Quality of Life, Blood Transfusions, and Toxicity, in Anemic Patients with Advanced Cancer Receiving Weekly Erythropoietin While on Chemotherapy: Results from a Phase III Randomized Double-Blind Placebo-Controlled Study.

Reviewer: Ryan Smith, MD
OncoLink
Last Modified: December 7, 2002

Presenter: Jeff A. Sloan
Presenter's Affiliation: Mayo Clinic
Type of Session: Poster

Background

Anemia is obviously a large problem in the population of patients who are receiving chemotherapy. This anemia is likely amplified in those patients with advanced cancer. Anemia causes fatigue and jointly affects patients' quality of life (QOL). Erythropoietin (EPO) has been previously shown to decrease fatigue and anemia in patients with low hemoglobin (HgB)levels. This placebo controlled randomized study was done to determine if EPO could decrease anemia and subsequently result in a better quality of life in patients with advanced cancer

Materials and Methods

330 anemic patients who were receiving chemotherapy for advanced cancer comprised the study group.
Arm 1: EPO + Oral Iron x 16 weeks (40,000 units subq every week)
Arm 2: Placebo + Oral Iron x 16 weeks
If after 4 weeks, HgB is not increased >1 g/dl, EPO was increased to 60,000 units every week
Median HgB was 9.6 (EPO group), 9.4 (Placebo group)
28% of patients had lung CA, with 16% with breast CA
All patients had PS 0-1 QOL questionnaires were used to access overall QOL, anemia related QOL, fatigue related QOL.
Patients were stratified to primary malignant disease, planned concurrent radiation, and degree of anemia
Patient characteristics were well balanced

Results

There was no increase in toxicity with the administration of EPO
Response to therapy (defined as > 2 g/dl increase in HgB) was 68% in the EPO group vs. 31% in the placebo group
Incidence of patients becoming severely anemic (< 9 g/dl) was 37% in the EPO group vs. 54%
Patients requiring transfusion over the time of therapy was 27% (EPO) vs. 39% (Placebo). This was decreased to 12% (EPO) and 27% (Placebo) after one cycle of therapy.
Clinical improvement in QOL was 27% (EPO) vs, 26% (Placebo)
Tumor response and survival was identical between the two groups.

Author's Conclusions

Toxicity of EPO is limited
EPO patients had a clear advantage in terms of HgB level and transfusions required.
EPO can give a QOL benefit, with an improvement in the QOL due to anemia score in the EPO group, according to this study
There was no affect on survival from the administration of EPO

Clinical/Scientific Implications

Anemia is an extremely large problem in cancer patients. The degree of anemia is almost always significantly worse in patients with advanced cancer and in patients being treated with chemotherapy. This anemia affects, not only a patient's overall energy level and QOL, but also the quality and quantity of therapy that is able to be delivered. For these reasons, the elimination of anemia is very helpful in these patients. This study shows a significant improvement in HgB levels with the administration of EPO. This led to a decrease in transfusions required. Although no comment was made on aggressiveness of therapy that was able to be delivered, there was no improvement in survival or response to therapy. Also, though it was stated by the authors that there was a QOL improvement, this was not reflected in the data for overall QOL. However, given the cost and possible toxicity of transfusion, the increase in HgB alone is enough evidence to warrant the administration of EPO in anemic patients who are receiving aggressive treatments for their cancer.

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