Table 1.
Data from prospective clinical trials comparing the safety and efficacy of direct oral anticoagulants and low molecular weight heparin in the treatment of thrombosis in cancer patients.
| Study | Hokusai Cancer VTE | SELECT-D | ADAM-VTE | Caravaggio | ||||
|---|---|---|---|---|---|---|---|---|
| Patient Population | Adults with cancer and newly diagnosed symptomatic or incidental thrombosis | Adults with cancer and newly diagnosed symptomatic or incidental thrombosis | Adults with cancer and newly diagnosed symptomatic or incidental thrombosis | Adults with cancer and newly diagnosed symptomatic or incidental thrombosis | ||||
| Observation time (months) | 12 | 6 | 6 | 6 | ||||
| Anticoagulant | Edoxaban | Dalteparin | Rivaroxaban | Dalteparin | Apixaban | Dalteparin | Apixaban | Dalteparin |
| Treatment | LMWH for 5 days, then edoxaban 60 mg daily |
200 IU/kg/day for 30 days, then 150 IU/kg/day | 15 mg twice daily for 3 weeks, then 20 mg once daily | 200 IU/kg/day for 1 month, then 150 IU/kg/day | 10 mg twice daily for 7 days, then 5 mg twice daily |
200 IU/kg/day for 1 month, then 150 IU/kg/day |
10 mg twice daily for 7 days, then 5 mg twice daily |
200 IU/kg/day for 1 month, then 150 IU/kg/day |
| Sample size | 522 | 524 | 203 | 203 | 145 | 142 | 576 | 579 |
| Mean age of patients (years) | 64.3 (SD = 11) |
63.7 (SD = 11.7) |
67 (22–87) |
67 (34–87) |
64.4 (SD = 11.3) |
64.0 (SD = 10.8) |
67.2 (SD = 11.3) |
67.2 (SD = 10.9) |
| Metastatic disease (%) | 52.2 | 53.4 | 58 | 58 | 65.3 | 66.0 | 67.5 | 68.4 |
| Recurrence of thrombosis (%) | 7.9 | 11.3 | 4 | 11 | 0.7 | 6.3 | 5.6 | 7.9 |
| HR 0.71, 95% CI 0.48–1.06 p = 0.09 |
HR 0.43, 95% CI 0.19–0.99 p = NR |
HR 0.099, 95% CI 0.01–0.78 p = 0.0281 |
HR 0.63, 95% CI 0.37–1.07 p = 0.09 |
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| Major bleeding (%) | 6.9 | 4 | 6 | 4 | 0 | 2.1 | 3.8 | 4.0 |
| HR 1.77, 95% CI 1.03–3.04 p = 0.04 |
HR 1.83, 95% CI 0.68–4.96 p = NR |
p = 0.138 | HR 0.82, 95% CI 0.40–1.69 p = 0.60 |
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| CRNMB (%) | 14.6 | 11.1 | 13 | 4 | 6.2 | 4.2 | 9.0 | 6.0 |
| HR 1.38, 95% CI 0.98–1.94 p = NR |
HR 3.76, 95% CI 1.63–8.69 p = NR |
NR * | HR 1.42, 95% CI 0.88–2.30 p = NR |
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| Mortality (%) | 39.5 | 36.6 | 25 | 30 | 16 | 11 | 23.4 | 26.4 |
| HR 1.12, 95% CI 0.92–1.37 p = NR |
NR | HR 1.40, 95% CI 0.82–2.43 p = 0.307 |
HR 0.82, 95% CI 0.62–1.09 p = NR |
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| Median duration of treatment | 211 days | 184 days | 5.9 months | 5.8 months | 5.78 months | 5.65 months | 178 days | 175 days |
CRNMB—clinically relevant non-major bleeding, NR—not reported; * statistics for CRNMB and major bleeding were tested cumulatively. The results of the comparison were statistically insignificant.