Matches in SemOpenAlex for { <https://semopenalex.org/work/W2941935239> ?p ?o ?g. }
- W2941935239 endingPage "3946" @default.
- W2941935239 startingPage "3946" @default.
- W2941935239 abstract "Abstract Mantle cell lymphoma (MCL) is an uncommon type of non- Hodgkin lymphoma (NHL) comprising <10% of all newly diagnosed patients. Classified as an aggressive NHL subtype, MCL has the worst prognosis of B-cell subtypes owing to its aggressive clinical disease course and incurability with standard chemo-immunotherapy. Conventional first-line therapy for bulky or advanced disease primarily consists of chemotherapy combined with rituximab, with possible consolidation with autologous stem cell transplantation for younger patients in remission to improve overall patient outcomes. However, options for relapsed MCL are limited although several single agents have been studied. Lenalidomide is available in Italy for patients with MCL (without any other therapeutic options) since May 2011, based on a local disposition of the Italian Drug Agency (AIFA) issued according to a national law (Law 648/96: medicinal products that are provided free of charge on the national health service). An observational retrospective study was conducted in 24 Italian hematology centers with the aim to improve information on efficacy and safety of lenalidomide use in real practice. Seventy patients received lenalidomide for 21/28 days with a median of 8 cycles. Doses (range 5-25 mg/day) were according to hematologic parameters. At the end of therapy there were 22 complete responses (31.4%), 9 partial responses, 6 stable diseases and 33 progressions with an overall response rate of 44.3%. Sixteen patients (22.9%) received lenalidomide in combination either with dexamethasone (N=12) or with rituximab (N=4). At 62 months overall survival (OS) was 26.2% (median reached at 33 months) and disease free survival (DFS) 37% at 42 months: 14/22 patients are in continuous complete response with a median of 26 months. We compared patients who received lenalidomide alone with patients who received lenalidomide in combination with other drugs: OS and DFS did not differ. Progression free survivals are significantly different: at 56 months 36% in combination group vs 13% in patients who received lenalidomide alone (p=0.04, hazard ratio 0.52). Toxicities were manageable, even if 17 of them led to an early drug discontinuation. Two secondary malignancies occurred: a myelodysplastic syndrome and a lung cancer after 10 and 15 months of therapy, respectively. There is a boundary zone in the passage from phase III to phase IV trials, i.e. from experimental to marketing and free use phases: in this zone we can find named patient program, compassionate and off-label use and, in Italy, request based on a local disposition. Despite the known potential bias of all the observational studies, reports on the real life experience make an important contribution to medical knowledge prior to market authorization: lenalidomide therapy is effective and tolerable also in compassionate use patients with good survival. Our results, in fact, are superimposable to those obtained in clinical trials. Disclosures Rusconi: Roche: Honoraria. Zinzani:Gilead: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; J&J: Membership on an entity's Board of Directors or advisory committees." @default.
- W2941935239 created "2019-05-03" @default.
- W2941935239 creator A5003017329 @default.
- W2941935239 creator A5004295563 @default.
- W2941935239 creator A5006157396 @default.
- W2941935239 creator A5015539158 @default.
- W2941935239 creator A5017237032 @default.
- W2941935239 creator A5017472528 @default.
- W2941935239 creator A5019034145 @default.
- W2941935239 creator A5020978640 @default.
- W2941935239 creator A5023850717 @default.
- W2941935239 creator A5034807520 @default.
- W2941935239 creator A5039006383 @default.
- W2941935239 creator A5039739851 @default.
- W2941935239 creator A5039773395 @default.
- W2941935239 creator A5041169669 @default.
- W2941935239 creator A5041326568 @default.
- W2941935239 creator A5044832096 @default.
- W2941935239 creator A5045518627 @default.
- W2941935239 creator A5046793649 @default.
- W2941935239 creator A5054592096 @default.
- W2941935239 creator A5059060009 @default.
- W2941935239 creator A5060753641 @default.
- W2941935239 creator A5068636893 @default.
- W2941935239 creator A5071466957 @default.
- W2941935239 creator A5077270786 @default.
- W2941935239 creator A5080861890 @default.
- W2941935239 creator A5082964368 @default.
- W2941935239 creator A5085216234 @default.
- W2941935239 creator A5091882595 @default.
- W2941935239 date "2015-12-03" @default.
- W2941935239 modified "2023-10-18" @default.
- W2941935239 title "Lenalidomide in Pretreated Mantle Cell Lymphoma Patients: An Italian Observational Multicenter Retrospective Study in Daily Clinical Practice, the Lenamant Study" @default.
- W2941935239 doi "https://doi.org/10.1182/blood.v126.23.3946.3946" @default.
- W2941935239 hasPublicationYear "2015" @default.
- W2941935239 type Work @default.
- W2941935239 sameAs 2941935239 @default.
- W2941935239 citedByCount "3" @default.
- W2941935239 countsByYear W29419352392017 @default.
- W2941935239 countsByYear W29419352392019 @default.
- W2941935239 crossrefType "journal-article" @default.
- W2941935239 hasAuthorship W2941935239A5003017329 @default.
- W2941935239 hasAuthorship W2941935239A5004295563 @default.
- W2941935239 hasAuthorship W2941935239A5006157396 @default.
- W2941935239 hasAuthorship W2941935239A5015539158 @default.
- W2941935239 hasAuthorship W2941935239A5017237032 @default.
- W2941935239 hasAuthorship W2941935239A5017472528 @default.
- W2941935239 hasAuthorship W2941935239A5019034145 @default.
- W2941935239 hasAuthorship W2941935239A5020978640 @default.
- W2941935239 hasAuthorship W2941935239A5023850717 @default.
- W2941935239 hasAuthorship W2941935239A5034807520 @default.
- W2941935239 hasAuthorship W2941935239A5039006383 @default.
- W2941935239 hasAuthorship W2941935239A5039739851 @default.
- W2941935239 hasAuthorship W2941935239A5039773395 @default.
- W2941935239 hasAuthorship W2941935239A5041169669 @default.
- W2941935239 hasAuthorship W2941935239A5041326568 @default.
- W2941935239 hasAuthorship W2941935239A5044832096 @default.
- W2941935239 hasAuthorship W2941935239A5045518627 @default.
- W2941935239 hasAuthorship W2941935239A5046793649 @default.
- W2941935239 hasAuthorship W2941935239A5054592096 @default.
- W2941935239 hasAuthorship W2941935239A5059060009 @default.
- W2941935239 hasAuthorship W2941935239A5060753641 @default.
- W2941935239 hasAuthorship W2941935239A5068636893 @default.
- W2941935239 hasAuthorship W2941935239A5071466957 @default.
- W2941935239 hasAuthorship W2941935239A5077270786 @default.
- W2941935239 hasAuthorship W2941935239A5080861890 @default.
- W2941935239 hasAuthorship W2941935239A5082964368 @default.
- W2941935239 hasAuthorship W2941935239A5085216234 @default.
- W2941935239 hasAuthorship W2941935239A5091882595 @default.
- W2941935239 hasBestOaLocation W29419352391 @default.
- W2941935239 hasConcept C126322002 @default.
- W2941935239 hasConcept C141071460 @default.
- W2941935239 hasConcept C143998085 @default.
- W2941935239 hasConcept C2776063141 @default.
- W2941935239 hasConcept C2776364478 @default.
- W2941935239 hasConcept C2776694085 @default.
- W2941935239 hasConcept C2777063308 @default.
- W2941935239 hasConcept C2777525834 @default.
- W2941935239 hasConcept C2779050716 @default.
- W2941935239 hasConcept C2779338263 @default.
- W2941935239 hasConcept C2779609412 @default.
- W2941935239 hasConcept C2780653079 @default.
- W2941935239 hasConcept C71924100 @default.
- W2941935239 hasConceptScore W2941935239C126322002 @default.
- W2941935239 hasConceptScore W2941935239C141071460 @default.
- W2941935239 hasConceptScore W2941935239C143998085 @default.
- W2941935239 hasConceptScore W2941935239C2776063141 @default.
- W2941935239 hasConceptScore W2941935239C2776364478 @default.
- W2941935239 hasConceptScore W2941935239C2776694085 @default.
- W2941935239 hasConceptScore W2941935239C2777063308 @default.
- W2941935239 hasConceptScore W2941935239C2777525834 @default.
- W2941935239 hasConceptScore W2941935239C2779050716 @default.
- W2941935239 hasConceptScore W2941935239C2779338263 @default.
- W2941935239 hasConceptScore W2941935239C2779609412 @default.
- W2941935239 hasConceptScore W2941935239C2780653079 @default.
- W2941935239 hasConceptScore W2941935239C71924100 @default.
- W2941935239 hasIssue "23" @default.
- W2941935239 hasLocation W29419352391 @default.