SAVE-ONCO
Trial question
What is the role of semuloparin in patients receiving chemotherapy for cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 3212
3212 patients (1282 female, 1930 male).
Inclusion criteria: patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy.
Key exclusion criteria: life expectancy < 3 months; ECOG performance status ≥ 3; calculated CrCl < 30 mL/min; major surgery in < 4 weeks; contraindication to anticoagulation; requirement to thromboprophylaxis.
Interventions
N=1608 semuloparin (subcutaneous dose of 20 mg once daily).
N=1604 placebo (matching placebo once daily).
Primary outcome
Composite outcome of symptomatic deep vein thrombosis, nonfatal pulmonary embolism, and death related to venous thromboembolism
1.2%
3.4%
3.4 %
2.5 %
1.7 %
0.8 %
0.0 %
Semuloparin
Placebo
Significant
decrease ▼
NNT = 45
Significant decrease in composite outcome of symptomatic DVT, nonfatal PE, and death related to VTE (1.2% vs. 3.4%; HR 0.36, 95% CI 0.21 to 0.6).
Secondary outcomes
No significant difference in death (43.4% vs. 44.5%; HR 0.96, 96% CI 0.86 to 1.06).
Significant decrease in symptomatic DVT (0.7% vs. 2.1%; HR 0.32, 95% CI 0.15 to 0.62).
Significant decrease in PE (0.6% vs. 1.5%; HR 0.41, 95% CI 0.19 to 0.85).
Safety outcomes
No significant differences in major bleeding, clinically relevant nonmajor bleeding and serious adverse events.
Conclusion
In patients with metastatic or locally advanced solid tumors who were beginning to receive a course of chemotherapy, semuloparin was superior to placebo with respect to the composite outcome of symptomatic DVT, nonfatal PE, and death related to VTE.
Reference
Giancarlo Agnelli, Daniel J George, Ajay K Kakkar et al. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9.
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