gms | German Medical Science

Background: EPO increases haemoglobin (Hb), decreases transfusion requirements, and improves quality of life (QOL) in anaemic cancer patients (pts) undergoing chemotherapy. The open-label, randomised, multicenter German lung cancer study EPO-GER-22 was designed to determine the effect of EPO on the 2-year-survival- rate in 612 pts with non-resectable NSCLC (stage IIIA/B) undergoing first-line sequential chemo-radiotherapy (CT-RT).

Methods: Pts are randomized (1:1) into treatment groups A and B to receive three 3- weekly cycles of cisplatin (50 mg/m2, days 1 and 8) and vinorelbine (30 mg/m2, days 1 and 8) followed by irradiation (66 Gy, 2 Gy/day). Additionally to their CT-RT, pts in arm B receive 40.000 IU/wk EPO sc. Dose adjustments are based on Hb-response and target- Hb (12–13 g/dL). Blood transfusions can be administered if medically indicated.

Results: Data of 215 pts (107 pts control group (CG), 108 pts EPO group (EPO)) were available for this safety interim analysis. Pts in the EPO group needed sign. less blood transfusions than pts in the CG (0.40 ± 1.24 units (EPO) and 1.31 ± 2.57 units (CG)). The mean Hb level in the EPO group was sign. higher than in the control group (nadir (CG) 9.71 ± 1.44 g/dL and 10.60 ± 1.24 g/dL (EPO) (P < 0.05).The mean Quality of life (QoL) scores (FACT-An quest.) dropped in both groups during CT and improved during RT with an overall tendency of better performance in the EPO-group. The median survival time was analyzed because at the time of evaluation only few pts had completed the two-year-interval. There was no stat. sign. difference in the median survival time between both groups (338 days (d) (EPO) vs. 299 d (CG) (P = 0.61)). The subgroup with a baseline Hb < 13 g/dl shows increased survival in the EPO group (446 d(EPO) vs. 282d(CG) (p<0.05)). The analysis of adverse events (AEs) displayed no sign. differences between both treatment groups. The most frequent AEs (ICD-10): Diseases of the haematopoietic system, lymphatic system, infections, symptoms of the circulatory and pulmonatory system, gastrointestinal and abdominal symptoms, and constitutional symptoms.

Conclusions: This interim analysis shows that EPO can be safely administered at a dose of 40.000 IU/wk in pts with stage-III-NSCLC. EPO stabilizes Hb and results in sign. higher Hb-levels as in pts receiving blood transfusions. The QoL and survival results should be interpreted carefully until the complete data from the full study cohort will be analyzed.