Por favor, use este identificador para citar o enlazar a este item:
http://hdl.handle.net/10261/168730
COMPARTIR / EXPORTAR:
SHARE CORE BASE | |
Visualizar otros formatos: MARC | Dublin Core | RDF | ORE | MODS | METS | DIDL | DATACITE | |
Título: | Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma |
Autor: | Dimopoulos, Meletios A.; Palumbo, Antonio; Corradini, Paolo; Cavo, Michele; Delforge, Michel; Di Raimondo, Francesco; Weisel, Katja C.; Oriol, Albert; Hansson, Markus; Vacca, Angelo; Blanchard, María Jesús; Goldschmidt, Hartmut; Doyen, Chantal; Kaiser, Martin; Petrini, Mario; Anttila, Pekka; Cafro, Anna Maria; Raymakers, Reinier; San Miguel, Jesús F. CSIC ORCID; Arriba, Felipe de; Knop, Stefan; Röllig, Christoph; Ocio, Enrique M. CSIC ORCID ; Morgan, Gareth J.; Miller, Neil; Simcock, Mathew; Peluso, Teresa; Herring, Jennifer; Sternas, Lars; Zaki, Mohamed H.; Moreau, Philippe | Fecha de publicación: | 2016 | Editor: | American Society of Hematology | Citación: | Blood 128(4): 497-503 (2016) | Resumen: | Patients with relapsed and/or refractory multiple myeloma (RRMM) have poor prognosis. The STRATUS study assessed safety and efficacy of pomalidomide plus low-dose dexamethasone in the largest cohort to date of patients with RRMM. Patients who failed treatment with bortezomib and lenalidomide and had adequate prior alkylator therapy were eligible. Pomalidomide 4 mg was given on days 1-21 of 28-day cycles with low-dose dexamethasone 40 mg (20 mg for patients aged >75 years) on days 1, 8, 15, and 22 until progressive disease or unacceptable toxicity. Safety was the primary end point; secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Among 682 patients enrolled, median age was 66 years, and median time since diagnosis was 5.3 years. Median number of prior regimens was 5. Most patients were refractory to both lenalidomide and bortezomib (80.2%). Median follow-up was 16.8 months; median duration of treatment was 4.9 months. Most frequent grade 3/4 treatment-emergent adverse events were hematologic (neutropenia [49.7%], anemia [33.0%], and thrombocytopenia [24.1%]). Most common grade 3/4 nonhematologic toxicities were pneumonia (10.9%) and fatigue (5.9%). Grade 3/4 venous thromboembolism and peripheral neuropathy were rare (1.6% each). The ORR was 32.6%, and the median DOR was 7.4 months. Median PFS and OS were 4.6 months and 11.9 months, respectively. We present the largest trial to date evaluating pomalidomide plus low-dose dexamethasone in patients with RRMM, further confirming that this regimen offers clinically meaningful benefit and is generally well tolerated. | Descripción: | Presented at the 50th Annual American Society of Clinical Oncology Meeting (2014), the 56th American Society of Hematology Annual Meeting (2014), the 20th Congress of the European Hematology Association (2015), the 15th International Myeloma Workshop (2015), and the 57th American Society of Hematology Annual Meeting (2015). | URI: | http://hdl.handle.net/10261/168730 | DOI: | 10.1182/blood-2016-02-700872 | Identificadores: | doi: 10.1182/blood-2016-02-700872 e-issn: 1528-0020 issn: 0006-4971 |
Aparece en las colecciones: | (IBMCC) Artículos |
Ficheros en este ítem:
Fichero | Descripción | Tamaño | Formato | |
---|---|---|---|---|
accesoRestringido.pdf | 15,38 kB | Adobe PDF | Visualizar/Abrir |
CORE Recommender
PubMed Central
Citations
61
checked on 19-abr-2024
SCOPUSTM
Citations
145
checked on 15-abr-2024
WEB OF SCIENCETM
Citations
135
checked on 24-feb-2024
Page view(s)
309
checked on 18-abr-2024
Download(s)
82
checked on 18-abr-2024
Google ScholarTM
Check
Altmetric
Altmetric
Artículos relacionados:
NOTA: Los ítems de Digital.CSIC están protegidos por copyright, con todos los derechos reservados, a menos que se indique lo contrario.