ERYTHROPOIETIN INCREASES HEMOGLOBIN IN CANCER-PATIENTS DURING RADIATION-THERAPY

Purpose: The hemoglobin (Hgb) level of patients during radiation thera py is associated with both survival and local tumor control in several organ sites. This clinical trial tested whether administering recombi nant human erythropoietin (r-HuEPO) to cancer patients would increase their Hgb level during the course of radiation therapy without adverse effects. Methods and Materials: The 40 participating patients had a H gb value < 13.5 g/dL and a malignant tumor located above the diaphragm without evidence of distant metastasis for which they were scheduled to undergo a 5-8 week course of daily radiation therapy. All 40 patien ts were given oral ferrous sulfate throughout their radiation therapy course. Half the patients also received 150-300 mg/kg of r-HuEPO subcu taneously three times per week starting 0-10 days prior to the first d ose of radiation. Results: The r-HuEPO and control groups did not diff er significantly in patient age, gender, tumor type, initial hemoglobi n, erythropoietin, or iron bioavailability. The Hgb level increased mo re than 6% during radiation therapy in all 20 of the r-HuEPO patients but in only 2/20 of the control patients (p < 0.001). The Hgb rose fro m a mean +/- standard deviation of 11.9 +/- 1.3 g/dL to > 14 g/dL duri ng radiation therapy in 80% of the r-HuEPO group compared to in 5% of the control group (p < 0.001). The mean +/- s.d. change in Hgb concent ration during radiation therapy was 27 +/- 15% (an average rise of 5% per week) in the r-HuEPO group and 0 +/- 6% in the control group (p < 0.001). r-HuEPO had no significant measurable effect on blood pressure , white blood cell, neutrophil or platelet count, or liver or renal fu nction. The only reported adverse effect of r-HuEPO administration was an asymptomatic skin rash in one patient. Conclusion: T-HuEPO with fe rrous sulfate significantly increased the Hgb level in cancer patients without interfering with their course of radiation therapy, whereas f errous sulfate alone did not. r-HuEPO appears to be a safe and effecti ve means of increasing red cell mass during radiation therapy.