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Procopio G.,Fondazione Instituto Nazionale Tumori | Giganti M.O.,Prostate Program | Mariani L.,Unit of Medical Statistics | Salvioni R.,Urologic | And 3 more authors.
BJU International | Year: 2011

OBJECTIVE To assess the efficacy of ketoconazole in patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS From April 2008 to November 2009, 37 patients with CRPC have been treated with ketoconazole. The primary endpoint was the prostate-specific antigen (PSA) response; the secondary endpoints were progression-free survival and safety profile. Ketoconazole was administered by oral route at a dose of 200 mg every 8 h continuous dosing until the onset of serious adverse events or disease progression. The study was based on a two-step design with an interim efficacy analysis carried out on the first 12 patients accrued. RESULTS Main characteristics of population were: median age 75 years (range 60-88); baseline mean PSA 28.8 ng/mL (4.3-1000); 30 patients previously challenged with at least two lines of hormone therapy; 15 patients previously treated with chemotherapy. Biochemical responses accounted for: two complete responses (5%), six partial responses (16%), 13 patients with stable disease (35%), and 14 with progressive disease (38%). Of 15 patients resistant to chemotherapy, overall disease control (complete plus partial responses plus stable disease) was recorded in seven of them. Treatment was feasible without inducing grade 3-4 adverse events. The most common grade 1-2 adverse events were asthenia (27%), vomiting (8%) and abdominal pain (8%). CONCLUSION Treatment with low-dose ketoconazole is feasible and well tolerated. The efficacy was satisfactory in patients previously treated with chemotherapy. © 2010 BJU INTERNATIONAL.


Esposito S.,University of Milan | Scarselli E.,ReiThera Srl formerly Okairos | Lelii M.,University of Milan | Scala A.,University of Milan | And 8 more authors.
Human Vaccines and Immunotherapeutics | Year: 2016

ABSTRACT: The development of a safe and effective respiratory syncytial virus (RSV) vaccine might be facilitated by knowledge of the natural immune response to this virus. The aims of this study were to evaluate the neutralizing antibody response of a cohort of healthy children <18 months old to RSV infection. During the RSV season, 89 healthy children <18 months old were enrolled and followed up weekly for 12 weeks. At each visit, a nasopharyngeal swab was obtained for RSV detection by real-time polymerase chain reaction (PCR). During the study period, 2 blood samples were drawn and they were used to determine RSV geometric mean neutralizing antibody titres (GMT) against RSV. A total of 35 (39.3%) children had RSV detected during the study period. Among RSV-positive patients, children ≥7 months showed a significantly higher increase in antibody response (p<0.001). A significantly higher number of patients with a ≥4 -fold increase in GMT were ≥7 months old (p = 0.02) and presented lower respiratory tract infections (LRTIs) during the study period (p = 0.01). Viral shedding was longer among children aged ≥7 months (p = 0.06), those with viral load ≥106 copies/mL (p = 0.03), and those with LRTIs during the study period (p = 0.03), but it was not associated with the immune response (p = 0.41). In conclusion, natural RSV infection seems to evoke a low immune response in younger children. To be effective in this infant population, which is at highest risk of developing severe LRTIs, vaccines must be able to induce in the first months of life a stronger immune response than that produced by the natural infection. © 2016 Taylor & Francis.


Slavcev A.,IKEM | Rybakova K.,IKEM | Svobodova E.,IKEM | Slatinska J.,IKEM | And 4 more authors.
Transplant Immunology | Year: 2015

Background: Our retrospective study included a cohort of 47 patients who underwent living donor kidney transplantation. The pre-transplant frequencies of donor-specific Interferon-gamma (IFN-γ) producing cellswere defined using enzyme-linked immunosorbent spot (ELISpot) assay and correlated with incidence of acute cellular (ACR), antibody-mediated rejection (AMR) and kidney graft survival up to one year after transplantation. Results: We found a statistically significant correlation between the frequencies of IFN-γ-producing cells and the number of mismatches in HLA antigens between patients and their respective donors - for Class I - A and B (r= 0.399, p b 0.01) and for Class I and Class II antigens - A, B and DR (r=0.409, p b 0.01). No significant relationship was observed between the numbers of IFN-γ-secreting cells and incidence of acute rejection (neither ACR, nor AMR). However, there was a trend of elevated frequencies of IFN-γ-producing cells in patients who developed ACR or AMR in comparison with kidney recipients free of rejection (91 ± 82 and 114 ± 75 vs. 72 ± 70/ 5 × 104 peripheral blood mononuclear cells respectively). Patients with concurrent acute cellular and antibody-mediated rejection had also higher numbers of IFN-?-producing memory/effector cells compared to patients with cellular rejection only. Conclusion: Pre-transplant determination of the numbers of IFN-?-producing donor-specific memory cells using the ELISpot technique may provide clinically relevant results when evaluating the risk of development of acute cellular and antibody-mediated rejection. These frequencies are influenced by the degree of HLA mismatching between patients and their respective kidney donors. © 2015 Elsevier B.V.


PubMed | Unit of Medical Statistics and IKEM
Type: Journal Article | Journal: Transplant immunology | Year: 2015

Our retrospective study included a cohort of 47 patients who underwent living donor kidney transplantation.The pre-transplant frequencies of donor-specific Interferon-gamma (IFN-) producing cells were define dusing enzyme-linked immunosorbent spot (ELISpot) assay and correlated with incidence of acute cellular(ACR), antibody-mediated rejection (AMR) and kidney graft survival up to one year after transplantation.We found a statistically significant correlation between the frequencies of IFN--producing cells and the number of mismatches in HLA antigens between patients and their respective donors for Class I A and B (r = 0.399, p b 0.01) and for Class I and Class II antigens A, B and DR (r = 0.409, p b 0.01). No significant relationship was observed between the numbers of IFN--secreting cells and incidence of acute rejection (neither ACR, nor AMR). However, there was a trend of elevated frequencies of IFN--producing cells in patients who developed ACR or AMR in comparison with kidney recipients free of rejection (91 82 and 114 75 vs. 72 70/5 10(4) peripheral blood mononuclear cells respectively). Patients with concurrent acute cellular and antibody-mediated rejection had also higher numbers of IFN--producing memory/effector cells compared to patients with cellular rejection only.Pre-transplant determination of the numbers of IFN--producing donor-specific memory cells using the ELISpot technique may provide clinically relevant results when evaluating the risk of development of acute cellular and antibody-mediated rejection. These frequencies are influenced by the degree of HLA mismatching between patients and their respective kidney donors.

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