Kroger N.,University of Hamburg |
Solano C.,Hospital Clinico Universitario |
Wolschke C.,University of Hamburg |
Bandini G.,S. Orsola Malpighi University Hospital |
And 30 more authors.
New England Journal of Medicine | Year: 2016
BACKGROUND Chronic graft-versus-host disease (GVHD) is the leading cause of later illness and death after allogeneic hematopoietic stem-cell transplantation. We hypothesized that the inclusion of antihuman T-lymphocyte immune globulin (ATG) in a myeloablative conditioning regimen for patients with acute leukemia would result in a significant reduction in chronic GVHD 2 years after allogeneic peripheral-blood stem-cell transplantation from an HLA-identical sibling. METHODS We conducted a prospective, multicenter, open-label, randomized phase 3 study of ATG as part of a conditioning regimen. A total of 168 patients were enrolled at 27 centers. Patients were randomly assigned in a 1:1 ratio to receive ATG or not receive ATG, with stratification according to center and risk of disease. RESULTS After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was 32.2% (95% confidence interval [CI], 22.1 to 46.7) in the ATG group and 68.7% (95% CI, 58.4 to 80.7) in the non-ATG group (P<0.001). The rate of 2-year relapse-free survival was similar in the ATG group and the non-ATG group (59.4% [95% CI, 47.8 to 69.2] and 64.6% [95% CI, 50.9 to 75.3], respectively; P = 0.21), as was the rate of overall survival (74.1% [95% CI, 62.7 to 82.5] and 77.9% [95% CI, 66.1 to 86.1], respectively; P = 0.46). There were no significant between-group differences in the rates of relapse, infectious complications, acute GVHD, or adverse events. The rate of a composite end point of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than in the non-ATG group (36.6% vs. 16.8%, P = 0.005). CONCLUSIONS The inclusion of ATG resulted in a significantly lower rate of chronic GVHD after allogeneic transplantation than the rate without ATG. The survival rate was similar in the two groups, but the rate of a composite end point of chronic GVHD-free survival and relapsefree survival was higher with ATG. (Funded by the Neovii Biotech and the European Society for Blood and Marrow Transplantation; ClinicalTrials.gov number, NCT00678275. Copyright © 2016 Massachusetts Medical Society.
Gobbi P.G.,University of Pavia |
Ferreri A.J.M.,San Raffaele Scientific Institute |
Ponzoni M.,San Raffaele Scientific Institute |
Levis A.,Azienda Ospedaliera ss. Antonio e Biagio e c. Arrigo
Critical Reviews in Oncology/Hematology | Year: 2013
Hodgkin lymphoma (HL) is a curable malignancy which shows a bimodal curve in incidence in economically developed countries; there is a putative association with Epstein-Barr virus. The WHO 2008 classification schema recognises two histological types of HL: the nodular lymphocyte predominant and the " classic" HL. The latter encompasses four entities: nodular sclerosis, mixed cellularity, lymphocyte depletion, and lymphocyte-rich. Most patients with HL present with asymptomatic superficial lymphadenopathy. The commonest sites of disease are the cervical, supraclavicular and mediastinal lymph nodes, while sub-diaphragmatic presentations and bone marrow and hepatic involvement are less common. Splenic involvement is usually concomitant with hepatic disease and systemic symptoms; extranodal presentations are quite rare. Systemic symptoms are present in ∼35% of cases. The stage of disease is defined according to the Ann Arbor staging system or its Cotswolds variant, and staging work-up includes physical examination, chest X-rays, chest and abdominal CT scan, and bone marrow biopsy. 18FDG-PET (18fluordeoxyglucose positron emission tomography) plays a central role in staging, response assessment and prognosis definition.Classic HL usually spreads by contiguity within the lymphatic tissue network, with a late extension to adjacent and distant viscera. Mortality from HL has been progressively decreasing, as confirmed by the most recent 5-year survival figure of 81%. The list of putative prognostic factors in HL has been increasing, but most factors still require prospective validation. Some of these variables are used to stratify early-stage disease into " favourable" and " unfavourable" categories, with " unfavourable early-stage" being intermediate between " favourable early-stage" and " advanced-stage" .ABVD (adriamycin(doxorubicin), bleomycin, vinblastine, dacarbazine) combination chemotherapy followed by involved-field irradiation is the standard treatment for patients with early-stage HL, with a 5-year OS >95%. Several trials assessing less intensive approaches for patients with favourable early-stage HL are ongoing. More intensified combinations, such as the BEACOPP (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine (Oncovin), procarbazine, prednisone) regimen, are being investigated, usually in patients with unfavourable early-stage HL and interim PET+. ABVD is the standard chemotherapy treatment also for patients with advanced disease. Although some evidence suggests that more intensive combinations provide better disease control, the inevitable increased risk of relevant late toxicity worries investigators. Consequently, there has been a shift towards investigating the innovative strategy of a more aggressive schedule for patients with 18FDG-PET positive results after the first 2 courses of ABVD. High-dose chemotherapy supported by ASCT (autologous stem cell transplantation) is considered the standard of care in patients with HL which has relapsed after, or is refractory to conventional chemoradiotherapy, while allogeneic transplant is a suitable tool for patients with chemorefractory disease and patients failed after ASCT. © 2012 Elsevier Ireland Ltd.
Rigacci L.,Azienda Ospedaliero Universitaria Careggi |
Fabbri A.,Azienda Ospedaliero Universitaria Le Scotte |
Puccini B.,Azienda Ospedaliero Universitaria Careggi |
Chitarrelli I.,Azienda Ospedaliero Universitaria Le Scotte |
And 5 more authors.
Cancer | Year: 2010
BACKGROUND: Patients affected by relapsed or primary refractory lymphomas currently have a poor prognosis and no standard salvage treatment options. This study was carried out to assess the efficacy and safety of a dexamethasone, high-dose cytarabine, and oxaliplatin as salvage therapy in those patients, replacing cisplatin with oxaliplatin in the standard dexamethasone, cytarabine, and cisplatin scheme. METHODS: Seventy patients with relapsed or refractory aggressive non-Hodgkin or Hodgkin lymphoma were treated from September 2001 to September 2007. The median age of patients was 51 years (range, 19-75 years). Histological subtypes were: diffuse large B-cell lymphoma (n = 47) and Hodgkin lymphoma (n = 23). The overall response rate was 73% (51 of 70), with 30 (43%) complete remissions and 21 (30%) partial remissions. Fifty-two patients were treated with dexamethasone, high-dose cytarabine, and oxaliplatin as second-line chemotherapy. Forty-eight patients were enrolled in an autologous stem cell transplantation program; forty (83%) finally proceeded to high-dose consolidation and autografting. RESULTS: No grade 3 or 4 nonhematological toxicity was demonstrated; in particular, no renal or neurotoxicity was reported. After a median follow-up period of 21 months (range, 2-87 months), 22 (31%) patients had died. Probabilities of 2-year progressionfree survival (PFS) and overall survival (OS) were 44% and 71%, respectively. In the chemosensitive patients, the PFS and OS were 52% and 83%, respectively. The only factor that significantly correlated with better OS was the response to therapy. CONCLUSIONS: This study confirms that dexamethasone, high-dose cytarabine, and oxaliplatin ± rituximab is an effective and feasible outpatient regimen for salvage therapy in patients affected by relapsed or refractory lymphoma. Moreover, the feasibility and efficacy of this scheme as an in vivo chemosensitive test in patients in autotransplantation programs was confirmed. © 2010 American Cancer Society.
Zandrino F.,Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo |
La Paglia E.,Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo |
Musante F.,Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo
Tumori | Year: 2010
Aims and background. To assess the diagnostic accuracy of magnetic resonance imaging in local staging of endometrial carcinoma, and to review the results and pitfalls described in the literature. Methods. Thirty women with a histological diagnosis of endometrial carcinoma underwent magnetic resonance imaging. Unenhanced T2-weighted and dynamic contrast-enhanced T1-weighted sequences were obtained. Hysterectomy and salpingooophorectomy was performed in all patients. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were calculated for the detection of deep myometrial and cervical infiltration. Results. For deep myometrial infiltration T2-weighted sequences reached a sensitivity of 85%, specificity of 76%, PPV of 73%, NVP of 87%, and accuracy of 80%, while contrast-enhanced scans reached a sensitivity of 90%, specificity of 80%, PPV of 82%, NPV of 89%, and accuracy of 85%. For cervical infiltration T2-weighted sequences reached a sensitivity of 75%, specificity of 88%, PPV of 50%, NPV of 96%, and accuracy of 87%, while contrast-enhanced scans reached a sensitivity of 100%, specificity of 94%, PPV of 75%, NPV of 100%, and accuracy of 95%. Conclusions. Unenhanced and dynamic gadolinium-enhanced magnetic resonance allows accurate assessment of myometrial and cervical infiltration. Information provided by magnetic resonance imaging can define prognosis and management.
PubMed | Azienda ospedaliera SS Antonio e Biagio e C. Arrigo
Type: Journal Article | Journal: Diagnostic and interventional imaging | Year: 2016
The goal of this study was to retrospectively assess the efficacy of emergency percutaneous transcatheter arterial embolization in patients with severe bleeding due to upper gastrointestinal or jejunal tumor.Twelve patients (7men, 5women; mean age, 74years14 (SD); range: 54-86years) with severe bleeding from the upper gastrointestinal tract, with failed endoscopic treatment not eligible for emergency surgery were treated by emergency percutaneous transcatheter arterial embolization. The bleeding cause was gastric tumor in 7patients, duodenal tumor in 4patients and jejunal tumor in one patient. Procedure details and follow-up were reviewed.Twelve embolization procedures were performed using various embolic agents. Embolization was achieved and bleeding was stopped in all patients. Five patients underwent surgery within the 30days following embolization. In the remaining 7patients, no bleeding occurred at 1month follow-up in 6patients and bleeding recurred in one patient at 1month. In this later patient, endoscopic treatment was successful.The results of our study suggest that transcatheter arterial embolization is safe and effective in patients with severe arterial bleeding due to upper gastrointestinal or jejunal tumor. In some patients, transcatheter arterial embolization can be used as a bridge to surgery.
PubMed | Azienda Ospedaliera SS Antonio e Biagio e C. Arrigo
Type: Journal Article | Journal: Clinical cases in mineral and bone metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases | Year: 2012
The osteonecrosis of the jaw is a new emergent disease, secondary to prolonged use of bisphosphonates. Bisphosphonates are a class of drug used in prevention and cure of bone diseases such as malignancy or bone metabolic diseases. In this article, we have tried to summarize, for patients taking IV or oral bisphosphonates-therapy, the most important informations on the pathogenesis and the risk factors in osteonecrosis of the jaw with particular attention about the preventive policies.