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Just a year after meeting her first grandchild, Claire received a lung cancer diagnosis. She was forced to give up her hobby as a frequent hiker and struggled to stay active due to the burdens of her treatment; Claire later developed a deep vein thrombosis (DVT). For the treatment of her DVT, Claire was prescribed rivaroxaban because she expressed a preference for an oral anticoagulant. Six months have passed, and Claire has not experienced a recurrent DVT nor any adverse events. A decision is now needed on whether she requires extended anticoagulation to reduce the risk of recurrent venous thromboembolism (VTE) or if treatment can be safely discontinued.
What do guidelines suggest is the best course of action to protect Claire?
Patients suffering from cancer make up approximately 20% of overall VTE incidence. Effective treatment is essential for cancer‑associated thrombosis (CAT) because it is the second biggest cause of death in patients with cancer, after the disease itself.1
Although patients with cancer face the highest risk of recurrent VTE in the first few months after cancer diagnosis, they may require protection from VTE recurrence for as long as their cancer is active.2,3 A 2019 real-world study highlighted that extended treatment can offer patients better protection from recurrent VTE than short-term treatment, with over twofold higher risk of recurrent VTE in patients with CAT treated for up to 3 months compared with those treated up to 6 months and beyond.2
Risk of VTE recurrence is higher in patients with CAT receiving 3 months of treatment compared with 6 months and beyond.
CAT, cancer‑associated thrombosis; VTE, venous thromboembolism.
The risk of bleeding events should be considered in patients with CAT using anticoagulation therapy.3,4 When choosing to extend anticoagulation therapy, cancer-related and treatment‑related risk factors need to be evaluated in order to balance the benefits of extended anticoagulation and the relative increased risk of major bleeding events in these vulnerable patients.2
A wealth of new data on the treatment of CAT has resulted in updated guidelines, including those for extended anticoagulation. During the 10th annual virtual International Conference on Thrombosis and Hemostasis Issues in Cancer (ICTHIC), Professor Alok Khorana (Cleveland Clinic, OH) reported: ‘updated guidelines include new recommendations for oral anticoagulants for initial, short‑term and long-term anticoagulation after diagnosis of VTE.’
ESC5, ASCO6, ITAC7, NCCN8 and ASH9 guideline recommendations for extended treatment of cancer-associated thrombosis. *Such as those with metastatic disease or receiving chemotherapy. #Conditional recommendation, very low certainty in the evidence of effects. ASCO, American Society of Clinical Oncology; ASH, American Society of Hematology; CrCl, creatinine clearance; DDI, drug–drug interactions; ESC, European Society of Cardiology; GI, gastrointestinal; ITAC, International Initiative on Thrombosis and Cancer; LMWH, low molecular weight heparin; NCCN, National Comprehensive Cancer Network; NOAC, non-vitamin K antagonist oral anticoagulant; PE, pulmonary embolism; VKA, vitamin K antagonist.
Recommendations on when to extend anticoagulation therapy for patients with CAT are based on individual assessment of the risk of recurrence.7 In general, this means that patients should continue to receive anticoagulation beyond 6 months for as long as their cancer is active, or if other risk factors persist.5,6,9,10 Patients should be re-evaluated frequently to assess riskؘ–benefit ratio of continued anticoagulation.10,11
Non-vitamin K antagonist oral anticoagulants (NOACs; including rivaroxaban) are endorsed by guidelines as an alternative to low molecular weight heparin (LMWH); when choosing between these, several factors should be considered including: tumour stage and type, risk of bleeding, potential drug–drug interactions and kidney function.7,8,10 These guidelines often recommend NOACs in patients with CAT that have a low risk of bleeding events, and caution against their use in high bleeding risk cancers, such as gastrointestinal cancer.10
Historically, LMWH has been the predominant recommendation for the treatment of CAT. However, this treatment relies on daily injections, a requirement that many may find burdensome when receiving extended therapy.12 Patient adherence to treatment is important for maintaining the effectiveness of anticoagulation treatment, and patient preferences for drug administration needs to be considered.12 Of all NOACs, rivaroxaban has accumulated the largest evidence base for the treatment of CAT, including having the only NOAC studies dedicated to treatment satisfaction and treatment persistence in patients with CAT.13
A Mayo Clinic study measured treatment duration when patients were treated with NOACs versus LMWHs. Patients receiving rivaroxaban had a longer mean treatment duration of 7.5 months versus 5.5 months with enoxaparin. Patients were also more likely to persist with their treatment beyond 6 months compared with those receiving enoxaparin (43.1% [113/262] versus 26.5% [131/494]).14
Persistence of patients with CAT treated with rivaroxaban or enoxaparin for an extended duration.
One of the most recent studies from the global, multi-study CALLISTO programme, CONKO‑011, compares real-life use and patient satisfaction with rivaroxaban versus LMWH in patients with CAT.15 Results demonstrated that patients receiving rivaroxaban were less likely to request early cessation of treatment than those receiving LMWHs up to 3 months.16 Patients consistently reported a lower relative anticoagulation-related burden with rivaroxaban than with LMWH over a 3 months period, and relative benefits favouring rivaroxaban up to 2 months.16
Fewer patients treated with rivaroxaban requested early cessation of therapy compared with LMWHs.
LMWH, low molecular weight heparin.
The findings from CONKO-011 and the Mayo Clinic study are supported by data from several previous studies. It has been shown that 61% of patients with CAT receiving rivaroxaban remain on the same therapy after 6 months, compared with 37% of patients initially receiving LMWH.17 Patients with CAT also reported improved quality of life and treatment satisfaction after switching from traditional anticoagulation therapy to rivaroxaban in the COSIMO study.13
When treating patients with CAT, it is necessary to evaluate the benefits and risks of extended anticoagulation in each individual patient. Patient-centric decision making should also consider the implications of treatment choice on adherence, persistence and quality of life to best protect your patients, like Claire.