2011 SGO News: ESAs Linked to Mortality Risk in Ovarian Cancer
Cancer recurrence and death occurred significantly more often in ovarian cancer patients treated with erythropoietin-stimulating agents (ESAs), data from a retrospective cohort review showed.
ESA treatment also was associated with a briefer progression-free survival (PFS) and reduced overall survival, Rodney P. Rocconi, MD, of the University of South Alabama in Mobile, reported here at the Society of Gynecologic Oncology meeting.
Patients with anemia had the worst outcomes, as median PFS was 17 months among ESA users compared with 24 months in patients who did not take ESAs (P=0.02) and overall survival was 37 months with ESA therapy and 146 months without (P<0.001).
“Our data evaluating the use of erythropoietin-stimulating agents as a treatment of chemotherapy-induced anemia in ovarian cancer patients is similar to reports in other tumor sites,” Rocconi said. “As such, the use of erythropoietin-stimulating agents in ovarian cancer patients should be restricted.”
Anemia is a common side effect of cancer chemotherapy and is associated with impaired functional status and quality of life and worse outcomes in certain types of malignancies. Multiple clinical studies have shown that ESAs effectively treat chemotherapy-induced anemia and reduce the need for transfusion.
However, an emerging body of literature has raised questions about the safety of ESAs, Rocconi said. Placebo-controlled clinical trials and meta-analyses have shown an increased risk of recurrence and decreased survival in cancer patients treated with the agents.
In response to the safety issues, the FDA has required a black box warning on prescribing information for ESAs. The warning cites evidence of decreased survival when ESAs are used in patients who have hemoglobin values ≥13 g/dL.
“Several criticisms of the data arose before the black box warning,” said Rocconi. “Few cancer types were studied and, most important, the studies did not mirror clinical practice.
In an effort to provide more data on ESA use consistent with clinical practice, Rocconi and colleagues retrospectively reviewed records of patients at several centers for the years 2005 through 2010. They identified all patients with a primary diagnosis of epithelial ovarian cancer.
Since introduction of the FDA black box warning in 2008, more data have emerged to show an association between ESA use and an increased risk of venous thromboembolism and an increased risk of cancer recurrence, said invited discussant William Winter, MD, of Northwest Cancer Specialists in Portland, Ore.
The data led to recommendations that use of ESAs for curative intent should be avoided, should not begin until a patient’s hemoglobin level falls to 10 mg/dL, and should not have a target greater than 12 g/dL.
Rocconi RP, et al “Treatment of chemotherapy-induced anemia in patients with ovarian cancer: Does the use of erythropoiesis-stimulating agents (ESA) worsen survival?” SGO2011; Abstract 27.
Adopted from MedPage Today.