title: A pilot study to evaluate the safety and clinical outcomes of once-weekly epoetin alfa 80,000 u in anemic patients with cancer receiving chemotherapy.
abstract: BACKGROUND
  Epoetin alfa is indicated for the treatment of chemotherapy-induced anemia at doses of 150 U/kg 3 times weekly or 40,000 U once weekly. Higher starting doses may lead to higher hematologic response rates (RRs), earlier hematologic responses, and earlier identification of nonresponders. The hematologic response and safety of epoetin alfa at a starting dose of 80,000 U once weekly in anemic patients (hemoglobin [Hb] </= 11 g/dL) with nonmyeloid malignancies receiving chemotherapy were evaluated in this open-label, multicenter pilot study.
  
  
  METHODS
  Epoetin alfa was initiated at 80,000 U once weekly and reduced if Hb increased to > 13 g/dL or increased > 1.3 g/dL in a 2-week period during the 12-week study. The primary efficacy endpoint was major hematologic response (Hb increase >/= 2 g/dL or Hb >/=12 g/dL, independent of transfusion). Secondary endpoints were minor hematologic response (Hb increase >/= 1 g/dL but > 2 g/dL) and incidence of transfusions.
  
  
  RESULTS
  Of 69 patients enrolled, 47 (68%) completed the study. A majority of patients (72%) exhibited a major hematologic response with epoetin alfa 80,000 U once weekly. Mean Hb levels increased by 2.2 g/dL from baseline after 12 weeks of therapy. Six patients (8.8%) received packed red blood cell transfusions during the study. The dose of epoetin alfa was reduced, or held then reduced, per protocol in 48 patients (69.6%). Ten patients (14.5%) in the safety population experienced a total of 11 clinically relevant thrombotic vascular events.
  
  
  CONCLUSIONS
  Epoetin alfa at a starting dose of 80,000 U once weekly (with appropriate dose reductions) increased Hb level, was associated with a packed red blood cell transfusion rate > 5% after 4 weeks of therapy, and was safe and generally well tolerated in anemic patients with cancer receiving chemotherapy. The hematologic RR, however, was not markedly improved compared with previous trials with 40,000-60,000 U once weekly, perhaps partly because of the high frequency of dose reductions.
authors.affiliation: Sections of Medical Oncology and Palliative Medicine, St. Vincent's Comprehensive Cancer Center, New York, NY.
authors.forename: Roger J
authors.initials: RJ
authors.lastname: Waltzman
authors.forename: Denise
authors.initials: D
authors.lastname: Williams
authors.forename: Patricia
authors.initials: P
authors.lastname: Braly