Darbepoetin alfa in the treatment of chemotherapoy-induced anaemia;Effects of target haemoglobin label change: data from the APRIORI study

Objectives: The aim of the prospective, observational APRIORI study was to assess adherence to treatment guidelines in Central and Eastern European (Czech Republic,Hungary, Poland, Slovakia and Slovenia) countries. In February 2008, the European product label for darbepoetin alfa (DA) was modified to specify a haemoglobin (Hb)target level range of 10-12 g/dL. We report here patient (pt) characteristics before and after label change.

Patients and methods: Between November 2006 and December 2008, 2972 pts with solid tumours and haematological malignancies treated with chemotherapy and DA were enrolled. Hb at enrolment, Hb at the end of treatment period (EOTP) and number of pts treated with red blood cell (RBC) transfusions were evaluated.

Results: This interim analysis includes 1641 pts enrolled before and 1331 pts enrolled
after label change. Mean Hb levels at enrolment were similar for pts included before and after label change (9.22 vs 9.23 g/dL). Prior to label change, 78.6% and 96.7% of pts had Hb levels <10 g/dL and <11 g/dL, respectively. After label change these figures were 82.5% and 97.6 %. At EOTP the target Hb range (10-12 g/dL) was reached in 42.3% and 45.8% of pts (before vs after label change). RBC transfusions were required by 9.4% of pts before label change and 7.8% after. One serious (pulmonary embolism) and 7 non-serious treatment-related adverse events were reported.

	All pts	Before label change	After label change
	n = 2972	n = 1641 (55.2%)	n = 1331 (44.8%)
Enrolment
*Hb mean (SD)	9.23 (0.98)	9.22 (1.04)	9.23 (0.90)
Hb<10, %	80.3	78.6	82.5
Hb≥10, %	19.7	21.4	17.5
EOTP
Hb mean (SD)	10.71 (1.66)	10.78 (1.71)	10.61 (1.58)
Hb <10, %	33.5	32.5	34.7
Hb ≥10, %	66.5	67.5	65.3
Hb 10-12, %	43.9	42.3	45.8
%Pts requiring RBC	8.7	9.4	7.8
transfusiona

*Hb in g/dL

^aFrom week (wk) 5 - EOTP; number of pts in study at wk 5 used as denominator (2140 (72%) pts, 1211 (73.8%) before label change, 929 (69.8%) after label change)

Conclusions: These findings suggest that the majority of pts were treated according to
the European product label for DA both before and after label change. This study is sponsored by Amgen GmbH CEE Headquarters.

Disclosure: V. Sárosi: The author is an investigator of this study and has served on the
speaker´s bureaus of Roche Ltd, Novartis and GSK. M. Balázs: The author is employed by and owns stock in Amgen. All other authors have declared no conflicts of interest.