30 research outputs found

    The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial

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    Malignant ascites is a common manifestation of advanced cancers, and treatment options are limited. The trifunctional antibody catumaxomab (anti-epithelial cell-adhesion molecule x anti-CD3) represents a targeted immunotherapy for the intraperitoneal (i.p.) treatment of malignant ascites secondary to epithelial cancers. In this phase II/III trial (EudraCT 2004-000723-15; NCT00836654), cancer patients (n = 258) with recurrent symptomatic malignant ascites resistant to conventional chemotherapy were randomized to paracentesis plus catumaxomab (catumaxomab) or paracentesis alone (control) and stratified by cancer type (129 ovarian and 129 nonovarian). Catumaxomab was administered as an i.p. infusion on Days 0, 3, 7 and 10 at doses of 10, 20, 50 and 150 μg, respectively. The primary efficacy endpoint was puncture-free survival. Secondary efficacy parameters included time to next paracentesis, ascites signs and symptoms and overall survival (OS). Puncture-free survival was significantly longer in the catumaxomab group (median 46 days) than the control group (median 11 days) (hazard ratio = 0.254: p < 0.0001) as was median time to next paracentesis (77 versus 13 days; p < 0.0001). In addition, catumaxomab patients had fewer signs and symptoms of ascites than control patients. OS showed a positive trend for the catumaxomab group and, in a prospectively planned analysis, was significantly prolonged in patients with gastric cancer (n = 66; 71 versus 44 days; p = 0.0313). Although adverse events associated with catumaxomab were frequent, they were manageable, generally reversible and mainly related to its immunologic mode of action. Catumaxomab showed a clear clinical benefit in patients with malignant ascites secondary to epithelial cancers, especially gastric cancer, with an acceptable safety profile

    First isolation and molecular characterization of Toxoplasma gondii strains from human congenital toxoplasmosis cases in Monastir, tunisia

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    International audienceToxoplasma gondii is a protozoon parasite that can cause severe clinical problems such as congenital toxoplasmosis. The distribution of T. gondii genotypes varies from one geographic area to another. So far, little is known about the parasite genotypes in Tunisia, North Africa. The present study aimed isolating and genotyping T. gondii from the amniotic fluid (AF) and placenta of pregnant women in Monastir, Tunisia. Amniotic fluid and/or placenta from 80 women who acquired toxoplasma infection during pregnancy were tested by PCR and/or mouse bioassay. Genotyping of T. gondii isolates from these samples was performed with 15 microsatellite markers. Four viable T. gondii strains were isolated from either the AF or placenta of four women. Specifically, strains TUN001-MON1 and TUN002-MON2 were isolated from both the AF and placenta, TUN003-AHA from only the placenta, and TUN004-NEL from only the AF. The four viable strains were not virulent for mice. Genotyping revealed that the four strains were type II strains. This is the first report on isolation and genotyping of T. gondii from AF human samples in Tunisia. Further studies focused on T. gondii genotyping on a larger number of human cases and on animals in Tunisia are needed to improve the knowledge and epidemiology of toxoplasmosis

    A case of congenital toxoplasmosis-associated miscarriage with maternal infection four months prior to conception

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    International audienceBackground: We report a case of fatal congenital toxoplasmosis with maternal infection dated four months before pregnancy in the absence of any specific immunosuppressive condition.Case: Ms. D. experienced submaxillary lymphadenitis in February 2018. The medical workup performed revealed an acute T. gondii infection. She became pregnant in June 2018 while she still had adenopathy. The second obstetrical ultrasound, performed at 16 weeks of pregnancy, revealed a fetal death. The research for T. gondii by PCR was positive in the products of conception.Conclusion: Diagnosis of toxoplasmosis should be discussed in case of miscarriage with lymphadenitis. As lymph nodes in T. gondii infection could be responsible for iterative release of parasites and fetal death, symptomatic toxoplasmosis should be treated in women of childbearing age
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