0000000001083807

AUTHOR

Anna Berkenblit

showing 3 related works from this author

Phase III Study to Evaluate Temsirolimus Compared With Investigator's Choice Therapy for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

2009

Purpose Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, has shown clinical activity in mantle cell lymphoma (MCL). We evaluated two dose regimens of temsirolimus in comparison with investigator's choice single-agent therapy in relapsed or refractory disease. Patients and Methods In this multicenter, open-label, phase III study, 162 patients with relapsed or refractory MCL were randomly assigned (1:1:1) to receive one of two temsirolimus regimens: 175 mg weekly for 3 weeks followed by either 75 mg (175/75-mg) or 25 mg (175/25-mg) weekly, or investigator's choice therapy from prospectively approved options. The primary end point was progression-free survival (P…

AdultMaleOncologyCancer Researchmedicine.medical_specialtyAntineoplastic AgentsKaplan-Meier EstimateLymphoma Mantle-CellDisease-Free SurvivalDrug Administration ScheduleRidaforolimuschemistry.chemical_compoundRefractoryRecurrenceInternal medicinemedicineHumansProspective StudiesProtein Kinase InhibitorsAgedNeoplasm StagingAged 80 and overSirolimusbusiness.industryLymphoma Non-HodgkinTOR Serine-Threonine KinasesMiddle Agedmedicine.diseaseTemsirolimusSurgeryFludarabineOncologychemistryDrug Resistance NeoplasmSirolimusRefractory Mantle Cell LymphomaFemaleRituximabMantle cell lymphomabusinessProtein Kinasesmedicine.drugJournal of Clinical Oncology
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Temsirolimus in mantle cell lymphoma and other non-Hodgkin lymphoma subtypes.

2009

Temsirolimus, an inhibitor of mammalian target of rapamycin (mTOR), has anti-tumor activity in patients with relapsed or refractory mantle cell lymphoma (MCL) and other mature lymphoid neoplasms. mTOR is an intracellular kinase that controls the mRNA translation of many proteins (eg, cyclin D1) that can act as oncogenes and contribute to lymphomagenesis. Characterized by overexpression of cyclin D1, MCL was identified as a disease that might be susceptible to mTOR inhibition. When single-agent temsirolimus was explored in two phase II studies for treatment of patients with relapsed or refractory MCL, it demonstrated anti-tumor activity, with overall response rates of 38% and 41%. Subsequent…

Oncologymedicine.medical_specialtyFollicular lymphomaAntineoplastic AgentsLymphoma Mantle-CellNeutropeniaModels BiologicalCyclin D1hemic and lymphatic diseasesInternal medicinemedicineHumansSirolimusClinical Trials as Topicbusiness.industryLymphoma Non-HodgkinTOR Serine-Threonine KinasesCancerHematologymedicine.diseaseTemsirolimusLymphomaOncologyImmunologyRefractory Mantle Cell LymphomaMantle cell lymphomabusinessProtein Kinasesmedicine.drugSeminars in oncology
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Supportive Efficacy Analyses for the Phase 3 Study of Temsirolimus Versus Investigator’s Choice Therapy for the Treatment of Patients with Relapsed o…

2008

Abstract Temsirolimus (Torisel®) is a specific inhibitor of the mTOR kinase with antitumor activity in patients with relapsed or refractory mantle cell lymphoma. In a phase 3, randomized, open-label study, patients treated with temsirolimus 175 mg weekly 3 times followed by 75 mg weekly (175/75-mg) had significantly longer progression-free survival (PFS) than those treated with investigator’s choice therapy (p-value temsirolimus: investigator’s choice = 0.0009; hazard ratio = 0.44; 97.5% CI = 0.25, 0.78; Hess et al. J Clin Oncol.2008, 28:abs 8513). Patients treated with temsirolimus 175 mg weekly 3 times followed by 25 mg weekly (175/25-mg) showed a trend towards longer PFS than those treat…

Oncologymedicine.medical_specialtyeducation.field_of_studyRandomizationbusiness.industryProportional hazards modelImmunologyPopulationHazard ratioPhases of clinical researchCell BiologyHematologymedicine.diseaseBiochemistryTemsirolimusSurgeryInternal medicineClinical endpointmedicinebusinesseducationProgressive diseasemedicine.drugBlood
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