The Oncologist, Vol. 11, No. 5, 536-537, May 2006; doi:10.1634/theoncologist.11-5-536
© 2006 AlphaMed Press
In Reply
Roger Waltzman
St. Vincent’s Comprehensive Cancer Center, New York, New York, USA
Correspondence: Roger Waltzman, M.D., St. Vincent’s Comprehensive Cancer Center, 325 West 15th Street, New York, New York 10011, USA. Telephone: 212-604-6058; Fax: 212-604-6038; e-mail: rwaltzman{at}aptiumoncology.com.
Received March 10, 2006;
accepted for publication March 23, 2006.
I read with interest and appreciated the insightful comments from Dr. Nowrousian [1] regarding our clinical trial, "Randomized Comparison of Epoetin alfa and Darbepoetin alfa in Anemic Patients with Cancer Receiving Chemotherapy" [2].
The selection of the primary end point of this trial, the rate of hemoglobin response (=1 g/dl within the first 4 weeks of treatment independent of transfusion), was specifically chosen to compare the efficacy of these two agents early in the course of treatment. The clinical benefits associated with an early hemoglobin response, namely reduced overall transfusion requirements, greater overall hemoglobin response, shorter treatment durations, and lower cumulative dose of erythropoietic agent have been documented [3–5]. As Dr. Nowrousian points out, the usual duration of therapy of erythropoietic agents is often short and further underscores the need for a treatment that provides maximal early benefit.
As discussed by Dr. Nowrousian, the transfusion end point in our trial was in fact selected to allow adequate time for sufficient hematopoiesis to potentially offset the need for transfusion and is consistent with the end point used for U.S. Food and Drug Administration approval of epoetin alfa for the treatment of chemotherapy-related anemia. The overall transfusion rates from baseline to end of study were 18% in the epoetin alfa group and 24% in the darbepoetin alfa group (p = .1921) [6]. In a post hoc analysis of transfusion requirements from this trial, Duh MS et al. [7] examined the rates of transfusion by weeks of therapy (Table 1
). In that analysis, the overall number of units transfused from baseline to end of study was 81 in the epoetin alfa group and 156 in the darbepoetin alfa group (p = .0587). These findings were consistent with other clinical trials reporting a lower proportion of patients treated with epoetin alfa requiring transfusion compared with those treated with darbepoetin alfa [8–9]. The resource and economic implications of these differences are of potential significance to payors and the health care system and require further study.
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DISCLOSURE OF POTENTIAL CONFLICTS OF INTEREST
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Dr. Waltzman has acted as a consultant for and performed contract work for Ortho Biotech Clinical Affairs, LLC. He also receives support from and has a financial interest in Ortho Biotech Products, L.P./Johnson & Johnson.
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REFERENCES
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- Nowrousian MR. Regarding "randomized comparison of epoetin alfa and darbepoetin alfa in anemic patients with cancer receiving therapy." The Oncologist 2006;11:535–536.[Free Full Text]
- Waltzman R, Croot C, Justice GR et al. Randomized comparison of epoetin alfa (40,000 U weekly) and darbepoetin alfa (200 µg every 2 weeks) in anemic patients with cancer receiving chemotherapy. The Oncologist 2005;10:642–650.[Abstract/Free Full Text]
- Campos SM, Duh MS, Lefebvre P et al. Benefits associated with an early hemoglobin response to epoetin alfa therapy in the treatment of chemotherapy-related anemia. J Natl Compr Canc Netw 2005;3:807–816.[Medline]
- Reed SD, Radeva JI, Daniel DB et al. Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia. Curr Med Res Opin 2005;21:1527–1533.[Medline]
- McKenzie RS, Mark TL, Fastenau JM et al. Clinical and economic benefits of early hemoglobin response following initiation of erythropoietic agents in chemotherapy-related anemia. Poster presented at the American Society of Health-System Pharmacists (ASHP) 39th Midyear Clinical Meeting and Exhibits, Orlando, FL, December 5–9, 2004.
- Ortho Biotech Clinical Affairs, LLC. Data on file.
- Duh MS Mody SH, McKenzie RS et al. Analysis of transfusion requirements from a clinical study comparing epoetin alfa 40,000 units QW to darbepoetin alfa 200 mcg Q2W. Poster presented at the 40th American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition, Las Vegas, NV, December 4–8, 2005.
- Glaspy J, Berg R, Tomita D et al. Final results of a phase 3, randomized open label study of darbepoetin alfa 200 mcg every two weeks (Q2W) versus epoetin alfa 40,000 U weekly (QW) in patients with chemotherapy-induced anemia (CIA). Poster presented at the American Society of Clinical Oncology 2005 Annual Meeting, Orlando, FL, May 13–17, 2005.
- Case AS, Rocconi RP, Barnes MN et al. Comparison of transfusion rates between erythropoietic stimulating agents in gynecologic oncology patients with chemotherapy induced anemia. Poster presented at the American Society of Clinical Oncology 2005 Annual Meeting, Orlando, FL, May 13–17, 2005.
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