Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban

Abstract

Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case‐control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4‐week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty‐four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01–12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5–16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1–1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5–3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. We were unable to identify other risk factors, mainly due to limited statistical power.

Risk Factors for Bleeding in Cancer Patients Treated with Conventional Dose Followed by Low-Dose Apixaban for Venous Thromboembolism

“…[23][24][25][26][27][28][29][30] A nested case-control study in patients with GI cancer randomized to edoxaban in the Hokusai VTE Cancer study has reported that advanced cancer and low hemoglobin levels were associated with bleeding. 31 Our study confirms that some of these factors are also associated with bleeding in cancer patients taking full-dose apixaban. In a recently published sub-analysis of the Caravaggio study, ECOG status of 2, genitourinary cancer, upper GI cancer, and nonresected luminal GI cancer were the predictors of major bleeding.…”

Efficacy and Safety of Edoxaban in Cancer-Associated Venous Thromboembolism: A Real World Retrospective Study

“…Recently, Bosch et al, in a nested case–control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, found that advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. 22 In the SELECT-D study, in 80.5% of cases of major or CRNM bleedings, the site of bleeding was gastrointestinal or genitourinary. 5 In the CARAVAGGIO study, 32.6% of tumors were gastrointestinal and 11.5% genitourinary; although not exceeding bleedings in the dalteparin arm, 29.7% of major and/or CRNM bleedings with apixaban involved the gastrointestinal, and 31% the genitourinary tract.…”

The phospholipase PNPLA7 functions as a positive indicator in human colorectal and gastric cancers

“…[ 17 ] Although we have made great progress in the diagnosis and treatment of digestive system tumors, most patients are already in the middle and late stages of cancer when they are diagnosed due to the difficulty of early diagnosis, and their treatment and prognosis are very poor. [ 18 ] Therefore, the molecular mechanism and early prediction of the occurrence and development of cancers are currently hot issues in research.…”