Virtual Medical Centre

Anaemia-reducing drugs given to cancer patients linked to risk of DVT and PE

30 November 2009
Medications frequently given to cancer patients to reduce their risk of anaemia are associated with an increased risk of deep vein thrombosis or pulmonary embolism, according to new research led by Dawn Hershman, MD, MS, co-director of the breast cancer program at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital/Columbia University Medical Center. The findings were published online 10 November 2009 in the Journal of the National Cancer Institute.

The anaemia-reducing medications, known as erythropoiesis-stimulating agents (i.e. erythropoietin and darbopoietin) or ESAs, stimulate red blood cell production and are intended to reduce the number of blood transfusions required during chemotherapy. However, concerns about the risks of deep vein thrombosis or pulmonary embolism (manifestations of venous thromboembolism) and mortality exist.

"This research answers important questions about outcomes of ESAs when used in long-term clinical practice with oncology patients," said Dr Hershman, the Florence Irving Assistant Professor of Medicine and Epidemiology at Columbia University Medical Center, whose research is dedicated to examining cancer survivorship. "While ESAs were given to reduce the need for blood transfusions, a substantial reduction in the use of blood transfusions was not observed. However, an increase risk of deep vein thrombosis or pulmonary embolism was confirmed."

"This analysis confirms the association between ESAs and venous thromboembolism, which was observed in previous meta-analysis," said Dr Hershman. "This new finding is significant because where the meta-analysis looked at pooled data from randomised clinical trials, this data is from community practice – real-life clinical settings – where you can often see things that wouldn't necessarily show-up in a short-term, 12-week study. Additionally, this analysis included data from more than 50,000 patients – including those with more advanced cancer or high-risk status, who therefore might not have been candidates for clinical trials."

Based on previous findings, in the spring of 2007, the FDA required a black-box warning on ESAs about the potential for venous thromboembolism, tumour promotion, and decreased survival in ESA users. The warning suggested limiting the use of ESAs to specific tumour types, durations, doses, and targeted haemoglobin levels. In addition, the Center for Medicare and Medicaid Services proposed eliminating or limiting coverage for ESAs as treatment for some cancers.