title: Fondaparinux vs warfarin for the treatment of unsuspected pulmonary embolism in cancer patients.
abstract: BACKGROUND
  In cancer patients, the chest computer tomography (CT) can be used to identify asymptomatic pulmonary embolism (APE). In most cases, these patients are treated with anticoagulant drugs for at least 3 months. The American College of Physicians recommend treatment of these patients as patients with symptomatic pulmonary embolism. In this study, we evaluated and compared the efficacy and safety of fondaparinux vs warfarin in the prevention of unsuspected pulmonary embolism in patients with active cancer.
  
  
  METHODS
  A prospective and parallel group study was performed on 64 cancer patients (29 males and 35 females) with APE. A multidetector CT angiography with high spatial and temporal resolution and quality of arterial opacification was used to make the diagnosis. Lung scintigraphy was reserved to selected patients only. Patients were randomized to either the warfarin (Group A) or the fondaparinux (Group B) for 90 days. The first end point of efficacy was the persistence, reduction, or disappearance of thrombosis after 90 days. The second end point was the reappearance of thrombosis after 1 year. The first end point of safety was the development of major bleeding.
  
  
  RESULTS
  We enrolled 32 patients into each treatment group. We reached the first end point of efficacy and safety in Group B which showed that fondaparinux was able to induce the disappearance of thrombotic pulmonary with a lower incidence of major bleeding events compared with warfarin. No difference in the secondary end point was recorded.
  
  
  CONCLUSIONS
  We suggest that the treatment of cancer patients with APE can be oriented with the administration of a standard dose of fondaparinux until the next CT lung control (3 months). However, the lack of a randomized clinical trial, including a larger patient cohort, does not allow formulation of final recommendations in these patients. A broader study would be desirable, involving a larger number of patients and a longer follow-up period.
authors.affiliation: Interuniversity Center of Phlebolymphology, International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, Catanzaro; Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Bruno
authors.initials: B
authors.lastname: Amato
authors.affiliation: Interuniversity Center of Phlebolymphology, International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, Catanzaro; Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Rita
authors.initials: R
authors.lastname: Compagna
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Aldo
authors.initials: A
authors.lastname: Rocca
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Bianco
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Marco
authors.initials: M
authors.lastname: Milone
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Luigi
authors.initials: L
authors.lastname: Sivero
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Vigliotti
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Amato
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Michele
authors.initials: M
authors.lastname: Danzi
authors.affiliation: Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Aprea
authors.affiliation: Department of Health Sciences.
authors.forename: Luca
authors.initials: L
authors.lastname: Gallelli
authors.affiliation: Interuniversity Center of Phlebolymphology, International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, Catanzaro; Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: de Franciscis
authors.affiliation: Interuniversity Center of Phlebolymphology, International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Viale Europa, Catanzaro; Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Serra
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000077425:Fondaparinux; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D011134:Polysaccharides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011655:Pulmonary Embolism / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D014859:Warfarin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D000970:Antineoplastic Agents; D011134:Polysaccharides; D014859:Warfarin; D000077425:Fondaparinux
keywords: asymptomatic pulmonary embolism; cancer patients; fondaparinux; warfarin