Table 1 Comparative table of randomized controlled trials comparing different types of anticoagulants for the long term treatment of venous thromboembolism in patients with cancer
Study | Methods* | Interventions† | Participants§ | Outcomes§ | Notes |
|---|---|---|---|---|---|
López-Beret 2001 | AC: Not clear Blinded: outcome assessors ITT analysis Sample size not calculated a priori 100% follow-up for primary outcome | Nadroparin 1.025 AXa IU/10 Kg twice daily for 3 days then randomized to Nadroparin 1.025 antiXa IU/10 Kg twice daily versus acenocoumarol (target INR 2–3) for 3–6 months. After the 3rd month, nadroparin was switched to once daily. 68% of INR values were on target. | 35 patients with known malignancy; treated for symptomatic DVT of the lower limbs; minimum age of 18 | Death at 12 months | Funding: Not reported |
Meyer 2002 (CANTHANOX trial) | AC: Adequate Blinded: outcome assessors, data analysts ITT analysis Stopped early for insufficient accrual Sample size calculated a priori 100% follow-up | Enoxaparin 1.5 mg/kg daily × 3 months vs. Enoxaparin 1.5 mg/kg daily × 4 days followed by warfarin (target INR 2–3) × 3 months; 41% of time on target. | 146 patients with cancer (solid or hematological; active or in remission but on treatment); with pulmonary embolism and/or DVT; minimum age of 18 years; minimum life expectancy of 3 months | Death, VTE, major bleeding at 3 months Death, minor bleeding, thrombocytopenia at 6 months | Funding: Aventis, Assistance Publique, Hospitaux de Paris |
Cesarone 2003 | Published only as abstract AC: Not clear Blinding: None, type of analysis not clear, Sample size calculation: not reported 97% follow-up. | Enoxaparin 100 UL/Kg twice daily × 3 months vs. coumadin (target INR 3) × 3 months. | 199 patients with cancer with DVT | Death at 3 months | Funding: Not reported |
Lee 2003 (CLOT trial) | AC: Adequate Blinded: outcome assessors, data analysts ITT analysis Sample size calculated a priori 99% follow-up | Dalteparin 200 IU/kg daily × 1 month followed by 150 IU/kg daily × 5 months vs. Dalteparin 200 IU/kg daily × 5–7 days followed by wafarin or acecumarol (target INR 2–3) × 6 months; 46% of time on target. | 979 patients with active cancer and with DVT or pulmonary embolism or both; ECOG 1 or 2 | Death, DVT, PE, VTE, major bleeding at 6 months Death at 1 year | Funding: Pharmacia |
Dietcher 2006 (ONCENOX trial) | AC: Not clear Blinding: none ITT analysis Sample size not calculated a priori 89% follow-up | Enoxaparin 1 mg/kg twice daily × 5 days followed by 1–1.5 mg/kg daily × 175 days vs. Enoxaparin 1 mg/kg twice daily × 5 days followed by warfarin (target INR 2–3) for a total of 180 days | 102 active patients with cancer with DVT and/or PE; minimum age of 18 years | Death, recurrent VTE, major bleeding, minor bleeding at 1 year | Funding: Aventis Pharmaceutical |
Hull 2006 (LITE study) | AC: Adequate Blinded: outcome assessors, data analysts ITT analysis Sample size not calculated a priori 99% follow-up | Tinzaparin 175 antiXa/kg SQ daily for 12 weeks vs. UFH for 5 days followed by vitamin K antagonist (target INR 2–3) for 12 weeks. | 200 patients with cancer (solid or hematological) with proximal DVT with or without PE; minimum age of 18 years; minimum life expectancy of 3 months | Death, recurrent VTE, major bleeding, minor bleeding, thrombocytopenia at 3 months Death, recurrent VTE at 1 year | Funding: Canadian Institute for Health Research, industry grant, Leo Pharmaceutical, Pharmion Pharmaceutical and Dupont Pharmaceutical. |