SOME
Trial question
What is the role of screening for occult cancer in patients with unprovoked VTE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 854
854 patients (278 female, 576 male).
Inclusion criteria: patients who had a first unprovoked VTE.
Key exclusion criteria: age < 18 years, allergy to contrast media, a CrCl < 60 mL/min, claustrophobia or agoraphobia, a weight > 130 kg, ulcerative colitis, or glaucoma.
Interventions
N=423 limited occult-cancer screening plus CT (basic blood testing, chest radiography, and screening for breast, cervical, and prostate cancer plus comprehensive CT (CT) of the abdomen and pelvis).
N=431 limited occult-cancer screening (basic blood testing, chest radiography, and screening for breast, cervical, and prostate cancer).
Primary outcome
Occult cancer diagnosis at 1 year
4.5%
3.2%
4.5 %
3.4 %
2.3 %
1.1 %
0.0 %
Limited occult-cancer screening plus
CT
Limited occult-cancer
screening
No significant
difference ↔
No significant difference in occult cancer diagnosis at 1 year (4.5% vs. 3.2%; RR 1.4, 95% CI -1.12 to 3.92).
Secondary outcomes
No significant difference in mean time to a cancer diagnosis (4 vs. 4.2; RR 0.95, 95% CI -10.48 to 12.38).
No significant difference in cancer-related death (0.9% vs. 1.4%; RR 0.64, 95% CI -3.1 to 4.38).
No significant difference in missed cancer in the primary outcome analysis (26% vs. 29%; RR 0.9, 95% CI -69114.8 to 69116.6).
Conclusion
In patients who had a first unprovoked VTE, limited occult-cancer screening plus CT was not superior to limited occult-cancer screening with respect to occult cancer diagnosis at 1 year.
Reference
Carrier M, Lazo-Langner A, Shivakumar S et al. Screening for Occult Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704.
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