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Mateos M.-V.,University of Salamanca | Gutierrez N.C.,University of Salamanca | Martin-Ramos M.-L.,Hospital 12 de Octubre | Paiva B.,University of Salamanca | And 21 more authors.
Blood | Year: 2011

Cytogenetic abnormalities (CAs) such as t(4;14), t(14;16) or del(17p), and nonhyperdiploidy are associated with poor prognosis in multiple myeloma. We evaluated the influence of CAs by FISH and DNA ploidy by flow cytometry on response and survival in 232 elderly, newly diagnosed multiple myeloma patients receiving an induction with weekly bortezomib followed by maintenance therapy with bortezomib-based combinations. Response was similar in the high-risk and standard-risk CAgroups, both after induction (21% vs 27% complete responses [CRs]) and maintenance (39% vs 45% CR). However, high-risk patients showed shorter progression-free survival (PFS) than standard-risk patients, both from the first (24 vs 33 months; P = .04) and second randomization (17 vs 27 months; P = .01). This also translated into shorter overall survival (OS) for high-risk patients (3-year OS: 55% vs 77%; P = .001). This adverse prognosis applied to either t(4;14) or del(17p). Concerning DNA ploidy, hyperdiploid patients showed longer OS than nonhyperdiploid patients (77% vs 63% at 3 years; P = .04), and this was more evident in patients treated with bortezomib, thalidomide, and prednisone (77% vs 53% at 3 years; P = .02). The present schema does not overcome the negative prognosis of high-risk CAs and nonhyperdiploidy. This trial was registered with www.ClinicalTrials.gov as NCT00443235. © 2011 by The American Society of Hematology.

Casares-Lopez M.J.,University of Oviedo | Gonzalez-Menendez A.,University of Oviedo | Bobes-Bascaran M.T.,Hospital Clinico de Valencia | Secades R.,University of Oviedo | And 2 more authors.
Adicciones | Year: 2011

Introduction: Data show that 92.5% of prison inmates report drug or alcohol use. In spite of this, only 2% of dual diagnosis research has been carried out in the prison context. Therefore, the aim of this descriptive cross-sectional study was to analyze the profiles of dual diagnosis in a Spanish prison and test the feasibility of two assessment instruments. Method: The sample was made up of 152 drugaddicts imprisoned in the Villabona Penitentiary Center (Asturias, Spain) who volunteered to be interviewed. The sixth version of the Addiction Severity Index and the International Neuropsychiatric Interview -MINI- were used for the assessment of inmates' psychopathological status and drug problems. Results: The results show that, in general, the offender's profile is: male, 34 years old, unmarried, with children and with an average time spent in prison of approximately five years. Only 4.5% of respondents did not use drugs at the time of the study. In the remainder, the most widely used substances are cocaine (37.6%), heroin (29.9%) and alcohol (10.8%), with 52.7% reporting having used drugs in the last month. With regard to psychopathological state, only 12.9% have no associated disorders, and the most prevalent symptoms correspond to antisocial personality disorder (65.6%), risk of suicide (45.2%), depression (35.9%) and anxiety (25.5%). Conclusion: The instruments proposed (ASI-6 and MINI) are feasible tools for detecting addiction severity and associated psychopathology in this context.

Paiva B.,Hospital Universitario Of Salamanca | Paiva B.,University of Salamanca | Gutierrez N.C.,Hospital Universitario Of Salamanca | Gutierrez N.C.,University of Salamanca | And 26 more authors.
Blood | Year: 2012

The achievement of complete response (CR) after high-dose therapy/autologous stem cell transplantation (HDT/ASCT) is a surrogate for prolonged survival in multiple myeloma; however, patients who lose their CR status within 1 year of HDT/ASCT (unsustained CR) have poor prognosis. Thus, the identification of these patients is highly relevant. Here, we investigate which prognostic markers can predict unsustained CR in a series of 241 patients in CR at day +100 after HDT/ASCT who were enrolled in the Spanish GEM2000 (n = 140) and GEM2005 < 65y (n = 101) trials. Twenty-nine (12%) of the 241 patients showed unsustained CR and a dismal outcome (median overall survival 39 months). The presence of baseline high-risk cytogenetics by FISH (hazard ratio 17.3; P = .002) and persistent minimal residual disease by multiparameter flow cytometry at day +100 after HDT/ASCT (hazard ratio 8.0; P = .005) were the only independent factors that predicted unsustained CR. Thus, these 2 parameters may help to identify patients in CR at risk of early progression after HDT/ASCT in whom novel treatments should be investigated. © 2012 by The American Society of Hematology.

Mateos M.-V.,University of Salamanca | Oriol A.,Institute Catala dOncologia Hospital Germans Trials IPujol | Martinez-Lopez J.,Hospital 12 de Octubre | Gutierrez N.,University of Salamanca | And 20 more authors.
Blood | Year: 2012

Maintenance therapy has become a hot field in myeloma, and it may be particularly relevant in elderly patients because the major benefit results from the initial therapy. We report the results of a randomized comparison of maintenance with bortezomib plus thalidomide (VT) or prednisone (VP) in 178 elderly untreated myeloma patients who had received 6 induction cycles with bortezomib plus either melphalan and prednisone or thalidomide and prednisone. The complete response (CR) rate increased from 24% after induction up to 42%, higher for VT versus VP (46% vs 39%). Median progression-free survival (PFS) was superior for VT (39 months) compared with VP (32 months) and overall survival (OS) was also longer in VT patients compared with VP (5-year OS of 69% and 50%, respectively) but the differences did not reach statistical significance. CR achievement was associated with a significantly longer PFS (P < .001) and 5-year OS (P < .001). The incidence of G3-4 peripheral neuropathy was 9% for VT and 3% for VP. Unfortunately, this approach was not able to overcome the adverse prognosis of cytogenetic abnormalities. In summary, these maintenance regimens result in a significant increase in CR rate, remarkably long PFS, and acceptable toxicity profile. The trial is registered at www.clinicaltrials.gov as NCT00443235. © 2012 by The American Society of Hematology.

Mateos M.-V.,University of Salamanca | Oriol A.,Institute Catala dOncologia | Martinez-Lopez J.,Hospital 12 de Octubre | Teruel A.-I.,Hospital Clinico de Valencia | And 19 more authors.
Blood | Year: 2014

Melphalan (M), in combination with prednisone (MP), has been the backbone of new combinations, including bortezomib plus MP (VMP). However, new alkylator-free schemes, such as lenalidomide plus low-dose dexamethasone, are challenging the role of alkylators in myeloma treatment of elderly patients. Here we have updated, after a long follow-up (median 6 years), the results of the GEM 2005 study that addressedthis question by comparing VMP with bortezomib plus thalidomide and prednisone (VTP)asinduction. Between April 2005 and October 2008, 260 patients were randomized to receive 6 cycles of VMP or VTP as induction. The median progression-free survival was 32 months for the VMP and 23 months for the VTP arms (P 5.09). VMP significantly prolonged the overall survival (OS) compared with VTP (median of 63 and 43 months, respectively; hazard ratio [HR]: 0.67, P 5.01). Achieving immunophenotypic complete response was associated with a significantly longer OS, especially in the VMP arm(66% remain alive after 8 years). Melphalan, plus bortezomib, should be maintained as standard care for the treatment of elderly multiple myeloma patients. This trial was registered at www.clinicaltrials.gov as #NCT00443235. © 2014 by The American Society of Hematology.

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