Performance status and outcomes in patients with cancer receiving thromboprophylaxis: a subanalysis of the AVERT trial

Abstract

Abstract Background The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) is central to cancer care planning and prognostication. Whether ECOG-PS also carries prognostic value in the setting of primary thromboprophylaxis for cancer-associated venous thromboembolism (VTE) remains unknown. Objectives To evaluate the impact of ECOG-PS on clinical outcomes in ambulatory patients with cancer initiating chemotherapy. Methods This was a post-hoc analysis of the AVERT randomized controlled trial that evaluated apixaban (2.5 mg twice daily) for thromboprophylaxis in patients at intermediate-to-high VTE risk. Multivariable survival models assessed the association between ECOG-PS (0–1 versus 2–3) and the composite primary outcome of VTE or clinically relevant bleeding (CRB), as well as its individual components and all-cause mortality, over 180 days. Results Of 428 patients included, 368 (86.0%) and 60 (14.0%) had an ECOG-PS of 0–1 and 2–3, respectively. The primary composite outcome occurred in 12.8% (n = 47) in those with ECOG 0–1 and 18.3% (n = 11) with ECOG-PS 2–3 (6-month cumulative incidence: 13.0% [95% CI: 9.8%–16.7%] versus 19.9% [95% CI: 10.5%–31.4%], respectively). Worse performance status was associated with higher risks for the composite outcome (aHR: 1.76; 95% CI: 1.14–2.72; p = 0.011), CRB (aHR: 1.58; 95%CI: 1.53–1.63; p < 0.0001), and all-cause mortality (aHR: 5.77; 95% CI: 4.98–6.67; p < 0.0001). In exploratory treatment-effect analyses, apixaban reduced VTE risk across ECOG-PS strata, including among participants with ECOG-PS 2–3, without clear evidence of excess CRB in this subgroup. Conclusions ECOG-PS predicts VTE-related outcomes in ambulatory patients with cancer and may inform individualized, value-based shared decision-making regarding anticoagulant thromboprophylaxis. Graphical Abstract