1567P - Effective management of chemotherapy-induced anaemia in clinical practice using darbepoetin alfa: final data from the correct II study

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Supportive Care
Presenter H. Tilman Steinmetz
Authors H..T. Steinmetz1, O. Lange2, U. Vehling-Kaiser3, M. Kindler4, U. Söling5, A. Kuhn6, E. Hellebrand6, J. Eggert7
  • 1Praxis fuer Haematologie und Onkologie, 50677 - Köln/DE
  • 2Praxis, Gemeinschaftspraxis für Strahlentherapie und Onkologie, Bonn/DE
  • 3Onkologisches und Palliativmedizinisches Netzwerk Landshut, 84028 - Landshut/DE
  • 4-, Onkoplan GmbH, Berlin/DE
  • 5Onkologische Schwerpunktpraxis, DE-34117 - Kassel/DE
  • 6Research And Development, Amgen, Munich/DE
  • 7Gemeinschaftspraxis Für Hämatologie & Onkologie, St. Josef Hospital Moers, Moers/DE

Abstract

Purpose

The CORRECT II study assessed: (1) the use of darbepoetin alfa (DA) in routine clinical practice; (2) whether DA is being used according to its European product label and EORTC guidelines.

Methods

A prospective multicentre observational study conducted in Germany enrolling 1,066 patients (pts) with non-myeloid malignancies, symptomatic chemotherapy-induced anaemia and planned treatment with DA. The primary endpoint was a haemoglobin (Hb) level of 10–12 g/dL at week (wk) 9 or, if earlier, at the end of treatment. Red blood cell (RBC) transfusion needs and quality of life (QoL) were also assessed.

Results

In total, 984 pts met the protocol criteria and were included into the analysis. Cancer types included breast (n = 260; 26%), lung (n = 118; 12%), ovarian (n = 103; 10%), colorectal (n = 95; 10%) and other (n = 408; 41%). Median Hb levels rose from 9.6 g/dL at baseline (BL) to 10.8 g/dL at wk9. 519 pts (53%) reached the primary endpoint over 3.7 wks (median; IQR 0.1–7.1) of DA treatment. Median time to Hb level ≥10 g/dL was 14 days (IQR 0–32 days). RBC transfusion was required by 32% of pts from wk1 to wk9; 16% of pts required RBC transfusion in the first 3 wks from DA initiation. QoL improved (measured using FACIT questionnaires and the Linear Analog Scale Assessment); however, a clinically important difference was only found using FACIT-F. Of 30 reported adverse drug reactions, the investigators classified 12 as DA related. Of these, 1 was fatal.

Conclusion

Overall, DA use was in line with the current label and guidelines; most pts started DA at Hb levels of ≤10 g/dL and were treated to the Hb target level of 10-12 g/dL. DA seems to be effective in enhancing Hb response and improving QoL. Study sponsor: Amgen Europe (GmbH). Editorial support: archimed medical communication ag.

Median (IQR) or n (%). Information available for 984°, 588∞, 726a, 978¤ or 980^ pts. *Primary endpoint or rise of 2 g/dL from BL.

Baseline
Age, years 66 (57–73)°
Female 617 (63%)°
Hb level, g/dL 9.6 (9–10.1)°
Hb level ≤10 g/dL 716 (73%)°
Performance status 1–2 818 (83%)°
Disease stage III–IV 350 (59%)∞
Prior chemotherapy 387 (53%)a
Anaemia treatment in 4 wks before BL 161 (16%)°
Wk9
Hb level, g/dL 10.8 (9.8–11.8)¤
Met primary endpoint (Hb 10–12 g/dL) 519 (53%)¤
Met modified response* 660 (67%)¤
Hb level >12 g/dL 178 (18%)¤
Required RBC transfusion 312 (32%)¤
Chemotherapy cycles 5 (3–6)^

Disclosure

H.T. Steinmetz: Consultation and advisory boards: Amgen, Roche, Janssen/Ortho-Biotec, Vifor, Medice, Hexal. Funding for scientific research: Amgen, Roche, VIifor. Travel costs: Amgen, Roche, Vifor.,

A. Kuhn: Employee and shareholder of Amgen.,

E. Hellebrand: Employee of Amgen.

All other authors have declared no conflicts of interest.