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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

From the John Radcliffe Hospital, Oxford, United Kingdom; National Cancer Institute, Milan, Italy; Leiden University Medical Center, Leiden, the Netherlands; R.W. Johnson Pharmaceutical Research Institute, Raritan, NJ; and The Medical Oncology Center of Rosebank, Johannesburg, South Africa.

Please visit http://www.jco.org to view the appendix for this article.Address reprint requests to Timothy J. Littlewood, MD, John Radcliffe Hospital, Headington, OX3 9DU Oxford, United Kingdom; email: tim.littlewood{at}orh.anglox.nhs.uk

PURPOSE: This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival.

PATIENTS AND METHODS: Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels 10.5 g/dL, or greater than 10.5 g/dL but 12.0 g/dL after a hemoglobin decrease of 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study.

RESULTS: Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P = .0057) and increased hemoglobin (P < .001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P < .01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P = .13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P = .052) favoring epoetin alfa. Adverse events were comparable between groups.

CONCLUSION: Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings.

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				J. Chang, F. Couture, S. Young, K.-L. McWatters, and C. Y. Lau Weekly Epoetin Alfa Maintains Hemoglobin, Improves Quality of Life, and Reduces Transfusion in Breast Cancer Patients Receiving Chemotherapy J. Clin. Oncol., April 20, 2005; 23(12): 2597 - 2605. [Abstract] [Full Text] [PDF]

				G. P. Browman Standards of Proof, Standards of Practice, and Proof of Standards: A Tale of Two Trials J. Clin. Oncol., April 20, 2005; 23(12): 2583 - 2585. [Full Text] [PDF]

				J. Bohlius, S. Langensiepen, G. Schwarzer, J. Seidenfeld, M. Piper, C. Bennett, and A. Engert Recombinant Human Erythropoietin and Overall Survival in Cancer Patients: Results of a Comprehensive Meta-analysis J Natl Cancer Inst, April 6, 2005; 97(7): 489 - 498. [Abstract] [Full Text] [PDF]

				G. Weiss and L. T. Goodnough Anemia of Chronic Disease N. Engl. J. Med., March 10, 2005; 352(10): 1011 - 1023. [Full Text] [PDF]

				U. Reinhardt, A. Tulusan, R. Angermund, H. Lutz, and For The German Epoetin Alfa Study Group Increased Hemoglobin Levels and Improved Quality-of-Life Assessments During Epoetin Alfa Treatment in Anemic Cancer Patients: Results of a Prospective, Multicenter German Trial Oncologist, March 1, 2005; 10(3): 225 - 237. [Abstract] [Full Text] [PDF]

				J. D. Herrington, S. L. Davidson, D. K. Tomita, L. Green, R. E. Smith, and R. V. Boccia Utilization of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia Am. J. Health Syst. Pharm., January 1, 2005; 62(1): 54 - 62. [Abstract] [Full Text] [PDF]

				M. O. Arcasoy, K. Amin, S.-C. Chou, Z. A. Haroon, M. Varia, and J. A. Raleigh Erythropoietin and Erythropoietin Receptor Expression in Head and Neck Cancer: Relationship to Tumor Hypoxia Clin. Cancer Res., January 1, 2005; 11(1): 20 - 27. [Abstract] [Full Text] [PDF]

				F. Couture, A.R. Turner, B. Melosky, L. Xiu, R.K. Plante, C.Y. Lau, and I. Quirt Prior Red Blood Cell Transfusions in Cancer Patients Increase the Risk of Subsequent Transfusions With or Without Recombinant Human Erythropoietin Management Oncologist, January 1, 2005; 10(1): 63 - 71. [Abstract] [Full Text] [PDF]

				K. Blackwell, P. Gascon, G. Sigounas, and L. Jolliffe rHuEPO and Improved Treatment Outcomes: Potential Modes of Action Oncologist, November 1, 2004; 9(suppl_5): 41 - 47. [Abstract] [Full Text] [PDF]

				H. Ludwig rHuEPO and Treatment Outcomes: The Preclinical Experience Oncologist, November 1, 2004; 9(suppl_5): 48 - 54. [Abstract] [Full Text] [PDF]

				C. A. Hudis, S. Van Belle, J. Chang, and K. Muenstedt rHuEPO and Treatment Outcomes: the Clinical Experience Oncologist, November 1, 2004; 9(suppl_5): 55 - 69. [Abstract] [Full Text] [PDF]

				H. Ludwig, C. A. Hudis, G. Goss, and B. Leyland-Jones Epoetin Alfa: Future Directions and Future Research Oncologist, November 1, 2004; 9(suppl_5): 70 - 73. [Full Text] [PDF]

				E. Lindholm, P. Daneryd, U. Korner, A. Hyltander, M. Fouladiun, and K. Lundholm Effects of Recombinant Erythropoietin in Palliative Treatment of Unselected Cancer Patients Clin. Cancer Res., October 15, 2004; 10(20): 6855 - 6864. [Abstract] [Full Text] [PDF]

				V. Voelter, C. Schuhmacher, R. Busch, C. Peschel, J. R. Siewert, and F. Lordick Incidence of anemia in patients receiving neoadjuvant chemotherapy for locally advanced esophagogastric cancer Ann. Thorac. Surg., September 1, 2004; 78(3): 1037 - 1041. [Abstract] [Full Text] [PDF]

				F. Dimeo, A. Schmittel, T. Fietz, S. Schwartz, P. Kohler, D. Boning, and E. Thiel Physical performance, depression, immune status and fatigue in patients with hematological malignancies after treatment Ann. Onc., August 1, 2004; 15(8): 1237 - 1242. [Abstract] [Full Text] [PDF]

				D. P. Lawrence, B. Kupelnick, K. Miller, D. Devine, and J. Lau Evidence Report on the Occurrence, Assessment, and Treatment of Fatigue in Cancer Patients J Natl Cancer Inst Monographs, July 1, 2004; 2004(32): 40 - 50. [Abstract] [Full Text] [PDF]

				V. Mock Evidence-Based Treatment for Cancer-Related Fatigue J Natl Cancer Inst Monographs, July 1, 2004; 2004(32): 112 - 118. [Abstract] [Full Text] [PDF]

				J. Patton, T. Reeves, and J. Wallace Effectiveness of Darbepoetin Alfa Versus Epoetin Alfa in Patients with Chemotherapy-Induced Anemia Treated in Clinical Practice Oncologist, July 1, 2004; 9(4): 451 - 458. [Abstract] [Full Text] [PDF]

				E. Cortesi, A. Mancuso, A. De Pasquale Ceratti, N. Pizzardi, G. D'Auria, C. Accettura, P. Beccaglia, D. Bertelletti, and F. De Marinis Effectiveness and Safety of an Induction Therapy with Epoetin Alfa in Anemic Cancer Patients Receiving Concomitant Chemotherapy Oncologist, July 1, 2004; 9(4): 459 - 468. [Abstract] [Full Text] [PDF]