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One Weekly Epoetin Beta Dose As Effective, Well Tolerated For Treatment Of Anaemia As Three Per Week: Presented at EHA

By Paula Moyer

LYON, FRANCE -- June 19, 2003 -- A once-weekly formulation of epoetin beta (NeoRecormon) is as effective in treating anaemia associated with haematological malignancies as is the standard 3 times daily regimen, according to a presentation made here June 13^th at the 8^th Congress of the European Hematology Association

"This more convenient dosing regimen was effective across different types of malignancies," said Mario Cazzola, MD., a haematologist at the University of Pavia Medical School in Pavia, Italy. In a presentation here June 13^th at the 8^th Congress of the European Haematology Association, Dr. Cazzola said that physicians would find the results reassuring if they want to offer patients the less frequent dosing regimen.

The once-weekly schedule had been shown to be as effective as the 3-times-weekly administration in increasing haemoglobin levels as well as in reducing transfusion requirements in patients with haematological malignancies. Dr. Cazzola and his investigative team wanted to know whether the weekly schedule was equally effective in patients across different types of malignancies of the blood and lymphatic systems.

They analysed data from the NeoRecormon Once Weekly (NOW) study in order to compare the efficacy and tolerability of the two dosing schedules by underlying malignancy. Patients had multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), or chronic lymphocytic leukaemia (CLL), and were given either 30,000 IU of subcutaneous epoetin beta given once weekly or 10,000 IU given 3 times weekly.

Patients had significant anaemia, consisting of a haemoglobin level of 9-11 g/dL, which was associated with their respective malignancies, and a serum erythropoietin of no more than 100mU/mL, which indicated defective endogenous erythropoietin production. The patients were randomised to receive open-label treatment, either with 30,000 IU of epoetin beta weekly or three doses per week of 10,000 IU. The treatment was for 16 weeks.

The study's primary endpoint was the difference in the time-adjusted area under the haemoglobin concentration-time curve (Hb-AUC) from weeks 5 through 16 in the protocol population. Secondary endpoints in the intent-to-treat population included the percentage of patients with a haemoglobin response, defined as a haemoglobin increase of at least 2 g/dL from baseline, without receiving a transfusion in the previous 6 weeks, as well as the percentage of patients with corrected anaemia, which consisted of a haemoglobin nadir of at lease 11 or 12 g/dL at 4-week intervals.

The investigators enrolled 241 patients in the study. Among these, 161 had MM, of whom 79 were in the weekly group and 82 were in the 3 times per week group; 32 had NHL, with 16 each in the two groups; and 48 had CLL with 24 each in the two groups.

The HbAUC was similar with the two dosing schedules, regardless of the underlying malignancy. The least squares mean difference between the treatments was -0.14 for MM (95% CI:-0.56, 0.28); -0.62 for NHL (95% CI: -2.05, 0.80); and -0.21 for CLL 95% CI: -1.20, 0.77).

The investigators found no significant interaction between patients' underlying malignancy and response to the two treatment schedules (p=0.66). A similar proportion of patients responded to the two different schedules, with any difference attributable to the twice-weekly assessment period.

The rates of patients with corrected anaemia were comparable between the two regimens in each of the malignancy subgroups. For the MM patients, the haemoglobin nadir rate of at least 11 g/dL was 76% for the weekly group and 82% for the 3 times weekly group; for the NHL patients those rates were 75 and 81% respectively. In the CLL patients, those rates were 95 and 81% respectively. The rates for the haemoglobin nadir at least 12 g/dL were as follows: in the MM patients 59% for the weekly dose and 63% for the 3 times weekly dose; in NHL patients, the rates were 56 and 63% respectively. For the CLL patients, those rates were 67% in both dosing schedules.

The investigators reported that both schedules were well tolerated across disease types. No antibodies to epoetin beta were detected in any of the participating patients.


[Study title: Once-Weekly Epoetin Beta Is Effective In Anaemic Patients With Lymphoid Malignancies And Defective Endogenous Erythropoietin Production Irrespective Of Disease Type. Abstract 0151]

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