Background <p>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.</p> Objectives <p>To evaluate the impact of ECOG-PS on clinical outcomes in ambulatory patients with cancer initiating chemotherapy.</p> Methods <p>This was a post-hoc analysis of the AVERT randomized controlled trial that evaluated apixaban (2.5&#xa0;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.</p> Results <p>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% (<i>n</i> = 47) in those with ECOG 0–1 and 18.3% (<i>n</i> = 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; <i>p</i> = 0.011), CRB (aHR: 1.58; 95%CI: 1.53–1.63; <i>p</i> &lt; 0.0001), and all-cause mortality (aHR: 5.77; 95% CI: 4.98–6.67; <i>p</i> &lt; 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.</p> Conclusions <p>ECOG-PS predicts VTE-related outcomes in ambulatory patients with cancer and may inform individualized, value-based shared decision-making regarding anticoagulant thromboprophylaxis.</p> Graphical Abstract <p></p>

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

  • Nicola Potere,
  • Yan Xu,
  • Ranjeeta Mallick,
  • Tzu-Fei Wang,
  • Danny Hill,
  • Alejandro Lazo-Langner,
  • Vicky Tagalakis,
  • Sudeep Shivakumar,
  • Marcello Di Nisio,
  • Philip S. Wells,
  • Marc Carrier

摘要

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