000 02746na a2200397 4500
999 _c2173
_d2173
003 PC2173
005 20191203094313.0
008 130622s2013
040 _cH12O
041 _aeng
100 _aLahuerta Palacios, Juan José
_9388
_eHematología y Hemoterapia
245 0 0 _aLenalidomide plus dexamethasone for high-risk smoldering multiple myeloma
_h[artículo]
260 _bNew England Journal of Medicine,
_c2013
300 _a369(5):438-47.
500 _aFormato Vancouver: Mateos MV, Hernández MT, Giraldo P, de la Rubia J, de Arriba F, López Corral L et al. Lenalidomide plus dexamethasone for high-risk smoldering multiple myeloma. N Engl J Med. 2013 Aug 1;369(5):438-47.
501 _aPMID:23902483
504 _aContiene 29 referencias
520 _aBackground For patients with smoldering multiple myeloma, the standard of care is observation until symptoms develop. However, this approach does not identify high-risk patients who may benefit from early intervention. Methods In this randomized, open-label, phase 3 trial, we randomly assigned 119 patients with high-risk smoldering myeloma to treatment or observation. Patients in the treatment group received an induction regimen (lenalidomide at a dose of 25 mg per day on days 1 to 21, plus dexamethasone at a dose of 20 mg per day on days 1 to 4 and days 12 to 15, at 4-week intervals for nine cycles), followed by a maintenance regimen (lenalidomide at a dose of 10 mg per day on days 1 to 21 of each 28-day cycle for 2 years). The primary end point was time to progression to symptomatic disease. Secondary end points were response rate, overall survival, and safety. Results After a median follow-up of 40 months, the median time to progression was significantly longer in the treatment group than in the observation group (median not reached vs. 21 months; hazard ratio for progression, 0.18; 95% confidence interval [CI], 0.09 to 0.32; P<0.001). The 3-year survival rate was also higher in the treatment group (94% vs. 80%; hazard ratio for death, 0.31; 95% CI, 0.10 to 0.91; P=0.03). A partial response or better was achieved in 79% of patients in the treatment group after the induction phase and in 90% during the maintenance phase. Toxic effects were mainly grade 2 or lower. Conclusions Early treatment for patients with high-risk smoldering myeloma delays progression to active disease and increases overall survival.
710 _9297
_aServicio de Hematología y Hemoterapia
856 _uhttp://pc-h12o-es.m-hdoct.a17.csinet.es/pdf/pc/2/pc2173.pdf
_ySolicitar documento
942 _n0
_2ddc
_cART