Apixaban voor de behandeling van veneuze trombo-embolie bij patiënten met kanker: een prospectieve gerandomiseerde open-label eindpunten (PROBE) studie (de CARAVAGGIO studie)

Venous thromboembolism (VTE) is a common clinical event in patients with
cancer. The development of VTE is presumed to be due to the production of
pro-coagulant molecules by cancer cells and to the pro-coagulant effective
cancer cells spread into the circulation. It should be taken into account that
cancer surgery and chemotherapy are associated with a substantial increase in
the risk of VTE (1). The risk for bleeding complications on anticoagulant
therapy is also higher in cancer patients than in non-cancer patients such
making crucial the balance between benefit and risk (1). The CLOT study,
performed more than 15 years ago, showed that in patients with cancer
associated VTE, anticoagulant treatment with the LMWH dalteparin was more
effective and similarly safe compared to vitamin K antagonists (2). These
results were confirmed in studies with a more limited number of patients (3).
Thus, current guidelines recommend the use of :MWH, given subcutaneously, for
the acute and long term treatment of VTE in cancer patients (4-5). In the
recently published CATCH study in cancer patients, the LMWH tinzaparin was
associated with a non-significant 35% risk reduction in recurrence of VTE
compared to vitamin K antagonists (6).In the CTACH study, there were no
differences in the incidence of major bleeding between the two treatment
groups. Due to the high risk for recurrence, cancer patients who experience VTE
are candidate to indefinite treatment duration or to prolong treatment until
cancer is completely cured (4-5). The availability of an oral anticoagulant
treatment, as effective and safe as LMWH would be a substantial advantage for
patient with cancer who develop VTE. During the last years, new oral
anticoagulants given at fixed doses without the need of laboratory monitoring
and dose adjustments were shown to be as effective as and probably safer than
vitamin K antagonists for the treatment of VTE (7). The results of phase III
clinical trialled to their approval for the acute and long term treatment of
VTE. Unfortunately, the clinical trials on the treatment of VTE with the new
oral anticoagulants included only a limited number of patients with cancer.
Thus, whether the results obtained in the general population of patients with
VTE also attain to cancer patients remains undefined. Subgroup analysis on the
efficacy and safety profile of the anti-Xa oral agent apixaban for the
treatment of VTE in cancer patients have been recently reported (8-11). In
these patient with all the limitations related to a subgroup analysis, apixaban
appeared to be at least as effective as LMWH given with and followed by vitamin
K antagonists (10). A recent meta-analysis in cancer patients showed a similar
efficacy and safety profile of of new oral anticoagulants in comparison with
LMWH given with and followed by vitamin K antagonists for the treatment of VTE
(12).

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