gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

Two different weekly doses of ERYPO® (EPO) in anemic tumor patients (pts.) undergoing chemotherapy or combined chemo-radiotherapy – results of a non-interventional, oberservational survey (OS)

Meeting Abstract

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  • corresponding author presenting/speaker Ralf Angermund - Ortho Biotech, Division of Janssen-Cilag GmbH, Neuss, Deutschland
  • Susanne Bammer - Ortho Biotech, Division of Janssen-Cilag GmbH, Neuss

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO626

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Veröffentlicht: 20. März 2006

© 2006 Angermund et al.
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Objectives: This OS was performed to document erythropoiesis parameters under Epoetin alfa (ERYPO®) therapy in anemic tumor pts. undergoing chemotherapy or combined chemo-radiotherapy. Information regarding the safety and tolerability of EPO treatment was documented also.

Methods: Pts. were treated up to 8 weeks (w). At baseline, demographic and medical history data were documented. Hemoglobin (Hb) and other lab values were documented weekly. EPO dosage and type of application were collected once weekly, adverse events (AEs) continuously.

Results: Over a period of 2 years (yrs.), n=984 pts. were included, of which n=977 were evaluated with at least one EPO application and Hb documentation. Of the 984 pts., 614 were female, 362 male (8 pts. not specified). The average age equaled 60.6 yrs. of age, 105 pts. (11%) had at least reached the age of 75. The most frequent tumors were: 26% breast, 10% ovarian, 9% bronchial, 7% plasmacytoma, NHL and CLL 4% each. EPO therapy was started after an average of 25.5±44.77 months since initial diagnosis.

The average Hb increased from 9.96 g/dl (SD: 1.44 g/dl) at baseline to 11.38 g/dl (SD: 1.96 g/dl) at the end of the OS. On average, an Hb increase of approx. 1.41 g/dl resulted. A total of 521 pts. (53%) had a Hb increase of at least 1 g/dl during the treatment course, for 301 pts. (31%), Hb increased approx. 2 g/dl. A total of 341 pts. (35%) showed an increase in the final Hb to > 12 g/dl, 76 pts. (8%) had a Hb level > 14 g/dl. A total of 47% of the pts. (n=458) achieved at least once a Hb > 12 g/dl during the course of treatment. Of the 977 pts., 612 (62,6%) started with 30,000 IU of EPO/w, 216 (22.1%) wit 40,000 IU of EPO/w. The percentage of the pts. with a Hb increase to > 12 g/dl after 4 w was 35.6% vs. 22.9% (40,000 IU vs. 30,000 IU EPO/w). After 8 w, the percentage increased to 50.9% (40,000 IU/w) vs. 44.8% (30,000 IU/w).

A total of 250 AEs was documented for 102 pts. (10%), in which 73 cases involving 48 pts. (5%) were serious. Progressive tumor diseases in 17 pts. were most frequently named, as well as generalized disorders in 10 pts. For 8 pts. with a total of 38 AEs, at least one AE was seen to be possible or probably related to EPO (for 2 of these, a deterioration of the tumor disease was involved). A total of 20 pts. died during the course of the OS.

Discussion: Pts. with a starting dose of 40,000 IU EPO/w experienced a Hb increase to > 12 g/dl more frequently and more quickly than with a starting dose of 30,000 IU/w.