Outcomes of VTE thromboprophylaxis in ambulatory oncology patients receiving chemotherapy
| Study . | Reference . | Treatment . | Thromboembolism . | Major bleeding . | Mortality . |
|---|---|---|---|---|---|
| PROTECHT | 29 | Nadroparin 3800 IU daily (N = 779) vs placebo (N = 387) for up to 4 mo during chemotherapy | Symptomatic ATE and VTE: Nadroparin 15/769 (2.0%); | Nadroparin 5/769 (0.7%); | Nadroparin 333/769 (43.3%); |
| Placebo 15/381 (3.9%); P = .02 | Placebo 0/381 (0%); P = .18 | Placebo 155/381 (40.7%) at 12 mo | |||
| SAVE-ONCO | 30 | Semuloparin 20 mg daily (N = 1608) vs placebo (N = 1604) for a minimum of 3 mo during chemotherapy | Symptomatic VTE or VTE-related death: Semuloparin 20/1608 (1.2%); Placebo 55/1604 (3.4%); HR, 0.36 (0.21-0.60); | Semuloparin 19/1589 (1.2%); Placebo 18/1583 (1.1%); OR, 1.05 (0.55-2.04) | Semuloparin (43.4%); Placebo (44.5%); HR, 0.96 (0.86-1.06) at 12 mo |
| P < .001 | |||||
| FRAGEM | 31 | Dalteparin 200 IU/kg × 4 wk, then 150 IU/kg × 8 wk plus gemcitabine (N = 60) vs gemcitabine alone (N = 63) | Symptomatic VTE: Dalteparin 0/59 (0%); Control 10/62 (17%) (5 fatal);RR, 0.048 (0.003-0.808); P = .001 | Dalteparin 2/59 (3.4%); Control 2/62 (3.2%) | Dalteparin 4/59 (7%); Control 7/62 (11%) at 100 d; P = .388 |
| CONKO-004 | 32 | ENOX 1 mg/kg daily for 3 mo followed by ENOX 40 mg daily plus chemotherapy (N = 160) vs chemotherapy alone (N = 152) | Symptomatic VTE at 3 mo: ENOX 2/160 (1.3%); Control 15/152 (10.2%); | ENOX 7/160 (4.5%); Control 5/152 (3.4%); | Median overall survival: ENOX 8.51 mo; |
| HR, 0.12 (0.03-0.52); P = .001 | HR, 0.35-3.72); P = 1.0 | Control 8.02 mo; HR, 1.01 (0.87-1.38); | |||
| P = .44 |
| Study . | Reference . | Treatment . | Thromboembolism . | Major bleeding . | Mortality . |
|---|---|---|---|---|---|
| PROTECHT | 29 | Nadroparin 3800 IU daily (N = 779) vs placebo (N = 387) for up to 4 mo during chemotherapy | Symptomatic ATE and VTE: Nadroparin 15/769 (2.0%); | Nadroparin 5/769 (0.7%); | Nadroparin 333/769 (43.3%); |
| Placebo 15/381 (3.9%); P = .02 | Placebo 0/381 (0%); P = .18 | Placebo 155/381 (40.7%) at 12 mo | |||
| SAVE-ONCO | 30 | Semuloparin 20 mg daily (N = 1608) vs placebo (N = 1604) for a minimum of 3 mo during chemotherapy | Symptomatic VTE or VTE-related death: Semuloparin 20/1608 (1.2%); Placebo 55/1604 (3.4%); HR, 0.36 (0.21-0.60); | Semuloparin 19/1589 (1.2%); Placebo 18/1583 (1.1%); OR, 1.05 (0.55-2.04) | Semuloparin (43.4%); Placebo (44.5%); HR, 0.96 (0.86-1.06) at 12 mo |
| P < .001 | |||||
| FRAGEM | 31 | Dalteparin 200 IU/kg × 4 wk, then 150 IU/kg × 8 wk plus gemcitabine (N = 60) vs gemcitabine alone (N = 63) | Symptomatic VTE: Dalteparin 0/59 (0%); Control 10/62 (17%) (5 fatal);RR, 0.048 (0.003-0.808); P = .001 | Dalteparin 2/59 (3.4%); Control 2/62 (3.2%) | Dalteparin 4/59 (7%); Control 7/62 (11%) at 100 d; P = .388 |
| CONKO-004 | 32 | ENOX 1 mg/kg daily for 3 mo followed by ENOX 40 mg daily plus chemotherapy (N = 160) vs chemotherapy alone (N = 152) | Symptomatic VTE at 3 mo: ENOX 2/160 (1.3%); Control 15/152 (10.2%); | ENOX 7/160 (4.5%); Control 5/152 (3.4%); | Median overall survival: ENOX 8.51 mo; |
| HR, 0.12 (0.03-0.52); P = .001 | HR, 0.35-3.72); P = 1.0 | Control 8.02 mo; HR, 1.01 (0.87-1.38); | |||
| P = .44 |
ATE, arterial thromboembolism; IU, international units.