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Originally published as JCO Early Release 10.1200/JCO.2006.07.1514 on February 20 2007

Journal of Clinical Oncology, Vol 25, No 9 (March 20), 2007: pp. 1027-1032
© 2007 American Society of Clinical Oncology.
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Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Non–Small-Cell Lung Cancer With Disease-Related Anemia

James R. Wright, Yee C. Ung, Jim A. Julian, Kathleen I. Pritchard, Timothy J. Whelan, Column Smith, Barbara Szechtman, Wilson Roa, Liam Mulroy, Leona Rudinskas, Bruno Gagnon, Gord S. Okawara, Mark N. Levine

From the Juravinski Cancer Centre at Hamilton Health Sciences; Department of Medicine, McMaster University; Department of Clinical Epidemiology, McMaster University; Ontario Clinical Oncology Group, Hamilton; Toronto-Sunnybrook Regional Cancer Centre; University of Toronto; Humber River Regional Hospital, Toronto, Ontario; Tom Baker Cancer Centre, Calgary; Cross Cancer Institute, Edmonton, Alberta; Nova Scotia Cancer Centre, Halifax, Nova Scotia; and McGill University, Montreal, Quebec, Canada

Address reprint requests to James R. Wright, MD, FRCP(C), MSc, Juravinski Cancer Center at Hamilton Health Sciences, 699 Concession St, Hamilton, Ontario, L8V 5C2, Canada; e-mail: jim.wright{at}hrcc.on.ca

Purpose: Previous trials have suggested a quality-of-life (QOL) improvement for anemic cancer patients treated with erythropoietin, but few used QOL as the primary outcome. We designed a trial to investigate the effects of epoetin alfa therapy on the QOL of anemic patients with advanced non–small-cell carcinoma of the lung (NSCLC).

Patients and Methods: A multicenter, randomized, double-blind, placebo-controlled trial was conducted. The proposed sample size was 300 patients. Eligible patients were required to have NSCLC unsuitable for curative therapy and baseline hemoglobin (Hgb) levels less than 121 g/L. Patients were assigned to 12 weekly injections of subcutaneous epoetin alpha or placebo, targeting Hgb levels between 120 and 140 g/L. The primary outcome was the difference in the change in Functional Assessment of Cancer Therapy–Anemia scores between baseline and 12 weeks.

Results: Reports of thrombotic events in other epoetin trials prompted an unplanned safety analysis after 70 patients had been randomly assigned (33 to the active arm and 37 to the placebo arm). This revealed a significant difference in the median survival in favor of the patients on the placebo arm of the trial (63 v 129 days; hazard ratio, 1.84; P = .04). The Steering Committee closed the trial. Patient numbers compromised the interpretation of the QOL analysis, but a positive Hgb response was noted with epoetin alfa treatment.

Conclusion: An unplanned safety analysis suggested decreased overall survival in patients with advanced NSCLC treated with epoetin alfa. Although infrequent, other similar reports highlight the need for ongoing trials evaluating erythropoietin receptor agonists to ensure that overall survival is monitored closely.

published online ahead of print at www.jco.org on February 20, 2007.

Supported by a grant-in-aid from Ortho Biotech to the Ontario Clinical Oncology Group.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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    JCO 2007 25: 1021-1023 [Full Text]


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