Efficacy and Safety of Epoetin beta 30 000 IU Once Weekly in Anemic Patients with Non-Myeloid Malignancies Receiving Chemotherapy.

Background: Once weekly (QW) epoetin beta (NeoRecormon^®) 30 000 IU rapidly increases hemoglobin (Hb) levels and prevents transfusions in patients with lymphoid malignancies (Cazzola et al 2003). The aim of this study was to evaluate the efficacy and safety of epoetin beta 30 000 IU QW in patients with non-myeloid malignancies.

Methods: Adult anemic patients (Hb 8–12 g/dl) with non-myeloid malignancies, WHO performance status 0–2 and who were scheduled to receive chemotherapy (CT) entered into this multicenter, open-label, single-arm study. Patients received epoetin beta 30 000 IU QW for 16 weeks. Primary efficacy endpoint was the % of Hb responders during epoetin beta therapy. Hb response was defined to account for the Hb level at baseline: Hb level of 13 g/dl achieved in patients with baseline Hb 11–12 g/dl or Hb increase of 2 g/dl and/or Hb level of 12 g/dl achieved in those with baseline Hb < 11g/dl.

Results: This analysis reports data of the first 98 patients (mean age 63.4 ± 12.4 years; 61% solid; 39% hematological malignancies). Overall, 67% of patients responded to epoetin beta treatment, with a greater number of patients with hematological malignancies (78.9%) obtaining a Hb response. Median time to response was 43 days. Mean Hb level at baseline was 10.1 ±1.04 g/dl. Hb levels increased to a mean of 12.8 ±1.75 g/dl over a median treatment period of 14 weeks with epoetin beta. Median Hb increase of 1.5 g/dl and 2 g/dl at 7 and 10 weeks, respectively, were recorded. A greater number of patients receiving non-platinum (Pt)-based CT responded (73.5%) than those receiving Pt-based CT (51.7%). At least one thromboembolic event (TEE) was observed in 5% of the patients. Only one TEE was considered to be related to the study treatment.

Conclusions: Epoetin beta 30 000 IU QW is an effective and safe treatment of anemia in patients with non-myeloid malignancies, regardless of CT type and appears particularly effective in patients not receiving Pt-based CT or with hematological malignancies.