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Brief Summary

GUIDELINE TITLE

American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.
  • August 16, 2007, Coumadin (Warfarin): Updates to the labeling for Coumadin to include pharmacogenomics information to explain that people's genetic makeup may influence how they respond to the drug.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Should Hospitalized Patients with Cancer Receive Anticoagulation for Venous Thromboembolism (VTE) Prophylaxis?

Recommendation

Hospitalized patients with cancer should be considered candidates for VTE prophylaxis with anticoagulants in the absence of bleeding or other contraindications to anticoagulation.

Should Ambulatory Patients with Cancer Receive Anticoagulation for VTE Prophylaxis During Systemic Chemotherapy?

Recommendations

  1. Routine prophylaxis with an antithrombotic agent is not recommended.
  2. Patients receiving thalidomide or lenalidomide with chemotherapy or dexamethasone are at high risk for thrombosis and warrant prophylaxis. Until such time as data are available from randomized clinical trials (RCTs), low-molecular-weight-heparin (LMWH) or adjusted-dose warfarin (international normalized ratio [INR] ~1.5) is recommended in myeloma patients receiving thalidomide plus chemotherapy or dexamethasone. This recommendation is based on extrapolation from studies of postoperative prophylaxis in orthopedic surgery and a trial of adjusted-dose warfarin in breast cancer.
  3. RCTs evaluating antithrombotic agents are needed in patients with multiple myeloma receiving thalidomide or lenalidomide plus chemotherapy and/or dexamethasone.
  4. Research identifying better markers of ambulatory patients with cancer most likely to develop VTE is urgently needed.

Should Patients with Cancer Undergoing Surgery Receive Perioperative VTE Prophylaxis?

Recommendations

  1. All patients undergoing major surgical intervention for malignant disease should be considered for thromboprophylaxis.
  2. Patients undergoing laparotomy, laparoscopy, or thoracotomy lasting greater than 30 minutes should receive pharmacologic thromboprophylaxis with either low-dose unfractionated heparin (UFH) or LMWH unless contraindicated because of a high risk of bleeding or active bleeding.
  3. Prophylaxis should be commenced preoperatively, or as early as possible in the postoperative period.
  4. Mechanical methods may be added to pharmacologic methods, but should not be used as monotherapy for VTE prevention unless pharmacologic methods are contraindicated because of active bleeding.
  5. A combined regimen of pharmacologic and mechanical prophylaxis may improve efficacy, especially in the highest-risk patients.
  6. Prophylaxis should be continued for at least 7 to 10 days postoperatively. Prolonged prophylaxis for up to 4 weeks may be considered in patients undergoing major abdominal or pelvic surgery for cancer with high-risk features such as residual malignant disease after operation, obese patients, and those with a previous history of VTE.

What is the Best Treatment for Patients with Cancer with Established VTE to prevent Recurrent VTE?

Recommendations

  1. LMWH is the preferred approach for the initial 5 to 10 days of anticoagulant treatment of the cancer patient with established VTE.
  2. LMWH given for at least 6 months is also the preferred approach for long-term anticoagulant therapy. Vitamin K antagonists with a targeted INR of 2 to 3 are acceptable for long-term therapy when LMWH is not available.
  3. After 6 months, indefinite anticoagulant therapy should be considered for selected patients with active cancer, such as those with metastatic disease and those receiving chemotherapy. This recommendation is based on Panel consensus in the absence of clinical trials data.
  4. The insertion of a vena cava filter is only indicated for patients with contraindications to anticoagulant therapy and in those with recurrent VTE despite adequate long-term therapy with LMWH.
  5. For patients with central nervous system (CNS) malignancies, anticoagulation is recommended for established VTE as described for other patients with cancer. Careful monitoring is necessary to limit the risk of hemorrhagic complications. Anticoagulation should be avoided in the presence of active intracranial bleeding, recent surgery, preexisting bleeding diathesis such as thrombocytopenia (platelet count <50,000/microliter) or coagulopathy.
  6. For elderly patients, anticoagulation is recommended for established VTE as described for other patients with cancer. Careful monitoring and dose adjustment is necessary to avoid excessive anticoagulation and further increase in the risk of bleeding.

Should Patients with Cancer Receive Anticoagulants in the Absence of Established VTE to Improve Survival?

Recommendations

  1. Anticoagulants are not recommended to improve survival in patients with cancer without VTE.
  2. Patients with cancer should be encouraged to participate in clinical trials designed to evaluate anticoagulant therapy as an adjunct to standard anticancer therapies.

CLINICAL ALGORITHM(S)

An algorithm entitled: American Society of Clinical Oncology (ASCO) Prophylaxis Algorithm for Venous Thromboembolism: 2007 is provided as a companion document (see "Availability of Companion Documents" field in this summary).

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations were based primarily on comprehensive review of published reports. In cases where the data did not appear conclusive, recommendations were based on the consensus opinion of the group. The type of evidence supporting each recommendation is summarized in Table 5 of the original guideline document.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2007 Dec

GUIDELINE DEVELOPER(S)

American Society of Clinical Oncology - Medical Specialty Society

SOURCE(S) OF FUNDING

American Society of Clinical Oncology

GUIDELINE COMMITTEE

American Society of Clinical Oncology (ASCO) Venous Thromboembolism Expert Panel

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Authors: Gary H. Lyman; Alok A. Khorana; Anna Falanga; Daniel Clarke-Pearson; Christopher Flowers; Mohammad Jahanzeb; Ajay Kakkar; Nicole M. Kuderer; Mark N. Levine; Howard Liebman; David Mendelson; Gary Raskob; Mark R. Somerfield; Paul Thodiyil; David Trent; Charles W. Francis

Members of the Venous Thromboembolism Expert Panel: Gary H. Lyman, MD, MPH, FRCP (Edin) (Co-Chair), Duke University Medical Center; Anna Falanga, MD (Co-Chair), Ospedali Riuiniti Bergamo, Italy; Daniel Clarke-Pearson, MD, University of North Carolina; Christopher Flowers, MD, MS, Winship Cancer Institute; Charles W. Francis, MD, University of Rochester Medical Center; Leigh Gates, Patient Representative, University of Colorado; Mohammad Jahanzeb, MD, University of Tennessee; Ajay Kakkar, MD, PhD, Barts and The London School of Medicine, Thrombosis Research Institute; Alok A. Khorana, MD, University of Rochester Medical Center; Nicole M. Kuderer, MD, Duke University Medical Center; Mark Levine, MD, PhD, McMaster University; Howard A. Liebman, MD, University of Southern California; David S. Mendelson, MD, Premiere Oncology; Gary Edward Raskob, PhD, University of Oklahoma Health Sciences Center; Paul A. Thodiyil, MD, New York Methodist Hospital, and David Trent, MD, PhD, Virginia Cancer Center

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

All members of the Expert Panel complied with American Society of Clinical Oncology (ASCO) policy on conflicts of interest, which requires disclosure of any financial or other interest that might be construed as constituting an actual, potential, or apparent conflict. Members of the Expert Panel completed ASCO's disclosure form and were asked to reveal ties to companies developing products that might be affected by promulgation of the guidelines. Information was requested regarding employment, consultancies, stock ownership, honoraria, research funding, expert testimony, and membership on company advisory committees. The Panel made decisions on a case-by-case basis as to whether an individual's role should be limited as a result of a conflict. No limiting conflicts were identified.

Although all authors completed the disclosure declaration, the following author(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 in the original journal of publication.

Employment or Leadership Position: None Consultant or Advisory Role: Ajay Kakkar, Sanofi-aventis (C), Pfizer (C), Eiasi Pharmaceuticals (C); Howard Liebman, laxoSmithKline (C), Pfizer (C), Bristol-Myers Squibb (C); Gary Raskob, Sanofi-aventis (C), Bayer (C), Bristol-Myers Squibb (C), Boehringer-Ingelheim (C), Darichi (C), Takeda (C); Charles W. Francis, Eisai Pharmaceuticals (C) Stock Ownership: None Honoraria: Alok A. Khorana, Sanofi-aventis, Eisai Pharmaceuticals; Ajay Kakkar, Sanofi-aventis, Pfizer, Eiasi Pharmaceuticals; Howard Liebman, GlaxoSmithKline, Pfizer, Pharmion; Gary Raskob, Sanofi-aventis, Bayer, Boehringer-Ingelheim; Charles W. Francis, Eisai Pharmaceuticals Research Funding: Ajay Kakkar, Sanofi-aventis; Mark N. Levine, Pfizer; Howard Liebman, Bristol-Myers Squibb, Pharmion, Pfizer Expert Testimony: Daniel Clarke-Pearson (C); Mark N. Levine (C); Gary Raskob (C) Other Remuneration: None

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the American Society of Clinical Oncology (ASCO) Web site.

Print copies: Available from American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 1900 Duke Street, Suite 200, Alexandria, VA 22314; E-mail: guidelines@asco.org.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Guidelines are available for Personal Digital Assistant (PDA) download from the ASCO Web site.

PATIENT RESOURCES

The following is available:

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.

NGC STATUS

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.

COPYRIGHT STATEMENT

This summary is based on the original guideline, which is subject to the American Society of Clinical Oncology's copyright restrictions.

DISCLAIMER

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