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Early Intervention with Epoetin Alfa During Platinum-Based Chemotherapy: An Analysis of the Results of a Multicenter, Randomized, Controlled Trial Based on Initial Hemoglobin Level

^a VU Medisch Centrum, Amsterdam, The Netherlands; ^b Ortho Biotech, a division of Janssen-Cilag B.V., Tilburg, The Netherlands

Key Words. Epoetin alfa • Anemia • Hemoglobin • Cancer • Quality of life

Correspondence: Guiseppe Giaccone, VU Medisch Centrum, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. Telephone: 31-20-4444321; Fax: 31-20-4444079; e-mail: g.giaccone{at}vumc.nl

Objective. This analysis of the results of a randomized, controlled trial evaluating the effects of epoetin alfa (EPO) therapy on transfusion requirements, hemoglobin (Hb), and quality of life (QOL) in patients with cancer receiving platinum-based chemotherapy was conducted to evaluate the effect of initial Hb level on study outcomes.

Methods. Patients with Hb levels 12.1 g/dl were randomized 2:1 to receive EPO, 10,000 U three times weekly s.c. or best supportive care (BSC) until 4 weeks after their last chemotherapy cycle. For this analysis, patients were stratified by baseline Hb level (9.7 g/dl, >9.7 g/dl to 10.5 g/dl, >10.5 g/dl to 11.3 g/ dl, and >11.3 g/dl to 12.1 g/dl), and study results were reanalyzed.

Results. Significantly fewer EPO patients than BSC patients with initial Hb levels >9.7 g/dl to 12.1 g/dl required transfusions. EPO maintained Hb levels throughout the study for patients with Hb levels >11.3 g/dl to 12.1 g/dl, compared with a decrease with BSC. For patients with baseline Hb levels >10.5 g/dl, for whom the mean changes from baseline to last assessment were measured by the Cancer Linear Analogue Scale assessments of energy and overall QOL as well as by the Functional Assessment of Cancer Therapy (FACT)-Fatigue and FACT-An Anemia subscale, QOL scores were significantly greater with EPO than with BSC. QOL declined in patients receiving BSC, and the mean decreases in QOL scores were greater for BSC patients with baseline Hb levels >10.5 g/dl, compared with the overall BSC group.

Conclusion. In patients with cancer receiving platinum-based chemotherapy and with baseline Hb levels >10.5 g/dl, early intervention with EPO reduces transfusions, maintains Hb level, and maintains or improves QOL. This study supports the positive effects of early intervention when analyzed according to initial Hb value.

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