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Title: Darbepoetin Associated With Increased Mortality in Cancer Patients With Anaemia: Presented at AACR

"Darbepoetin Associated With Increased Mortality in Cancer Patients With Anaemia: Presented at AACR"

By Ed Susman LOS ANGELES, CA -- April 19, 2007 -- Cancer patients who have anaemia and are treated with darbepoetin alfa (Aranesp) have increased mortality rates compared with placebo patients, doctors reported here at the American Association for Cancer Research (AACR) annual meeting. Compared with placebo, patients treated with darbepoetin required fewer -- although not significantly fewer -- transfusions, but they also had a 23% increase in the risk of death ([P = .031), said John Glaspy, MD, director, Women's Cancers Program Area, Johnsson Comprehensive Cancer Center, and professor of medicine - haematology/oncology, University of California, Los Angeles School of Medicine, Los Angeles, California, United States.

"The evidence does not support the use of erythropoietin in these patients," Dr. Glaspy said in a late-breaker oral presentation on April 17^th. However, he said, the trial did not address the use of darbepoetin and other anti-anaemia agents for treatment of anaemia due to chemotherapy. "That really represents the more common use of darbepoetin for cancer patients," he said.

Dr. Glaspy said it was unclear why treatment with erythropoietin products would increase mortality in cancer patients, but he said a number of theories are being actively investigated, including the possibility that "there may be erythropoietin receptors on the cancer cells themselves."

David Steensma, MD, haematologist, Mayo Clinic, Rochester, Minnesota, United States, who was the discussant for the paper, said that reducing the need for transfusion is an important goal because transfusions are associated with a worse outcome in other settings, including in patients treated in intensive care units. "And transfusions are not, themselves, without risk," he added, noting that risks include "infection through the units transfused, prions, for example, are now a concern as well as the potential for febrile reaction, volume overload or iron overload."

The study randomised 985 patients to darbepoetin 6.75 mcg/kg or placebo every four weeks for 16 weeks. There was an end of study assessment at 19 weeks and patients were followed for two years to evaluate survival.

Patents were enrolled in the study if they had haemoglobin level of 11 g/dL or less as well as no chemotherapy or radiation therapy within four seeks of screening for the study.

The primary endpoint was occurrence of transfusion from week 5 to week 17. The secondary endpoints were incidence of transfusion from week 5 to week 17, change in haemoglobin level from baseline to week 17, and safety.

The analysis included data from 419 darbepoetin patients and 432 placebo patients.

Dr. Glaspy reported that 176 transfusions were required among the darbepoetin group and 215 in the placebo group (P = .320). There were also 216 deaths in the placebo arm and 250 in the darbepoetin arm (P = .031).

The trial was funded by Amgen.

[Presentation title: Results From a Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin Alfa (DA) for the Treatment of Anemia in Patients not Receiving Chemotherapy or Radiotherapy, Abstract LB-3]

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