Incidence and significance of thromboembolic events (TE) in patients with gastrointestinal (GI) and non-GI malignancies on systemic cytotoxic therapy

Abstract

9049 Background: Although venous thromboembolic events (TE) are commonly associated with solid tumor malignancies, the precise incidence and significance of TE in cancer patients has not been well established. We previously reported a high incidence of TE in patients with GI malignancies enrolled on clinical studies at Memorial Sloan Kettering (MSKCC) (Asmis, GI ASCO 2007), and now explore the prognostic impact of TE in GI and non-GI malignancies. Methods: All patients above the age of 18 enrolled on prospective, investigator-initiated therapeutic clinical trials at MSKCC from January 1, 2003 to December 31, 2005 were reviewed. Serious adverse event monitoring was recorded prospectively and patients were followed regularly as per their protocol. All patients with Grade 3–4 TE were identified and confirmed at chart review. 100 patients without TE were audited to verify TE status, and 4 patients with TE were identified(sensitivity 96.8%, 95%CI 92.1–99.1%; specificity 100%, 95%CI 96.2–100%). Patients were followed for survival. All records were reviewed for baseline anticoagulation use, prior therapy, and date of cancer diagnosis. Results: 2482 patients with solid tumor malignancies were enrolled from 2003 to 2005: median age 58 (range 18–90), 43% female, 7% baseline anticoagulation, 44% previously untreated. 122 (4.8%, 95%CI 4%- 5.7%) had a TE. TE is associated with decreased median survival in patients with non-GI malignancy (10 months vs. 19.5 months) (p=0.0003), whereas the development of TE was not associated with reduced survival in GI malignancies (16.7 months vs 15.6 months (p=0.45)). Conclusions: In patients with non-GI solid tumors, the development of a venous thromboembolism is significantly associated with poor survival. Understanding why this is the case may provide insight to tumor biology and an opportunity to positively impact patient survival. [Table: see text] No significant financial relationships to disclose.