Darbepoetin Alfa Reduces Anemia and Fatigue in Lung Cancer

Laurie Barclay, MD

August 22, 2002

Aug. 23, 2002 —The erythropoietin analogue darbepoetin alfa reduced the need for transfusions, increased hemoglobin concentrations, and decreased fatigue in patients with lung cancer, according to the results of a double-blind phase III trial reported in the Aug. 21 issue of the Journal of the National Cancer Institute.

"Patients with chemotherapy-associated anemia can safely and effectively be treated with weekly darbepoetin alfa therapy," write Johan Vansteenkiste, MD, PhD, of the University Hospital Gasthuisberg in Leuven, Belgium, and colleagues. "Patients receiving darbepoetin alfa did not appear to have any untoward effect in disease outcome and did not develop antibodies to the drug."

In this multicenter study, 320 anemic lung cancer patients with hemoglobin <=11.0 g/dL were randomized to receive darbepoetin alfa or placebo injections weekly for 12 weeks. Patients receiving darbepoetin alfa required fewer transfusions (27% vs. 52%; mean difference, 25%; 95% confidence interval [CI], 14%-36%; P<.001), required fewer units of blood (0.67 vs. 1.92; mean difference, 1.25; 95% CI, 0.65-1.84; P<.001), had more hematopoietic responses (66% vs. 24%; mean difference, 42%; 95% CI, 31%-53%; P<.001), and had better improvement in FACT-Fatigue scores (56% vs. 44% overall improvement). Adverse events were similar in both groups.

"Although no conclusions can be drawn about survival from this study, the potential salutary effect on disease outcome warrants further investigation in a prospectively designed study," the authors write. Future studies will evaluate the feasibility of administering the drug every two or three weeks rather than weekly, which could allow patients to miss less time from work and potentially increase compliance.

In an accompanying editorial, Claudette G. Varricchio, DSN, RN, FAAN, from the National Institute of Nursing Research in Bethesda, Maryland, and Jeff A. Sloan, PhD, from the Mayo Clinic in Rochester, Minnesota, applaud this study for incorporating the management of treatment-related symptoms into clinical trials.

"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."

J Natl Cancer Inst. 2002;94(16):1211-1220

Reviewed by Gary D. Vogin, MD

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