PMID- 28768446
OWN - NLM
STAT- MEDLINE
DCOM- 20190111
LR  - 20190116
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 59
IP  - 3
DP  - 2018 Mar
TI  - Comparison of two doses of intravenous temsirolimus in patients with 
      relapsed/refractory mantle cell lymphoma.
PG  - 670-678
LID - 10.1080/10428194.2017.1357175 [doi]
AB  - 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.
FAU - Jurczak, Wojciech
AU  - Jurczak W
AD  - a Department of Haematology , Jagiellonian University , Krakow , Poland.
FAU - Ramanathan, Sundra
AU  - Ramanathan S
AD  - b Haematology Department , Cancer Care Centre, The St George Hospital , Kogarah , 
      Australia.
FAU - Giri, Pratyush
AU  - Giri P
AD  - c Lyell McEwin Hospital (LMH), Royal Adelaide Hospital (RAH) , Adelaide , 
      Australia.
FAU - Romano, Alessandra
AU  - Romano A
AD  - d Division of Hematology , A.O.U. Policlinico-Vittorio Emanuele, University of 
      Catania , Catania , Italy.
FAU - Mocikova, Heidi
AU  - Mocikova H
AD  - e Department of Clinical Hematology , University Hospital Kralovske Vinohrady, 
      Third Faculty of Medicine, Charles University in Prague , Prague , Czech 
      Republic.
FAU - Clancy, Jill
AU  - Clancy J
AD  - f inVentiv Health Clinical , Princeton , NJ , USA.
FAU - Lechuga, Mariajose
AU  - Lechuga M
AD  - g Pfizer S.r.l , Milan , Italy.
FAU - Casey, Michelle
AU  - Casey M
AD  - h Pfizer Inc , Collegeville , PA , USA.
FAU - Boni, Joseph
AU  - Boni J
AD  - h Pfizer Inc , Collegeville , PA , USA.
FAU - Giza, Agnieszka
AU  - Giza A
AD  - a Department of Haematology , Jagiellonian University , Krakow , Poland.
FAU - Hess, Georg
AU  - Hess G
AD  - i Department of Hematology/Oncology , Johannes Gutenberg University , Mainz , 
      Germany.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170803
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antineoplastic Agents)
RN  - 624KN6GM2T (temsirolimus)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Drug Administration Schedule
MH  - Drug Resistance, Neoplasm/*drug effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Injections, Intravenous
MH  - Lymphoma, Mantle-Cell/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy/pathology
MH  - Prognosis
MH  - *Salvage Therapy
MH  - Sirolimus/administration & dosage/*analogs & derivatives
MH  - Survival Rate
OTO - NOTNLM
OT  - Temsirolimus
OT  - mantle cell lymphoma
OT  - overall survival
OT  - progression-free survival
OT  - safety
EDAT- 2017/08/05 06:00
MHDA- 2019/01/12 06:00
CRDT- 2017/08/04 06:00
PHST- 2017/08/05 06:00 [pubmed]
PHST- 2019/01/12 06:00 [medline]
PHST- 2017/08/04 06:00 [entrez]
AID - 10.1080/10428194.2017.1357175 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2018 Mar;59(3):670-678. doi: 10.1080/10428194.2017.1357175. Epub 
      2017 Aug 3.