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Aranesp Phase 3 Study in Patients with Active Cancer Not Receiving,Concurrent Chemotherapy or Radiotherapy Presented at AACR Annual,Meeting

, who are anemic due to the cancer itself. Unfortunately, the benefit of ESA treatment was not observed in these gravely ill patients," said John Glaspy, M.D., professor, David Geffen School of Medicine, University of California at Los Angeles. "Since this was not designed as a survival study and statistical significance diminished when the analyses were adjusted for known prognostic factors, there is no clear explanation for the increase of deaths in the Aranesp group."

About the Study

This Phase 3 study was designed to evaluate the efficacy and safety of Aranesp 6.75 mcg/kg administered every four weeks for the treatment of anemia in cancer patients not receiving chemotherapy or radiotherapy. The study was conducted in 21 countries, including sites in Western Europe, Central and Eastern Europe, Australia and North America. The majority of patients (60 percent) were from Central and Eastern Europe.

Patient eligibility included: greater than or equal to 18 years, nonmyeloid malignancy (with active disease), hemoglobin (Hb) less than or equal to 11 g/dL, and no chemotherapy or radiotherapy treatment within four weeks of screening or during the study. Patients (n=985) were randomized to Aranesp 6.75 mcg/kg or placebo every four weeks, with an end of study visit at week 19, and two years of follow up to evaluate survival. Patients were stratified by screening Hb (less than 10 g/dL or greater than or equal to 10 g/dL), geographic region (Europe versus rest of world), RBC transfusion in the prior 12 weeks, tumor type/treatment (specifically, diagnoses of chronic lymphocyctic leukemia or low grade lymphoma, ongoing hormonal or antibody therapy versus all other eligible patients), and ECOG status (0-1, 2).

Demographics were broadly similar between the groups. The mean (SD) age was 64.1 (11.6) years; the most common cancers were non-small cell lung (18 percent), breast (13 percent), and prostate (11 percent); most patients had disease stage III o
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