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Area-Under-the-Curve More Sensitive than Haemoglobin Alone to Determine Quality of Life in Cancer Patients with Anaemia: Presented at ASHP

Maury M. Breecher, PhD, MPH

SAN DIEGO, CA -- June 9, 2003 -- The area-under-the-curve (AUC) measurement of haemoglobin is more informative of a patient's overall medical condition and quality of life (QoL) than haematopoietic response (HR) alone, say researchers.

The study was presented here at the American Society of Health-System Pharmacists (ASHP) Annual Meeting held here May 31-June 4.

AUC represents an average of all the haemoglobin information over the length of the study, demonstrating how well a patient is doing at Week 4, 8, 12, and 16. On the other hand, haematopoietic response (HR) represents a single discrete HR point during a study, a common end point to assess the efficacy of erythropoietic agents in treating chemotherapy-related anaemia (CRA).

To access the relative sensitivity of HR and AUC as measures of the efficacy of erythropoietic agents for the treatment of CRA, researchers led by M.S. Dug, of the Analysis Group, in Boston, Massachusetts, conducted a prospective, open label study of 2,964 patients with CRA. For their study, they used overall quality of life (QoL) as the "gold standard" to gauge the comparison between HR and AUC.

Patients were divided into quartiles based on their AUC, and both HR and AUC measurements were taken during a 16-week period in which they were treated with erythropoietin.

If the HR measurement can be likened to a snapshot of one discrete point in time, the AUC average, being a more continuous measure, can be likened to a film strip providing continuous information, the researchers said. Their study findings showed a "positive trend of mean QoL by AUC quartile for HR".

"This suggests that AUC provides additional information regarding QoL, given patient response to treatment according to the HR criteria," the authors state in their poster.

They concluded that AUC provides additional information regarding QoL given HR, and that HR provides no additional information regarding QoL, given AUC. They also found that two treatments that yield the same HR might yield different AUCs. In addition, they found that early response to treatment would be reflected in the AUC, whereas HR would reflect response that occurs at the end of treatment.

AUC appears to be a more sensitive measure of efficacy in patients treated for CRA, the researchers concluded.

Dr. Dug's co-authors were P. Y. Crémieux, of the Analysis Group and the University of Québec at Montréal, and C. T. Piech, of Ortho Biotech Products, L.P., of Bridgewater, New Jersey.


[Study title: Assessing the Efficacy of Erythropoietic Agents in Treating Chemotherapy-Related Anaemia: Haematopoietic Response vs Area Under the Haemoglobin Change Curve.]

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