Dr. Straus has participated in clinical consultant meetings as well as acted as a speaker and author in continuing medical education activities supported by Ortho Biotech, for which he has received honoraria. He has also received small amounts of salary support to conduct investigator-initiated clinical trials supported by Ortho Biotech.
Quality-of-life and health benefits of early treatment of mild anemia
A randomized trial of epoetin alfa in patients receiving chemotherapy for hematologic malignancies†
Article first published online: 14 SEP 2006
Copyright © 2006 American Cancer Society
Volume 107, Issue 8, pages 1909–1917, 15 October 2006
How to Cite
Straus, D. J., Testa, M. A., Sarokhan, B. J., Czuczman, M. S., Tulpule, A., Turner, R. R. and Riggs, S. A. (2006), Quality-of-life and health benefits of early treatment of mild anemia. Cancer, 107: 1909–1917. doi: 10.1002/cncr.22221
Clinical Investigators: 45–80 subjects: Fernando Cabanillas, MD, and Shirley A. Riggs, MD (University of Texas M. D. Anderson Cancer Center); Myron S. Czuczman, MD (Roswell Park Cancer Institute); David J. Straus, MD (Memorial Sloan-Kettering Cancer Institute); and Anil Tulpule, MD (USC Norris Cancer Center Hospital); 10–30 subjects: Hamid Al-Mondhiry, MD (Kissinger Health Systems); Philip Cohen, MD (Georgetown University Medical Center) John P. Greer, MD (Vanderbilt University Medical Center), Stephanie A. Gregory, MD (Rush University Medical Center), Sandra J. Horning, MD (Stanford University Medical Center), Joseph O. Moore, MD (Duke University Medical Center), Peter J. Rosen, MD (UCLA School of Medicine), and Todd M. Zimmerman, MD (University of Chicago); <10 subjects: Richard Ambinder MD (Johns Hopkins Hospital); James Berenson, MD (Cedars Sinai); Dennis Berman, MD (Chester County Hematology/Oncology Services); Reed E. Drews, MD (Beth Israel Deaconess Medical Center) David Irwin MD (Alta Bates Comprehensive Cancer Center); Sanford Kempin, MD (St. Vincent Comprehensive Cancer Center); Brad L. Pohlman, MD (Cleveland Clinic Taussig Cancer Center); Hussain I. Saba, MD (H. Lee Moffitt Cancer and Research Center); Robert S. Siegel, MD (George Washington University); and Mitchell R. Smith, MD (Fox Chase Cancer Center)
- Issue published online: 3 OCT 2006
- Article first published online: 14 SEP 2006
- Manuscript Accepted: 27 JUL 2006
- Manuscript Revised: 26 JUL 2006
- Manuscript Received: 1 MAR 2006
- Ortho Biotech Clinical Affairs, LLC, Bridgewater, NJ
- epoetin alfa;
- hematologic malignancies;
- quality of life;
Chemotherapy-related anemia is prevalent among patients with hematologic malignancies. A randomized, open-label, multicenter trial of early versus late epoetin alfa in this population was conducted, focusing on quality of life (QOL).
Patients with non-Hodgkin lymphoma, Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma and baseline hemoglobin of 10 to 12 g/dL who were scheduled for ≥4 months of myelosuppressive chemotherapy were randomized to receive ≤16 weeks of epoetin alfa at a dose of 40,000 U once weekly immediately (early) or to wait and only receive epoetin alfa if hemoglobin decreased to <9 g/dL (late). Those patients with a hemoglobin level >12 g/dL after 3 chemotherapy cycles were not randomized. The primary endpoint was a mean change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) total.
In all, 269 patients with a hemoglobin level ≤12 g/dL were randomized. The mean total FACT-An increased 3.84 (95% confidence interval [95% CI], 0.21–7.46) in early patients and decreased 4.37 (95% CI, −7.99 to −0.74) in late patients (P = .003). Early patients had significantly (P < .05) higher mean scores for total FACT-General; FACT-General physical and functional well-being subscales, total anemia scale, and fatigue subscale; and daily activity, energy, and important activity Linear Analog Scale Assessment scales, as well as reduced bedrest days and restricted activity days. The mean hemoglobin increased 1.2 g/dL (95% CI, 0.98–1.46) in early patients but decreased 0.2 g/dL (95% CI, −0.32–0.12) in late patients (P < .0001). Adverse events were similar between groups (with fatigue being the most prevalent); clinically relevant thromboembolic events were more common in early patients.
Treating mild anemia immediately with epoetin alfa during chemotherapy for hematologic malignancy significantly improved QOL, productivity, and hemoglobin compared with delaying treatment until the hemoglobin level decreases to <9.0 g/dL. Cancer 2006. © 2006 American Cancer Society.