gms | German Medical Science

Objectives: This OS was performed to document the effect of treatment with ERYPO® FS 10.000 on hemoglobin value (Hb), the WHO performance status and the anemic-specific effects in tumor patients undergoing chemotherapy. Information regarding the safety and tolerability of EPO treatment was documented also.

Methods: Pts. were treated up to 16 weeks. At baseline, demographic and medical history data were documented. The Hb and EPO dosage were collected once weekly. The WHO performance status and details regarding quality of life (QoL) were documented monthly, adverse events (AEs) continuously.

Results: Over a period of 2 years, n=1101 pts. were included, of which n=938 (85.2%) were evaluated with at least one EPO application. Of the 1101 pts., 473 were male and 583 female (81 pts. not specified). The average age equaled 59.2 years of age. The average duration of the disease at the start of therapy was 17.2±29.3 months. Hematological malignancies were documented in 242 pts. (22.0%) (thereof, 18.2% lymphoma; 2.0% leukemia; 1.1% MDS), solid tumors were documented in 856 pts. (77.7%) (thereof, 35.1% gynecological; 12.3% urological; 11.5% GI; 9.9% lung and 5.6% head-neck tumors; 0.3% of pts. without specification of tumor disease).

The average Hb of all pts. increased from 9.78 g/dl (range: 5.2–16.8 g/dl) at baseline to 11.47 g/dl (range: 4.7–19.3 g/dl) at the end of treatment. On average, a Hb increase of 1.67 g/dl resulted. 707 pts. (75.4%) had a Hb increase of at least 1 g/dl in the course of treatment, in which the period till achievement of this increase equaled 28 days. For 508 pts. (54.2%), the Hb increased 2 g/dl (average duration to the occurrence of this increase: 59 days). A total of 498 pts. (53.1%) had a Hb of at least 12 g/dl. A total of 280 AEs was documented for 200 pts. (18%), in which 177 cases involving 154 pts. (14%) were serious (SAEs). For 108 pts., progressive tumor diseases were mentioned most frequently (not related to EPO). All other SAEs occurred with a frequency of <1%, among those operative interventions (n=6), pneumonias (n=4), as well as 3 cases each of renal failure, venous thrombosis and asthenia. For 22 pts., at least one AE was seen to be possible or probably related to EPO. A total of 84 pts. died during the course of the OS.

Discussion: The findings of the OS show that the clinical use of EPO in accordance with the SMPC is safe and tolerable and they thereby confirm the results of clinical trials.