R S Lavey1, W H Dempsey. 1. Department of Radiation Oncology, University of California, Los Angeles 90024-6951.
Abstract
PURPOSE: The hemoglobin (Hgb) level of patients during radiation therapy is associated with both survival and local tumor control in several organ sites. This clinical trial tested whether administering recombinant 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 Hgb 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 patients were given oral ferrous sulfate throughout their radiation therapy course. Half the patients also received 150-300 mg/kg of r-HuEPO subcutaneously three times per week starting 0-10 days prior to the first dose of radiation. RESULTS: The r-HuEPO and control groups did not differ significantly in patient age, gender, tumor type, initial hemoglobin, erythropoietin, or iron bioavailability. The Hgb level increased more 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 from a mean +/- standard deviation of 11.9 +/- 1.3 g/dL to > 14 g/dL during 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 concentration 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 function. The only reported adverse effect of r-HuEPO administration was an asymptomatic skin rash in one patient. CONCLUSION: r-HuEPO with ferrous sulfate significantly increased the Hgb level in cancer patients without interfering with their course of radiation therapy, whereas ferrous sulfate alone did not. r-HuEPO appears to be a safe and effective means of increasing red cell mass during radiation therapy.
PURPOSE: The hemoglobin (Hgb) level of patients during radiation therapy is associated with both survival and local tumor control in several organ sites. This clinical trial tested whether administering recombinant humanerythropoietin (r-HuEPO) to cancerpatients would increase their Hgb level during the course of radiation therapy without adverse effects. METHODS AND MATERIALS: The 40 participating patients had a Hgb 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 patients were given oral ferrous sulfate throughout their radiation therapy course. Half the patients also received 150-300 mg/kg of r-HuEPO subcutaneously three times per week starting 0-10 days prior to the first dose of radiation. RESULTS: The r-HuEPO and control groups did not differ significantly in patient age, gender, tumor type, initial hemoglobin, erythropoietin, or iron bioavailability. The Hgb level increased more 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 from a mean +/- standard deviation of 11.9 +/- 1.3 g/dL to > 14 g/dL during 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 concentration 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 function. The only reported adverse effect of r-HuEPO administration was an asymptomatic skin rash in one patient. CONCLUSION: r-HuEPO with ferrous sulfate significantly increased the Hgb level in cancerpatients without interfering with their course of radiation therapy, whereas ferrous sulfate alone did not. r-HuEPO appears to be a safe and effective means of increasing red cell mass during radiation therapy.