Statistical analyses were conducted using the intent-to-treat analysis set (ie, all patients randomized to study drug who received at least one dose) with the last observation carried forward approach used to impute missing values. Use in Cancer. More About Darbepoetin Alfa. Epoetin alfa use has been shown to improve cancer-associated anemia and the patient’s subsequent quality of life, yet some significant limitations do exist. A dose increase to 5.0 µg/kg of darbepoetin alfa administered every 2 weeks may be appropriate in patients with an inadequate initial response. 2003;63(11):1067-74; discussion 1075-7 This was an open-label, randomized. SeminHematol 37(4 suppl 6):14-17, 2000. The data presented here were obtained from a phase I/II, multicenter, randomized, active-controlled, open-label study in anemic patients with solid tumors who were receiving multicycle chemotherapy. 12. Doses in excess of 4.5 µg/kg did not appear to confer any increase in efficacy. With respect to red blood cell transfusions, the epoetin alfa group had an observed higher incidence of transfusions from week 5 to the end of treatment than either the 3.0- or 5.0-µg/kg groups; however, as the sample size is small, meaningful conclusions with respect to treatment differences for this end point cannot be drawn. Kellokumpu-Lehtinen PL, Puistola U, Paija O, Taimela E, Hirvonen O, Raassina S, Riska H. Support Care Cancer. The high number of sialic acid moieties in darbepoetin alfa results in a prolonged half-life and enhanced in vivo biological activity compared with rHuEPO (as demonstrated in animal studies) and permits a reduction in the frequency of administration. Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. In randomised, controlled clinical trials, the drug increased haemoglobin levels and reduced the need for blood transfusions in patients with various types of nonmyeloid malignancies and also ameliorated anaemia-related fatigue, thereby improving their health-related quality of life (HR-QOL) scores. Anemia is a significant complication of cancer and of the myelosuppressive chemotherapy used to treat cancer patients. Amgen will not sell, rent, or otherwise distribute your information outside of Amgen and related third parties. The prolonged half-life has been confirmed in patients with chronic renal failure and in cancer patients undergoing multiple cycles of chemotherapy. J Am Soc Nephrol 10:2392-2395, 1999. All rights reserved. Background: Anaemia associated with cancer and cancer therapy is an important clinical factor in the treatment of malignant diseases. The limitations of this study include the relatively small sample size and its open-label design.

13. However, descriptive comparisons can be made between the two groups. In contrast to epoetin alfa, the added patient benefit of less-frequent dosing does not require an increase in the overall dose and thus does not come at an added economic cost over more frequent administration. USA.gov. The mean change in hemoglobin and the incidence of transfusions were similar for the 1.5-µg/kg darbepoetin alfa dose group and the epoetin alfa group, with additional benefit observed at higher doses (Table 1). Study Design-Anemic patients with solid tumors who were receiving multicycle chemotherapy. The percentage of patients achieving a hemoglobin response (³ 2.0 g/dL increase in hemoglobin from baseline) ranged from 23% (95% confidence interval [CI] = 0%-46%) for the 0.5-µg/kg group to 76% (95% CI = 59%-94%) for the 4.5-µg/kg group over the 12-week treatment period. [1] Anemia is associated with many symptoms, including weakness, dyspnea, lethargy, and fatigue.

Curt GA: Impact of fatigue on quality of life in oncology patients. An increase to 5.0 µg/kg every 2 weeks may be appropriate in patients with an inadequate initial response to darbepoetin alfa at 3.0 mg/kg every 2 weeks.

*Prior to treatment, inform patients of the risks and benefits of Aranesp®. The etiology of cancer-associated anemia is multifactorial. J Clin Oncol. Anaemia: a rare but neglected problem among Finnish patients receiving chemotherapy for solid tumours. 2. Patients were randomized to receive 12 weeks of subcutaneous therapy with darbepoetin alfa or epoetin alfa. All patients who received at least one dose of study drug were included in the safety analysis. 1. Cheung W, Minton N, Gunawardena K: Pharmacokinetics and pharmacodynamicsof epoetin alfa once weekly and three times weekly. Egrie JC, Dwyer E, Lykos M, et al: Novel erythropoiesis stimulatingprotein (NESP) has longer serum half-life and greater in vivo biologicalactivity than recombinant human erythropoietin (rHuEPO). 3. Acknowledgment:Kathleen Raftery, MD, assisted in writing the manuscript. In general, however, 1.5-µg/kg darbepoetin alfa weekly appeared to have a similar effect on hemoglobin variables compared with the epoetin alfa control arm up to week 8. Subcutaneous darbepoetin alfa 2.25 microg/kg once weekly or 500 microg once every 3 weeks (with a provision for dose adjustments) is an effective and well tolerated erythropoietic agent in anaemic patients with cancer receiving chemotherapy. Clin Cancer Res 4(4):929-934, 1998. J Clin Oncol 19:2865-2874, 2001. The lowest clinically effective doses of darbepoetin alfa in this study were 3.0 and 5.0 µg/kg every 2 weeks, with no additional benefit observed at higher doses. A total of 128 patients received one of the every-2-week darbepoetin alfa doses and 32 patients received epoetin alfa. Finally, as this study permitted a dose escalation in the epoetin alfa group at week 6, direct comparisons between the darbepoetin alfa and epoetin alfa groups are somewhat confounded. In general, baseline demography and clinical characteristics were similar between the darbepoetin alfa dose groups, although the 7.0-µg/kg group had a slightly lower baseline hemoglobin concentration, and had a lower proportion of subjects with a baseline hemoglobin above 10 g/dL (25% vs at least 44% for the other three dose groups). Methods Metastatic, solid tumor cancer patients receiving concomitant myelosuppressive chemotherapy and darbepoetin alfa with an associated hemoglobin <10 g/dL during 2011-2015 were identified. Patients also were required to be anemic (hemoglobin ≤ 11.0 g/dL), to have adequate serum folate and vitamin B12 concentrations, a life expectancy of at least 6 months, an Eastern Cooperative Oncology Group performance status of 0 to 2, and adequate renal and liver function. In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. Limitations of treatment with epoetin alfa include ambiguity about the optimal dose and schedule due to lack of published systematic dose-finding studies, and a lack of pharmacokinetic data in the cancer setting. Consequently, comparisons with darbepoetin alfa after this time point are confounded. Discontinuation of study drug treatment was due primarily to death, disease progression, or changes in chemotherapy unrelated to study drug. -. 4. The prolonged half-life of darbepoetin alfa permits less frequent administration compared with epoetin alfa. The open-label nature of the study could, however, have caused some potential bias in adverse event reporting. As a substitute for RBC transfusions in patients who require immediate correction of anemia. Contributing factors to cancer-associated anemia include decreased endogenous erythropoietin levels, erythropoietin resistance, and decreased red blood cell survival. However, the results reported here support the conclusion that all darbepoetin alfa doses were clinically effective, and that some increase in response was observed as the dose increased from 3.0 to 5.0 µg/kg, above which a plateau effect was noted. Therefore, the 3.0- and 5.0-µg/kg every-2-week doses were identified as the lowest clincally effective doses for darbepoetin alfa. © 2018 Amgen Inc. All rights reserved. [5-7] For example, epoetin alfa has a short half-life and must be administered weekly or more often, requiring the patient to make frequent trips to the doctor and to receive multiple injections. For patients you determine to be appropriate candidates for erythropoiesis-stimulating agent (ESA) therapy, when hemoglobin (Hb) < 10 g/dL and, upon initiation, there is a minimum of two additional months of planned chemotherapy1,*. BioDrugs. Adverse events occurred at a similar frequency within the weekly darbepoetin alfa, every-2-week darbepoetin alfa, and epoetin alfa groups in both parts of the study.

Although darbepoetin alfa stimulates erythropoiesis in the same manner as epoetin alfa, it is a glycoprotein that is biochemically distinct from epoetin alfa. The efficacy end points evaluated included hemoglobin response (³ 2.0 g/dL increase in hemoglobin over baseline in the absence of a red blood cell transfusion in the past 28 days), hemoglobin correction (hemoglobin ³ 12 g/dL in the absence of any red blood cell transfusion in the past 28 days), and hematopoietic response (hemoglobin value > 12.0 g/dL or a ³ 2.0-g/dL increase in hemoglobin over baseline in the absence of a red blood cell transfusion in the past 28 days) as defined in previous studies with epoetin alfa,[5,6] and mean change in hemoglobin from baseline. The percentage of patients who achieved a hematopoietic response in the 3.0- and 5.0-µg/kg groups was 66% (95% confidence interval [CI] = 46%-86%) and 84% (95% CI = 67%-100%), respectively, compared with 63% (95% CI = 46%-81%) in the epoetin alfa group.

7. Miller CB, Jones RJ, Piantadosi S, et al: Decreased erythropoietinresponse in patients with anemia of cancer. HHS Get the latest research from NIH: https://www.nih.gov/coronavirus. -, Eur J Haematol.  | 

The rates of serious adverse events and adverse events of grade 3 or greater were similar in patients receiving darbepoetin alfa and in those receiving epoetin alfa, and were generally expected and consistent with known complications of cancer and cytotoxic chemotherapy.