Article of the Month
Eduardo Bruera, M.D.
Professor & Chair
Department of Palliative Care & Rehabilitation Medicine
Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Non-Small-Cell Lung Cancer With Disease-Related Anemia
by James R. Wright, et. al, Journal of Clinical Oncology, Vol 25, No 9 (March 20), 2007: pp. 1027-1032
© 2007 American Society of Clinical Oncology.
In this article the authors set out to evaluate the effectiveness of erythropoietin alpha on the quality of life (QOL) of anemic patients with advanced non-small cell lung cancer. This was a multicenter study using a randomized , double-blind, placebo controlled protocol. 300 patients were proposed to participate in the study, however after 70 patients were entered, the authors conducted an unplanned safety analysis of epoetin because of published reports of thrombotic events in other trials using this agent. This analysis determined that there was a significant difference in the median duration of survival of patients on placebo (129 days) compared to those on epoetin (63 days) with a hazard ratio, 1.84; P = .04. The trial was ended prematurely because of this finding. The QOL analysis could not be performed due to the small number of patients studied, however the hemoglobin level did increase in the group treated with epoetin. The authors concluded that any future studies using erythropoietin receptor agonists should evaluate, “monitor”, the survival of the study subjects.
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Why did I chose this article?
The authors of this Canadian clinical trial have confirmed findings initially reported by another Canadian study and a number of American studies regarding the negative impact on survival of Epoetin Alpha and Beta, respectively.
These agents were initially used in cancer patients with the specific purpose of reducing the number of blood transfusions during chemotherapy. These agents were also found to have statistically significant beneficial effects on cancer-related fatigue in those patients. The actual level of clinical improvement was minor in these patients, but they became massively used and were frequently requested by patients and families as a result of direct patient advertising. Because of the extremely high cost of these agents hospices and palliative care programs had great difficulty in maintaining this therapy near the end of life.
Recent results when studies attempted to increase the hemoglobin level above 120 g/l, as in the case of this study, and studies conducted in patients not receiving chemotherapy have led to a recent FDA [Food and Drug Administration] severe warning about the possibility of an increase in thromboembolic events and early deaths in patients treated with Epoetin.
This study as well as the FDA warning suggest that these agents should be used cautiously and their use should be restricted to patients undergoing active chemotherapy.
Future research should attempt to better characterize the role of Epoetin in both transfusion prevention and fatigue management. Ideally, such studies should be conducted by independently funded organizations.
Eduardo Bruera, M.D.
Professor & Chair
Department of Palliative Care & Rehabilitation Medicine
UT M. D. Anderson Cancer Center
1515 Holcombe Blvd.
Houston, TX 77030
The full text of the abstract may be viewed on line at URL: http://jco.ascopubs.org/cgi/content/abstract/25/9/1027
Please visit the following link to read past Articles Of The Month:
http://www.hospicecare.com/AOM/
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