La adición de la comorbilidad permite una mejor estratificación y desarrollo de un scorepronóstico específico en el grupo de pacientes con síndrome mielodisplásico de bajo riesgo por IPSS

YesEl pronóstico de los pacientes (pts) con síndrome mielodisplásico(SMD) de bajo riesgo (SMD-BR) por IPSS es muy heterogéneo. Diferentes parámetros clínicos han permitido una mejor estratificación de estos pts con SMD-BR en términos de supervivencia global (SG). La adición de la comorbilidad a los modelos pronósticos globales en los SMD ha resultado con significación pronostica, aunque su impacto sobre el grupo concreto de SMD-BR no ha sido evaluado

La respuesta molecular mayor en el estudio IRIS: Una reflexión a partir de un grupo de pacientes respondedores subóptimos con leucemia mieloide crónica (LMC) de más de 5 años de seguimiento.

YesLos análisis efectuados a partir del estudio IRIS, ensayo aleatorizado fase III a nivel europeo sobre pacientes con LMC que permitió la aprobación de imatinib en esta enfermedad, establecían que el mayor riesgo de progresión de la enfermedad se acumulaba en los 4 primeros años desde el inicio del fármaco en pacientes no respondedores o respondedores subóptimos, entre los que se incluía aquéllos que no alcanzaban una respuesta molecular mayor (tránscritos bcr-abl inferiores al 0,1%) en los primeros 18 meses de tratamiento

Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens

BACKGROUND: Compared with World Health Organization-defined acute myeloid leukaemia (AML) not otherwise specified, patients with AML with myelodysplasia-related changes (AML-MRC) are generally older and more likely to have poor-risk cytogenetics, leading to poor response and prognosis. More than one-half of all older (≥65 years) patients in the phase 3 AZA-AML-001 trial had newly diagnosed AML-MRC. METHODS: We compared clinical outcomes for patients with AML-MRC treated with azacitidine or conventional care regimens (CCR; induction chemotherapy, low-dose cytarabine, or supportive care only) overall and within patient subgroups defined by cytogenetic risk (intermediate or poor) and age (65-74 years or ≥75 years). The same analyses were used to compare azacitidine with low-dose cytarabine in patients who had been preselected to low-dose cytarabine before they were randomized to receive azacitidine or CCR (ie, low-dose cytarabine). RESULTS: Median overall survival was significantly prolonged with azacitidine (n = 129) versus CCR (n = 133): 8.9 versus 4.9 months (hazard ratio 0.74, [95%CI 0.57, 0.97]). Among patients with intermediate-risk cytogenetics, median overall survival with azacitidine was 16.4 months, and with CCR was 8.9 months (hazard ratio 0.73 [95%CI 0.48, 1.10]). Median overall survival was significantly improved for patients ages 65-74 years treated with azacitidine compared with those who received CCR (14.2 versus 7.3 months, respectively; hazard ratio 0.64 [95%CI 0.42, 0.97]). Within the subgroup of patients preselected to low-dose cytarabine before randomization, median overall survival with azacitidine was 9.5 months versus 4.6 months with low-dose cytarabine (hazard ratio 0.77 [95%CI 0.55, 1.09]). Within the low-dose cytarabine preselection group, patients with intermediate-risk cytogenetics who received azacitidine had a median overall survival of 14.1 months versus 6.4 months with low-dose cytarabine, and patients aged 65-74 years had median survival of 14.9 months versus 5.2 months, respectively. Overall response rates were similar with azacitidine and CCR (24.8% and 17.3%, respectively), but higher with azacitidine versus low-dose cytarabine (27.2% and 13.9%). Adverse events were generally comparable between the treatment arms. CONCLUSIONS: Azacitidine may be the preferred treatment for patients with AML-MRC who are not candidates for intensive chemotherapy, particularly patients ages 65-74 years and those with intermediate-risk cytogenetics. TRIAL REGISTRATION: This study was registered at clinicalTrials.gov on February 16, 2010 ( NCT01074047 )

Luspatercept in patients with lower-risk myelodysplastic syndromes

Background: Patients with anemia and lower-risk myelodysplastic syndromes in whom erythropoiesis-stimulating agent therapy is not effective generally become dependent on red-cell transfusions. Luspatercept, a recombinant fusion protein that binds transforming growth factor β superfamily ligands to reduce SMAD2 and SMAD3 signaling, showed promising results in a phase 2 study. Methods: In a double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients with very-low-risk, low-risk, or intermediate-risk myelodysplastic syndromes (defined according to the Revised International Prognostic Scoring System) with ring sideroblasts who had been receiving regular red-cell transfusions to receive either luspatercept (at a dose of 1.0 up to 1.75 mg per kilogram of body weight) or placebo, administered subcutaneously every 3 weeks. The primary end point was transfusion independence for 8 weeks or longer during weeks 1 through 24, and the key secondary end point was transfusion independence for 12 weeks or longer, assessed during both weeks 1 through 24 and weeks 1 through 48. Results: Of the 229 patients enrolled, 153 were randomly assigned to receive luspatercept and 76 to receive placebo; the baseline characteristics of the patients were balanced. Transfusion independence for 8 weeks or longer was observed in 38% of the patients in the luspatercept group, as compared with 13% of those in the placebo group (P Conclusions: Luspatercept reduced the severity of anemia in patients with lower-risk myelodysplastic syndromes with ring sideroblasts who had been receiving regular red-cell transfusions and who had disease that was refractory to or unlikely to respond to erythropoiesis-stimulating agents or who had discontinued such agents owing to an adverse event. (Funded by Celgene and Acceleron Pharma; MEDALIST ClinicalTrials.gov number, NCT02631070. opens in new tab; EudraCT number, 2015-003454-41. opens in new tab.)</p

C-111 INAUGURAN FIL POLITÉCNICA 2013; VISITARÁ 12 ESTADOS

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