6533b828fe1ef96bd12885b8
RESEARCH PRODUCT
Comparison of two doses of intravenous temsirolimus in patients with relapsed/refractory mantle cell lymphoma
Heidi MocikovaAgnieszka GizaMariajose LechugaAlessandra RomanoJoseph BoniSundra RamanathanJill S. ClancyGeorg HessPratyush GiriWojciech JurczakMichelle Caseysubject
MaleTemsirolimusCancer ResearchLymphomaDrug ResistanceLymphoma Mantle-CellGastroenterology0302 clinical medicineAntineoplastic Combined Chemotherapy Protocols80 and overClinical endpointmedia_commonAged 80 and overHazard ratioHematologyMiddle AgedPrognosisTemsirolimusSurvival RateLocalOncology030220 oncology & carcinogenesisInjections IntravenousRefractory Mantle Cell LymphomaFemaleIntravenousmedicine.drugsafetymedicine.medical_specialtyoverall survivalmantle cell lymphomaAntineoplastic AgentsDrug Administration ScheduleInjections03 medical and health sciencesRefractoryInternal medicinemedicineHumansmedia_common.cataloged_instanceProgression-free survivalEuropean unionAgedSirolimusSalvage Therapybusiness.industryMantle-Cellmedicine.diseaseSurgeryNeoplasm RecurrenceDrug Resistance NeoplasmNeoplasmMantle cell lymphomaNeoplasm Recurrence Localbusinessprogression-free survivalFollow-Up Studies030215 immunologydescription
Temsirolimus 175 mg once-weekly for 3 weeks, followed by 75 mg once-weekly intravenously dosed (175/75 mg) is approved in the European Union for treatment of relapsed/refractory mantle cell lymphoma (MCL). A phase IV study explored whether similar efficacy, but improved safety could be achieved with 75 mg without 175 mg loading doses (ClinicaTrials.gov: NCT01180049). Patients with relapsed/refractory MCL were randomized to once-weekly temsirolimus 175/75 mg (n = 47) or 75 mg (n = 42). Treatment continued until objective disease progression. Primary endpoint: progression-free survival (PFS). Secondary endpoints included overall survival (OS) and adverse events (AEs). Median PFS was 4.3 versus 4.5 months (hazard ratio [HR] 0.731; 80% confidence interval [CI], 0.520-1.027), and median OS 18.7 versus 11.0 months (HR 0.681; 80% CI, 0.472-0.982) with 175/75 mg versus 75 mg. There were fewer patients with serious AEs, dose reduction, or death with 175/75 mg (57.4%, 48.9%, and 48.9%) versus 75 mg (73.8%, 64.3%, and 65.1%). Temsirolimus 175/75 mg remains the preferred dosing regimen for relapsed/refractory MCL.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2018-01-01 |