e20719 Background: To determine in patients with cancer related anaemia (Hb<11,3 g/d) starting with their chemotherapy the efficacy and safety of up-front red blood cell transfusion and subsequently maintenance epoetin-alpha (Epo) administration. The study target was the range of low-normal Hb levels of 11,3 to 12,9 g/dL aiming at improving tumor oxygenation. Methods: A multicenter, open label, single-arm phase II study. All eligible patients with metastatic solid cancers received around their first or second chemotherapy cycle a transfusion of 1–3 units of erythrocytes depending on their Hb level. This was followed by Epo subcutaneously weekly at an initial dose of 40,000 IU during the chemotherapy period. Epo was only administered when the Hb level was below the lower margin of the target Hb range. All patients started with pre-emptive oral iron suppletion. Primary objectives were: correction of anemia to the Hb level target range and safety. Secondary objectives were: Quality of Life, Length of Treatment Duration and Time to Treatment Failure. Safety included: blood pressure, thrombo-embolic events, adverse events and serious adverse event. Results: 18 Patients enrolled in this study from March 30, 2006 to November 11, 2008. An intention-to-treatment analysis was performed for the primary objectives in 16 patients (8 with breast-, 4 with colorectal-, 1 with ovarian- and 1 with pancreatic cancer) and reported here. Patients were during a median of 12 weeks (range 1 to 32 weeks) on study. Median Hb increased from 10,2 g/dL to 11,2 g/dL after transfusion and stayed at that level during the first 19 weeks of Epo administration; Hb levels were between 10,0 and 11,5 g/dL. In the following period until the final 32nd studyweek, Hb levels increased slightly, ranging from 10,3 to 11,8 g/dL. Two patients remained during the study in the Hb level target range. The safety of Epo was good. Grade 3/4 adverse events and serious adverse events that occurred were found to be all chemotherapy or progressive disease related. Conclusions: Although this up-front treatment increased Hb to stable levels during chemotherapy, the target Hb levels were not reached in most patients. This was presumably related to the lesser than projected yield of the red blood cell transfusion. [Table: see text]
Effect of different levels of Fenugreek powder supplementation on performance, Influenza, Sheep red blood cell, New Castle diseases anti-body titer and intestinal microbial flora on Cobb 500 broiler chicks
