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

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)