Assessing the clinical benefits of erythropoietic agents using area under the hemoglobin change curve

Oncologist

Volumn 10, Issue 6, 2005, Pages 438-448

  Duh, Mei Sheng ^a   Lefebvre, Patrick ^b   Fastenau, John ^c   Piech, Catherine Tak ^c   Waltzman, Roger J ^d  

^a ANALYSIS GROUP   (United States)

^b GROUPE D ANALYSE   (Canada)

^c Ortho Biotech Products LP   (United States)

^d ST VINCENT S COMPREHENSIVE CANCER CENTER   (United States)

Author keywords

Anemia; Area under the curve; Chemotherapy induced anemia; Erythropoietin

Indexed keywords

ANTINEOPLASTIC AGENT; CISPLATIN; HEMOGLOBIN; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; PLATINUM DERIVATIVE; RECOMBINANT ERYTHROPOIETIN;

ANEMIA; AREA UNDER THE CURVE; AREA UNDER THE HEMOGLOBIN CHANGE CURVE; ARTICLE; BLOOD TRANSFUSION; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; CONFIDENCE INTERVAL; DIGESTIVE SYSTEM CANCER; GYNECOLOGIC CANCER; HEMATOPOIESIS; HODGKIN DISEASE; HUMAN; LUNG CANCER; MAJOR CLINICAL STUDY; MULTIPLE MYELOMA; NONHODGKIN LYMPHOMA; OPEN STUDY; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; RECEIVER OPERATING CHARACTERISTIC; RELIABILITY; STATISTICAL ANALYSIS; TREATMENT OUTCOME; UROGENITAL TRACT CANCER;

ANEMIA; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CLINICAL TRIALS, PHASE III; EPOETIN ALFA; FEMALE; HEMATINICS; HEMOGLOBINS; HUMANS; MALE; REPRODUCIBILITY OF RESULTS; RISK FACTORS; TIME FACTORS;

EID: 22244491033     PISSN: 10837159     EISSN: None     Source Type: Journal    
DOI: 10.1634/theoncologist.10-6-438     Document Type: Article

References (57)

1. Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst 1999;91:1616-1634.
2. Sobrero A, Puglisi F, Guglielmi A et al. Fatigue: a main component of anemia symptomatology. Semin Oncol 2001;28(suppl 8):15-18.
3. Schwartz AL. Daily fatigue patterns and effect of exercise in women with breast cancer. Cancer Pract 2000;8:16-24.
4. Visovsky C, Schneider SM. Cancer-related fatigue. J Issues Nurs 2003;8:1-23.
5. Cella D, Zagari MJ, Vandoros C et al. Epoetin alfa treatment results in clinically significant improvements in quality of life in anemic cancer patients when referenced to the general population. J Clin Oncol 2003;21:366-373.
6. Glaspy J, Bukowski R, Steinberg D et al. Impact of therapy with epoetin alfa on clinical outcomes in patients with non-myeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol 1997;15:1218-1234.
7. Demetri GD, Kris M, Wade J et al. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol 1998;16:3412-3425.
8. Fallowfield L, Gagnon D, Zagari M et al. Multivariate regression analyses of data from a randomised, double-blind, placebo-controlled study confirm quality of life benefit of epoetin alfa in patients receiving non-platinum chemotherapy. Br J Cancer 2002;87:1341-1353.
9. 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 chemotherapy for malignant disease. Cancer 2003;97:1312-1320.
10. Jumbe NL, Doshi S, Yao B et al. Darbepoetin alfa rational dose/schedule evaluation based on quantitative understanding of erythropoiesis for early and sustained alleviation of anemia. Proc Am Soc Clin Oncol 2003;22:765.
11. Sabbatini P. The relationship between anemia and quality of life in cancer patients. The Oncologist 2000;5(suppl 2):19-23.
12. 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 2003;25:1786-1805.
13. Shasha D, George MJ, Harrison LB. Once-weekly dosing of epoetin-alfa increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy. Cancer 2003;98:1072-1079.
14. 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;19:2875-2882.
15. Rosberg J, Lefebvre P, Fastenau J et al. Clinical significance of a ≥1 gram/deciliter (g/dL) rise in hemoglobin (Hb) at week 4 (early response) or at week 8 during epoetin alfa (EPO) treatment. Blood 2003;102:510b.
16. Fahrbach KR, Frame D, Scheye R et al. Comparison of anemia treatment outcomes in patients with cancer receiving epoetin alfa and darbepoetin alfa. Blood 2003;102:510b.
17. Mark TL, McKenzie SR, Piech CT. Better early and overall hematologic outcomes and lower drug cost with epoetin alfa (EPO) compared with darbepoetin alfa (DARB) in patients with chemotherapy-related anemia. Poster presented at the Academy of Managed Care Pharmacy's (AMCP) 16th Annual Meeting and Showcase, San Francisco, CA, March 31-April 3, 2004.
18. Papatheofanis FJ, Fastenau JM, Chiang TH et al. Epoetin alfa and darbepoetin alfa anemia treatment outcomes in cancer patients from a veterans administration perspective. Poster presented at the International Society for Pharmacoeconomics and Outcomes Research's (ISPOR) 9th Annual International Meeting, Arlington, VA, May 16-19, 2004.
19. Papatheofanis FJ, Fastenau JM, Chiang TH et al. Management of chemotherapy-related anemia: a study of epoetin alfa and darbepoetin alfa use in a self-insured managed care organization. Poster presented at the Academy of Managed Care Pharmacy's (AMCP) 16th Annual Meetings and Showcase, San Francisco, CA, March 31-April 3, 2004.
20. 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;94:1211-1220.
21. 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;19:2865-2874.
22. 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.
23. 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;87:268-276.
24. Cremieux PY, Finkelstein SN, Berndt ER et al. Cost effectiveness, quality-adjusted life-years and supportive care. Recombinant human erythropoietin as a treatment of cancer-associated anaemia. Pharmacoeconomics 1999;16:459-472.
25. 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;31:290-299.
26. Wilkinson GR. Pharmacokinetics: the dynamics of drug absorption, distribution, and elimination. In: Hardman JG, Limbird LE, Gilman AG, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics, Tenth Edition. New York: McGraw-Hill, 2001:3-29.
27. Kahan BD, Keown P, Levy GA et al. Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther 2002;24:330-350.
28. Oleson FB Jr, Berman CL, Kirkpatrick JB et al. Once-daily dosing in dogs optimizes daptomycin safety. Antimicrob Agents Chemother 2000;44:2948-2953.
29. Kim HC, McMillan CW, White GC et al. Purified factor IX using monoclonal immunoaffinity technique: clinical trials in hemophilia B and comparison to prothrombin complex concentrates. Blood 1992;79:568-575.
30. Canal P, Gamelin E, Vassal G et al. Benefits of pharmacological knowledge in the design and monitoring of cancer chemotherapy. Pathol Oncol Res 1998;4:171-178.
31. Lee M, Kern SE, Kisicki JC et al. A pharmacokinetic study to compare two simultaneous 400 μg doses with a single 800 μg dose of oral transmucosal fentanyl citrate. J Pain Symptom Manage 2003;26:743-747.
32. U.S. Food and Drug Administration. Guideline for the Clinical Evaluation of Analgesic Drugs (publication 91D-0425). Rockville, MD: US Department of Health and Human Services, 1992.
33. Turnidge J. Pharmacodynamics and dosing of aminoglycosides. Infect Dis Clin North Am 2003;17:503-528.
34. Choueiri TK, Hutson TE, Bukowski RM. Evolving role of pegylated interferons in metastatic renal cell carcinoma. Expert Rev Anticancer Ther 2003;3:823-829.
35. Raskin P, Klaff L, McGill J et al. Efficacy and safety of combination therapy: repaglinide plus metformin versus nateglinide plus metformin. Diabetes Care 2003;26:2063-2068.
36. Comfort MB, Tse AS, Tsang AC et al. A study of the comparative efficacy of three common analgesics in the control of pain after third molar surgery under local anaesthesia. Aust Dent J 2002;47:327-330.
37. Cheung W, Minton N, Gunawardena K. Pharmacokinetics and pharmacodynamics of epoetin alfa once weekly and three times weekly. Eur J Clin Pharmacol 2001;57:411-418.
38. Cazzola M, Beguin Y, Kloczko J et al. Once-weekly epoetin beta is highly effective in treating anaemic patients with lymphoproliferative malignancy and defective endogenous erythropoietin production. Br J Haematol 2003;122:386-393.
39. Rosberg JH, Ben-Hamadi R, Crémieux PY et al. Dose conversion and cost-effectiveness of erythropoietic therapies in chemotherapy-related anemia: a meta-analysis. Clin Drug Investig 2005;25:33-48.
40. Zagari M, Wacholtz M, Xiu L. An open-label, controlled, randomized, dose comparison study of epoetin alfa for the treatment of anemia in cancer patients receiving platinum-containing chemotherapy. Hematol J 2003;4(suppl 2):61.
41. Reigner B, Jordan P, Pannier A et al. CERA (continuous erythropoiesis receptor activator), an innovative erythropoietic agent: dose-dependent response in phase I studies. Proc Am Soc Clin Oncol 2003;22:732.
42. Tavio M, Milan I, Tirelli U. Cancer-related fatigue (review). Int J Oncol 2002;21:1093-1099.
43. Lipman AJ, Lawrence DP. The management of fatigue in cancer patients. Oncology (Huntingt) 2004;18:1527-1535; discussion 1536-1538.
44. Abdel-Razeq HN. Cancer-related anemia. Saudi Med J 2004;25:15-20.
45. Rosso R, Del Mastro L, Venturini M et al. [Use of erythropoietin in oncology]. Tumori 1997;83(suppl 2):S26-S30.
46. Lesage P, Portenoy RK. Management of fatigue in the cancer patient. Oncology (Huntingt) 2002;16:373-378,381; discussion 381-382, 385-386, 388-389.
47. Chen ML, Chang HK. Physical symptom profiles of depressed and nondepressed patients with cancer. Palliat Med 2004;18:712-718.
48. Holzner B, Kemmler G, Greil R et al. The impact of hemoglobin levels on fatigue and quality of life in cancer patients. Ann Oncol 2002;13:965-973.
49. Shargel L, Wu-Pong S, Yu ABC. Review of mathematical fundamentals. In: Applied Biopharmaceutics and Pharmacokinetics, Fifth Edition. New York: McGraw-Hill, 2004:21-51.
50. Tallarida RJ, Murray RB. Procedure 25 area under a curve: trapezoidal and Simpson's rules. In: Manual of Pharmacologic Calculations With Computer Programs, Second Edition. New York: Springer-Verlag, 1987:77-81.
51. Witzig TE, Silberstein PT, Loprinzi CL et al. Phase III, randomized, double-blind study of epoetin alfa versus placebo in anemic patients with cancer undergoing chemotherapy. J Clin Oncol 2004 Sep 27; [Epub ahead of print].
52. 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;1:131-138.
53. 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;100:859-868.
54. Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982;143:29-36.
55. Swets JA. Measuring the accuracy of diagnostic systems. Science 1988;240:1285-1293.
56. DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics 1988;44:837-845.
57. Vandenhende F, Comblain M, Delsemme MH et al. Construction of an optimal destructive sampling design for noncompartmental AUC estimation. J Pharmacokinet Biopharm 1999;27:191-212.