Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor‐bearing microparticles: a randomized‐controlled phase II trial (the Microtec study)

Abstract

SUMMARY Elevated levels of circulating tissue factor-bearing microparticles (TFMP) have been associated with an increased risk of developing venous thromboembolism (VTE) in cancer patients. We performed a randomized phase II study to evaluate the cumulative incidence of VTE in advanced cancer patients with lower levels of TFMP not receiving thromboprophylaxis and those with higher levels of circulating TFMP randomized to enoxaparin or observation. The cumulative incidence of VTE at 2 months in the higher TFMP group randomized to enoxaparin (N=23) was 5.6% while the higher TFMP group observation arm (N=11) was 27.3% (Gray test P=0.06). The cumulative incidence of VTE in the low TFMP was 7.2% (N=32). No major haemorrhages were observed in the enoxaparin arm. The median survival for patients with higher levels of TFMP followed by observation was 11.8 months compared with 17.8 months on enoxaparin (P=0.58). In a prospective randomized trial, increased numbers of circulating TFMP detected by impedance flow cytometry identified cancer patients with a high incidence of VTE. Enoxaparin demonstrated a clear trend towards reducing the rate of VTE in patients with elevated levels of TFMP, with an overall rate of VTE similar in magnitude to the lower TFMP group.

Optimal management of venous thromboembolism in advanced pancreatic cancer with low-molecular-weight heparin: current evidence

“…While the role of primary thrombophylaxis in cancer patients remains unclear, future studies, some of which are ongoing, might shed a light on its impact in the subset of the highly thrombogenic PC. The use of surrogate predictive biomarkers such as circulating tissue factor-bearing microparticles, as seen in the MicroTec trial, 13 may further optimize our understanding for the finest patient selection for this treatment.…”

“…Because gemcitabine represents a major therapeutic alternative in PC, it may induce further risk for VTE. 12 According to the MicroTec study, 13 circulating tissue factor-bearing microparticles are associated with a higher risk of VTE. Thromboprophylaxis with low-molecular-weight heparin (LMWH) in patients with high levels of tissue factorbearing microparticles significantly reduces VTE.…”

“…Thromboprophylaxis with low-molecular-weight heparin (LMWH) in patients with high levels of tissue factorbearing microparticles significantly reduces VTE. 13 In addition to chemotherapy, supportive care measures used in cancer patients may enhance the risk of VTE. The use of colony-stimulating hormones such as erythropoietin for treating symptomatic anemia has been associated with an increased risk of VTE.…”

A kórházi és az ambuláns kemoterápiában részesülő onkológiai betegek vénásthromboembolia-profilaxisának aktuális kérdései

“…Az első olyan vizsgálat, ahol bár többféle nagy rizikójú beteg szerepelt, a bevonási kritérium az emelkedett, szöveti faktort hordozó mikropartikulum-szint volt (TF-MP) (MICROTEC tanulmány) [34]. Ebben enoxaparint kaptak a magas TF-MP szintű betegek, akiknél a VTE-profilaxis lényegesen hatékonyabb volt (5,6% vs. 27,3%).…”

Modulating thrombotic diathesis in hereditary thrombophilia and antiphospholipid antibody syndrome: a role for circulating microparticles?

“…Indeed, the direct link between MPs and VTE is supported by a considerable amount of new evidence [24,25,27]. MPs may become in the future one of the novel biomarkers for early primary and/or secondary VTE prevention protocols [28]. Therefore, the aim of this review is to offer a new perspective on the current knowledge and research trends regarding the possible role of MPs in hereditary thrombophilia and antiphospholipid syndrome.…”