Table 3.
Prophylaxis of VTE in ambulatory cancer patients during chemotherapy: recent clinical trials and meta-analysis
| Study | Number of patients | Type of tumor | Risk of thrombosis | LMWH | Dose |
|---|---|---|---|---|---|
| PROTECHT Lancet Onc’09 | 1,150 | Lung, pancreas, stomach, colorectal, breast, ovarian, head and neck cancer | High (pancreas, stomach) Low (breast, head and neck) | Nadroparin | 3,800 UI/24 h |
| FRAGEM UK EJC’11 | 123 | Pancreas | High | Dalteparin | 200 UI/kg/24 h × 4 weeks followed 150 UI/kg/24 h × 8 weeks |
| CONKO 004 ASCO’10 | 312 | Pancreas | High | Enoxaparin | 1 mg/kg/24 h × 3 m, followed 40 mg/24 h × 3 m |
| SAVE ONCO NEJM’12 | 3,212 | Lung, colorectal, stomach, pancreas, kidney and ovarian cancer | Moderate–high | Semuloparin | 20 mg/24 h |
| Meta-analysis Cochrane 2012 | 3,538 | Multiple neoplasms | Not defined | – | – |
| Akl pooled analysis NEJM’12 | ≈6.000 | Multiple neoplasms | Not defined | – | – |
| Duration | VTE (%) CT + LMWH vs. CT | Major bleeding CT + LMWH vs. QT | Minor bleeding CT + LMWH vs. CT | NNT |
|---|---|---|---|---|
| 4 months | 2.0 vs. 3.9 % *(VTE + ATE) p = 0.02 | 0.7 vs. 0 % p = 0.18 | 7.4 vs. 7.9 % | 53 |
| 12 weeks | 3.4 vs. 23.0 % RR 0.145, p = 0.002 | 3.4 vs. 3.2 % | 9.0 vs. 3.0 % | – |
| 6 months | 5.1 vs. 15.6 % p < 0.05 | No difference p = NS | NR | 12 (sVTE) |
| Until a change of CT regimen | 1.2 % vs. 3.4 % HR 0.36, p < 0.001 | 1.2 vs. 1.2 % | 1.6 vs. 0.9 % | 46 |
| – | Heparin vs. no prophylaxis | 60 (sVTE) | ||
| 0.55 (0.34–0.88) | 1.57 (0.69–3.60) | – | ||
| – | Heparin vs. no prophylaxis | – | ||
| 0.57 (0.40–0.81) | 1.06 (0.71–1.57) | 1.18 (0.89–1.55) | ||
m months, mg milligram, CT chemotherapy, NNT number of patients needed to treat to avoid one event, sVTE symptomatic venous thromboembolism, NS not significant, HR hazard ratio
* Venous thromboembolism incidence plus arterial thormboembolism incidence