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Spano J.P.,Groupe hospitalier Pitie Salpetriere Charles Foix | Spano J.P.,French Institute of Health and Medical Research | Spano J.P.,Paris-Sorbonne University | Poizot-Martin I.,Aix - Marseille University | And 25 more authors.
Annals of Oncology | Year: 2016

Malignancies represent a major cause of morbidity and mortality in human immunodeficiency virus (HIV)-infected patients. The introduction of combined antiretroviral therapy has modified the spectrum of malignancies in HIV infection with a decreased incidence of acquired immunodeficiency syndrome (AIDS) malignancies such as Kaposi's sarcoma and non-Hodgkin's lymphoma due to partial immune recovery and an increase in non-AIDS-defining malignancies due to prolonged survival. Management of HIV-infected patients with cancer requires a multidisciplinary approach, involving both oncologists and HIV physicians to optimally manage both diseases and drug interactions between anticancer and anti-HIV drugs. The French CANCERVIH group presents here a review and an experience of managing non-AIDS malignancies in HIV-infected individuals. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


PubMed | Pneumology Service, Florida Hospital, University of Latvia, Italian National Cancer Institute and 11 more.
Type: | Journal: Clinical lung cancer | Year: 2016

Onartuzumab is a monovalent monoclonal antibody that binds with the extracellular domain of the MET receptor. Given the role of MET in non-small-cell lung cancer (NSCLC), we investigated whether onartuzumab added to first-line chemotherapy efficacy in non-squamous NSCLC.Patients with untreated stage IIIB/IV non-squamous NSCLC, stratified by MET diagnostic status, were randomized to receive onartuzumab (15 mg/kg intravenously every 3 weeks) or placebo in combination with either paclitaxel/platinum/bevacizumab (bevacizumab cohort), or in combination with platinum/pemetrexed (pemetrexed cohort) with maintenance bevacizumab or pemetrexed and onartuzumab/placebo as appropriate. Co-primary endpoints of this phase II study were progression-free survival (PFS) in all patients and in MET+ patients (2+/3+), defined by the Ventana immunohistochemistry assay; secondary endpoints included overall survival (OS), objective response rate (ORR), safety, and pharmacokinetics.Efficacy data were available for 139 and 120 patients in the bevacizumab and pemetrexed cohorts, respectively. No benefit was seen in the PFS endpoint in the intent-to treat population of either cohort, but was numerically worse in the onartuzumab arm of the MET+ subgroup of the bevacizumab cohort. The onartuzumab and placebo arms had similar ORR and OS results in both cohorts. A higher incidence of some adverse events was observed with onartuzumab versus placebo, including peripheral edema (30% vs. 3%, bevacizumab cohort; 48% vs. 14%, pemetrexed cohort) and venous thromboembolic events (bevacizumab cohort only, 15% vs. 6%).Onartuzumab does not appear to provide any additional clinical benefit when given in combination with current first-line standard-of-care chemotherapy for non-squamous NSCLC.


Leonardi S.,University of Catania | Arena A.,Respiratory Center Disease | Bruno M.E.,Lofarma S.p.A | Cannao P.M.,Allergology Ambulatory | And 9 more authors.
Allergy and Asthma Proceedings | Year: 2010

Sublingual immunotherapy (SLIT) with monomeric carbamylated allergoid administered in accordance with the standard regimen has proven to be effective and safe. Achieving clinical benefit, however, requires a lengthy period of time so it is not very suitable for short-lasting allergies. We thus performed this study to compare an administration protocol starting in the coseasonal period (with a 4-day build-up phase) with a precoseasonal scheme to verify if the former regimen provides the same benefit in a shorter period of time. The prospective, randomized, drug therapy-controlled study was conducted in 33 rhinitic patients monosensitized to Olea with or without asthma. Ten patients were assigned to the coseasonal therapy with 5000 allergic units (AU)/week for 6 weeks, 11 to the precoseasonal therapy with 3000 AU/week for 10 weeks, and 12 to drug therapy. They were treated from April or May to June 2008. A visual analog scale (VAS) was performed at baseline and after treatment to assess the well being of the patients. Drug consumption was evaluated by means of a monthly diary. There was greater VAS improvement in both the SLIT groups versus the controls, but it was statistically significant only in the coseasonal group (p < 0.01). Furthermore, there was a reduction in the rescue medication only in the coseasonal SLIT (p < 0.05 versus drug therapy). One mild adverse event was observed. The allergoid SLIT was shown to be effective and safe in Olea allergy in particular when a coseasonal regimen was used. Copyright © 2010, OceanSide Publications, Inc., U.S.A.


Domingo C.,Pneumology Service | Domingo C.,Autonomous University of Barcelona | Moreno A.,Pneumology Service | Moreno A.,Autonomous University of Barcelona | And 5 more authors.
Current Medical Research and Opinion | Year: 2011

Background: Several studies have demonstrated the beneficial effects of omalizumab in asthma patients. Here we describe the drug's tolerance and oral corticosteroid sparing capacity in a long-term observational study. Methods: Thirty-two patients aged 18 years with obstructive airway disease and FEV1 reversibility 12 and 200mL, with an oral steroid requirement 7.5mg per day of prednisolone during a period of 1 year, a positive prick test or in vitro reactivity (RAST) to at least one perennial aeroallergen and a baseline immunoglobulin E level ranking between 30700IU/mL were prospectively followed for 17.2±8.5 months. Patients were visited once or twice a month, depending on their schedule for omalizumab administration. Intervention: blood analysis every six months; spirometry and nitric oxide measurement at every visit. Results: One patient who dropped out early was excluded. Follow-up period: the treatment benefited 83.9 (26/31) of the cohort; oral corticosteroids were reduced from 7.19±11.1 to 3.29±11.03mg (p<0.002) and withdrawn in 74.2 of patients. FEV1 (percent predicted) was 64.4±22.7 at the beginning and 62.9±24.3 at the end. IgE at entry was 322.2±334.2IU/mL and increased 2.34-fold. Respiratory function and NO did not present statistically significant changes. We identified three groups of patients: the first (n17) receiving oral steroid at entry in whom the accumulated dose of oral steroids progressively decreased; another (n10) including patients who had quit oral steroids before starting omalizumab although they had not been instructed to do so and whose oral steroid dose at the end of follow-up was zero; and a third group (n4) that did not benefit from omalizumab treatment. The only relevant side effect was a flu-like syndrome which required discontinuation of treatment in one patient. Conclusion: In our series, a substantial, safe decrease in oral corticosteroid requirements was observed due, at least to some extent, to omalizumab therapy. Oral corticosteroids were withdrawn in three-quarters of the patients. We were unable to identify a factor able to predict which patients would benefit most from omalizumab treatment. © 2011 Informa UK Ltd.


Domingo C.,Pneumology Service | Domingo C.,Autonomous University of Barcelona | Pomares X.,Pneumology Service | Pomares X.,Autonomous University of Barcelona | And 3 more authors.
European Journal of Inflammation | Year: 2014

To date, the pharmacological activity and clinical benefits of omalizumab have been well described, however several questions still remain unanswered, such as the moment to withdraw the drug as well as the possible biological markers that may be useful to do so. In the present case report, we describe our experience with our dose-reduction protocol in a middle-aged patient and elucidate the usefulness of free IgE levels. Copyright © by BIOLIFE, s.a.s.


PubMed | Pneumology Service
Type: Clinical Trial | Journal: Current medical research and opinion | Year: 2010

Several studies have demonstrated the beneficial effects of omalizumab in asthma patients. Here we describe the drugs tolerance and oral corticosteroid sparing capacity in a long-term observational study.Thirty-two patients aged 18 years with obstructive airway disease and FEV(1) reversibility 12% and 200 mL, with an oral steroid requirement 7.5 mg per day of prednisolone during a period of 1 year, a positive prick test or in vitro reactivity (RAST) to at least one perennial aeroallergen and a baseline immunoglobulin E level ranking between 30-700 IU/mL were prospectively followed for 17.2 8.5 months. Patients were visited once or twice a month, depending on their schedule for omalizumab administration.blood analysis every six months; spirometry and nitric oxide measurement at every visit.One patient who dropped out early was excluded. Follow-up period: the treatment benefited 83.9% (26/31) of the cohort; oral corticosteroids were reduced from 7.1911.1 to 3.2911.03 mg (p<0.002) and withdrawn in 74.2% of patients. FEV(1) (percent predicted) was 64.422.7 at the beginning and 62.924.3 at the end. IgE at entry was 322.2334.2 IU/mL and increased 2.34-fold. Respiratory function and NO did not present statistically significant changes. We identified three groups of patients: the first (n=17) receiving oral steroid at entry in whom the accumulated dose of oral steroids progressively decreased; another (n=10) including patients who had quit oral steroids before starting omalizumab although they had not been instructed to do so and whose oral steroid dose at the end of follow-up was zero; and a third group (n=4) that did not benefit from omalizumab treatment. The only relevant side effect was a flu-like syndrome which required discontinuation of treatment in one patient.In our series, a substantial, safe decrease in oral corticosteroid requirements was observed due, at least to some extent, to omalizumab therapy. Oral corticosteroids were withdrawn in three-quarters of the patients. We were unable to identify a factor able to predict which patients would benefit most from omalizumab treatment.

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