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Pesaro, Italy

Baronzio G.,Cancer Center | Schwartz L.,Hopital Raymond Poincare | Schwartz L.,Ecole Polytechnique - Palaiseau | Crespi E.,Cancer Center | And 4 more authors.
Biomedical Research | Year: 2012

The metabolism of tumor cells plays an important role in cancer development. Although aerobic glycolysis is inefficient from the standpoint of ATP production, it provides cancer cells with biomolecules implicated in the synthesis of lipids and nucleotides required for cellular proliferation. Thus, targeting aerobic glycolysis has clearly been recognized as a potentially fruitful approach for the treatment of cancer. The inhibition of aerobic glycolysis by a combination of alpha lipoic acid and hydroxycitrate (METABLOC) is efficient to inhibit tumor development in several mouse models. In association with chemotherapy, it seems to improve survival of patients with tumors difficult to treat when compared to a single chemotherapy regimen. We herein report our preliminary cases on both the clinical efficacy and side effects of METABLOC. Eleven patients with advanced metastatic cancer from were treated with per os 0.4 to 1.8 g of lipoic acid and 1.2 to 3 g of hydroxycitrate during 2 to 21 months inaddition to their normal chemotherapeutic regimen. Side effects occurred in half of the patients but were mild (grade 1-3) and limited to gastrointestinal disorders that disappeared on using proton pump inhibitors or decreasing the doses. Five patients were characterized by a partial regression, 3 by a stable disease, and 3 by disease progression. In conclusion the results from these preliminary treatments support that METABLOC can be used safely with various common standard chemotherapeutic regimens. It also suggests that its use may slow down tumor growth, an observation that needs to be confirmed by a randomized controlled trial. Source

Zaja F.,Azienda Ospedaliero Universitaria S. Maria della Misericordia | Baccarani M.,Institute Of Hematology L A Seragnoli | Mazza P.,Ospedale Nord | Bocchia M.,Ematologia e Trapianti | And 17 more authors.
Blood | Year: 2010

Previous observational studies suggest that rituximab may be useful in the treatment of primary immune thrombocytopenia (ITP). This randomized trial investigated rituximab efficacy in previously untreated adult ITP patients with a platelet count of 20 × 109/L or less. One hundred three patients were randomly assigned to receive 40 mg/d dexamethasone for 4 days with or without 375 mg/m2 rituximab weekly for 4 weeks. Patients who were refractory to dexamethasone alone received salvage therapy with dexamethasone plus rituximab. Sustained response (ie, platelet count ≥ 50 × 10 9/L at month 6 after treatment initiation), evaluable in 101 patients, was greater in patients treated with dexamethasone plus rituximab (n = 49) than in those treated with dexamethasone alone (n = 52; 63% vs 36%, P = .004, 95% confidence interval [95% CI], 0.079-0.455). Patients in the experimental arm showed increased incidences of grade 3 to 4 adverse events (10% vs 2%, P = .082, 95% CI, -0.010 to 0.175), but incidences of serious adverse events were similar in both arms (6% vs 2%, P = .284, 95% CI, -0.035 to 0.119). Dexamethasone plus rituximab was an effective salvage therapy in 56% of patients refractory to dexamethasone. The combination of dexamethasone and rituximab improved platelet counts compared with dexamethasone alone. Thus, combination therapy may represent an effective treatment option before splenectomy. This study is registered at http://clinicaltrials.gov as NCT00770562. © 2010 by The American Society of Hematology. Source

Gavazzi A.,FROM Research Foundation | De Maria R.,CNR Institute of Clinical Physiology | Manzoli L.,University of Chieti Pescara | Bocconcelli P.,Ospedale San Salvatore | And 7 more authors.
International Journal of Cardiology | Year: 2015

Background: Heart failure (HF) and chronic obstructive pulmonary disease (COPD) share a common organ failure trajectory marked by prognostic uncertainty, which is a barrier to appropriate provision of palliative care. We describe in a prospective cohort from specialist hospital services the epidemiology and late clinical course of these chronic diseases to trace criteria for transition to palliative care in the community. Methods and results: Seven centers enrolled 267 patients with advanced HF (n = 174) or COPD (n = 93) using common (multiple hospitalizations or severely impaired functional status or cachexia) and disease-specific (HF: systolic dysfunction, NYHA classes III-IV, end-organ hypoperfusion; COPD: very severe airflow obstruction, hypoxemia, hypercapnia, or long-term oxygen therapy) entry criteria. These patients represented 7.2% and 13% respectively of the overall HF and COPD population hospitalized during one year. They showed similar symptom burden, functional and quality of life impairment, recurrent hospitalizations, and 6-month mortality (39% and 37%, respectively). Organ failure progression was the cause of death in >75%. In-hospital overall stay during the previous year was the main mortality predictor in both. Disease-specific predictors included anemia, hyponatremia, no beta-blockers in HF; older age, hypercapnia in COPD. Conclusions: Patients with advanced HF/COPD represent almost 10% of subjects hospitalized yearly with a primary diagnosis of HF or COPD, have similarly impaired functional status, disabling symptoms and reduced survival. Overall days spent in-hospital during the previous year, a "red flag" in the late clinical course of both diseases, might be used as a simple, reliable screening tool for appropriate transition to palliative care in the community. © 2015 The Authors. Source

Olivieri A.,Marche Polytechnic University | Gini G.,Marche Polytechnic University | Bocci C.,Marche Polytechnic University | Montanari M.,Marche Polytechnic University | And 12 more authors.
Oncologist | Year: 2012

Background. Elderly patients with diffuse large B-cell lymphoma (DLBCL) are a heterogeneous population; clinical trials have evaluated a minority of these patients. Patients and Methods. Ninety-one elderly patients with DLBCL received tailored treatment based on a comprehensive geriatric assessment (CGA). Three groups were identified: I, fit patients; II, patients with comorbidities; III, frail patients. Group I received 21-day cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-21), group II received R-CHOP-21 with liposomal doxorubicin, and group III received 21-day cycles of reduced-dose CHOP. Fifty-four patients (59%) were allocated to group I, 22 (25%) were allocated to group II, and 15 (16%) were allocated to group III. Results. The complete response (CR) rates were 81.5% in group I, 64% in group II, and 60% in group III. With a median follow-up of 57 months, 42 patients are alive, with 41 in continuous CR: 31 patients (57%) in group I, seven patients (32%) in group II, and four patients (20%) in group III. The 5-year overall survival, event-free survival, and disease-free survival rates in all patients were 46%, 31%, and 41%, respectively. Multivariate analysis selected group I assignment as the main significant prognostic factor for outcome. Conclusions. This approach in an unselected population of elderly DLBCL patients shows that treatment tailored according to a CGA allows the evaluation of elderly patients who are currently excluded from clinical trials. ©AlphaMed Press. Source

Latagliata R.,University of Rome La Sapienza | Isidori A.,Ospedale San Salvatore | Breccia M.,University of Rome La Sapienza | Carmosino I.,University of Rome La Sapienza | And 12 more authors.
Acta Haematologica | Year: 2013

Aim: To address the incidence and the prognostic role of a very early standard complete cytogenetic response (CCyR) or all Ph-metaphases (MET-, when <20 cells were evaluable). Methods: We revised 182 chronic phase chronic myelogenous leukemia patients treated with frontline imatinib (IM) at two institutions from June 2002 to June 2011. Results: After 3 months of treatment, 138 patients (75.8%) achieved CCyR/MET-while 44 patients (24.2%) still presented Ph+ metaphases (MET+) (<33%, 24 patients; ≥33%, 20 patients). On univariate analysis, palpable spleen enlargement (p < 0.001), WBC count >100.0 × 109/l at onset (p < 0.001), and male gender (p = 0.019) had a negative impact on achievement of CCyR/MET-at 3 months. Among patients with CCyR/MET-after 3 months, there were 15 failures (10.8%) compared to 21 (47.7%) among patients with MET+ (p < 0.001). The 5-year overall survival was 97.0% in patients CCyR/MET-at 3 months and 91.8% in patients MET+ at 3 months (p = 0.277); the 5-year progression-free survival was 88.2% in patients CCyR/MET-at 3 months and 48.4% in patients MET+ at 3 months (p < 0.001). Conclusions: The achievement of CCyR/MET-at 3 months seems to have prognostic relevance and could be a very early and useful indicator of an excellent response to IM beyond European LeukemiaNet guidelines. © 2012 S. Karger AG, Basel. Source

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