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Darbepoetin Alfa for the Treatment of Chemotherapy-Induced Anemia: Disease Progression and Survival Analysis From Four Randomized, Double-Blind, Placebo-Controlled Trials

From the Sundsvall Hospital, Sundsvall, Sweden; University Hospital Gasthuisberg, Leuven, Belgium; Ashford Cancer Centre, Ashford, Australia; and Amgen Inc, Thousand Oaks, CA

Address reprint requests to Michael Hedenus, MD, Department of Internal Medicine, Sundsvall Hospital, Sundsvall S-851 86, Sweden; e-mail: Michael.Hedenus{at}lvn.se

PURPOSE: To determine the effect of darbepoetin alfa (DA) on progression-free survival (PFS) and overall survival (OS) in patients with chemotherapy-induced anemia (CIA).

PATIENTS AND METHODS: Two 16-week randomized, double-blind, placebo-controlled phase III studies of weekly DA in anemic patients with lung cancer (n = 314) or lymphoproliferative malignancies (LPMs; n = 344) undergoing chemotherapy were analyzed with prospectively defined long-term PFS and OS end points. Short-term effects of DA on PFS and OS were analyzed by including two additional 16-week dose-finding, double-blind, placebo-controlled studies in anemic patients with multiple tumor types (n = 405) and LPMs (n = 66).

RESULTS: Median follow-up is 15.8 months (lung cancer) and 32.6 months (LPM). Median duration of PFS was comparable between DA and placebo: 5.1 months (95% CI, 4.1 to 6.9 months) versus 4.4 months (95% CI, 3.7 to 5.3 months) for lung cancer and 14.2 months (95% CI, 12.2 to 17.5 months) versus 15.9 months (95% CI, 13.1 to 19.0 months) for LPMs. The estimated hazard ratio (HR) of death related to DA use for lung cancer was 0.77 (95% CI, 0.59 to 1.01) and 1.26 (95% CI, 0.92 to 1.71) for LPMs. In the pooled analyses of all four studies (n = 1,129), no differences in PFS or OS were observed between DA and placebo (HR = 0.92; 95% CI, 0.78 to 1.07; and HR = 0.95; 95% CI, 0.78 to 1.16, respectively).

CONCLUSION: Treatment with DA does not seem to influence PFS or OS in patients with CIA. Prospective, randomized clinical trials will provide additional insights into the effects of DA on PFS and OS in specific tumor types.

Supported by Amgen Inc, Thousand Oaks, CA.

Presented in part at the 29th Congress of the European Society for Medical Oncology, October 29-November 2, 2004, Vienna, Austria; 16th International Symposium of the Multinational Association of Supportive Care in Cancer, June 24–27, 2004, Miami, FL; and 9th Congress of the European Hematology Association, June 10-13, 2004, Geneva, Switzerland.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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