Originally published as JCO Early Release 10.1200/JCO.2008.21.7752 on July 27 2009

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D-Dimer and Prothrombin Fragment 1 + 2 Predict Venous Thromboembolism in Patients With Cancer: Results From the Vienna Cancer and Thrombosis Study

From the Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Core Unit for Medical Statistics and Informatics, Section of Clinical Biometrics, Clinical Division of Oncology, Department of Medicine I, Department of Medical and Chemical Laboratory Diagnostics, Medical University of Vienna, Austria.

Corresponding author: Ingrid Pabinger, MD, Clinical Division of Haematology and Haemostaseology, Department of Medicine I, Medical University of Vienna, Waehringer GuerA-1090 Vienna, Austria; e-mail: ingrid.pabinger{at}meduniwien.ac.at.

Purpose Venous thromboembolism (VTE) is a well-recognized complication of cancer. Laboratory parameters might be useful to assess the VTE risk in patients with cancer. The aim of this study was to investigate D-dimer and prothrombin fragment 1 + 2 (F 1 + 2), which reflect activation of blood coagulation and fibrinolysis, for prediction of cancer-associated VTE.

Patients and Methods In a prospective, observational, cohort study of 821 patients with newly diagnosed cancer or progression of disease who did not recently receive chemotherapy, radiotherapy, or surgery were enrolled and followed for a median of 501 days (interquartile range, 255 to 731 days). The malignancies in these patients were as follows: breast (n = 132), lung (n = 119), stomach (n = 35), lower gastrointestinal tract (n = 106), pancreas (n = 46), kidney (n = 22), and prostate (n = 101) cancers; high-grade glioma (n = 102); malignant lymphoma (n = 94); multiple myeloma (n = 17); and other tumor types (n = 47). The study end point was occurrence of objectively confirmed symptomatic or fatal VTE.

Results VTE occurred in 62 patients (7.6%). The cutoff level for elevated D-dimer and elevated F 1 + 2 was set at the 75th percentile of the total study population. In multivariable analysis that included elevated D-dimer, elevated F 1 + 2, age, sex, surgery, chemotherapy, and radiotherapy, the hazard ratios (HRs) of VTE in patients with elevated D-dimer (HR, 1.8; 95% CI, 1.0 to 3.2; P = .048) and elevated F 1 + 2 (HR, 2.0; 95% CI, 1.2 to 3.6; P = .015) were statistically significantly increased. The cumulative probability of developing VTE after 6 months was highest in patients with both elevated D-dimer and elevated F 1 + 2 (15.2%) compared with patients with nonelevated D-dimer and nonelevated F 1 + 2 (5.0%; P < .001).

Conclusion High D-dimer and F 1 + 2 levels independently predict occurrence of VTE in patients with cancer.

Supported by project Grant No. 10935 from the Jubiläumsfonds of the Austrian National Bank and by an unrestricted grant from Pfizer Austria.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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