncologySorafenibmedicine.medical_specialtyCombination therapymedicine.drug_classMedizinCancer epigeneticPharmacology03 medical and health scienceschemistry.chemical_compound0302 clinical medicineCancer epigeneticsResminostatInternal medicineClinical endpointmedicineCarcinomaneoplasmsEpigenetic treatmentFirst-in-man studyHistone deacetylase inhibitorHepatologybusiness.industryHistone deacetylase inhibitormedicine.diseasedigestive system diseases030104 developmental biologyZinc finger protein 64chemistryCancer epigenetics; Drug resistance; Epigenetic treatment; Histone deacetylase inhibitor; Zinc finger protein 64030220 oncology & carcinogenesisHepatocellular carcinomaDrug resistancebusinessmedicine.drug
researchProduct