Clinical evaluation of once-weekly dosing of epoetin alfa in chemotherapy patients: Improvements in hemoglobin and quality of life are similar to three-times-weekly dosing

purpose: To prospectively evaluate the effectiveness, safety, and clinical benefit. of once-weekly epoetin alfa therapy as an adjunct to chemotherapy in anemic cancer patients. Patients and Methods: A total of 3,012 patients with nonmyeloid malignancie s who received chemotherapy were enrolled onto this multicenter, open-label , nonrandomised study conducted in 600 United States community-based practi ces. patients received epoetin alfa 60,000 U once weekly, which could be in creased to 50,000 U once weekly after 4 weeks dependent on hemoglobin respo nse. Treatment was continued for a maximum of 16 weeks. Results: Among the 2,964 patients assessable for efficacy, epoetin alfa the rapy resulted in significant increases in hemoglobin levels, decreases in t ransfusion requirements, and improvements in functional status and fatigue as assessed by the linear analog scale assessment (energy level, ability to perform daily activities, and overall quality of life) and the anemia subs cale of the Functional Assessment of Cancer Therapy-Anemia questionnaire. I mprovements in quality-of-life parpameters correlated significantly (P < .0 01) with increased hemoglobin levels. The direct relationship between hemog lobin and quality-of-life improvement was sustained during the 16-week stud y period, which is similar to findings of large community-based trials of t hree-times-weekly dosing. Once-weekly epoetin alfa was well tolerated, with most adverse events attributed to the underlying disease or concomitant ch emotherapy, Conclusion: The results from this large, prospective, community-based trial suggest that once-weekly epoetin alfa therapy increases hemoglobin levels, decreases transfusion requirements, and improves quality of life in patien ts with cancer and anemia who undergo concomitant chemotherapy, Based on th e results of this study, the clinical benefits and the adverse event profil e of once-weekly epoetin alfa therapy in community-based practice are simil ar to there observed in the historical experience with the three-times-week ly dosage schedule.