Jose Falantes
Spanish National Research Council
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Featured researches published by Jose Falantes.
Blood | 2015
Hervé Dombret; John F. Seymour; Aleksandra Butrym; Agnieszka Wierzbowska; Dominik Selleslag; Jun Ho Jang; Rajat Kumar; J Cavenagh; Andre C. Schuh; Anna Candoni; Christian Recher; Irwindeep Sandhu; Teresa Bernal del Castillo; Haifa Kathrin Al-Ali; Giovanni Martinelli; Jose Falantes; Richard Noppeney; Richard Stone; Mark D. Minden; Heidi McIntyre; S. Songer; Lela M. Lucy; C.L. Beach; Hartmut Döhner
This multicenter, randomized, open-label, phase 3 trial evaluated azacitidine efficacy and safety vs conventional care regimens (CCRs) in 488 patients age ≥65 years with newly diagnosed acute myeloid leukemia (AML) with >30% bone marrow blasts. Before randomization, a CCR (standard induction chemotherapy, low-dose ara-c, or supportive care only) was preselected for each patient. Patients then were assigned 1:1 to azacitidine (n = 241) or CCR (n = 247). Patients assigned to CCR received their preselected treatment. Median overall survival (OS) was increased with azacitidine vs CCR: 10.4 months (95% confidence interval [CI], 8.0-12.7 months) vs 6.5 months (95% CI, 5.0-8.6 months), respectively (hazard ratio [HR] was 0.85; 95% CI, 0.69-1.03; stratified log-rank P = .1009). One-year survival rates with azacitidine and CCR were 46.5% and 34.2%, respectively (difference, 12.3%; 95% CI, 3.5%-21.0%). A prespecified analysis censoring patients who received AML treatment after discontinuing study drug showed median OS with azacitidine vs CCR was 12.1 months (95% CI, 9.2-14.2 months) vs 6.9 months (95% CI, 5.1-9.6 months; HR, 0.76; 95% CI, 0.60-0.96; stratified log-rank P = .0190). Univariate analysis showed favorable trends for azacitidine compared with CCR across all subgroups defined by baseline demographic and disease features. Adverse events were consistent with the well-established safety profile of azacitidine. Azacitidine may be an important treatment option for this difficult-to-treat AML population. This trial was registered at www.clinicaltrials.gov as #NCT01074047.
Haematologica | 2011
Beatriz Martín-Antonio; Magdalena Carmona; Jose Falantes; Encarnación Gil; Alicia Báez; Marı́a Jesús Suárez; Pedro Marin; Ildefonso Espigado; Alvaro Urbano-Ispizua
Background The number of CD34+ cells mobilized from bone marrow to peripheral blood after administration of granulocyte colony-stimulating factor varies greatly among healthy donors. This fact might be explained, at least in part, by constitutional differences in genes involved in the interactions tethering CD34+ cells to the bone marrow. Design and Methods We analyzed genetic characteristics associated with CD34+ cell mobilization in 112 healthy individuals receiving granulocyte colony-stimulating factor (filgrastim; 10 μg/kg; 5 days). Results Genetic variants in VCAM1 and in CD44 were associated with the number of CD34+ cells in peripheral blood after granulocyte colony-stimulating factor administration (P=0.02 and P=0.04, respectively), with the quantity of CD34+ cells ×106/kg of donor (4.6 versus 6.3; P<0.001 and 7 versus 5.6; P=0.025, respectively), and with total CD34+ cells ×106 (355 versus 495; P=0.002 and 522 versus 422; P=0.012, respectively) in the first apheresis. Of note, granulocyte colony-stimulating factor administration was associated with complete disappearance of VCAM1 mRNA expression in peripheral blood. Moreover, genetic variants in granulocyte colony-stimulating factor receptor (CSF3R) and in CXCL12 were associated with a lower and higher number of granulocyte colony-stimulating factor-mobilized CD34+ cells/μL in peripheral blood (81 versus 106; P=0.002 and 165 versus 98; P=0.02, respectively) and a genetic variant in CXCR4 was associated with a lower quantity of CD34+ cells ×106/kg of donor and total CD34+ cells ×106 (5.3 versus 6.7; P=0.02 and 399 versus 533; P=0.01, respectively). Conclusions In conclusion, genetic variability in molecules involved in migration and homing of CD34+ cells influences the degree of mobilization of these cells.
Haematologica | 2012
Manuela Aguilar-Guisado; Almudena Martín-Peña; Ildefonso Espigado; Maite Ruiz Pérez de Pipaón; Jose Falantes; Fátima Cruz; José Miguel Cisneros
Background Giving antifungal therapy exclusively to selected patients with persistent febrile neutropenia may avoid over-treatment without increasing mortality. The aim of this study was to validate an innovative diagnostic and therapeutic approach based on assessing patients’ risk profile and clinical criteria in order to select those patients requiring antifungal therapy. The efficacy of this approach was compared to that of universal empirical antifungal therapy. Design and Methods This was a prospective study which included all consecutive adult hematology patients with neutropenia and fever refractory to 5 days of empirical antibacterial therapy admitted to a teaching hospital in Spain over a 2-year period. A diagnostic and therapeutic approach based on clinical criteria and risk profile was applied in order to select patients for antifungal therapy. The sensitivity, specificity and negative predictive value of this approach and also the overall success rate, according to the same criteria of efficacy described in classical clinical trials, were analyzed. Results Eighty-five episodes were included, 35 of them (41.2%) in patients at high risk of invasive fungal infections. Antifungal therapy was not indicated in 33 episodes (38.8%). The overall incidence of proven and probable invasive fungal infections was 14.1%, all of which occurred in patients who had received empirical antifungal therapy. The 30-day crude mortality rate was 15.3% and the invasive fungal infection-related mortality rate was 2.8% (2/72). The overall success rate following the diagnostic and therapeutic approach was 36.5% compared with 33.9% and 33.7% obtained in the trial by Walsh et al. The sensitivity, specificity and negative predictive value of the study approach were 100%, 52.4% and 100%, respectively. Conclusions Based on the high negative predictive value of this diagnostic and therapeutic approach in persistent febrile neutropenia patients with hematologic malignancies or patients who have received a hematopoietic stem cell transplant, the approach is useful for identifying patients who are not likely to develop invasive fungal infection and do not, therefore, require antifungal therapy. The effectiveness of the strategy is similar to that of universal empirical antifungal therapy reported in controlled trials.
Leukemia Research | 2014
Regina García-Delgado; Dunia de Miguel; Alicia Bailen; José Ramón González; Joan Bargay; Jose Falantes; Rafael Andreu; Fernando Ramos; Mar Tormo; Salut Brunet; Antonio Figueredo; Javier Casaño; Angeles Medina; Llorenç Badiella; Antonio Fernández Jurado; Guillermo Sanz
We investigated the effectiveness and tolerability of azacitidine in patients with World Health Organization-defined myelodysplastic syndromes, or acute myeloid leukemia with 20-30% bone marrow blasts. Patients were treated with azacitidine, with one of three dosage regimens: for 5 days (AZA 5); 7 days including a 2-day break (AZA 5-2-2); or 7 days (AZA 7); all 28-day cycles. Overall response rates were 39.4%, 67.9%, and 51.3%, respectively, and median overall survival (OS) durations were 13.2, 19.1, and 14.9 months. Neutropenia was the most common grade 3-4 adverse event. These results suggest better effectiveness-tolerability profiles for 7-day schedules.
Clinical Lymphoma, Myeloma & Leukemia | 2014
Jose Falantes; Cristina Calderón; Francisco J. Márquez-Malaver; Manuela Aguilar-Guisado; Almudena Martín-Peña; María L. Martino; Isabel Montero; J. A. González; Rocio Parody; José A. Pérez-Simón; Ildefonso Espigado
Incidence, etiology, and outcome of infectious episodes in patients with myeloid neoplasms receiving azacitidine are uncertain, with no prospective data available in this group of patients. The aim of the current study was to analyze the incidence and factors related to the probability of infection in a cohort of patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) treated with azacitidine who did not receive any type of antimicrobial prophylaxis. Significantly, the group of patients who received prior intensive chemotherapy had more infectious episodes (P = 10(-4)), and particularly, invasive aspergillosis (P = .015), than patients who received frontline azacitidine. Primary antifungal prophylaxis might be recommended in MDS and AML patients receiving azacitidine as salvage therapy after intensive regimens.
Clinical Lymphoma, Myeloma & Leukemia | 2013
Jose Falantes; Cristina Calderón; Francisco J. Márquez Malaver; Dora Alonso; Antonio Martín Noya; Estrella Carrillo; María L. Martino; Isabel Montero; J. A. González; Rocio Parody; Ildefonso Espigado; José A. Pérez-Simón
UNLABELLED Prognosis of myelodysplastic syndromes (MDS) is an area of ongoing interest. Identification of patients with poor outcome in the categories of lower risk disease is critical. In this study, we classify a cohort of 332 lower risk MDS into 3 groups with differences in survival and risk for leukemic progression that could drive treatment approaches to improve prognosis in a fraction of these patients. BACKGROUND Prognosis of MDS and particularly in patients categorized as lower risk (< 10% blasts or low and intermediate-1 International Prognostic Scoring System [IPSS]) is very heterogeneous and includes patients with very different outcomes with current scoring systems. Recently, a new cytogenetic classification has been proposed for the revised IPSS in predicting the outcome for MDS. PATIENTS AND METHODS To evaluate the prognostic significance of multiple variables for survival and risk of progression to acute myeloid leukemia, we analyzed baseline characteristics of 332 lower risk MDS patients within the lower risk cytogenetic categories by IPSS and the recent proposal for the new cytogenetic classification. RESULTS In multivariate analysis, severity of cytopenias, age > 60 years, bone marrow blasts (5%-9%) and transfusion dependency significantly influenced outcome. The combination of these variables allowed development of a model which categorizes patients in 3 different groups with median survival of 95, 44, and 13 months for groups 1, 2, and 3, respectively (P < .001). In addition, this score also stratified patients for their risk for leukemic progression, estimated at 2 years in 3.1%, 7.6%, and 21.3% for each group (P = .024). CONCLUSION Although karyotype remains the main prognostic factor in MDS, the current study identifies clinical parameters predicting outcome among patients with the better cytogenetic profile. Degree of cytopenias, blasts 5%-9% and transfusion dependence might identify a subset of patients within the nonadverse karyotype, in which early or more aggressive approaches could possibly be required to improve survival or prevent disease progression.
Leukemia Research | 2015
Jose Falantes; Regina Garcia Delgado; Cristina Calderón-Cabrera; Francisco J. Márquez-Malaver; David Valcárcel; Dunia de Miguel; Alicia Bailén; Joan Bargay; Teresa Bernal; José Ramón González-Porras; Mar Tormo; Fernando Ramos; Rafael Andreu; Blanca Xicoy; Benet Nomdedeu; Salut Brunet; Joaquin Sanchez; Antonio Fernández Jurado; Santiago Bonanad; José A. Pérez-Simón; Guillermo Sanz
Scoring systems for lower-risk myelodysplastic syndrome (LR-MDS) recognize patients with a poorer than expected outcome. This study retrospectively analyzes the role of azacitidine in LR-MDS with adverse risk score and compared to an historical cohort treated with best supportive care or erythropoiesis-stimulating agents. Overall response to AZA was 40%. One and 2-year probabilities of survival were 62% and 45% for AZA vs. 25% and 11% (P=10(-4)). In a multivariable time-dependent analysis, response to AZA (CR/PR/HI) was associated with an improved survival (HR=0.234, 95% CI, 0.063-0.0863; P=0.029). Thrombocytopenia (<50 × 10(9)L(-1)) is confirmed as an adverse parameter in LR-MDS (HR=1.649, 95% CI, 1.012-2.687; P=0.045).
British Journal of Haematology | 2014
Joaquin Sanchez-Garcia; Consuelo del Cañizo; Ignacio Lorenzo; Benet Nomdedeu; Elisa Luño; Blanca Xicoy; David Valcárcel; Salut Brunet; Víctor Marco-Betés; Marta García-Pintos; Santiago Osorio; Mar Tormo; Alicia Bailen; Carlos Cerveró; Fernando Ramos; María Díez-Campelo; Esperanza Such; Beatriz Arrizabalaga; Gemma Azaceta; Joan Bargay; María J. Arilla; Jose Falantes; Josefina Serrano-López; Guillermo Sanz
The impact of lenalidomide treatment on long‐term outcomes of patients with lower risk myelodysplastic syndromes (MDS) and chromosome 5q deletion (del(5q)) is unclear. This study used time‐dependent multivariate methodology to analyse the influence of lenalidomide therapy on overall survival (OS) and acute myeloblastic leukaemia (AML) progression in 215 patients with International Prognostic Scoring System (IPSS) low or intermediate‐1 risk and del(5q). There were significant differences in several relevant characteristics at presentation between patients receiving (n = 86) or not receiving lenalidomide (n = 129). The 5‐year time‐dependent probabilities of OS and progression to AML were 62% and 31% for patients receiving lenalidomide and 42% and 25% for patients not receiving lenalidomide; differences were not statistically significant in multivariate analysis that included all variables independently associated with those outcomes (OS, P = 0·45; risk of AML, P = 0·31, respectively). Achievement of RBC transfusion independency (P = 0·069) or cytogenetic response (P = 0·021) after lenalidomide was associated with longer OS in multivariate analysis. These data clearly show that response to lenalidomide results in a substantial clinical benefit in lower risk MDS patients with del(5q). Lenalidomide treatment does not appear to increase AML risk in this population of patients.
Future Oncology | 2016
Gail J. Roboz; Pau Montesinos; Dominik Selleslag; Andrew Wei; Jun Ho Jang; Jose Falantes; Maria Teresa Voso; Hamid Sayar; Kimmo Porkka; Paula Marlton; Antonio Almeida; Sanjay R. Mohan; Farhad Ravandi; Guillermo Garcia-Manero; Barry S. Skikne; Hagop M. Kantarjian
Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged ≥55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.
Leukemia Research | 2013
Judit Sánchez-Castro; Víctor Marco-Betés; Xavier Gómez-Arbonés; Leonor Arenillas; David Valcárcel; Teresa Vallespi; Dolors Costa; Benet Nomdedeu; María-José Jiménez; Isabel Granada; Javier Grau; María Teresa Ardanaz; Javier de la Serna; Felix Carbonell; José Cervera; Adriana Sierra; Elisa Luño; Carlos Cerveró; Jose Falantes; María José Calasanz; José Ramón González-Porras; Alicia Bailen; M. Luz Amigo; Guillermo Sanz; Francesc Solé
The prognosis of chromosome 17 (chr17) abnormalities in patients with primary myelodysplastic syndrome (MDS) remains unclear. The revised International Prognostic Scoring System (IPSS-R) includes these abnormalities within the intermediate cytogenetic risk group. This study assessed the impact on overall survival (OS) and risk of acute myeloid leukemia transformation (AMLt) of chr17 abnormalities in 88 patients with primary MDS. We have compared this group with 1346 patients with primary MDS and abnormal karyotype without chr17 involved. The alterations of chr17 should be considered within group of poor prognosis. The different types of alterations of chromosome 17 behave different prognosis. The study confirms the intermediate prognostic impact of the i(17q), as stated in IPSS-R. The results of the study, however, provide valuable new information on the prognostic impact of alterations of chromosome 17 in complex karyotypes.