Impact of ECOG performance status on cancer-associated thrombosis treated with DOACs: Data from a multicenter cohort...

Data on safety and effectiveness of direct oral anticoagulants (DOACs) in patients with cancer-associated thrombosis (CAT) and impaired functional status are limited. We evaluated the impact of Eastern Cooperative Oncology Group (ECOG) performance status on bleeding and thrombotic events in a real-world cohort.

Patients with CAT on DOACs were prospectively included from six Italian centers and stratified by ECOG status (0-1 vs. 2-4). Primary outcomes were major bleeding (MB) and recurrent venous thromboembolism (VTE); secondary outcome was all-cause mortality. Incidence rates were calculated, and predictors of MB and VTE recurrence were assessed using Cox models within each ECOG subgroup.

Among 817 patients, 702 had ECOG 0-1 and 115 had ECOG 2-4. Patients with ECOG ≥2 were older, had worse renal function and more comorbidities. MB occurred at 10.3% vs. 2.8% patient-years (HR 2.92, 95% CI 1.43-5.94) and recurrent VTE at 7.2% vs. 3.6% patient-years (HR 2.16, 95% CI 0.96-4.86) in patients with ECOG 2-4 vs. 0-1, respectively. Factors associated with bleeding differed according to ECOG status, with treatment-related factors more frequently associated with bleeding in ECOG 0-1 patients, whereas chronic kidney disease emerged as the strongest predictor in ECOG 2-4 patients. All-cause mortality occurred at 78.4% patient-years in ECOG 2-4 and 10.5% patient-years in ECOG 0-1 (HR 6.28, 95% CI 4.69-8.41).

Impaired functional status was associated with higher MB and mortality, whereas no statistically significant difference in VTE recurrence was observed across ECOG strata. These findings suggest individualized anticoagulation strategies, particularly in frail or end-of-life patients.