Meloni A.,CNR Institute of Neuroscience |
Positano V.,CNR Institute of Neuroscience |
Keilberg P.,CNR Institute of Neuroscience |
De Marchi D.,CNR Institute of Neuroscience |
And 13 more authors.
Magnetic Resonance in Medicine | Year: 2012
This study aimed to determine the feasibility, reproducibility, and reliability of the multiecho T2 * Magnetic resonance imaging technique at 3 T for myocardial and liver iron burden quantification and the relationship between T2 * values at 3 and 1.5 T. Thirty-eight transfusion-dependent patients and 20 healthy subjects were studied. Cardiac segmental and global T2 * values were calculated after developing a correction map to compensate the artifactual T2 * variations. The hepatic T2 * value was determined over a region of interest. The intraoperator and interoperator reproducibility for T2 * measurements at 3 T was good. A linear relationship was found between patients' R *2 (1000/T2 *) values at 3 and 1.5 T. Segmental correction factors were significantly higher at 3 T. A conversion formula returning T2 * values at 1.5 T from values at 3 T was proposed. A good diagnostic reliability for T 2 * assessment at 3 T was demonstrated. Lower limits of normal for 3 T T2 * values were 23.3 ms, 21.1 ms, and 11.7 ms, for the global heart, mid-ventricular septum, and liver, respectively. In conclusion, T2 * quantification of iron burden in the mid-ventricular septum, global heart, and no heavy-moderate livers resulted to be feasible, reproducible, and reliable at 3 T. Segmental heart T2 * analysis at 3 T may be challenging due to significantly higher susceptibility artifacts. Magn Reson Med, 2012. © 2011 Wiley Periodicals, Inc. Copyright © 2011 Wiley Periodicals, Inc.
Bringhen S.,Myeloma Unit |
Petrucci M.T.,University of Rome La Sapienza |
Larocca A.,Myeloma Unit |
Conticello C.,Ospedale Ferrarotto |
And 16 more authors.
Blood | Year: 2014
This multicenter, open-label phase 2 trial determined the safety and efficacy of carfilzomib, a novel and irreversible proteasome inhibitor, in combination with cyclophosphamide and dexamethasone (CCyd) in patients with newly diagnosed multiple myeloma (NDMM) ≥65 years of age or who were ineligible for autologous stem cell transplantation. Patients (N 5 58) received CCyd for up to 9 28-day cycles, followed by maintenance with carfilzomib until progression or intolerance. After a median of 9 CCyd induction cycles (range 1-9), 95% of patients achieved at least a partial response, 71% achieved at least a very good partial response, 49% achieved at least a near complete response, and 20% achieved stringent complete response. After a median follow-up of 18 months, the 2-year progression-free survival and overall survival rates were 76% and 87%, respectively. The most frequent grade 3 to 5 toxicities were neutropenia (20%), anemia (11%), and cardiopulmonary adverse events (7%). Peripheral neuropathy was limited to grades 1 and 2 (9%). Fourteen percent of patients discontinued treatment because of adverse events, and 21% of patients required carfilzomib dose reductions. In summary, results showed high complete response rates and a good safety profile. This trial was registered at clinicaltrials.gov as #NCT01346787. © 2014 by The American Society of Hematology.
PubMed | Instituto Clinico Sant Ambrogio, CHU le Bocage, Ospedale Ferrarotto, King Fahad National Guard Hospital and 24 more.
Type: Journal Article | Journal: European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery | Year: 2016
After a panel process, recommendations on the use of sutureless and rapid deployment valves in aortic valve replacement were given with special respect as an alternative to stented valves.Thirty-one international experts in both sutureless, rapid deployment valves and stented bioprostheses constituted the panel. After a thorough literature review, evidence-based recommendations were rated in a three-step modified Delphi approach by the experts.Literature research could identify 67 clinical trials, 4 guidelines and 10 systematic reviews for detailed text analysis to obtain a total of 28 recommendations. After rating by the experts, 12 recommendations were identified and degree of consensus for each was determined. Proctoring and education are necessary for the introduction of sutureless valves on an institutional basis as well as for the individual training of surgeons. Sutureless and rapid deployment should be considered as the valve prosthesis of first choice for isolated procedures in patients with comorbidities, old age, delicate aortic wall conditions such as calcified root, porcelain aorta or prior implantation of aortic homograft and stentless valves as well as for concomitant procedures and small aortic roots to reduce cross-clamp time. Intraoperative transoesophageal echocardiography is highly recommended, and in case of right anterior thoracotomy, preoperative computer tomography is strongly recommended. Suitable annular sizes are 19-27 mm. There is a contraindication for bicuspid valves only for Type 0 and for annular abscess or destruction due to infective endocarditis. Careful but complete decalcification of the aortic root is recommended to avoid paravalvular leakage; extensive decalcification should be avoided not to create annular defects. Proximal anastomoses of concomitant coronary artery bypass grafting should be placed during a single aortic cross-clamp period or alternatively with careful side clamping. Available evidence suggests that the use of sutureless and rapid deployment valve is associated with (can translate into) reduced early complications such as prolonged ventilation, blood transfusion, atrial fibrillation, pleural effusions and renal replacement therapy, respectively, and may result in reduced intensive care unit and hospital stay in comparison with traditional valves.The international experts recommend various benefits of sutureless and rapid deployment technology, which may represent a helpful tool in aortic valve replacement for patients requiring a biological valve. However, further evidence will be needed to reaffirm the benefit of sutureless and rapid deployment valves.
Koch K.T.,University of Amsterdam |
Grundeken M.J.,University of Amsterdam |
Vos N.S.,Onze Lieve Vrouwe Gasthuis |
IJsselmuiden A.J.J.,Albert Schweitzer Ziekenhuis |
And 9 more authors.
EuroIntervention | Year: 2015
Aims: The aim of APPOSITION III was to evaluate the feasibility and performance of the STENTYS Self-Apposing® stent (STENTYS S.A., Paris, France) in the setting of primary percutaneous coronary intervention (PCI). Methods and results: APPOSITION III was an international, prospective, multicentre registry. The study population consisted of 965 patients. The rate of the primary endpoint major adverse cardiac events (MACE), defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularisation (CD-TLR), at one year was 9.3%. One-year cardiac death rate was 2.0%, TV-MI rate was 1.3%, CD-TLR rate was 7.4% and definite/probable stent thrombosis (ST) rate was 3.5% (definite ST 2.8%). An interim safety analysis of in-hospital outcomes in the first 400 patients showed higher event rates if post-dilation was not performed, and post-dilations became highly recommended in the remaining cohort. Patients undergoing post-dilation eventually showed a numerically lower one-year MACE rate (8.4% vs. 11.3%, p=0.137). One-year TV-MI (0.8% vs. 2.5%, p=0.027) and definite ST (1.9% vs. 5.0%, p=0.010) rates were significantly lower if post-dilation was performed, with the divergence occurring at <30 days. Conclusions: The use of the STENTYS Self-Apposing® stent in the setting of primary PCI was feasible and associated with acceptable cardiovascular event rates which improved when post-dilation was performed. © Europa Digital & Publishing 2015. All rights reserved.
Bjorkstrand B.,Karolinska Institutet |
Iacobelli S.,University of Rome Tor Vergata |
Hegenbart U.,University of Heidelberg |
Gruber A.,Karolinska Institutet |
And 13 more authors.
Journal of Clinical Oncology | Year: 2011
Purpose: Results of allogeneic stem-cell transplantation (allo) in myeloma are controversial. In this trial autologous stem-cell transplantation (auto) followed by reduced-intensity conditioning matched sibling donor allo (auto-allo) was compared with auto only in previously untreated multiple myeloma. Patients and Methods: In all, 357 patients with myeloma up to age 69 years were enrolled from 2001 to 2005. Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) and patients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104) auto was optional. Conditioning for the auto arm was melphalan 200 mg/m2; conditioning for the allo arm was total-body irradiation 2 Gy plus fludarabine 30 mg/m2/d for 3 days. Median follow-up time was 61 months. Primary end point was progression-free survival. Results: Progression-free survival at 60 months was significantly better with auto-allo than with allo alone (35% v 18%; P = .001), as was the risk of death and of relapse in the long term (P = .047 and P = .003, respectively). Overall survival at 60 months was 65% versus 58%, and relapse incidence was 49% versus 78%. Complete remission rates were 51% and 41%, respectively (P = .020). Nonrelapse mortality at 24 months was 12% after auto-allo compared with 3% in the auto group (P < .001). The incidence of grade 2 to 4 acute graft-versus-host disease (GvHD) was 20%, and the incidence of limited and extensive chronic GvHD was 31% and 23%. Conclusion: In patients with previously untreated multiple myeloma, long-term outcome with respect to progression-free survival, overall survival, and relapse rate is superior after auto-allo compared with auto only. Nonrelapse mortality is at a reasonable level in both groups. © 2011 by American Society of Clinical Oncology.
Passera R.,Azienda Ospedaliera Citta della Salute e della Science di Turin |
Pollichieni S.,Italian Bone Marrow Donor Registry |
Brunello L.,University of Turin |
Patriarca F.,University of Udine |
And 24 more authors.
Biology of Blood and Marrow Transplantation | Year: 2013
To evaluate trends in allografting from unrelated donors, we conducted a study on 196 consecutive myeloma patients transplanted between 2000 and 2009 in Italy. Twenty-eight percent, 37%, and 35%, respectively, received myeloablative, reduced-intensity, and nonmyeloablative conditioning. In these 3 cohorts, 1-year and 5-year transplantation-related mortalities were 28.8% and 37.0%, 20.3% and 31.3%, and 25.0% and 30.3%, respectively (. P = .745). Median overall survival (OS) and event-free survival from transplantation for the 3 cohorts were 29 and 10 months, 11 and 6 months, and 32 and 13 months, respectively (. P = .039 and P = .049). Overall cumulative incidences of acute and chronic graft-versus-host-disease (GVHD) were 46.1% and 51.1%. By Cox multivariate analyses, chronic GVHD was significantly associated with longer OS (hazard ratio [HR], .51; P = .009), whereas the use of peripheral blood stem cells was borderline significant (HR, .55; P = .051). Better response posttransplantation was associated with longer event-free survival (HR, 2.13 to 4.25; P < .001). Acute GVHD was associated with poorer OS (HR, 2.53; P = .001). This analysis showed a strong association of acute and chronic GVHD and depth of response posttransplantation with clinical outcomes. Long-term disease control remains challenging regardless of the conditioning. In the light of these results, prospective trials may be designed to better define the role of allografting from unrelated donors in myeloma. © 2013 American Society for Blood and Marrow Transplantation.
Basile A.,Ospedale Ferrarotto |
Tsetis D.,University of Crete |
Cavalli M.,Ospedale Ferrarotto |
Fiumara P.,Ospedale Ferrarotto |
And 7 more authors.
CardioVascular and Interventional Radiology | Year: 2010
The purpose of this study was to assess the efficacy of cementoplasty in the treatment of sacral multiple myelomas. We retrospectively reviewed the records of eight patients (four women and four men; age range 47-68 years; mean age 57.8) who underwent cementoplasty for painful osteolytic localization of multiple myeloma between April 2007 and May 2009. The patients had difficulty walking because of increasing pain. Six patients had persistent pain despite other cementoplasties for vertebral and femoral localization, whereas two patients referred at the time of diagnosis had only sacral lesions. The clinical indication for treatment was (1) a pain intensity score ≥5 on visual analogue scale (VAS) and (2) pain totally or partially refractory to analgesic treatment in patients with a life expectancy >3 months. Technical planning was based on computed tomography and/or magnetic resonance imaging. Six patients had previously undergone radiotherapy or chemotherapy and were receiving varying doses of analgesics, whereas sacroplasty represented the first treatment for two patients. Five patients had monolateral local involvement, and the other patients had massive involvement of the sacrum; Technical success was achieved in all cases. We had only one small and asymptomatic foraminal leak. All patients experienced improvement in symptoms after the procedure, as demonstrated by improved VAS scores and performance status (PS) and decreased analgesic dose constant during follow-up. In our experience, percutaneous stabilization can be used effectively and safely in patients with focal or extensive involvement of the sacrum by multiple myeloma. © 2009 Springer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
Federico M.,University of Modena and Reggio Emilia |
Luminari S.,University of Modena and Reggio Emilia |
Dondi A.,University of Modena and Reggio Emilia |
Tucci A.,Azienda Ospedaliera Spedali Civili |
And 16 more authors.
Journal of Clinical Oncology | Year: 2013
Purpose Although rituximab (R) is commonly used for patients with advanced follicular lymphoma (FL) requiring treatment, the optimal associated chemotherapy regimen has yet to be clarified. Patients and Methods We conducted an open-label, multicenter, randomized trial among adult patients with previously untreated stages II to IV FL to compare efficacy of eight doses of R associated with eight cycles of cyclophosphamide, vincristine, and prednisone (CVP) or six cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or six cycles of fludarabine and mitoxantrone (FM). The principal end point of the study was time to treatment failure (TTF). Results There were 534 patients enrolled onto the study. Overall response rates were 88%, 93%, and 91% for R-CVP, R-CHOP, and R-FM, respectively (P = .247). After a median follow-up of 34 months, 3-year TTFs were 46%, 62%, and 59% for the respective treatment groups (R-CHOP v R-CVP, P = .003; R-FM v R-CVP, P = .006; R-FM v R-CHOP, P = .763). Three-year progression-free survival (PFS) rates were 52%, 68%, and 63% (overall P = .011), respectively, and 3-year overall survival was 95% for the whole series. R-FM resulted in higher rates of grade 3 to 4 neutropenia (64%) compared with R-CVP (28%) and R-CHOP (50%; P = .001). Overall, 23 second malignancies were registered during follow-up: four in R-CVP, five in R-CHOP, and 14 in R-FM. Conclusion In this study, R-CHOP and R-FM were superior to R-CVP in terms of 3-year TTF and PFS. In addition, R-CHOP had a better risk-benefit ratio compared with R-FM. © 2013 by American Society of Clinical Oncology.
Romano A.,Ospedale Ferrarotto |
Vetro C.,SSC Scuola Superiore di Catania |
Adriani M.,Johns Hopkins University
Cancer Biology and Therapy | Year: 2011
The Regulatory Myeloid Cells - International Immunopharmacology Conference in October 21-24, 2010 reviewed the recent advances in our understanding of the biological mechanisms of expansion, activation, metabolism and mechanisms of T-cell suppression of myeloid derived suppressor cells (MDSC). Lectures were focused on the control of the microenvironment and cytokines needed for myelopoiesis, interactions with the neoplastic surrounding cells for a negative immune control and the role of MDSC in cancer promotion. The complexity of the tumor microenvironment and opportunities for therapeutic interventions by targeting, and/or manipulating MDSCs was emphasized. A better understanding of the crosstalk between myelo- and lymphoid arms of the immune system and of the metabolic alterations contributing to cancer phenotype provide new insights for the development of more efficient tumor immunotherapy strategies. This meeting report aims to provide the readers with a summary of the research highlights on human and mouse MDSCs presented in the meeting. © 2011 Landes Bioscience.
Basile A.,Ospedale Ferrarotto |
Cavalli M.,Ospedale Ferrarotto |
Fiumara P.,Ospedale Ferrarotto |
Di Raimondo F.,Ospedale Ferrarotto |
And 6 more authors.
Skeletal Radiology | Year: 2011
Aim The goal of this study was to specifically address the incidence of dorsal leakage when performing vertebroplasty in patients with posterior wall osteolysis or fracture, by using a delayed injection of cement with the aim of increasing its viscosity. Materials and methods We prospectively reviewed the records of 24 patients (13 women, 11 men; age range 42- 67 years; mean age 54.7) with diagnosis of multiple myeloma (MM) who underwent 34 vertebroplasties between January 2007 and January 2010 for painful osteolytic localization of MM with dorsal cortical osteolysis or fracture. All vertebroplasties were performed with an 8 min delay, which was half of the allotted injecting time given for the chosen cement. In 11 cases there were fractures involving the posterior wall, in 1 case with dorsal fragment dislocation, and in 33 cases there was dorsal cortical osteolysis. All of the patients showed no response to standard treatments such as radiotherapy, chemotherapy, and analgesic treatments. Results Technical success was achieved in all cases. In 20 patients, we treated only one high-risk vertebral lesion, in six patients we treated two segments, and in one patient we treated three segments. All patients experienced improvement in symptoms after the procedure as demonstrated by improved visual analogue scores (VAS) and performance status (PS) and decreased doses of analgesic. There was a dorsal leakage in 2/34 (5.8%) treated vertebral bodies in which an epidural space tumor extension was also diagnosed, without increasing neurological symptoms after the intervention. Conclusion From these results vertebroplasty with delayed injection of cement is safe and effective in the treatment of vertebral localization of myeloma with osteolysis or fracture of the posterior vertebral wall. © ISS 2011.