Uwe Pelzer1, Bernhard Opitz2, Gerd Deutschinoff2, Martina Stauch2, Peter C Reitzig2, Sabine Hahnfeld2, Lothar Müller2, Martina Grunewald2, Jens M Stieler2, Marianne Sinn2, Timm Denecke2, Sven Bischoff2, Helmut Oettle2, Bernd Dörken2, Hanno Riess2. 1. 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. 2. 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.
Abstract
PURPOSE: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. PATIENTS AND 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 theenoxaparin 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. CONCLUSION: 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.
RCT Entities:
PURPOSE: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. PATIENTS AND 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. CONCLUSION: 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: B Laquente; A Calsina-Berna; A Carmona-Bayonas; P Jiménez-Fonseca; I Peiró; A Carrato Journal: Clin Transl Oncol Date: 2017-06-13 Impact factor: 3.405
Authors: A J Muñoz Martín; E Gallardo Díaz; I García Escobar; R Macías Montero; V Martínez-Marín; V Pachón Olmos; P Pérez Segura; T Quintanar Verdúguez; M Salgado Fernández Journal: Clin Transl Oncol Date: 2020-01-24 Impact factor: 3.405
Authors: Jeffrey I Zwicker; Joanna Roopkumar; Maneka Puligandla; Benjamin L Schlechter; Anish V Sharda; David Peereboom; Robin Joyce; Bruno Bockorny; Donna Neuberg; Kenneth A Bauer; Alok A Khorana Journal: Blood Adv Date: 2020-05-26