Abstract
Anemia is the most frequent hematologic complication of cancer, affecting 68% of patients at some time (Ludwig et al, Eur J Cancer 2004). Anemia causes debilitating fatigue and has a major impact on quality of life. Epoetin beta* (NeoRecormon®) is an effective treatment for anemia that has traditionally been administered three times weekly; however, a once weekly (QW) schedule would be more convenient and may encourage patient compliance. This open-label, single-arm study evaluated the efficacy and safety of epoetin beta 30 000 IU QW in patients with solid or lymphoid malignancies. Adult patients with anemia (hemoglobin [Hb] levels 8–12 g/dL), a WHO performance status 0–2 and who were scheduled to receive chemotherapy were enrolled from 87 centers in France between 31 Dec 2003 and 30 Aug 2005. Patients received SC epoetin beta 30 000 IU QW for up to 16 weeks. Primary efficacy parameter was change in Hb level. Hb response was defined according to patients’ baseline Hb level: in patients with Hb levels of 11–12 g/dL, response was defined as achievement of Hb level of ≥ 13 g/dL; in patients with Hb levels of <11 g/dL, response was defined as Hb increase of ≥ 2 g/dL or Hb level of ≥ 12 g/dL. Of the 691 patients included in the intent-to-treat population, 540 had baseline Hb levels <11 g/dL and 151 had baseline Hb levels of 11–12 g/dL. Fifty-three percent had solid tumors and 47% had lymphoid malignancies. The median duration of treatment was 14 weeks. Mean (±SD) baseline Hb level was 10.1±1.1 g/dL. At endpoint, mean Hb level had increased to 12.0±2.2 g/dL. Hb levels increased rapidly in the subgroup of patients with baseline Hb <11 g/dL, which corresponds to the intervention level recommended by the EORTC (figure). Hb response was seen equally in patients with lymphoid malignancies (60%) or solid tumors (61%). Median time to response was 49 (range 10–130) days. Hb response was seen with all types of chemotherapy. Epoetin beta was well tolerated. Seven percent of patients presented with thromboembolic events, a rate consistent with information provided in the current label for epoetin beta. Epoetin beta 30 000 IU QW is effective in anemic patients with solid tumors or lymphoid malignancies. This regimen provides a convenient and well tolerated treatment which may encourage patient compliance.
Increase in Hb levels during epoetin beta therapy: patients with baseline Hb levels <11g/dl (n=540)
Increase in Hb levels during epoetin beta therapy: patients with baseline Hb levels <11g/dl (n=540)
Disclosures: FP and LB are employees of Roche; DS has received honoraria from Roche, Amgen and Ortho Biotech and research funding from Roche.; DS has received research funding from Roche.; DS has received honoraria from Roche, Amgen and Ortho Biotech.
