Comparison of two doses of intravenous temsirolimus in patients with relapsed/refractory mantle cell lymphoma
| Autor: | Heidi Mocikova, Agnieszka Giza, Mariajose Lechuga, Alessandra Romano, Joseph Boni, Sundra Ramanathan, Jill S. Clancy, Georg Hess, Pratyush Giri, Wojciech Jurczak, Michelle Casey |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Temsirolimus Cancer Research Lymphoma Drug Resistance Lymphoma Mantle-Cell Gastroenterology 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols 80 and over Clinical endpoint media_common Aged 80 and over Hazard ratio Hematology Middle Aged Prognosis Survival Rate Local Oncology 030220 oncology & carcinogenesis Injections Intravenous Refractory Mantle Cell Lymphoma Female Intravenous medicine.drug safety medicine.medical_specialty overall survival mantle cell lymphoma Antineoplastic Agents Drug Administration Schedule Injections 03 medical and health sciences Refractory Internal medicine medicine Humans media_common.cataloged_instance Progression-free survival European union Aged Sirolimus Salvage Therapy business.industry Mantle-Cell medicine.disease Surgery Neoplasm Recurrence Drug Resistance Neoplasm Neoplasm Mantle cell lymphoma Neoplasm Recurrence Local business progression-free survival Follow-Up Studies 030215 immunology |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|