Table 6. Randomized trial of non-vitamin K oral anticoagulants for patients with cancer associated thrombosis152,154-156.
Hokusai VTE Cancer | SELECT-D | ADAM VTE | Caravaggio | |
NCT02073682 | ISRCTN86712308 | NCT02585713 | NCT03045406 | |
Publication year | 2018 | 2018 | 2020 | 2020 |
Patient no. | 1050 | 406 | 300 | 1170 |
Study arm treatment | Edoxaban 60 mg (30 mg in patients with CrCl of 30 to 50 mL/min or weight of 60 kg or less or in those receiving concomitant treatment with potent P-glycoprotein inhibitors) once daily after 5-day low-molecular-weight heparin lead-in | Rivaroxaban, 15 mg twice daily for the first 3 weeks followed by 20 mg once daily | Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily | Apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily |
Control arm treatment | Dalteparin 200 IU/kg once daily for 30 days then 150 IU/kg once daily | Dalteparin 200 IU/kg once daily for 30 days then 150 IU/kg once daily | Dalteparin 200 IU/kg once daily for the first month followed by 150 IU/kg | Dalteparin 200 IU/kg once daily for the first month followed by 150 IU/kg |
Study duration | 12 months | 6 months | 6 months | 6 months |
Specific exclusion | ECOG performance status > 2 | Weight < 40 kg | CrCl < 30 mL/min | ECOG performance status > 2 |
CrCl < 30 mL/min | ECOG performance status > 2 | Concomitant use of strong CYP3A4 inducers | CrCl < 30 mL/min | |
Concomitant use of P-glycoprotein inhibitors | Concomitant use of strong CYP3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers | Concomitant use of strong CYP3A4 inhibitors or inducers or P-glycoprotein inhibitors or inducers | ||
Thrombocytopenia (< 50000/μL) | Primary esophageal or gastro-esophageal cancer | Thrombocytopenia (< 75000/μL) | ||
Primary endpoint | Recurrent VTE or major bleeding | Recurrent VTE | Major bleeding | Recurrent VTE |
CrCl, creatinine clearance; CYP, cytochrome P-450; ECOG, Eastern Cooperative Oncology Group; VTE, venous thromboembolism.