Chemotherapy-related anemia often results from decreased production of the hormone erythropoietin, a hormone that stimulates the formation of red blood cells. Anemia can be treated with red blood cell transfusions, but risks associated with this procedure include adverse reactions and infection.
A newer approach to treating anemia has been the use of recombinant human erythropoietin (rHuEPO). However, to sufficiently increase levels of hemoglobin (the oxygen-carrying component of red blood cells) and reduce the number of blood transfusions, a patient must receive treatment three times a week. The erythropoietic protein darbepoetin alfa, an analogue of rHuEPO, stays in the blood for longer periods of time and can be given less frequently.
In randomized, placebo-controlled phase III trial of the safety and efficacy of darbepoetin alfa, Johan Vansteenkiste, M.D., Ph.D., of the University Hospital Gasthuisberg in Belgium, and his colleagues from the Aranesp 980297 Study Group, treated 321 anemic patients receiving chemotherapy for lung cancer with either weekly injections of darbepoetin alfa or a placebo.
By 12 weeks, patients receiving darbepoetin alfa required about half as many blood transfusions, nearly a third fewer units of blood, had elevated hemoglobin levels, and experienced significantly less fatigue than patients given the placebo. Adverse events were similar to those in cancer patients receiving chemotherapy, and were similar in both groups. Overall survival rates were not statistically significantly different between the two treatment groups.
The dosing advantage of darbepoetin alfa could allow patients to miss less time from work and potentially increase compliance, the researchers say. They add that further studies are under way to examine the possibility to administering darbepoetin alfa at an even lower frequency, such as every two to three weeks.
In an accompanying editorial, Claudette G. Varricchio, DSN, RN, FAAN, of the National Institute of Nursing Research in Bethesda, Md., and Jeff A. Sloan, Ph.D., of the Mayo Clinic in Rochester, Minn., note that researchers now recognize cancer as a chronic disease. The editorialists point to the increasing need to incorporate the management of treatment-related symptoms into clinical trials, and they praise the current study as a successful effort to do just that.
"Clinical trials of various approaches to the management of symptoms related to cancer or its treatment are needed to promote the well-being of persons with cancer, especially in the context of cancer as a chronic condition," they write. "These clinical trials must be as rigorous as those that evaluate cancer treatments."
Contact: Johan Vansteenkiste, M.D., Ph.D., University Hospital Gasthuisberg, +32 16 3468 02 (07:00-16:00 GMT), fax: +32 16 3468 03, firstname.lastname@example.org
Editorial: Linda Cook, National Institute of Nursing Research, (301) 496-0209, fax: (301) 480-8845; email@example.com
Vansteenkiste J, Pirker R, Massuti B, Barata F, Font A, Fiegl M, et al. Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J Natl Cancer Inst 2002;94:1211-20.
Editorial: Varricchio C, Sloan J. The need for and characteristics of randomized, phase III trials to evaluate symptom management in patients with cancer. J Natl Cancer Inst 2002;94:1184-5.
Attribution to the Journal of the National Cancer Institute is requested in all news coverage.