Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
Literature Search Strategy
The effectiveness search included the MEDLINE, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials databases. Conference proceedings from annual meetings of the American Society of Clinical Oncology (ASCO), the American Society of Hematology, the European Society of Medical Oncology, and the International Society of Thrombosis and Hemostasis were searched through 2012 or the most recent year available. The risk assessment search was completed in MEDLINE.
Reference lists from seminal articles, guidelines from other organizations, and recent review articles were hand searched for additional citations. The Update Committee reviewed the list of included reports for completeness. Subject headings and keywords used in the efficacy literature search included four major categories: venous thromboembolism (VTE), anticoagulation, malignancy, and randomized controlled trials (RCTs). The full search string is available in the Data Supplement of the original guideline document (see the "Availability of Companion Documents" field). The risk literature search also included four major categories: risk assessment, VTE, cancer, and cohort studies.
Inclusion and Exclusion Criteria
Articles for the efficacy systematic review were selected for inclusion if they were RCTs or systematic reviews of RCTs that assessed the efficacy and safety of anticoagulation in patients with cancer and included at least 50 patients per arm. Only data from conference proceedings available as full presentations or posters were included. For the risk systematic review, studies from the ambulatory setting that either developed or validated risk models were included. Only reports that included multivariate analyses were eligible. Risk assessment models limited to single cancer types were excluded.
Guideline Update Process
PubMed and the Cochrane Library were searched for randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines for the period from November 5, 2012, through July 2014. The disease and intervention search terms were those that were used for the 2013 guideline update. An update committee, formed in accordance with the ASCO Conflict of Interest Management Procedures for Clinical Practice Guidelines, reviewed the abstracts that were identified for predefined signals that would suggest the need to change a previous recommendation. Additional information about the results of the updated literature search and 2014 search strategy string and results are available in the 2014 Data Supplement (see the "Availability of Companion Documents" field) A QUOROM diagram of the updated search and the clinical questions are also provided in the 2014 Data Supplement.
The search yielded 53 publications. After careful review of the identified publications, the update committee concluded that there were no results that would change the 2013 guideline recommendations. A bibliography of the results of the updated literature search is provided in the 2014 Data Supplement.
Number of Source Documents
42 publications met eligibility criteria, including 16 systematic reviews and 24 randomized controlled trials.
Methods Used to Assess the Quality and Strength of the Evidence
Rating Scheme for the Strength of the Evidence
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Eligible reports for both reviews were preliminarily identified after the literature search. Full-text copies were obtained to further assess eligibility. Articles that met eligibility for the efficacy search underwent data extraction by American Society of Clinical Oncology (ASCO) staff for study design and quality, patient characteristics, outcomes, and adverse events. Outcomes of interest included symptomatic and asymptomatic thrombotic events found on screening, major and minor bleeding, early and overall mortality, sudden death, and adverse events. For the risk review, data extraction included study characteristics, quality, and risk assessment model development and evaluation. Outcomes of interest included factors incorporated into the risk assessment model, model equation, and outcomes according to risk.
Evidence summary tables (Data Supplement of the original guideline document, [see the "Availability of Companion Documents" field]) were reviewed for accuracy and completeness by an ASCO staff member who was not involved in data extraction. Disagreements were resolved through discussion; the Steering Committee was consulted if necessary.
Trial characteristics from the randomized controlled trials (RCTs) were extracted to evaluate the potential for bias. Study quality was also assessed for the reports in the risk systematic review.
Methods Used to Formulate the Recommendations
Description of Methods Used to Formulate the Recommendations
The American Society of Clinical Oncology (ASCO) first published an evidence-based clinical practice guideline on prophylaxis and treatment of venous thromboembolism (VTE) in 2007. ASCO guidelines are updated at intervals determined by an Up-date Committee; this is a full guideline update. Table 1 in the original guideline document provides a summary of the 2007 and 2012 guideline recommendations.
An Update Committee was formed to review data published since the initial guideline and update recommendations, as warranted, considering evidence identified by the systematic review.
The Update Committee met in July 2012 and had a second meeting via teleconference. During those meetings, the Update Committee reviewed evidence identified by the systematic review and revised guideline recommendations. Additional work on the guideline was completed electronically. The steering committee and lead ASCO staff person prepared an updated guideline to share with the Update Committee members for review.
Rating Scheme for the Strength of the Recommendations
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation
As per standard practice, the guideline was submitted to Journal of Clinical Oncology for review. The Venous Thromboembolism (VTE) Update Committee and the ASCO Clinical Practice Guideline Committee reviewed and approved this guideline document before publication.
Identifying Information and Availability
|Lyman GH, Khorana AA, Kuderer NM, Lee AY, Arcelus JI, Balaban EP, Clarke JM, Flowers CR, Francis CW, Gates LE, Kakkar AK, Key NS, Levine MN, Liebman HA, Tempero MA, Wong SL, Prestrud AA, Falanga A, American Society of Clinical Oncology Clinical Practice. Venous thromboembolism prophylaxis and treatment in patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Jun 10;31(17):2189-204. PubMed |
Not applicable: The guideline was not adapted from another source.
2007 Dec (revised 2013 Jun; reaffirmed 2015 Feb)
American Society of Clinical Oncology - Medical Specialty Society
Source(s) of Funding
American Society of Clinical Oncology (ASCO)
American Society of Clinical Oncology (ASCO) Clinical Guideline Update Committee
Composition of Group That Authored the Guideline
Authors: Anna Falanga, MD, Hospital Papa Giovanni XXIII, Bergamo, Italy; Gary H. Lyman, MD, MPH, Duke University and Duke Cancer Institute, Durham, NC; Alok A. Khorana, MD, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH; Nicole M. Kuderer, MD, Duke University and Duke Cancer Institute, Durham, NC; Juan Ignacio Arcelus, Hospital Universitario Virgen de las Nieves, University of Granada, Granada, Spain; Edward P. Balaban, DO, University of Pittsburgh Cancer Centers Network, Pittsburgh, PA; Jeffrey M. Clarke, MD, Duke University and Duke Cancer Institute, Durham, NC; Christopher R. Flowers, MD, MS, Emory University School of Medicine and Winship Cancer Institute, Atlanta, GA; Charles W. Francis, MD, James P. Wilmot Cancer Center and University of Rochester, Rochester, NY; Leigh E. Gates, BA, CPHQ Patient representative, Denver, CO; Ajay K. Kakkar, MD, BS, PhD, Thrombosis Research Institute, London, United Kingdom; Nigel S. Key, MB, ChB, FRCP, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Agnes Y. Lee, MD, MSc, FRCPC, University of British Columbia, Vancouver, British Columbia; Mark N. Levine, MD, MSc, McMaster University, Hamilton, Ontario, Canada; Howard A. Liebman, MD, Keck School of Medicine, University of Southern California, Los Angeles; Margaret A. Tempero, MD, University of California–San Francisco Pancreas Center, San Francisco, CA; Sandra L. Wong, MD, University of Michigan, Ann Arbor, MI; Ann Alexis Prestrud, American Society of Clinical Oncology, Alexandria, VA
Members of the Expert Panel: Gary H. Lyman, MD, MPH, (Co-chair); Alok A. Khorana, MD; Nicole M. Kuderer, MD; Agnes Y. Lee, MD, MSc, FRCPC; Juan Ignacio Arcelus; Edward P. Balaban, DO; Jeffrey M. Clarke, MD; Christopher R. Flowers, MD, MS; Charles W. Francis, MD; Leigh E. Gates, BA; Ajay K. Kakkar, MD, BS, PhD; Nigel S. Key, MB, ChB, FRCP; Mark N. Levine, MD, MSc; Howard A. Liebman, MD; Margaret A. Tempero, MD; Sandra L. Wong, MD; Anna Falanga, MD, (Co-chair)
Financial Disclosures/Conflicts of Interest
The Update Committee was assembled in accordance with American Society of Clinical Oncology's (ASCO's) Conflict of Interest Management Procedures for Clinical Practice Guidelines ("Procedures," summarized at the ASCO Web site ). Members of the Update Committee completed ASCO's disclosure form, which requires disclosure of financial and other interests that are relevant to the subject matter of the guideline, including relationships with commercial entities that are reasonably likely to experience direct regulatory or commercial impact as the result of promulgation of the guideline. Categories for disclosure include employment relationships, consulting arrangements, stock ownership, honoraria, research funding, and expert testimony. In accordance with the Procedures, the majority of the members of the Update Committee did not disclose any such relationships.
Although all authors completed the disclosure declaration, the following author(s) and/or an author's immediate family member(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors. Authors marked with an asterisk (*) are participants in ASCO's Disclosure Management System Pilot; their disclosure is not limited to subject matter under consideration in this article and includes payments to themselves, an immediate family member (I), and/or their institutions (INST). For information on the pilot program, or to provide feedback, please visit the ASCO Web site .
Employment or Leadership Position: None Consultant or Advisory Role: Alok Khorana, Daiichi Sankyo (C), Johnson & Johnson (C), Eisai (C), sanofi-aventis (C), LEO Pharma (C), Bristol-Myers Squibb (C), Genentech (C), Eli Lilly (C); Agnes Lee, Bristol-Myers Squibb (C); Charles W. Francis, Eisai (C); Ajay K. Kakkar, Bayer HealthCare Pharmaceuticals (C), Boehringer Ingelheim (C), Eisai (C), GlaxoSmithKline (C), Pfizer (C), sanofi-aventis (C); Howard A. Liebman, Eisai (C), GlaxoSmithKline (C), Johnson & Johnson (C), sanofi-aventis (C) Stock Ownership: None Honoraria: Alok Khorana, Eli Lilly, sanofi-aventis, Daiichi Sankyo, Johnson & Johnson, Eisai, LEO Pharma, Bristol-Myers Squibb, Genentech; Agnes Lee, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, LEO Pharma, Pfizer, sanofi-aventis; Juan Ignacio Arcelus, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb, Pfizer, sanofi-aventis Research Funding: *Gary H. Lyman, Amgen; Alok Khorana, LEO Pharma, sanofi-aventis; Agnes Lee, LEO Pharma; Charles W. Francis, Eisai; Ajay K. Kakkar, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Eisai, GlaxoSmithKline, Pfizer, sanofi-aventis Expert Testimony: None Other Remuneration: None
This is the current release of the guideline.
This guideline updates a previous version: Lyman GH, Khorana AA, Falanga A, Clarke-Pearson D, Flowers C, Jahanzeb M, Kakkar A, Kuderer NM, Levine MN, Liebman H, Mendelson D, Raskob G, Somerfield MR, Thodiyil P, Trent D, Francis CW. American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol. 2007 Dec 1;25(34):5490-505. [146 references]
The American Society of Clinical Oncology reaffirmed the currency of this guideline in 2015.
Availability of Companion Documents
The following is available:
- Venous thromboembolism prophylaxis and treatment in patients with Cancer: American Society of Clinical Oncology clinical practice guideline update. Patient handout. 2013. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site .
Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.
This NGC summary was completed by ECRI Institute on February 19, 2008. The information was verified by the guideline developer on February 20, 2008. This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection. This summary was updated by ECRI Institute on December 26, 2008 following the FDA advisory on Innohep (tinzaparin). This summary was updated by ECRI Institute on July 27, 2010 following the FDA drug safety communication on Heparin. This summary was updated by ECRI Institute on June 24, 2013. This summary was updated by ECRI Institute on March 10, 2014 following the U.S. Food and Drug Administration advisory on Low Molecular Weight Heparins. The currency of the guideline was reaffirmed by the developer in 2015 and this summary was updated by ECRI Institute on June 25, 2015.
This summary is based on the original guideline, which is subject to the American Society of Clinical Oncology's copyright restrictions.