Objective: This study was aimed at investigating the effectiveness and safety of once-weekly epoetin beta for anaemic cancer patients receiving chemotherapy.
Methods: A total of 104 patients with a haemoglobin level of </=11.0 g/dL were enrolled. Patients received a once-weekly subcutaneous dose of 36 000 IU epoetin beta for 12 weeks. If the increase in the haemoglobin level was <1.0 g/dL after 6 weeks, or a red blood cell transfusion was required between days 15 and 42, the dose of epoetin beta was increased to 54 000 IU from the subsequent week. The primary endpoint was the percentage of patients who achieved a haemoglobin increase of >/=2.0 g/dL; the haemoglobin response rate. Quality of life (QOL) was assessed using the Functional Assessment of Cancer Therapy-Anaemia (FACT-An) questionnaire.
Results: The haemoglobin response rate was 66.3% among the 98 patients (breast cancer: n = 25; malignant lymphoma: n = 21; ovarian cancer: n = 20; lung cancer: n = 15; other cancers: n = 17) assessable for a haemoglobin response. Thirty-nine patients (39.8%) required a dose escalation to 54 000 IU. At the end of the study, QOL assessable patients (n = 96) showed a mean improvement in the FACT-An total fatigue subscale score (FSS) of 0.3 points from baseline. Patients with a haemoglobin response had a mean change in the total FSS of +3.2, compared with -3.4 for patients without a haemoglobin response. No serious adverse event of epoetin beta was observed.
Conclusions: Epoetin beta administered at an initial dose of 36 000 IU once-weekly was well tolerated, with increased haemoglobin levels and improved QOL in anaemic cancer patients receiving myelosuppressive chemotherapy.