The novel ONCO-DOAC BLEED risk score, developed by Tomoyuki Nagai, MD, et al., provided clinically relevant major bleeding risk stratification for patients with cancer-associated venous thromboembolism (VTE) receiving direct oral anticoagulants (DOAC), according to research published June 16 in JACC: CardioOncology.

The ONCO-DOAC BLEED score, derived using data from 1,166 patients (mean age, 67.9 years; 57% women) in the prospective COMMAND VTE Registry-2 in Japan, incorporates history of major bleeding, chronic kidney disease, nonsteroidal anti-inflammatory drug (NSAID) use, distant metastatic cancer, terminal cancer, upper gastrointestinal cancer, pancreatic cancer and uterine cancer, assigning points to stratify risk as low (0), intermediate (1) and high (≥2). The score was validated using data from 779 patients from the ONCO DVT and ONCO PE studies.

Results at a median follow-up of 163 days showed that 127 patients (11%) in the COMMAND VTE Registry-2 and 53 patients (7%) in the ONCO DVT and ONCO PE studies experienced major bleeding, defined by the International Society on Thrombosis and Haemostasis criteria – with the score demonstrating moderate discrimination in both the derivation (Harrell’s C-index 0.68; Uno’s C-index 0.67) and validation (Harrell’s C-index 0.62; Uno’s C-index 0.63) cohorts.

ONCO-DOAC BLEED showed higher discrimination in the derivation cohort and comparable discrimination in the validation cohort compared with the VTE-BLEED, RIETE, CAT-BLEED and Perform scores.

“The ONCO-DOAC BLEED score integrates cancer-related characteristics, such as cancer type and disease status (including metastatic and terminal cancers), together with patient comorbidities and concomitant medications,” write the authors, noting this approach is intended to balance simplicity with clinical relevance. “Identifying high-risk patients may prompt closer clinical follow-up, careful review of concomitant medications, particularly the use of NSAIDs, and monitoring of changes in patient condition, thereby supporting uninterrupted cancer treatment and optimal VTE management.”

While calling the score “an important advance toward individualized anti-coagulation strategies,” in an accompanying editorial comment, Larissa Araújo de Lucena, MD; Juliana M. Giorgi, MD, FACC; and Caroline Fischer-Bacca, MD, FACC, write “this risk-stratification tool is best viewed as a risk-stratification instrument rather than a precise individual predictive model.” They further highlight that bleeding risk in oncology is dynamic and influenced by evolving disease status, treatment exposure and clinical trajectory. Thus, static baseline models therefore capture only part of the underlying risk and should complement, rather than replace, clinical judgment.