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Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial
M. Trněný, T. Lamy, J. Walewski, D. Belada, J. Mayer, J. Radford, W. Jurczak, F. Morschhauser, J. Alexeeva, S. Rule, B. Afanasyev, K. Kaplanov, A. Thyss, A. Kuzmin, S. Voloshin, K. Kuliczkowski, A. Giza, N. Milpied, C. Stelitano, R. Marks, L....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu klinické zkoušky, fáze II, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
ProQuest Central
od 2000-09-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2000-09-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2000-09-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2000-09-01 do Před 2 měsíci
- MeSH
- analýza přežití MeSH
- antitumorózní látky farmakologie terapeutické užití MeSH
- inhibitory angiogeneze škodlivé účinky terapeutické užití MeSH
- interval spolehlivosti MeSH
- invazivní růst nádoru patologie MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie mortalita patologie MeSH
- lymfom z plášťových buněk farmakoterapie mortalita patologie MeSH
- následné studie MeSH
- přežití po terapii bez příznaků nemoci MeSH
- proporcionální rizikové modely MeSH
- prospektivní studie MeSH
- rozvrh dávkování léků MeSH
- senioři MeSH
- staging nádorů MeSH
- thalidomid škodlivé účinky analogy a deriváty terapeutické užití MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Lenalidomide, an immunomodulatory drug with antineoplastic and antiproliferative effects, showed activity in many single-group studies in relapsed or refractory mantle cell lymphoma. The aim of this randomised study was to examine the efficacy and safety of lenalidomide versus best investigator's choice of single-agent therapy in relapsed or refractory mantle cell lymphoma. METHODS: The MCL-002 (SPRINT) study was a randomised, phase 2 study of patients with mantle cell lymphoma aged 18 years or older at 67 clinics and academic centres in 12 countries who relapsed one to three times, had Eastern Cooperative Oncology Group performance status of 0-2, at least one measurable lesion to be eligible, and who were ineligible for intensive chemotherpy or stem-cell transplantation. Using a centralised interactive voice response system, we randomly assigned (2:1) patients in a permuted block size of six to receive lenalidomide (25 mg orally on days 1-21 every 28 days) until progressive disease or intolerability, or single-agent investigator's choice of either rituximab, gemcitabine, fludarabine, chlorambucil, or cytarabine. Randomisation was stratified by time from diagnosis, time from last anti-lymphoma therapy, and previous stem-cell transplantation. Individual treatment assignment between lenalidomide and investigator's choice was open label, but investigators had to register their choice of comparator drug before randomly assigning a patient. Patients who progressed on investigator's choice could cross over to lenalidomide treatment. We present the prespecified primary analysis results in the intention-to-treat population for the primary endpoint of progression-free survival, defined as the time from randomisation to progressive disease or death, whichever occurred first. Patient enrolment is complete, although treatment and collection of additional time-to-event data are ongoing. This study is registered with ClinicalTrials.gov, number NCT00875667. FINDINGS: Between April 30, 2009, and March 7, 2013, we enrolled 254 patients in the intention-to-treat population (170 [67%] were randomly assigned to receive lenalidomide, 84 [33%] to receive investigator's choice monotherapy). Patients had a median age of 68·5 years and received a median of two previous regimens. With a median follow-up of 15·9 months (IQR 7·6-31·7), lenalidomide significantly improved progression-free survival compared with investigator's choice (median 8·7 months [95% CI 5·5-12·1] vs 5·2 months [95% CI 3·7-6·9]) with a hazard ratio of 0·61 (95% CI 0·44-0·84; p=0·004). In the 167 patients in the lenalidomide group and 83 patients in the investigator's choice group who received at least one dose of treatment the most common grade 3-4 adverse events included neutropenia (73 [44%] of 167 vs 28 [34%] of 83) without increased risk of infection, thrombocytopenia (30 [18%] vs 23 [28%]), leucopenia (13 [8%] vs nine [11%]), and anaemia (14 [8%] vs six [7%]). INTERPRETATION: Patients with relapsed or refractory mantle cell lymphoma ineligible for intensive chemotherapy or stem-cell transplantation have longer progression-free survival, with a manageable safety profile when treated with lenalidomide compared with monotherapy investigator's choice options. FUNDING: Celgene Corporation.
1st Pavlov State Medical University of St Petersburg St Petersburg Russia
A O Bianchi Melacrino Morelli Reggio Calabria Italy
Celgene Corporation Summit NJ USA
Celgene Sarl Boudry Switzerland
Centre Hospitalier Universitaire Régional de Lille Unité GRITA Lille France
Department of Haematology Jagiellonian University Krakow Poland
Department of Hematology and Oncology University Medical Center Freiburg Freiburg Germany
Department of Hematology Charles University Hospital Prague Czech Republic
Department of Hematology Derriford Hospital Plymouth UK
Department of Hematology Rennes University Hospital Rennes France
Federal Medical Research Center St Petersburg Russia
Medical Oncology Department Centre Antoine Lacassagne Nice France
Republican Clinical Oncology Dispensary Kazan Russia
Russian Research Institute of Hematology and Transfusion St Petersburg Russia
Service d'Hématologie et de Thérapie Cellulaire CHU Haut Lévêque Bordeaux France
The University of Manchester and The Christie NHS Foundation Trust Manchester UK
University of Bordeaux Bordeaux France
Volgograd Regional Clinical Oncology Dispensary Number 1 Department of Hematology Volgograd Russia
Citace poskytuje Crossref.org
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