Abstract
20743 Background: To determine the efficacy and safety of epoetin beta in the prevention and treatment of anaemia in non-small cell lung cancer (NSCLC) patients treated with chemotherapy. Methods: It is a multicenter, open-label, single-arm study. All eligible patients receive treatment of epoetin beta subcutaneously 3 times weekly at the initial dose of 150 IU/kg for 16 weeks. Primary efficacy parameter is the percentage of patients with increase in haemoglobin values by ≥ 2 g/dl compared to baseline without blood transfusion in previous 6 weeks (defined as response rate). Secondary efficacy parameters are increase in haemoglobin,number and volume of blood transfusion per patient and red cell count. Safety includes blood pressure, adverse events and serious adverse event. Median progression-free survival (mPFS) is calculated only for the advanced NSCLC patients in the first line setting.Statistical computations are performed with SPSS13.0. Results: 26 male and 24 female NSCLC patients treated with chemotherapywere enrolled in this study from October 12, 2006 to December 8, 2006. Response rate of epoetin beta is 74% for intent-to-treatment (ITT) analysis population but 86% for Per-Protocol (PP) analysis population; haemoglobin has increased significantly since the 4th week and is significantly different among different duration of epoetin beta treatment, and change of red cell count is similar to that of haemoglobin. Fewer patients (4%, 2/50) need blood transfusion. After epoetin beta treatment, blood pressure shows no significant difference compared to the baseline. Safety of epoetin beta is good. Grade 3/4 adverse events: neutropenia 14%, diarrhea 2%, vomitting 2%, palpitation 2%, anemia 2%, oral ulcers 2% and arrhythmia (serious adverse events) 2%, all of which were not related to epoetin beta. When epoetin beta is used, mPFS was 152.0 days, 95% CI (115.9∼188.1) for those in the first line setting. Conclusions: Epoetin beta may prevent and treat anaemia in non-small cell lung cancer (NSCLC) patients treated with chemotherapy. No significant financial relationships to disclose.
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