Patient Adherence and Experience with Extended Use of Prophylactic Low-Molecular-Weight Heparin Following Pancreas and Liver Resection

Lemke, Madeline; Beyfuss, Kaitlyn; Hallet, Julie; Coburn, Natalie; Law, Calvin; Karanicolas, Paul J.

doi:10.1007/s11605-016-3274-0

Cited by 22 publications

(27 citation statements)

References 34 publications

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“…Clearly, several questions remain unresolved with regard to the optimal dosing, timing and duration of LMWH treatment to achieve inhibition of tumour growth. Adherence rates were estimated to 85% using the anti-FXa assay, which is consistent with a study by Lemke et al [28], reporting adherence rates of 81% in patients with cancer completing a 4-week course of prophylactic enoxaparin following pancreatic or liver resection. In the literature, adherence rates of !80% are often considered acceptable [29e31], which supports the conclusion that the participants in the RASTEN trial were adequately adherent to LMWH.…”

Section: Discussionsupporting

confidence: 88%

Low-molecular-weight heparin adherence and effects on survival within a randomised phase III lung cancer trial (RASTEN)

Gezelius

Bendahl

Oliveira

et al. 2019

European Journal of Cancer

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Background: Coagulation activation is a hallmark of cancer, and anticoagulants have shown tumour-inhibiting properties. However, recent trials have failed to demonstrate improved survival with low-molecular-weight heparin (LMWH) in cancer populations. This has raised the question of suboptimal adherence as a possible explanation for the lack of benefit. Still, there is no standardised method to directly monitor LMWH in patient plasma. Here, we directly determine LMWH levels in patients using the Heparin Red assay to objectively assess adherence and how this associates with the patient outcome in the RASTEN trial. Methods: RASTEN is a multicentre, randomised phase III trial investigating if the addition of LMWH to standard therapy can improve survival in small-cell lung cancer. LMWH was measured in plasma (N Z 258) by the Heparin Red assay and compared with the antiefactor Xa (anti-FXa) activity assay. Results: Both methods could differentiate patients in the LMWH arm from the control arm and patients receiving therapeutic LMWH owing to thrombosis. Receiver Operating Characteristic (ROC) analysis yielded adherence rates of 85% for anti-FXa and 68% for

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Section: Discussionsupporting

confidence: 88%

Low-molecular-weight heparin adherence and effects on survival within a randomised phase III lung cancer trial (RASTEN)

Gezelius

Bendahl

Oliveira

et al. 2019

European Journal of Cancer

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“…Sixteen studies evaluated patient RIOs for the burden associated with treatments. 24,32,39,40,[43][44][45][46][47][51][52][53][54]60,65,80 One study, including patients taking long-term anticoagulation, reported that only some (12%) patients using direct oral anticoagulants (DOACs) may switch to VKAs because of complications and fear of adverse effects, as well as for not being reimbursed (subgroup of 19 participants from 1 study including 1001 total participants; low certainty) 65 (Table 4). With regard to the use of oral VKAs in general, although routine monitoring does not seem to represent a limitation for patients accepting it, many (58-64%) would switch to another anticoagulant if it were equally effective and required less monitoring or dietary restrictions (2070 participants from 5 studies; low certainty) 40,45,47,52,65 (Table 4).…”

Section: Nonutility Resultsmentioning

confidence: 99%

“…Treatment burden of injection (Lemke et al, 51 Maxwell et al, 53 Noble et al, 54 Trade-off between treatment burden and benefits with LMWH (Cajfinger et al, 46 Noble et al 54 ) Cancer patients place highest value on "the interference with cancer treatment," followed by "efficacy of the VTE treatment" and "risk for major bleeding." They place low value on monitoring through blood tests, frequency of administration, mistakes, and costs.…”

Section: Cancermentioning

confidence: 99%

Patient values and preferences regarding VTE disease: a systematic review to inform American Society of Hematology guidelines

Etxeandia-Ikobaltzeta

Zhang

Brundisini

et al. 2020

Blood Advances

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Values and preferences relate to the importance that patients place on health outcomes (eg, bleeding, having a deep venous thrombosis) and are essential when weighing benefits and harms in guideline recommendations. To inform the American Society of Hematology guidelines for management of venous thromboembolism (VTE) disease, we conducted a systematic review of patients’ values and preferences related to VTE. We searched Medline, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature from inception to April of 2018 (PROSPERO-CRD42018094003). We included quantitative and qualitative studies. We followed Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance for rating the certainty and presenting findings for quantitative research about the relative importance of health outcomes and a grounded theory approach for qualitative thematic synthesis. We identified 14 quantitative studies (2465 participants) describing the relative importance of VTE-related health states in a widely diverse population of patients, showing overall small to important impact on patients’ lives (certainty of the evidence from low to moderate). Additionally, evidence from 34 quantitative studies (6424 participants) and 15 qualitative studies (570 participants) revealed that patients put higher value on VTE risk reduction than on the potential harms of the treatment (certainty of evidence from low to moderate). Studies also suggested a clear preference for oral medication over subcutaneous medication (moderate certainty). The observed variability in health state values may be a result of differences in the approaches used to elicit them and the diversity of included populations rather than true variability in values. This finding highlights the necessity to explore the variability induced by different approaches to ascertain values.

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“…Moreover, our results are limited by the primary studies. While adherence could be an important issue in an injectable medication such as tinzaparin, unlike trials observing the use of LMWH following surgery in patients with cancer, 23 none of the included trials reported on the adherence of the patients to assessed treatments. Furthermore, the number of events in all meta-analyses we performed was low.…”

Section: Discussionmentioning

confidence: 99%

Tinzaparin for Long-Term Treatment of Venous Thromboembolism in Patients With Cancer: A Systematic Review and Meta-Analysis

Martínez-Zapata

Mathioudakis

Mousa

et al. 2017

Clin Appl Thromb Hemost

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Patients with cancer are at increased risk of recurrent venous thromboembolism (VTE) and bleeding. Thus, long-term treatment with anticoagulants for secondary prevention is challenging. The objective of this review was to evaluate current evidence on the safety and efficacy of tinzaparin compared with other anticoagulants for long-term VTE treatment in patients with cancer. Based on a preregistered protocol, we identified randomized controlled trials (RCTs) comparing long-term tinzaparin (therapeutic dose: 175 IU/kg) versus other anticoagulants for at least 3 months after an acute episode of VTE that included adult patients with underlying malignancy. We extracted predefined, clinically relevant outcomes of patients with cancer and, using standard methodology, pooled available data and assessed risk of bias and quality of evidence for each study. . The overall quality of evidence was deemed moderate, mainly due to small sample size in 2 of the studies and limited number of events in the meta-analyses. In conclusion, both short-and long-term treatments with tinzaparin were found to be superior to vitamin K antagonists for avoiding recurrences of VTE.

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Patient Adherence and Experience with Extended Use of Prophylactic Low-Molecular-Weight Heparin Following Pancreas and Liver Resection

Cited by 22 publications

References 34 publications

Low-molecular-weight heparin adherence and effects on survival within a randomised phase III lung cancer trial (RASTEN)

Low-molecular-weight heparin adherence and effects on survival within a randomised phase III lung cancer trial (RASTEN)

Patient values and preferences regarding VTE disease: a systematic review to inform American Society of Hematology guidelines

Tinzaparin for Long-Term Treatment of Venous Thromboembolism in Patients With Cancer: A Systematic Review and Meta-Analysis

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