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Symptom Management and Supportive Care

A Randomized, Open-Label, Multicenter Trial of Immediate Versus Delayed Intervention with Darbepoetin Alfa for Chemotherapy-Induced Anemia

^aPacific Cancer Medical Center, Anaheim, California, USA; ^bMedical Oncology Associates, Kingston, Pennsylvania, USA; ^cCache Valley Cancer Treatment and Research Center, Logan, Utah, USA; ^dPacific Coast Hematology Oncology Medical, Fountain Valley, California, USA; ^eAmgen Inc., Thousand Oaks, California, USA; ^fHematology Oncology Consultants, St. Louis, Missouri, USA; ^gDepartment of Medicine-Hematology and Oncology, University of California, Los Angeles School of Medicine, Los Angeles, California, USA

Key Words. Chemotherapy • Anemia • Darbepoetin alfa • Hemoglobin • Cancer

Correspondence: John Glaspy, M.D., M.P.H., Department of Medicine-Hematology and Oncology, University of California, Los Angeles School of Medicine, Box 956996, Suite 550, 100 Medical Plaza, Los Angeles, California 90095, USA. Telephone: 310-794-0066; Fax: 310-443-0477; e-mail: jglaspy{at}mednet.ucla.edu

Disclosure: This research was supported by Amgen Inc. (Study 20020167, ClinicalTrials.gov Identifier: NCT00120705). V.C., D.T., and G.R. own stock in Amgen. T.R. has acted as a consultant to Amgen. No other potential conflicts of interest were reported by the authors, planners, reviewers, or staff managers of this article.

The optimal hemoglobin concentration at which to initiate erythropoietic therapy for chemotherapy-induced anemia (CIA) is not well defined. This randomized, open-label, multicenter study evaluated the ability of darbepoetin alfa (300 µg every 3 weeks) to maintain hemoglobin levels 10g/dl in patients with CIA (hemoglobin 10.5 g/dl and 12.0 g/dl) randomized 1:1 to an immediate-intervention group (received darbepoetin alfa immediately) or observation group (received darbepoetin alfa if hemoglobin fell to <10 g/dl). In 201 evaluable patients, there was a significant difference between the two groups in the Kaplan–Meier proportion of patients with a hemoglobin decrease to <10g/dl during weeks 1–13 (test period) (primary endpoint): 29% for immediate-intervention patients versus 65% for observation patients. Sixty-four patients in the observation group received darbepoetin alfa (delayed-intervention subgroup). The Kaplan–Meier proportion of patients who received transfusions was lower in the immediate-intervention group than in the delayed-intervention subgroup (14% versus 31% for the test period; 17% versus 36% over the whole study). The target hemoglobin level (11 g/dl) was achieved by a higher percentage of patients (crude percentage) in less time in the immediate-intervention group (94% in 2 weeks) than in the delayed-intervention subgroup (73% in 6 weeks); hemoglobin endpoints for the delayed-intervention subgroup were calculated from recalibrated study week 1 (the date patients first received darbepoetin alfa). For both groups, a higher mean change in hemoglobin from baseline led to a greater improvement in Functional Assessment of Cancer Therapy–Fatigue scores. In conclusion, immediate intervention resulted in a significantly lower proportion of patients who experienced a decline in hemoglobin, lower requirement for transfusions, and greater proportion of patients achieving and maintaining the target hemoglobin level.