306
Views
21
CrossRef citations to date
0
Altmetric
Original Article

Randomized, double-blind, placebo-controlled trial of every-3-week darbepoetin alfa 300 micrograms for treatment of chemotherapy-induced anemia

, , , , , , & show all
Pages 2109-2120 | Accepted 02 Jun 2009, Published online: 14 Jul 2009

References

  • Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst 1999;91:1616-34
  • Littlewood TJ, Bajetta E, Nortier JW, et al. 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 2001;19:2865-74
  • 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
  • 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
  • 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
  • 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
  • Glaspy JA, Tchekmedyian NS. Darbepoetin alfa administered every 2 weeks alleviates anemia in cancer patients receiving chemotherapy. Oncology (Williston Park) 2002;16:23-9
  • 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
  • Vadhan-Raj S, Mirtsching B, Charu V, et al. Assessment of hematologic effects and fatigue in cancer patients with chemotherapy-induced anemia given darbepoetin alfa every two weeks. J Support Oncol 2003;1:131-8
  • Canon J-L, 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
  • 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
  • Amgen Inc. Aranesp (Darbepoetin alfa) Package Insert. Thousand Oaks, California, April 2009
  • 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 Cancer 2007;43:258-70
  • Rizzo JD, Somerfield MR, Hagerty KL, et al. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. J Clin Oncol 2008;26:132-49
  • Rodgers GM, Becker PS, Bennett CL, et al. NCCN Practice Guidelines in Oncology: Cancer and chemotherapy-induced anemia. National Comprehensive Cancer Network, 2008
  • Boccia R, Malik IA, Raja V, et al. Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia. Oncologist 2006;11:409-17
  • Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). National Cancer Institute, United States Department of Health and Human Services, 2003
  • Rodgers GM, ed. Guidelines for supportive care: Cancer and treatment-related anemia. v.2.2004 edn: National Comprehensive Cancer Network. Available at: http://www.nccn.org/physician_gls/index.html. Accessed: March 24, 2005
  • 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
  • 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
  • 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
  • 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
  • Gabrilove JL, Cleeland CS, Livingston RB, et al. 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. J Clin Oncol 2001;19:2875-82
  • Acs G, Xu X, Chu C, et al. Prognostic significance of erythropoietin expression in human endometrial carcinoma. Cancer 2004;100:2376-86
  • Arcasoy MO, Amin K, Chou SC, et al. Erythropoietin and erythropoietin receptor expression in head and neck cancer: relationship to tumor hypoxia. Clin Cancer Res 2005;11:20-7
  • Arcasoy MO, Amin K, Vollmer RT, et al. Erythropoietin and erythropoietin receptor expression in human prostate cancer. Mod Pathol 2005;18:421-30
  • Dagnon K, Pacary E, Commo F, et al. Expression of erythropoietin and erythropoietin receptor in non-small cell lung carcinomas. Clin Cancer Res 2005;11:993-9
  • Amgen Inc. Amgen Announces Interim Results of Aranesp “PREPARE” Study in Breast Cancer Patients. 2007 [cited 2007 November 30]; Available from: http://www.immunex.com/media/media_pr_detail.jsp?year=2007&releaseID=1083091
  • 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
  • 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. [see comment]. Lancet 2003;362:1255-60
  • 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. [see comment]. J Clin Oncol 2005;23:5960-72
  • Overgaard J, Hoff C, Sand Hansen H, et al. Randomized study of the importance of Novel Erythropoiesis Stimulating Protein (Aranesp) for the effect of radiotherapy in patients with primary squamous cell carcinoma of the head and neck (HNSCC) – the Danish Head and Neck Cancer Group (DAHANCA 10). Eur J Cancer 2007;5:7 (Abstract)
  • Smith RE Jr, Aapro MS, Ludwig H, et al. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. [see comment]. J Clin Oncol 2008;26:1040-50
  • Thomas G, Ali S, Hoebers FJ, et al. Phase III trial to evaluate the efficacy of maintaining hemoglobin levels above 12.0 g/dL with erythropoietin vs above 10.0 g/dL without erythropoietin in anemic patients receiving concurrent radiation and cisplatin for cervical cancer. Gynecol Oncol 2008;108:317-25
  • Wright JR, Ung YC, Julian JA, et al. Randomized, double-blind, placebo-controlled trial of erythropoietin in non-small-cell lung cancer with disease-related anemia.[see comment]. J Clin Oncol 2007;25:1027-32
  • U.S. Department of Health and Human Services US FDA. Summary Minutes of the Oncologic Drugs Advisory Committee. 2008 March 13, 2008 [cited May 5, 2008]; Available from: http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4345m2.doc
  • 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

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.