Journal ArticleDOI
Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study
Giancarlo Agnelli,Gualberto Gussoni,Carlo Bianchini,Melina Verso,Mario Mandalà,Luigi Cavanna,Sandro Barni,Roberto Labianca,Franco Buzzi,Giovanni Scambia,Rodolfo Passalacqua,Sergio Ricci,Giampietro Gasparini,Vito Lorusso,Erminio Bonizzoni,Maurizio Tonato +15 more
Reads0
Chats0
TLDR
Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy, and future studies should focus on patients who are at a high risk for thrombolic events.Abstract:
Summary Background Clinical trials are needed to assess the clinical benefit of antithrombotic prophylaxis in patients with cancer who are receiving chemotherapy, since these patients are at an increased risk of developing a thromboembolism. We did a trial to assess the clinical benefit of the low-molecular-weight heparin nadroparin for the prophylaxis of thromboembolic events in ambulatory patients receiving chemotherapy for metastatic or locally advanced solid cancer. Methods Between October, 2003, and May, 2007, ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer were randomly assigned in a double-blind manner to receive subcutaneous injections of nadroparin (3800 IU anti-Xa once a day, n=779) or placebo (n=387), in a 2:1 ratio. Study treatment was given for the duration of chemotherapy up to a maximum of 4 months. The primary study outcome was the composite of symptomatic venous or arterial thromboembolic events, as assessed by an independent adjudication committee. All randomised patients who received at least one dose of study treatment were included in the efficacy and safety analyses (modified intention-to-treat population). The study is registered with ClinicalTrials.gov, NCT 00951574. Findings 1150 patients were included in the primary efficacy and safety analyses: 769 patients in the nadroparin group and 381 patients in the placebo group. 15 (2·0%) of 769 patients treated with nadroparin and 15 (3·9%) of 381 patients treated with placebo had a thromboembolic event (single-sided p=0·02). Five (0·7%) of 769 patients in the nadroparin group and no patients in the placebo group had a major bleeding event (two-sided p=0·18). The incidences of minor bleeding were 7·4% (57 of 769) with nadroparin and 7·9% (30 of 381) with placebo. There were 121 (15·7%) serious adverse events in the nadroparin goup and 67 (17·6%) serious adverse events in the placebo group. Interpretation Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy. Future studies should focus on patients who are at a high risk for thromboembolic events. Funding Italfarmaco SpA, Milan, Italy.read more
Citations
More filters
Journal ArticleDOI
2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines
José Luis Zamorano,Patrizio Lancellotti,Daniel Rodriguez Muñoz,Victor Aboyans,Riccardo Asteggiano,Maurizio Galderisi,Gilbert Habib,Daniel J. Lenihan,Gregory Y.H. Lip,Alexander R. Lyon,Teresa López Fernández,Dania Mohty,Massimo F. Piepoli,Juan Tamargo,Adam Torbicki,Thomas M. Suter +15 more
TL;DR: This document describes the development and use of angiotensin-converting enzyme, a non-volatile substance that acts as a “spatially aggregating substance” to reduce the chances of heart attack in women.
Journal ArticleDOI
2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC)
José Luis Zamorano,Patrizio Lancellotti,Daniel Rodriguez Muñoz,Victor Aboyans,Riccardo Asteggiano,Maurizio Galderisi,Gilbert Habib,Daniel J. Lenihan,Gregory Y.H. Lip,Alexander R. Lyon,Teresa López Fernández,Dania Mohty,Massimo F. Piepoli,Juan Tamargo,Adam Torbicki,Thomas M. Suter,Stephan Achenbach,Stefan Agewall,Lina Badimon,Gonzalo Barón-Esquivias,Helmut Baumgartner,Jeroen J. Bax,Héctor Bueno,Scipione Carerj,Veronica Dean,Çetin Erol,Donna Fitzsimons,Oliver Gaemperli,Paulus Kirchhof,Philippe Kolh,Petros Nihoyannopoulos,Piotr Ponikowski,Marco Roffi,Antonio Vaz Carneiro,Stephan Windecker +34 more
TL;DR: No abstract available Keywords: European Society of Cardiology; arrhythmias; cancer therapy; cardio-oncology; cardiotoxicity; chemotherapy; early detection; ischaemia; myocardial dysfunction; surveillance.
Journal ArticleDOI
Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2014
Gary H. Lyman,Gary H. Lyman,Kari Bohlke,Alok A. Khorana,Nicole M. Kuderer,Agnes Y.Y. Lee,Juan I. Arcelus,Edward P. Balaban,Jeffrey M. Clarke,Christopher R. Flowers,Charles W. Francis,Leigh E. Gates,Ajay K. Kakkar,Nigel S. Key,Mark Levine,Howard A. Liebman,Margaret A. Tempero,Sandra L. Wong,Mark R. Somerfield,Anna Falanga +19 more
TL;DR: Current recommendations about the prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer and oncology professionals should educate patients about the signs and symptoms of VTE.
Journal ArticleDOI
International clinical practice guidelines for the treatment and prophylaxis of venous thromboembolism in patients with cancer
Dominique Farge,Philippe Debourdeau,M Beckers,C. Baglin,Rupert Bauersachs,Barry M. Brenner,Dialina Brilhante,Anna Falanga,G T Gerotzafias,Nissim Haim,Ajay K. Kakkar,Alok A. Khorana,Ramón Lecumberri,Mario Mandalà,Michel Marty,Manuel Monreal,Shaker A. Mousa,Simon Noble,Ingrid Pabinger,Paolo Prandoni,Martin H. Prins,Mohammed H. Qari,Michael B. Streiff,Konstantinos N. Syrigos,Henri Bounameaux,H. R. Büller +25 more
TL;DR: The use of LMWH for VTE prevention in cancer patients undergoing laparoscopic surgery may be recommended as for laparotomy and mechanical methods are not recommended as monotherapy except when pharmacological methods are contraindicated.
Journal ArticleDOI
Apixaban to Prevent Venous Thromboembolism in Patients with Cancer
Marc Carrier,Karim Abou-Nassar,Ranjeeta Mallick,Vicky Tagalakis,Sudeep Shivakumar,Ariah Schattner,Philip Kuruvilla,Danny Hill,Silvana Spadafora,Katerine Marquis,Mateya Trinkaus,Anna Tomiak,Agnes Y.Y. Lee,Peter L. Gross,Alejandro Lazo-Langner,Robert El-Maraghi,Glenwood D. Goss,Grégoire Le Gal,David J. Stewart,Tim Ramsay,Marc A. Rodger,Debra Witham,Philip S. Wells,Avert Investigators +23 more
TL;DR: Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate‐to‐high‐risk ambulatory patients with cancer who were starting chemotherapy.
References
More filters
Journal ArticleDOI
Prevention of Venous Thromboembolism* American College of Chest Physicians Evidence- Based Clinical Practice Guidelines (8th Edition)
William H. Geerts,David Bergqvist,Graham F. Pineo,John A. Heit,Charles M. Samama,Michael R. Lassen,Clifford W. Colwell +6 more
TL;DR: This article discusses the prevention of venous thromboembolism (VTE) and is part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).
Journal ArticleDOI
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients: Definitions of major bleeding in clinical studies
S. Schulman,C. Kearon +1 more
TL;DR: A definition of major bleeding in non‐surgical patients was developed that should be applicable to studies with all agents that interfere with hemostasis, including anticoagulants, platelet function inhibitors and fibrinolytic drugs.
Journal ArticleDOI
Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.
Sam Schulman,U. Angerås,David Bergqvist,Bengt I. Eriksson,Michael R. Lassen,William D. Fisher +5 more
TL;DR: A definition of major bleeding that should be applicable to all agents that interfere with hemostasis is developed and is to seek approval from the regulatory authorities to enhance its incorporation into future clinical trial protocols.
Journal ArticleDOI
Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis.
Paolo Prandoni,Anthonie W. A. Lensing,Andrea Piccioli,Enrico Bernardi,Paolo Simioni,Bruno Girolami,Antonio Marchiori,Paola Sabbion,Martin H. Prins,Franco Noventa,Antonio Girolami +10 more
TL;DR: Possibility for improvement using the current paradigms of anticoagulation seem limited and new treatment strategies should be developed, as cancer patients with venous thrombosis are more likely to develop recurrent thromboembolic complications and major bleeding during anticoaggerant treatment than those without malignancy.
Journal ArticleDOI
Development and validation of a predictive model for chemotherapy-associated thrombosis
TL;DR: A simple model for predicting chemotherapy-associated venous thromboembolism using baseline clinical and laboratory variables can identify patients with a nearly 7% short-term risk of symptomatic VTE and may be used to select cancer outpatients for studies of thromboprophylaxis.
Related Papers (5)
Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2014
Gary H. Lyman,Gary H. Lyman,Kari Bohlke,Alok A. Khorana,Nicole M. Kuderer,Agnes Y.Y. Lee,Juan I. Arcelus,Edward P. Balaban,Jeffrey M. Clarke,Christopher R. Flowers,Charles W. Francis,Leigh E. Gates,Ajay K. Kakkar,Nigel S. Key,Mark Levine,Howard A. Liebman,Margaret A. Tempero,Sandra L. Wong,Mark R. Somerfield,Anna Falanga +19 more