Epoetin Alfa Treatment Improves Quality of Life and Increases Hemoglobin Levels during Chemotherapy for Lymphoma, Chronic Lymphocytic Leukemia (CLL), and Multiple Myeloma (MM) Patients with Mild-to-Moderate Anemia

Reviewer: Ryan Smith, MD
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Ultima Vez Modificado: 10 de diciembre del 2002

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Presenter: David J. Straus
Presenter's Affiliation: Memorial Sloan Kettering Cancer Center/ Procrit Hematologic Malignancies Study Group
Type of Session: Scientific

Background

    Anemia affects up to 80% of patients with hematologic malignancies. While the effects of severe anemia are known, symptoms of more mild anemia is less well-known, mainly because they are masked by other symptomatology. This study was done to determine if the use of recombinant human erythropoietin (EPO) increases hemoglobin (HgB) levels, decreases transfusion requirements, and increases quality of life in those patients with mild-to-moderate anemia.

Materials and Methods

  • 265 patients with lymphoma, CLL, or MM with HgB >10 g/dl were enrolled in the study.
  • 85% of the population consisted of patients with non-Hodgkin's lymphoma.
  • Patients with HgB >12 g/dl were observed until their HgB decreased to below 12, at which time they were randomized.
  • Patients with HgB 10-12 g/dl were randomized to either EPO 40,000 units q week x 16 weeks vs. observation and treatment with EPO only if HgB dropped below 9 g/dl.
  • EPO could be increased to 60,000 units per week if no response was noted after 4 weeks.
  • 179 patients are reported on in this analysis: 77 receiving EPO, 102 in the observation arm
  • Assessments done included HgB change, transfusion requirement, 2 quality of life (QOL) evaluations (LASA and FACT-Anemia) and a hospital untilization scale, which reports on costs.
  • Since this was an interim analysis, direct comparisons between the two groups was not performed.

Results

  • From time of randomization, HgB increased by median of 1.6 g/dl in the EPO group compared to 0.2 in the observation group
  • 16% of patients in the observation group had their HgB drop below 9 g/dl
  • The FACT-Anemia scale reported a significant increase in the anemia and fatigue subscales in those patients treated with EPO
  • The LASA QOL scale reported an increase in energy, activity level, and overall quality of life in the EPO arm, compared to no increase in the observation arm.
  • In terms of health care utilization, clinic days were decreased, days with decreased activity were decreased, there was a 20% decrease in missed work days, but an overall increase in nursing visits in those patients treated with EPO.

Author's Conclusions

  • EPO treatment of mild to moderate anemia in patients receiving chemotherapy for CLL, lymphoma, and MM resulted in an increase in HgB and functional capacity with a decrease in health care use
  • Final data from this study will be available in June 2003. This includes direct comparisons between groups.

Clinical/Scientific Implications

    The current ASCO/ASH guidelines for EPO administration include a patient's HgB <10 g/dl, with proven increases in HgB, decreases in transfusions, and a likely improvement in QOL. For patients with HgB 10-12 g/dl, the treatment with EPO is optional. This study reports on just those patients. As expected, there is an improvement in HgB levels and it seems to have a positive effect on quality of life. This is an especially important finding in these patients, as they are continuing to undergo chemotherapy which will presumably be detrimental to their subsequent HgB levels. This is evident by the 16% of patients in the observation group having their HgB levels drop to low levels. Although this is not an insignificant number, it is fairly low, meaning that the majority in the observation arm do not have significant decreases in their levels. Also, there is no direct correlation between groups at this point and there was no data presented on transfusion rates or cost. The argument for the cost-effectiveness of EPO in severly anemic patients is that it saves patients from undergoing fairly expensive transfusions. It is unknown if the same argument can be made in these patients with more mild anemia. In chemotherapy patients, the less anemic they are the better, likely both in terms of QOL and abiltiy to tolerate treatment. EPO seems to show a benefit in these regards, according to this report. However, the cost-effectiveness of EPO administration and direct comparison to a control (observed) group is unknown and the final report of this study will make an important contribution to understanding the treatment of anemia in patients with a HgB between 10-12 g/dl.

Oncolink's ASH Coverage made possible by an unrestricted Educational Grant from Ortho Biotech.


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