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Table 1 Randomised clinical trials of VTE treatment in patients with cancer (adapted from Khorana 2009[18])

From: CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients

Study n Population Treatments Follow-up Outcomes Key limitations compared with the CATCH study design
CLOT [28] 672 Acute symptomatic proximal DVT and/or PE Dalteparin qd (5–7 days) + warfarin* (6 months) 6 months Recurrent VTE (primary)
15.8% (W), 8.0% (D); P = 0.002
Full-dose dalteparin not maintained for entire 6-month treatment period
    Dalteparin qd (6 months)   Major bleeding
4% (W), 6.0% (D); P = 0.27
No outcomes for PTS, HRQoL, predictors of recurrence, and healthcare resource utilisation
Main-LITE[27] 200 Proximal DVT UFH + warfarin (6 days) then warfarin (3 months) 3 months and 12 months Recurrent VTE (primary)
3 months: 10.0% (W), 6.0% (T)
12 months: 16.0% (W), 7.0% (T); P = 0.044
Duration of randomised treatment only 3 months
    Tinzaparin qd (3 months)   Major bleeding
3 months: 7.0% (W), 7.0% (T)
Modest sample size with limited statistical power
CANTHANOX [29] 146 DVT and/or PE Enoxaparin qd (initial) + warfarin (3 months) 3 months Treatment failure § (primary)
21.1% (W), 10.5% (E); P = 0.09
Composite primary endpoint (recurrent VTE and major bleeding)
    Enoxaparin qd (3 months)   Major bleeding
16.0% (W), 7.0% (E); P = 0.09
Duration of randomised treatment only 3 months
Small study with limited statistical power
Trial stopped early because of slow recruitment
ONCENOX [26] 122 Acute symptomatic VTE Enoxaparin LD bid (5 days) + warfarin (6 months) 6 months Recurrent VTE (secondary)
10.0% (W), 6.9% (LD), 6.3% (HD)
Recurrent VTE was only a secondary objective (study did not meet its primary objective, which was to recruit the necessary number of patients within a 12-month time frame)
Small study with limited statistical power
    Enoxaparin LD bid (5 days) then LD qd (6 months)    
    Enoxaparin LD bid (5 days) then HD qd (6 months)   Major bleeding
2.9% (W), 6.5% (LD), 11.1% (HD)
 
  1. *Except in Spain and The Netherlands, where acenocoumarol was used; full dose (200 IU/kg) for first month then reduced dose (~150 IU/kg) for the remaining 5 months; cancer subpopulation; §composite endpoint of recurrent VTE and/or major bleeding within 3-month treatment period.
  2. Abbreviations: bid twice daily; D dalteparin, DVT deep vein thrombosis, E enoxaparin, HD high dose (1.5 mg/kg), HRQoL health-related quality of life, LD low dose (1.0 mg/kg), PE pulmonary embolism, PTS post-thrombotic syndrome, qd each day, T tinzaparin, UFH unfractionated heparin, VTE venous thromboembolism, W warfarin.