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Apixaban reduces recurrence of cancer-associated venous thromboembolism

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SAN DIEGO — Patients with cancer-associated venous thromboembolism treated with oral apixaban appeared significantly less likely to experience VTE recurrence than those who received parenteral dalteparin, according to study results presented at ASH Annual Meeting and Exposition.

The regimen also was associated with very low bleeding rates.

“Apixaban [also] was well tolerated, with superior patient satisfaction and significantly fewer study drug discontinuations compared [with] dalteparin,” researcher Robert D. McBane II, MD, consultant in the vascular and hematology divisions at Mayo Clinic in Rochester, Minnesota, said during his presentation. “These data support the use of apixaban for the acute treatment of cancer-associated VTE.”

An estimated 1.8 million new cancer cases are diagnosed each year in the United States, and there are approximately 14 million cancer survivors in the country. Approximately one in five of these individuals will develop VTE.

Among individuals who receive anticoagulation, rates of VTE recurrence range from 4% to 16% at 6 months, and rates of major bleeding range from 4% to 6%, according to study background.

Low-molecular weight heparin is the guideline-recommended treatment for patients with cancer-associated VTE.

Apixaban (Eliquis; Bristol-Myers Squibb, Pfizer) received FDA approval for treatment of acute VTE; however, data regarding its use for individuals with cancer are limited.

The primary analysis of the ADAM-VTE trial included 287 patients with cancer-associated acute VTE.

Key inclusion criteria included acute VTE, age older than 18 years, active cancer, life expectancy of at least 60 days, and ECOG performance status of 0 to 2.

The most prevalent malignancies were colorectal, lung, pancreatic and breast cancers.

Two-thirds (65.6%) had metastatic disease and 74% were receiving concurrent systemic cancer therapy.

McBane and colleagues randomly assigned 145 patients to apixaban 10 mg twice daily for 7 days, followed by 5 mg twice daily. The other 142 patients received subcutaneous dalteparin — a low-molecular weight heparin — dosed at 200 IU/kg once daily for 30 days, followed by 150 IU/kg per day. Treatment in both groups continued for a total duration of 6 months.

The treatment groups were balanced with regard to age, sex and qualifying thrombosis, with the exception of a higher percentage of splanchnic venous thrombosis in the dalteparin group (18% vs. 8%; P = .01).

Major bleeding served as the primary outcome measure. Secondary outcomes included VTE recurrence, as well as a composite of major bleeding and clinically relevant nonmajor bleeding.

Researchers reported no significant differences between the apixaban and dalteparin groups with regard to major bleeding (0% vs. 2.1%), or the composite of major plus clinically relevant nonmajor bleeding (6.2% vs. 6.3%; HR = 0.93; 95% CI, 0.43-2.02).

However, a significantly lower percentage of apixaban-treated patients developed recurrent VTE (0.7% vs. 6.3%; HR = 0.09; 95% CI, 0.12-0.78).

Results showed no significant difference in mortality at 6 months between the apixaban and dalteparin groups (HR = 1.4; 95% CI, 0.82-2.43).

Study participants completed monthly quality-of-life surveys. Results for several survey measures favored apixaban, including stress, irritation, burden of delivery, concern for excess bruising, and overall satisfaction of anticoagulant therapy (P < .05).

A separate monthly questionnaire that specifically assessed bruising also favored apixaban at each interval (P < .002).

A significantly higher percentage of patients assigned dalteparin required premature discontinuation (15% vs. 4%; P = .0012). – by Mark Leiser

Reference:

McBane RD, et al. Abstract 421. Presented at: ASH Annual Meeting and Exposition; Dec. 1-4, 2018; San Diego.

Disclosures : The study was funded by the Bristol-Myers Squibb-Pfizer Alliance. The authors report no relevant financial disclosures.