Darbepoetin alfa for chemotherapy-induced anemia: evolution to extended dosing intervals

References

• Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J. Natl Cancer Inst.91, 1616–1634 (1999).
   PubMed Web of Science ®Google Scholar
• Weiss G, Goodnough LT. Anemia of chronic disease. N. Engl. J. Med.352, 1011–1023 (2005).
   PubMed Web of Science ®Google Scholar
• Ludwig H, Van Belle S, Barrett-Lee P et al. The European Cancer Anaemia Survey (ECAS): a large, multinational, prospective survey defining the prevalence, incidence, and treatment of anaemia in cancer patients. Eur. J. Cancer40, 2293–2306 (2004).
   PubMed Web of Science ®Google Scholar
• Cascinu S, Fedeli A, Del Ferro E, Luzi Fedeli S, Catalano G. Recombinant human erythropoietin treatment in cisplatin-associated anemia: a randomized, double-blind trial with placebo. J. Clin. Oncol.12, 1058–1062 (1994).
   PubMed Web of Science ®Google Scholar
• Osterborg A, Brandberg Y, Molostova V et al. Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin beta, in hematologic malignancies. J. Clin. Oncol.20, 2486–2494 (2002).
   PubMed Web of Science ®Google Scholar
• Elliott S, Lorenzini T, Asher S et al. Enhancement of therapeutic protein in vivo activities through glycoengineering. Nat. Biotechnol.21, 414–421 (2003).
   PubMed Web of Science ®Google Scholar
• Egrie JC, Dwyer E, Browne JK, Hitz A, Lykos MA. Darbepoetin alfa has a longer circulating half-life and greater in vivo potency than recombinant human erythropoietin. Exp. Hematol.31, 290–299 (2003).
   PubMed Web of Science ®Google Scholar
• Heatherington AC, Schuller J, Mercer AJ. Pharmacokinetics of novel erythropoiesis stimulating protein (NESP) in cancer patients: preliminary report. Br. J. Cancer84(Suppl. 1), 11–16 (2001).
   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. Cancer100, 859–868 (2004).
   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.94, 1211–1220 (2002).
   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.122, 394–403 (2003).
   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. Cancer39, 2026–2034 (2003).
   PubMed Web of Science ®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.98, 273–284 (2006).
   PubMed Web of Science ®Google Scholar
• Henke M, Laszig R, Rube C et al. Erythropoietin to treat head and neck cancer patients with anaemia undergoing radiotherapy: randomised, double-blind, placebo-controlled trial. Lancet362, 1255–1260 (2003).
   Google Scholar
• Leyland-Jones B, Semiglazov V, Pawlicki M et al. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J. Clin. Oncol.23, 5960–5972 (2005).
   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.16, 1192–1198 (2005).
   PubMed Web of Science ®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. Cancer41, 1140–1149 (2005).
   PubMed Web of Science ®Google Scholar
• Auerbach M, Ballard H, Trout JR et al. Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial. J. Clin. Oncol.22, 1301–1307 (2004).
   PubMed Web of Science ®Google Scholar
• Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist12, 231–242 (2007).
   PubMed Web of Science ®Google Scholar
• Vandebroek A, Gaede B, Altintas S et al. A randomized open-label study of darbepoetin alfa administered every 3 weeks with or without parenteral iron in anemic subjects with nonmyeloid malignancies receiving chemotherapy. J. Clin. Oncol.24(Suppl.) 496S (2006) (Abstract).
   Google Scholar
• Bohlius J, Langensiepen S, Schwarzer G et al. Recombinant human erythropoietin and overall survival in cancer patients: results of a comprehensive meta-analysis. J. Natl Cancer Inst.97, 489–498 (2005).
   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.98, 708–714 (2006).
   PubMed Web of Science ®Google Scholar
• Littlewood TJ, Bajetta E, Nortier JW, Vercammen E, Rapoport B. Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: results of a randomized, double-blind, placebo-controlled trial. J. Clin. Oncol.19, 2865–2874 (2001).
   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: 2006 update. Eur. J. Cancer43, 258–270 (2007).
   PubMed Web of Science ®Google Scholar
• Hedenus M, Canon JL, Kotasek D et al. Effects of dose adjustment rules on safety during erythropoietic therapy: a retrospective analysis of darbepoetin alfa administered either every 3 weeks or weekly. Blood106, P3376 (2005) (Abstract).
   Web of Science ®Google Scholar
• Steensma DP, Loprinzi CL. Erythropoietin use in cancer patients: a matter of life and death? J. Clin. Oncol.23(25), 5865–5868 (2005).
   PubMed Web of Science ®Google Scholar
• Haddad R, Posner M. Erythropoietin to treat anaemia in patients with head and neck cancer. Lancet363, 79–80 (2004).
   PubMed Web of Science ®Google Scholar
• Freemantle N, Yao B, Calvert M, Lillie T. Impact of darbepoetin alfa on transfusion, haemoglobin response, and survival in cancer patients with chemotherapy-induced anaemia: results of a meta-analysis of randomised, placebo-controlled trials. Blood106, A871, (2005) (Abstract 3116).
   Google Scholar
• Ross SD, Fahrbach K, Frame D et al. The effect of anemia treatment on selected health-related quality-of-life domains: a systematic review. Clin. Ther.25, 1786–1805 (2003).
   PubMed Web of Science ®Google Scholar
• Hedenus M, Vansteenkiste J, Kotasek D, Austin M, Amado RG. Darbepoetin alfa for the treatment of chemotherapy-induced anemia: disease progression and survival analysis from 4 randomized, double-blind, placebo-controlled trials. J. Clin. Oncol.23, 6941–6948 (2005).
   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.119, 79–86 (2002).
   PubMed Web of Science ®Google Scholar