“…These findings in our randomized study confirm the erythropoietic effect of r-HuEPO demonstrated in previous non-randomized studies of anaemic cancer patients undergoing RT as well as our preliminary report (Lavey and Dempsey, 1993;Vijayakumar et al, 1993;Dusenbery et al, 1994). Lavey and Dempsey (1993) described an improvement in mean haemoglobin level from 11.9 g dl-' to 15.1 g dl-' in 20 patients who received r-HuEPO while undergoing RT for supradiaphragmatic tumours (Kushner, 1992).…”
Section: Discussionsupporting
confidence: 92%
“…Our study used 200 units kg-' for 5 consecutive days as the initial dose and then decreased the dose by 50% once the anaemia was corrected. This was similar to the dose and scheduling of Dusenbery et al (1994) and reflects the favourable results of patients with chemotherapy-induced anaemia reported by Platanias et al (1991) in a dose escalation study of r-HuEPO that demonstrated the highest response rates in patients who received either 200 or 300 U kg-' for 5 days rather than lower dose levels. However, Lavey and Dempsey (1993) used 300 U kg-' three times only during the first week and then 150 U kg-' (three times a week) for the remainder of the RT.…”
Section: Discussionsupporting
confidence: 85%
“…Similarly, Dusenbery et al (1994) showed an improvement in mean haemoglobin from 10.3 to 13.2 g dl-' in 15 patients with uterine cervix cancer who received r-HuEPO during RT, which is an increase of 0.5 g dl' per week (Dusenbery et al, 1994). These studies demonstrate an increase in mean haemoglobin that is slightly greater than the average weekly haemoglobin increase in our study of 0.41 g dl-'.…”
Section: Discussionmentioning
confidence: 88%
“…Recombinant erythropoietin (r-HuEPO) has previously been shown to increase the haematocrit and reduce the transfusion requirement in patients with end-stage renal disease undergoing haemodialysis (Esbach et al, 1989) and in AIDS patients treated with zidovudine (Fischl et al, 1990). In addition, there are now a number of reports on the use of r-HuEPO to correct anaemia in cancer patients (Platanias et al, 1991;Abels, 1992aAbels, ,b, 1993Miller et al, 1992;Case et al, 1993;Lavey and Dempsey, 1993;Ludwig et al, 1993Ludwig et al, , 1994Vijayakumar et al, 1993;Dusenbery et al, 1994;Leitgeh et al, 1994;deCampos et al, 1995). In the largest randomized trial published to date, Abels (1993) demonstrated that r-HuEPO corrected anaemia and reduced transfusion requirements compared with a control group for patients with a variety of cancers undergoing chemotherapy.…”
Summary The purpose of this study was to determine the safety, efficacy and impact on quality of life of recombinant human erythropoietin (r-HuEPO) for cancer patients undergoing radiotherapy (RT). An open-labelled randomized design was used, with patients randomized to either treatment or control arms. Patients in the treatment arm received r-HuEPO given by subcutaneous injection at a dose of 200 units kg-' day-' plus oral iron supplements (ferrous sulphate 325 mg p.o. t.i.d.). Entry was restricted to patients with carcinoma of the lung, uterine cervix, prostate or breast who presented for RT with anaemia parameters reflective of 'the anaemia of chronic disease'. Radiotherapy policies (portals, doses, fraction size, etc.) were determined by the site and stage of disease. Complete blood counts (CBCs) were obtained weekly. The target level of haemoglobin was 15 g dl-1 for men and 14 g dl-1 for women. Quality of life (QOL) was assessed weekly by using an analogue scale to judge energy, activities of daily living and overall quality of life. Forty-eight patients were entered in the study, 24 in the treatment arm and 24 in the control arm. The prerandomization demographic characteristics and mean laboratory values were comparable in both arms. The mean haemoglobin at completion was 13.6 g dl-1 for r-HuEPO-treated patients compared with 11.0 g dl-1 for control subjects (P= 0.0012). Patients who received r-HuEPO demonstrated a mean weekly haemoglobin increase of 0.41 g dl-1 compared with a decrease in mean haemoglobin level in controls for 6 of the 7 weeks of the study (mean weekly decrease of 0.073 g dl-'). Target levels of haemoglobin were achieved by 41.6% of r-HuEPO-treated patients compared with none of the control subjects. The mean platelet count declined in both arms of the study with RT but the decline from pretreatment was less rapid in r-HuEPO-treated patients (11.2% decrease) compared with controls (26.3% decrease) and was statistically significant during weeks 4-6. Toxicity was minor with only mild irritation at the injection site. Mean quality of life end points were superior in the treatment arm but not statistically significant. r-HuEPO had a beneficial effect on weekly haemoglobin levels in patients undergoing RT with response rates similar to other studies. There was also a less rapid decline in weekly platelet counts in r-HuEPO-treated patients compared with control subjects. Further studies are needed to address the optimum dose and scheduling as well as the impact of r-HuEPO on clinical outcomes.
“…These findings in our randomized study confirm the erythropoietic effect of r-HuEPO demonstrated in previous non-randomized studies of anaemic cancer patients undergoing RT as well as our preliminary report (Lavey and Dempsey, 1993;Vijayakumar et al, 1993;Dusenbery et al, 1994). Lavey and Dempsey (1993) described an improvement in mean haemoglobin level from 11.9 g dl-' to 15.1 g dl-' in 20 patients who received r-HuEPO while undergoing RT for supradiaphragmatic tumours (Kushner, 1992).…”
Section: Discussionsupporting
confidence: 92%
“…Our study used 200 units kg-' for 5 consecutive days as the initial dose and then decreased the dose by 50% once the anaemia was corrected. This was similar to the dose and scheduling of Dusenbery et al (1994) and reflects the favourable results of patients with chemotherapy-induced anaemia reported by Platanias et al (1991) in a dose escalation study of r-HuEPO that demonstrated the highest response rates in patients who received either 200 or 300 U kg-' for 5 days rather than lower dose levels. However, Lavey and Dempsey (1993) used 300 U kg-' three times only during the first week and then 150 U kg-' (three times a week) for the remainder of the RT.…”
Section: Discussionsupporting
confidence: 85%
“…Similarly, Dusenbery et al (1994) showed an improvement in mean haemoglobin from 10.3 to 13.2 g dl-' in 15 patients with uterine cervix cancer who received r-HuEPO during RT, which is an increase of 0.5 g dl' per week (Dusenbery et al, 1994). These studies demonstrate an increase in mean haemoglobin that is slightly greater than the average weekly haemoglobin increase in our study of 0.41 g dl-'.…”
Section: Discussionmentioning
confidence: 88%
“…Recombinant erythropoietin (r-HuEPO) has previously been shown to increase the haematocrit and reduce the transfusion requirement in patients with end-stage renal disease undergoing haemodialysis (Esbach et al, 1989) and in AIDS patients treated with zidovudine (Fischl et al, 1990). In addition, there are now a number of reports on the use of r-HuEPO to correct anaemia in cancer patients (Platanias et al, 1991;Abels, 1992aAbels, ,b, 1993Miller et al, 1992;Case et al, 1993;Lavey and Dempsey, 1993;Ludwig et al, 1993Ludwig et al, , 1994Vijayakumar et al, 1993;Dusenbery et al, 1994;Leitgeh et al, 1994;deCampos et al, 1995). In the largest randomized trial published to date, Abels (1993) demonstrated that r-HuEPO corrected anaemia and reduced transfusion requirements compared with a control group for patients with a variety of cancers undergoing chemotherapy.…”
Summary The purpose of this study was to determine the safety, efficacy and impact on quality of life of recombinant human erythropoietin (r-HuEPO) for cancer patients undergoing radiotherapy (RT). An open-labelled randomized design was used, with patients randomized to either treatment or control arms. Patients in the treatment arm received r-HuEPO given by subcutaneous injection at a dose of 200 units kg-' day-' plus oral iron supplements (ferrous sulphate 325 mg p.o. t.i.d.). Entry was restricted to patients with carcinoma of the lung, uterine cervix, prostate or breast who presented for RT with anaemia parameters reflective of 'the anaemia of chronic disease'. Radiotherapy policies (portals, doses, fraction size, etc.) were determined by the site and stage of disease. Complete blood counts (CBCs) were obtained weekly. The target level of haemoglobin was 15 g dl-1 for men and 14 g dl-1 for women. Quality of life (QOL) was assessed weekly by using an analogue scale to judge energy, activities of daily living and overall quality of life. Forty-eight patients were entered in the study, 24 in the treatment arm and 24 in the control arm. The prerandomization demographic characteristics and mean laboratory values were comparable in both arms. The mean haemoglobin at completion was 13.6 g dl-1 for r-HuEPO-treated patients compared with 11.0 g dl-1 for control subjects (P= 0.0012). Patients who received r-HuEPO demonstrated a mean weekly haemoglobin increase of 0.41 g dl-1 compared with a decrease in mean haemoglobin level in controls for 6 of the 7 weeks of the study (mean weekly decrease of 0.073 g dl-'). Target levels of haemoglobin were achieved by 41.6% of r-HuEPO-treated patients compared with none of the control subjects. The mean platelet count declined in both arms of the study with RT but the decline from pretreatment was less rapid in r-HuEPO-treated patients (11.2% decrease) compared with controls (26.3% decrease) and was statistically significant during weeks 4-6. Toxicity was minor with only mild irritation at the injection site. Mean quality of life end points were superior in the treatment arm but not statistically significant. r-HuEPO had a beneficial effect on weekly haemoglobin levels in patients undergoing RT with response rates similar to other studies. There was also a less rapid decline in weekly platelet counts in r-HuEPO-treated patients compared with control subjects. Further studies are needed to address the optimum dose and scheduling as well as the impact of r-HuEPO on clinical outcomes.
“…EPO reduces red cell transfusion requirements in patients undergoing allogeneic bone marrow transplantation [12] but not in those subjected to transplantation of autologous bone marrow or peripheral blood stem cells. EPO administration also appears to be a safe and effective method of increasing red cell mass during radiation therapy [13,14],…”
Section: Clinical Application Of Erythropoietin In Chronic Anaemia Ofmentioning
Recombinant human erythropoietin (epoetin alfa) has been used in clinical settings for more than a decade. Its indications have expanded considerably from its original use as hormone therapy in the treatment of anemia in adults with chronic kidney disease. Since the introduction of epoetin alfa, a greater understanding of anemia pathophysiology and the interactions of erythropoietin, iron, and erythropoiesis has been elucidated. Anemia is now independently associated with increased mortality and disease progression. Potential survival benefits associated with correction of anemia in various patient populations are leading to consideration of earlier, more aggressive treatment of mild to moderate anemia with epoetin alfa. Moreover, this agent's therapeutic use may extend beyond currently accepted roles. Epoetin alfa is undergoing evaluation with promising results in a variety of new clinical settings, including anemia associated with congestive heart failure, ribavirin-interferon alfa treatment of hepatitis C virus infection, and critical illness. Preclinical studies also have established erythropoietin and its recombinant equivalent to be a pleiotropic cytokine with antiapoptotic activity and neuroprotective actions in the central nervous system. The therapeutic potential of epoetin alfa appears yet to be fully realized.
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