title: Efficacy of Prophylactic Low-Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial.
abstract: OBJECTIVE
  Advanced pancreatic cancer (APC), in addition to its high mortality, accounts for the highest rates of venous thromboembolic events (VTEs). Enoxaparin, a low-molecular weight heparin, is effective in prevention and treatment of VTEs. Some small studies have indicated that this benefit might extend to patients with cancer.
  
  
  METHODS
  Patients with histologically proven APC were randomly assigned to ambulant first-line chemotherapy and prophylactic use of enoxaparin or chemotherapy alone to investigate the probable reduction in symptomatic VTEs and the impact on survival.
  
  
  RESULTS
  A total of 312 patients were recruited as one of the protocol end points was reached. Within the first 3 months, the numbers of symptomatic VTEs were as follows: 15 of 152 patients in the observation group and two of 160 patients in the enoxaparin group (hazard ratio [HR], 0.12; 95% CI, 0.03 to 0.52; χ(2) P = .001). The numbers of major bleeding events were as follows: five of 152 patients in the observation arm and seven of 160 patients in the enoxaparin arm (HR, 1.4; 95% CI, 0.35 to 3.72; χ(2) P = 1.0). Overall cumulative incidence rates of symptomatic VTEs were 15.1% (observation) and 6.4% (enoxaparin; HR, 0.40; 95% CI, 0.19 to 0.83; P = .01). Progression-free (HR, 1.06; 95% CI, 0.84 to 1.32; P = .64) and overall survival (HR, 1.01; 95% CI, 0.87 to 1.38; P = .44) did not differ between groups.
  
  
  CONCLUSIONS
  This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic VTEs in outpatients with APC. Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting.
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany. uwe.pelzer@charite.de.
authors.forename: Uwe
authors.initials: U
authors.lastname: Pelzer
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Opitz
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Deutschinoff
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Stauch
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Reitzig
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Hahnfeld
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Müller
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Grunewald
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Jens M
authors.initials: JM
authors.lastname: Stieler
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Marianne
authors.initials: M
authors.lastname: Sinn
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Timm
authors.initials: T
authors.lastname: Denecke
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Bischoff
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Oettle
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Dörken
authors.affiliation: Uwe Pelzer, Jens M. Stieler, Marianne Sinn, Timm Denecke, Sven Bischoff, Bernd Dörken, and Hanno Riess, Charité-Universitätsmedizin Berlin; Peter C. Reitzig, Hospital Sana Klinikum Lichtenberg, Berlin; Bernhard Opitz, Hospital St Elisabeth/St Barbara, Halle; Gerd Deutschinoff, Allgemeins Krankenhaus, Hagen; Martina Stauch, Clinical Center, Kronach; Sabine Hahnfeld, Clinical Center, Jena; Lothar Müller, Clinical Center, Leer; Martina Grunewald, Hospital Aschersleben, Aschersleben; and Helmut Oettle, Clinical Center, Friedrichshafen, Germany.
authors.forename: Hanno
authors.initials: H
authors.lastname: Riess
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage; D017984:Enoxaparin / Q000008:administration & dosage; D005260:Female; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000150:complications / Q000517:prevention & control
chemical_list: D000970:Antineoplastic Agents; D017984:Enoxaparin; D006495:Heparin, Low-Molecular-Weight