A PROSPECTIVE DATA AUDIT OF THE MANAGEMENT OF CHEMOTHERAPY-INDUCED ANEMIA WITH DARBEPOETIN ALFA – THE APRIORI STUDY

Background

 Darbepoetin alfa (DA, Aranesp®) is an erythropoesis-stimulating agent (ESA) used to treat chemotherapy (CT) induced anaemia (CIA). In 2008 EORTC guidelines changed to recommend starting ESA treatment at haemoglobin (Hb) 9 - 11 g/dL and stopping ESA if Hb was > 13 g/dL. In February 2008, the SmPC for DA was revised to recommend treatment start at Hb ≤ 10 g/dL and Hb be maintained in the 10 - 12 g/dL range. APRIORI was a prospective, noninterventional, observational, longitudinal, multicentre study collecting data from patients (pts) in Central and Eastern Europe with CIA receiving DA and CT. The aims were to evaluate the compliance with international guidelines and EU label for use of DA in treating CIA, to assess effectiveness of DA, and describe DA dosing characteristics.

Methods

 This study collected clinical data of cancer pts over 4 consecutive years (11/2006 – 12/2010), at 120 centers in Poland, Czech Republic, Slovakia, Slovenia, Hungary, and Russia. Pts were enrolled before the label change (BLC) as well as after the label change (ALC). The data were collected at enrolment and at follow-up visits during CT until the first follow-up visit after the end of CT.

Results

 Out of 6408 pts enrolled (mean (sd) age of 59.9 (±12.57) years, 44.4% male), 929/1648 (56.4%) pts enrolled BLC had Hb in the target 9 - 11 g/dL range, while 4284/4760 (90.0%) pts enrolled ALC had Hb in the target range of ≤ 10 g/dL. Total 666 (40.4%) pts had Hb < 9 g/dL and 53 (3.2%) pts had Hb > 11 g/dL BLC, while 476 (10.0%) pts had Hb > 10 g/dL ALC. BLC, 38 (35.8%) pts had any DA dosing withheld while exceeding the 13 g/dL Hb concentration limit, at any time during the study and ALC, 55 (7.8%) pts had the doses reduced while exceeding the 12 g/dL Hb concentration limit, at any time during the study. DA effectively increased Hb concentrations; mean Hb after achieving the target anaemia Hb level BLC 11.94 g/dL vs. 11.29 g/dL ALC. Only 4.9% of pts required RBC transfusion after 5 weeks of DA initiation. Out of 9 ADRs no serious and no fatal ADRs was reported during the study. Mortality was 4.9% (305 pts).

Conclusion

 Based on these data, the patients are being treated in accordance with the current European SmPC for darbepoetin alfa. This study was sponsored by Amgen GmbH CEE Headquarters.

Disclosure

P. Boguradzki: Corporate-sponsored research - Amgen APRIORI,

K. Boér: Corporate sponsored study - APRIORI study Amgen,

A. Cipková: Corporate-sponsored research - Amgen APRIORI,

E. Wojciechowska-Lampka: Corporate-sponsored research - Amgen -APRIORI,

M. Schützová: Corporate-sponsored research - Amgen; member of advisory board - Amgen,

J. Ocvirk: Corporate-sponsored research - Amgen APRIORI,

E. Tóth: Amgen contract worker.

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