ASCO Expands Therapeutic Options for Venous Thromboembolism Prophylaxis in Patients With Cancer

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ASCO has updated its recommendations for the prevention and treatment of venous thromboembolism (VTE) in patients with cancer. “The recommendations were last updated in 2015, but since then, new, significant publications have emerged, which prompted this

Nigel S. Key, MBChB

Nigel S. Key, MBChB

update,” said Nigel S. Key, MBChB, of the University of North Carolina Hemophilia and Thrombosis Center and Guideline Co-Chair. “We are now increasingly thinking about the risk of VTE and the need to identify those patients who are at highest risk based on simple indices such as body mass index, cancer type, and routine labs.”

Expanded Therapeutic Options

The new recommendations were based on results from 35 publications focused on VTE prophylaxis and treatment and 18 publications on VTE risk-assessment models. These sources were identified in a literature search of randomized controlled trials and meta-analyses of such trials published between August 1, 2014, and December 4, 2018.

“These updated recommendations reflect the new evidence and outline expanded therapeutic and prophylactic options for VTE in the cancer population,” said Senior Guideline Co-Chair

Anna Falanga, MD

Anna Falanga, MD

Anna Falanga, MD, of Hospital Papa Giovanni XXIII, Italy. “We can now tailor treatment based on patient characteristics, type of cancer, and disease phase.”

Dr. Falanga said anticoagulation for VTE can be particularly challenging in patients with cancer. The reasons are the “increased risk of bleeding; frequent invasive procedures such as biopsies and central venous catheter insertion; chemotherapy, which can interfere with coagulation; nausea and vomiting; drug interactions and, possibly, hepatic and renal disfunction; and very low body weight.”

Advantages of Direct Oral Anticoagulants

Dr. Falanga said new evidence shows that treatment with direct oral anticoagulants compared with low–molecular-weight heparin (LMWH) lowers the risk of recurrent thrombosis but may carry a higher risk of bleeding in the gastrointestinal tract. “For this reason, direct oral anticoagulants may not be the best option in patients with gastrointestinal cancers, and we would recommend LMWH for these patients. However, in other cases, treatment with direct oral anticoagulants may be more convenient because they are delivered orally and do not require monitoring,” she said.

Dr. Key agreed. “The convenience of an oral agent, as opposed to an injectable, will be much more attractive to both prescribers and patients on an ongoing basis,” he said.

Personalizing Anticoagulation Therapy

The updated guideline addresses anticoagulation for VTE in specific groups of patients and different clinical situations in the form of responses to six clinical questions:

  1. Should hospitalized patients receive anticoagulation for VTE prophylaxis?
  2. Should ambulatory patients receive anticoagulation for VTE prophylaxis during systemic chemotherapy?
  3. Should patients undergoing surgery receive perioperative VTE prophylaxis?
  4. Should patients receive anticoagulants to improve survival in the absence of established VTE?
  5. What is the best therapeutic approach to prevent recurrence in patients with established VTE?
  6. How to predict risk and raise awareness of VTE among patients.

“The expert panel found that pharmacologic thromboprophylaxis may be offered to hospitalized patients with active malignancy without additional risk factors in the absence of bleeding or other contraindications. However, it may not be suitable for those patients admitted for chemotherapy or minor procedures, or those undergoing stem cell/bone marrow transplantation,” Dr. Key said.

The new guideline also does not recommend routine pharmacologic thromboprophylaxis to all outpatients. Dr. Falanga summarized the main changes relevant to this patient group. She said that compared with the previous recommendations, clinicians can now offer thromboprophylaxis with apixaban or rivaroxaban, or LMWH, to high-risk outpatients with cancer.

“Another important change is that two direct oral anticoagulants, rivaroxaban and apixaban, have been added to LMWH as options for VTE treatment,” Dr. Falanga said. “Other changes involve the inclusion of patients with brain metastases in the VTE treatment section, whereas before only patients with primary brain tumors were mentioned.” However, the expert panel acknowledged the need for additional studies in this vulnerable group of patients. The panel also expanded the recommendation regarding long-term postoperative LMWH to include patients undergoing major open or laparoscopic abdominal or pelvic surgery for cancer.

Reassessing the Risk of VTE and Educating Patients

The final set of recommendations emphasizes the importance of periodically reevaluating patients’ status and risk of VTE, as well as improving patient awareness of VTE warning signs. Research has shown that patients are often not aware of the early symptoms and signs of VTE or situations that may increase the risk of VTE, such as major surgery or hospitalization. Physicians should educate patients about VTE and discuss treatment options with them, Dr. Falanga said.

“The clinical course of malignant disease and the appropriateness of anticoagulant therapy should be evaluated approximately every 3 months,” she said. “In addition, the risk profile, preferences, and therapy objectives should be discussed with each patient on a regular basis. The decision to stop therapy can be made in those cases when clinical remission of cancer occurred and where there is no indication to continue anticoagulant therapy.”

DISCLOSURE: Dr. Key has received honoraria from Novo Nordisk; has served in a consulting or advisory role for Genentech/Roche, Seattle Genetics, Shire Human Genetic Therapies, and uniQure; and has received institutional research funding from Baxter BioScience, Grifols, and Pfizer. Dr. Falanga has received honoraria from Bayer and Medscape.

Originally published in ASCO Daily News. © American Society of Clinical Oncology. ASCO Daily News, August 6, 2019. All rights reserved.