A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer

British Journal of Cancer

Volumn 88, Issue 12, 2003, Pages 1851-1858

  Smith Jr , R E ^a   Tchekmedyian, N S ^b   Chan, D ^c   Meza, L A ^d   Northfelt, D W ^e   Patel, R ^f   Austin, M ^g   Colowick, A B ^g   Rossi, G ^g   Glaspy, J ^c  

^a South Carolina Oncology Associates   (United States)

^b Pacific Shores Medical Group   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Southwest Oncology Associates   (United States)

^e MAYO CLINIC   (United States)

^f Compreh Blood and Cancer Center ^*  (United States)

^g AMGEN INC   (United States)

Author keywords

Anaemia; Chronic disease; Darbepoetin alpha; Erythropoietin

Indexed keywords

ANTINEOPLASTIC AGENT; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PLACEBO;

ADULT; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER; CANCER CHEMOTHERAPY; CARDIOVASCULAR DISEASE; CAREGIVER; CHRONIC DISEASE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; FATIGUE; FEMALE; HEMOLYSIS; HUMAN; IRON BLOOD LEVEL; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR;

AGED; ANEMIA; CHRONIC DISEASE; DRUG ADMINISTRATION SCHEDULE; ERYTHROPOIETIN; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; TREATMENT OUTCOME;

EID: 0037561012     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6600994     Document Type: Article

References (33)

1. Abels RI (1992) Use of recombinant human erythropoietin in the treatment of anemia in patients who have cancer. Semin Oncol 19: 29-35
2. Abels RI, Larholt KM, Krantz KD, Bryant EC (1991) Recombinant human erythropoietin (rHuEPO) for the treatment of the anemia of cancer, In Blood Cell Growth Factors: Their Present and Future Use in Hematology and Oncology. Proceedings of the Beijing Symposium., Murphy Jr MJ (ed.), pp 121-142. Dayton, OH, USA: alphaMed Press
3. Cartwright GE (1966) The anemia of chronic disorders. Semin Hematol 3: 351-375
4. Cella D (1997a) 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 34: 13-19
5. Celia D (1997b) Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Scales, Version 4. Evanston, IL Center on Outcomes, Research and Education, Evanston Northwestern Healthcare and Northwestern University
6. Curt GA (2000) Impact of fatigue on quality of life in oncology patients. Semin Hematol 37: 14-17
7. Dammacco F, Castoldi G, Rödjer S (2001) Efficacy of epoetin alpha in the treatment of anaemia of multiple myeloma. Br J Haematol 113: 172-179
8. Demetri GD, Kris M, Wade J, Degos L, Celia D, for the Procrit Study Group (1998) Quality-of-life benefit in chemotherapy patients treated with epoetin alpha is independent of disease response or tumor type: results from a prospective community oncology study. J Clin Oncol 16: 3412-3425
9. Egrie J, Browne J (2001) Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer 84(Supp 1): 3-10
10. Egrie JC, Grant JR, Gillies DK, Aoki KH, Strickland TW (1993) The role of carbohydrate on the biological activity of erythropoietin. Glycoconjugate J 10: 263
11. Foley RN, Parfrey PS, Harnett JD, Kent GM, Murray DC, Barre PE (1996) The impact of anemia on cardiomyopathy, morbidity, and and mortality in end-stage renal disease. Am J Kidney Dis 28: 53-61
12. Gabrilove JL, Cleeland CS, Livingston RB et al (2001) Clinical evaluation of once-weekly dosing of epoetin alpha in chemotherapy patients: improvements in hemoglobin and quality of life are similar to three-times-weekly dosing. J Clin Oncol 19: 2875-2882
13. Glaspy J, Bukowski R, Steinberg D, Taylor C, Tcheckmedyian S, Vadhan-Raj S (1997) Impact of therapy with epoetin alpha on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol 15: 1218-1234
14. Glaspy JA, Jadeja JS, Justice G, Kessler J, Richards D, Schwartzberg L, Tcheckmedyian NS, Armstrong S, O'Byrne J, Rossi G, Colowick AB (2002) Darbepoetin alpha given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br J Cancer 87: 268-276
15. Hayashi T, Suzuki A, Shoji T, Togawa M, Okada N, Tsubakihara Y, Imai E, Hori M (2000) Cardiovascular effect of normalizing the hematocrit level during erythropoietin therapy in predialysis patients with chronic renal failure. Am J Kidney Dis 35: 250-256
16. Hedenus M, Hansen S, Taylor K, Arthur C, Emmerich B, Dewey C, Watson D, Rossi G, Österborg A (2002) Randomized, dose-finding study of darbepoetin alfa in anemic patients with lymphoproliferative malignancies. Br J Haematol 119: 79-86
17. Jelkmann W (1988) Proinflammatory cytokines lowering erythropoietin production. J Interferon Cytokine Res 18: 555-559
18. Kalbfleisch JD, Prentice RL (1980) The statistical analysis of failure time data. New York: Wiley, pp 1-316
19. Koeller JM (1998) Clinical guidelines for the treatment of cancer-related anemia. Pharmacotherapy 18: 156-169
20. Kotasek D, Albertsson M, Mackey J, Darbepoetin alpha 980291 Study Group, Berg R, Robinson J, Colowick A (2002) Randomized, double-blind, placebo-controlled, dose-finding study of darbepoetin alpha administered once every 3 (Q3W) or 4 (Q4W) weeks in patients with solid tumors. Proc ASCO 21: 356a
21. Lee GR (1983) The anemia of chronic disease. Semin Hematol 20: 61-80
22. Littlewood TJ, Bajetta E, Nortier JWR, Vercammen E, Rapoport B, the Epoetin alpha Study Group (2001) Effects of epoetin alpha 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
23. Macdougall IC (2000) Higher target hemoglobin level and early anemia treatment: Different or complementary concepts? Nephrol Dial Transplant 15(Suppl 3): 3-7
24. Macdougall IC, Gray SJ, Elston O, Breen C, Jenkins B, Browne J, Egrie J (1999) Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alpha in dialysis patients. J Am Soc Nephrol 10: 2392-2395
25. Means Jr RT, Kranz SB (1992) Progress in understanding the pathogenesis of the anemia of chronic disease. Blood 80: 1639-1647
26. Miller CB, Jones RJ, Piantadosi S, Abeloff MD, Spivak JL (1990) Decreased erythropoietin response in patients with the anemia of cancer. N Engl J Med 322: 1689-1692
27. Moliterno AR, Spivak JL (1996) Anemia of cancer. Hematol Oncol Clin North Am 10: 345-363
28. NKF Anemia Work Group (1997) NKF-DOQI clinical practice guidelines for the treatment of anemia of chronic renal failure. Am J Kidney Dis 30(Supp 3): S192-S237
29. Nowrousian MR (1998) Recombinant human erythropoietin in the treatment of cancer-related or chemotherapy-induced anemia in patients with solid tumours. Med Oncol 15(Supp 1): S19-S28
30. Obrador GT, Ruthazer R, Arora P, Kausz AT, Pereira BJ (1999) Prevalence of and factors associated with suboptimal care before initiation of dialysis in the United States. J Am Soc Nephrol 10: 1793-1800
31. Ozguroglu M, Arun B, Demir G, Demirelli F, Mandel NM, Buyukunal E, Serdengecti S, Berkarda B (2000) Serum erythropoietin level in anemic cancer patients. Med Oncol 17: 29-34
32. Quirt I, Robeson C, Lau CY, Kovacs M, Burdette-Radoux S, Dolan S, Tang SC, McKenzie M, Couture F (2001) Epoetin alpha therapy increases hemoglobin levels and improves quality of life in patients with cancer-related anemia who are not receiving chemotherapy and patients with anemia who are receiving chemotherapy. J Clin Oncol 19: 4126-4134
33. Vogelzang NJ, Breithart W, Celia D, Curt GA, Groopman JE, Horning SJ, Itri LM, Johnson DH, Scherr SL, Portenoy RK, Coalition TF (1997) Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. Semin Hematol 34: 4-12