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Rimini, Italy

Mignani R.,Infermi Hospital | Feriozzi S.,Belcolle Hospital | Schaefer R.M.,University of Munster | Breunig F.,University of Wurzburg | And 3 more authors.
Clinical Journal of the American Society of Nephrology

ESRD is a major cause of morbidity and premature mortality in Fabry disease, particularly in classically affected males. The decline of renal function in Fabry nephropathy is adversely affected by male gender, advanced chronic kidney disease (CKD), and severe proteinuria. The diagnosis of Fabry nephropathy may be missed if not specifically addressed in progressive CKD and patients have been first identified in screening programs of dialysis patients. Fabry patients have worse 3-year survival rates on dialysis as compared with nondiabetic controls. The 5-year survival rate of transplanted Fabry patients is also lower than that of controls. However, because Fabry nephropathy does not recur in the allograft and transplanted Fabry patients appear to have better overall outcomes than those maintained on dialysis, kidney transplantation should be recommended as a first choice in renal replacement therapy (RRT) for Fabry disease. Appropriately designed and powered studies are not available to answer the question whether enzyme replacement therapy (ERT) influences outcomes, the course of cardiomyopathy, events, or survival in Fabry patients on RRT. The authors are not aware of compelling indications for ERT in RRT patients because progression of cardiomyopathy was documented during ERT. Whether the excess mortality risk of Fabry patients on RRT can be prevented by ERT is unknown. Despite observational reports of symptomatic improvement, the available evidence supporting ERT for such patients is not compelling enough. To clarify this issue, studies are needed to test the effectiveness of agalsidases in preventing cardiac and cerebrovascular complications in Fabry patients with ESRD. Copyright © 2010 by the American Society of Nephrology. Source

Vitolo U.,Hematology | Chiappella A.,Hematology | Franceschetti S.,University of Piemonte Orientale | Carella A.M.,University of Genoa | And 21 more authors.
The Lancet Oncology

Background: Up to 40% of elderly patients with untreated diffuse large B-cell lymphoma (DLBCL) given a regimen of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone every 21 days (R-CHOP21) relapse or develop refractory disease. Lenalidomide has high activity in relapsed or refractory aggressive B-cell lymphomas. In phase 2 of the REAL07 trial, we aimed to establish the safety and efficacy of the combination of lenalidomide and R-CHOP21 in elderly patients with untreated DLBCL. Methods: REAL07 was an open-label, multicentre trial that was done in 13 centres in Italy and one in Germany. Eligible patients were aged 60-80 years; had newly diagnosed, untreated, CD20-positive, Ann Arbor stage II-IV DLBCL or grade 3b follicular lymphoma; had an Eastern Cooperative Oncology Group performance status of 0-2; had an International Prognostic Index (IPI) risk of low-intermediate, intermediate-high, or high; and were fit according to comprehensive geriatric assessment. Participants were to receive 15 mg oral lenalidomide on days 1-14 of six 21-day cycles, and standard doses of R-CHOP21 chemotherapy (375 mg/m2 intravenous rituximab, 750 mg/m2 intravenous cyclophosphamide, 50 mg/m2 intravenous doxorubicin, and 1·4 mg/m2 intravenous vincristine on day 1, and 40 mg/m2 oral prednisone on days 1-5). The primary endpoint was frequency of overall response (complete response [CR] and partial response [PR]), which was assessed by 18F-fluorodeoxyglucose (18F-FDG) PET at the end of the treatment. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00907348. Findings: 49 patients were included in phase 2: nine had been enrolled into phase 1 between Oct 23, 2008, and June 4, 2009, and had received the maximum tolerated dose of 15 mg lenalidomide; and 40 were enrolled into phase 2 between April 28, 2010, and June 3, 2011. 45 patients (92%, 95% CI 81-97) achieved a response (42 [86%] CR; three [6%] PR). Three patients (6%) did not respond and one (2%) died for reasons unrelated to treatment or disease. 277 (94%) of 294 planned cycles of lenalidomide and R-CHOP21 were completed. Grade 3-4 neutropenia was reported in 87 cycles (31%), grade 3-4 leukopenia in 77 (28%), and grade 3-4 thrombocytopenia in 35 (13%). No grade 4 non-haematological adverse events were reported. No patients died during the study as a result of toxic effects. Interpretation: Lenalidomide with R-CHOP21 is effective and safe in elderly patients with untreated DLBCL. Funding: Fondazione Italiana Linfomi and Celgene. © 2014 Elsevier Ltd. Source

Giuliani J.,University of Ferrara | Drudi F.,Infermi Hospital
Archives of Gynecology and Obstetrics

Purpose: The aim of this study was to examine if treatment strategies differ by age in the elderly population with ovarian cancer in daily clinical practice. Methods: A retrospective analysis of elderly patients with ovarian cancer who were referred to our institution between January 2007 and August 2010 was done. A univariate analysis for overall survival was estimated according to the Kaplan-Meier method, censoring surviving patients at the time of last follow-up. Results: We evaluated 32 elderly patients: 17 "young-old" patients (65-74 years old), 14 "old-old" patients (75-84 years old) and 1 "oldest-old" patient (≥85 years old). At last follow-up, 20 patients (62.5 %) were alive and 12 patients (37.5 %) were deceased. Median time follow-up was 18.52 months. Median overall survival was 19.05 months. Median age was 73.50 years. In the subgroup of "young-old" patients, there were less "high malignant potential" (64.3 vs. 70.0 %) and grade 3 ovarian cancers (84.6 vs. 90.0 %), less advanced stages (III-IV: 64.7 vs. 86.7 %), higher number of optimal surgical procedures (50.0 vs. 30.0 %) and more frequent use of chemotherapy (82.4 vs. 66.7 %). Single agent carboplatin was administered in 81.8 vs. 77.8 % of "young-old" and "old-oldest old" patients, and average number of lines was 2 vs. 1. Other characteristics were similar in the two subgroups ("young-old" vs. "old-oldest old" patients). By the univariate analysis, there was no statistical significance difference in overall survival (p = 0.393) between the two subgroups, with only a positive trend for young-old patients. Conclusions: In old- and oldest-old patients, the characteristics of disease are worse and optimal treatment strategy is less frequently applied. The management of patients by multidisciplinary team is needed and it could better individualize and apply the optimal treatment approach. © 2012 Springer-Verlag. Source

Giuliani J.,University of Ferrara | Drudi F.,Infermi Hospital
Cancer Biotherapy and Radiopharmaceuticals

Introduction: Currently, the best sequence of targeted therapy in patients with metastatic renal cell carcinoma (mRCC) has not been sufficiently defined and is based on the patient's and physician's decision, which may be influenced by comorbidities and toxicity profiles. The aim of this study was to evaluate the outcome of target therapies on clinical practice after the era of cytokine-based therapy in mRCC. Materials and Methods: We retrospectively analyzed all consecutive patients with mRCC treated at our Clinical Oncology Unit from June 1998 to September 2010. Results: We evaluated 61 patients: 21 (34.4%) with only cytokine-based therapy (95.2% interferon-α), 24 (39.3%) with target therapies in first line (100% sunitinib), and 16 (26.2%) with target therapies in second or subsequent line. Median time follow-up was 16.18 months (range 2.1-171.1). Considering the type of therapy, the univariate analysis for overall survival showed statistically significant advantages for the use of target therapies in second or subsequent line (p=0.024). Conclusions: Our data and consequently our proposal to revaluate the role of immunotherapy (also with the possibility of adding bevacizumab) in the first line are heavily provocative to point out the attention to this actually partially unsolved question; other larger experiences, pre-eminent opinion, and clinical trials are needed. © Copyright 2012, Mary Ann Liebert, Inc. 2012. Source

Valgimigli M.,Erasmus Medical Center | Gagnor A.,Cardiology Unit | Calabro P.,The Second University of Naples | Frigoli E.,Cardiology Unit | And 32 more authors.
The Lancet

Summary Background It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. Methods We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. Findings We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). Interpretation In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. Funding The Medicines Company and Terumo. © 2015 Elsevier Ltd. Source

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