Prospective subgroup analyses of the ...
Type de document :
Article dans une revue scientifique
DOI :
PMID :
URL permanente :
Titre :
Prospective subgroup analyses of the randomized MCL-002 (SPRINT) study: lenalidomide versus investigator''s choice in relapsed or refractory mantle cell lymphoma
Auteur(s) :
Arcaini, Luca [Auteur]
Lamy, Thierry [Auteur]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Walewski, Jan [Auteur]
Medical University of Warsaw - Poland
Belada, David [Auteur]
University of Hradec Králové
Mayer, Jiri [Auteur]
University Hospital Brno
Radford, John [Auteur]
University of Manchester [Manchester]
Jurczak, Wojciech [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Alexeeva, Julia [Auteur]
Saint Petersburg University [SPBU]
Rule, Simon [Auteur]
Plymouth University
Cabecadas, Jose [Auteur]
Centro Hospitalar de Lisboa Central E.P.E
Campo, Elias [Auteur]
Institut d'Investigacions Biomèdiques August Pi i Sunyer [IDIBAPS]
Pileri Stefano, A [Auteur]
Medical Oncology Unit, Dept of Medical Oncology and Hematology [Fondazione IRCCS Istituto Nazionale Tumori, Milan]
Biyukov, Tsvetan [Auteur]
Celgene Corporation
Patturajan, Meera [Auteur]
Celgene Corporation
Casadebaig Bravo, Marie-Laure [Auteur]
Celgene Corporation
Trneny, Marek [Auteur]
Lamy, Thierry [Auteur]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Walewski, Jan [Auteur]
Medical University of Warsaw - Poland
Belada, David [Auteur]
University of Hradec Králové
Mayer, Jiri [Auteur]
University Hospital Brno
Radford, John [Auteur]
University of Manchester [Manchester]
Jurczak, Wojciech [Auteur]
Morschhauser, Franck [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Alexeeva, Julia [Auteur]
Saint Petersburg University [SPBU]
Rule, Simon [Auteur]
Plymouth University
Cabecadas, Jose [Auteur]
Centro Hospitalar de Lisboa Central E.P.E
Campo, Elias [Auteur]
Institut d'Investigacions Biomèdiques August Pi i Sunyer [IDIBAPS]
Pileri Stefano, A [Auteur]
Medical Oncology Unit, Dept of Medical Oncology and Hematology [Fondazione IRCCS Istituto Nazionale Tumori, Milan]
Biyukov, Tsvetan [Auteur]
Celgene Corporation
Patturajan, Meera [Auteur]
Celgene Corporation
Casadebaig Bravo, Marie-Laure [Auteur]
Celgene Corporation
Trneny, Marek [Auteur]
Titre de la revue :
British journal of haematology
Nom court de la revue :
Br. J. Haematol.
Numéro :
180
Pagination :
224-235
Date de publication :
2018
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here ...
Lire la suite >In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here we present the long-term follow-up data and results of preplanned subgroup exploratory analyses from MCL-002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on PFS. In MCL-002, patients with relapsed/refractory MCL were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1-21; 28-day cycles) or single-agent IC therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent-to-treat population comprised 254 patients (lenalidomide, n = 170; IC, n = 84). Subgroup analyses of PFS favoured lenalidomide over IC across most characteristics, including risk factors, such as high MCL International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (LDH), stage III/IV disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer PFS (other than lenalidomide treatment) included normal LDH levels (P < 0·001), nonbulky disease (P = 0·045), <3 prior antilymphoma treatments (P = 0·005), and ≥6 months since last prior treatment (P = 0·032). Overall, lenalidomide improved PFS versus single-agent IC therapy in patients with relapsed/refractory MCL, irrespective of many demographic factors, disease characteristics and prior treatment history.Lire moins >
Lire la suite >In the mantle cell lymphoma (MCL)-002 study, lenalidomide demonstrated significantly improved median progression-free survival (PFS) compared with investigator's choice (IC) in patients with relapsed/refractory MCL. Here we present the long-term follow-up data and results of preplanned subgroup exploratory analyses from MCL-002 to evaluate the potential impact of demographic factors, baseline clinical characteristics and prior therapies on PFS. In MCL-002, patients with relapsed/refractory MCL were randomized 2:1 to receive lenalidomide (25 mg/day orally on days 1-21; 28-day cycles) or single-agent IC therapy (rituximab, gemcitabine, fludarabine, chlorambucil or cytarabine). The intent-to-treat population comprised 254 patients (lenalidomide, n = 170; IC, n = 84). Subgroup analyses of PFS favoured lenalidomide over IC across most characteristics, including risk factors, such as high MCL International Prognostic Index score, age ≥65 years, high lactate dehydrogenase (LDH), stage III/IV disease, high tumour burden, and refractoriness to last prior therapy. By multivariate Cox regression analysis, factors associated with significantly longer PFS (other than lenalidomide treatment) included normal LDH levels (P < 0·001), nonbulky disease (P = 0·045), <3 prior antilymphoma treatments (P = 0·005), and ≥6 months since last prior treatment (P = 0·032). Overall, lenalidomide improved PFS versus single-agent IC therapy in patients with relapsed/refractory MCL, irrespective of many demographic factors, disease characteristics and prior treatment history.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Équipe(s) de recherche :
Innovation/évaluation des médicaments injectables
Date de dépôt :
2019-02-26T17:07:01Z
2021-04-12T13:12:36Z
2021-04-12T13:12:36Z
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