A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating chemotherapy-induced anemia

References

• Cella D, Dobrez D, Glaspy J. Control of cancer-related anemia with erythropoietic agents: a review of evidence for improved quality of life and clinical outcomes. Ann Oncol 2003;14:511–19
   Google Scholar
• Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst 1999;91:1616–34
   PubMed Web of Science ®Google Scholar
• Herrington JD, Davidson SL, Tomita DK, et al. Utilization of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia. Am J Health Syst Pharm 2005;62:54–62
   PubMed Web of Science ®Google Scholar
• Schwartzberg LS, Yee LK, Senecal FM, et al. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist 2004;9:696–707
   PubMed Web of Science ®Google Scholar
• Cheer SM, Wagstaff AJ. Epoetin Beta: a review of its clinical use in the treatment of anaemia in patients with cancer. Drugs 2004;64:323–46
   PubMed Web of Science ®Google Scholar
• Hedenus M, Adriansson M, San Miguel J, et al. Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br J Haematol 2003;122:394–403
   PubMed Web of Science ®Google Scholar
• Vansteenkiste J, Pirker R, Massuti B, et al. Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J Natl Cancer Inst 2002;94:1211–20
   PubMed Web of Science ®Google Scholar
• Glaspy J, Vadhan-Raj S, Patel R, et al. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol 2006;24:2290–7
   PubMed Web of Science ®Google Scholar
• Bohlius J, Wilson J, Seidenfeld J, et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 2006;98:708–14
   PubMed Web of Science ®Google Scholar
• Bokemeyer C, Aapro MS, Courdi A, et al. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer 2004;40:2201–16
   PubMed Web of Science ®Google Scholar
• Rizzo JD, Lichtin AE, Woolf SH, et al. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. Blood 2002;100:2303–20
   PubMed Web of Science ®Google Scholar
• Rodgers GM, Cella D, Chanan-Khan A, et al. Clinical practice guidelines in oncology: cancer- and treatment-related anemia. v.2.2006 ed: National Comprehensive Cancer Network. http://www.nccn.org. Accessed August 23, 2006.
   Google Scholar
• Amgen Inc. Aranesp® (Darbepoetin alfa) Package Insert. Thousand Oaks, CA; 2006.
   Google Scholar
• Canon JL, Vansteenkiste J, Bodoky G, et al. Randomized, double-blind, active-controlled trial of every-3-week darbepoetin alfa for the treatment of chemotherapy-induced anemia. J Natl Cancer Inst 2006;98:273–84
   PubMed Web of Science ®Google Scholar
• Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer 2001;84 Suppl 1:3–10
   PubMed Web of Science ®Google Scholar
• Egrie JC, Dwyer E, Browne JK, et al. Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp Hematol 2003;31:290–9
   PubMed Web of Science ®Google Scholar
• Hedenus M, Hansen S, Taylor K, et al. Randomized, dose-finding study of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies. Br J Haematol 2002;119:79–86
   PubMed Web of Science ®Google Scholar
• Kotasek D, Steger G, Faught W, et al. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer 2003;39:2026–34
   PubMed Web of Science ®Google Scholar
• Glaspy JA, Jadeja JS, Justice G, et al. Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br J Cancer 2002;87:268–76
   PubMed Web of Science ®Google Scholar
• Glaspy JA, Jadeja JS, Justice G, et al. A randomized, active-control, pilot trial of front-loaded dosing regimens of darbepoetin-alfa for the treatment of patients with anemia during chemo-therapy for malignant disease. Cancer 2003;97:1312–20
   PubMed Web of Science ®Google Scholar
• Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol 1997;34:13–19
   Web of Science ®Google Scholar
• Medical Dictionary for Regulatory Activities Terminology (MedDRA). Version 6.1, October 2003. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA/MSSO resources page. Available at: http://www. meddramsso.com/MSSOWeb/index.htm. Accessed March 3, 2007
   Google Scholar
• Cella D, Eton DT, Lai JS, et al. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 2002;24:547–61
   PubMed Web of Science ®Google Scholar
• Hesketh PJ, Arena F, Patel D, et al. A randomized controlled trial of darbepoetin alfa administered as a fixed or weight-based dose using a front-loading schedule in patients with anemia who have nonmyeloid malignancies. Cancer 2004;100:859–68
   PubMed Web of Science ®Google Scholar
• Justice G, Kessler JF, Jadeja J, et al. A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia. Ann Oncol 2005;16:1192–8
   PubMed Web of Science ®Google Scholar
• Amgen (Europe). Aranesp® (Darbepoetin alfa) Package Insert. Lucerne, Switzerland; 2004.
   Google Scholar
• Glaspy J, Henry D, Patel R, et al. Effects of chemotherapy on endogenous erythropoietin levels and the pharmacokinetics and erythropoietic response of darbepoetin alfa: a randomised clinical trial of synchronous versus asynchronous dosing of darbepoetin alfa. Eur J Cancer 2005;41:1140–9
   PubMed Web of Science ®Google Scholar
• Altman DG, Schulz KF, Moher D, et al. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 2001;134:663–94
   PubMed Web of Science ®Google Scholar