Epoetin Alfa 60,000 U Once Weekly Followed by 120,000 U Every 3 Weeks Increases and Maintains Hemoglobin Levels in Anemic Cancer Patients Undergoing Chemotherapy

Abstract

Purpose. Epoetin alfa administered s.c. three times weekly or once weekly increases hemoglobin (Hb) levels, decreases transfusion requirements, and improves quality of life in anemic cancer patients receiving chemotherapy. This study assessed the feasibility of using higher initial doses of once-weekly epoetin alfa followed by less frequent maintenance doses to increase and then maintain adequate Hb levels in this population. Materials and Methods.In this open-label, nonrandomized, pilot study, anemic (baseline Hb ≤11 g/dl) cancer patients undergoing chemotherapy received initial doses of epoetin alfa of 60,000 U s.c. once weekly to increase Hb levels by at least 2 g/dl, followed by 120,000 U s.c. every 3 weeks to maintain Hb levels. The maximum treatment duration was 24 weeks.Results. The mean baseline Hb level was 10.1 ± 0.8 g/dl (n = 20). Once-weekly dosing resulted in mean Hb level increases of 1.0 ± 1.1 g/dl by week 4 and 2.9 ± 1.9 g/dl by week 8; 86% and 79% of patients evaluable at week 8 and week 12, respectively, demonstrated increases of at least 2 g/dl (target Hb level of ≥12 g/dl). Thirteen patients (65%) received at least one maintenance dose; the mean Hb level increased from 12.8 ± 1.1 g/dl before starting maintenance therapy to 13.3 ± 1.4 g/dl at the last maintenance week. Both dosage regimens were well tolerated. TheOncologist ® LEARNING OBJECTIVESAfter completing this course, the reader will be able to:1. List the recommendations in current clinical practice guidelines on epoetin alfa dosing and administration regimens for patients with cancer and chemotherapy-related anemia.2. Discuss the benefits associated with epoetin alfa therapy in cancer patients with anemia receiving chemotherapy, in terms of increased hemoglobin levels, lower transfusion needs, and improved quality of life.3. Explain how higher initial doses of once-weekly epoetin alfa followed by less frequent maintenance dosing with epoetin alfa in anemic cancer patients undergoing chemotherapy may be beneficial, both to the patient and to the health care provider.Access and take the CME test online and receive one hour of AMA PRA category 1 credit at CME.TheOncologist.com CME CME Patton, Kuzur, Liggett et al. 91 Conclusions. Once-weekly epoetin alfa at a dose of 60,000 U effectively increased Hb levels by week 8; 86% of patients achieved rises of at least 2 g/dl or Hb levels ≥12 g/dl. Moreover, epoetin alfa at doses of 120,000 U every 3 weeks maintained or increased Hb levels. Results from this pilot study suggest that higher initial once-weekly dosing of epoetin alfa followed by less frequent maintenance dosing appears to be feasible for treating anemia in cancer patients undergoing chemotherapy. Further evaluation of these and other epoetin alfa dosage regimens is warranted. The Oncologist 2004;9:90-96

The Evolving Role of Epoetin Alfa in Cancer Therapy

“…In one of those studies, patients whose Hb levels increased by ≥2 g/dl were placed on a maintenance dosing schedule of 120,000 U every 3 weeks. Little change in mean Hb level was observed from the end of initial therapy through the maintenance period, suggesting the benefit of higher initial qw epoetin alfa doses and less frequent dosing during maintenance [38].…”

“…More recently, alternative dosing regimens have been investigated that may be as effective as currently utilized regimens at increasing Hb levels, decreasing transfusion needs, and improving QOL, while providing greater flexibility and convenience to patients and physicians [38,39]. In two pilot studies of patients with chemotherapy-related anemia (Hb level ≤11 g/dl), an initial epoetin alfa dose of 60,000 U qw increased Hb levels by ≥2.6 g/dl from baseline at 8 weeks [38,39]. In one of those studies, patients whose Hb levels increased by ≥2 g/dl were placed on a maintenance dosing schedule of 120,000 U every 3 weeks.…”

rHuEPO and Treatment Outcomes: the Clinical Experience

“…Patton et al [39], in an open-label, nonrandomized pilot study, evaluated the efficacy of epoetin alfa at a dose of 60,000 IU once weekly followed by a maintenance dose of 120,000 IU every 3 weeks. Study participants were 20 anemic cancer patients with nonmyeloid malignancies who were undergoing chemotherapy.…”

Anemia in Patients With Cancer or Undergoing Cancer Therapy: Impact and Current Treatment Practice

“…52 Other benefits of epoetin alfa that are under current investigation include: treatment of anemia in patients not undergoing cancer therapy; neuroprotective effects during chemotherapy; and novel dosing strategies that could improve overall response rates and time to response. [30][31][32][33][53][54][55][56] Results of studies in these areas are reported later in this article. Epoetin beta.…”

“…A proof-of-concept study was conducted in 20 anemic (Hb ≤ 11 g/dL; mean baseline Hb, 10.1 g/dL) patients with nonmyeloid malignancies receiving chemotherapy. 56 week study evaluated a 60,000 U QW initial dose of epoetin alfa SC followed by a 120,000 U every-3-week (Q3W) dose in patients whose Hb increased ≥ 2 g/dL from baseline after at least 8 weeks of QW dosing. Mean Hb increased 1.0 ± 1.1 g/dL after 4 weeks and 2.9 ± 1.9 g/dL after 8 weeks to 13.0 g/dL.…”