A prospective cohort study on the impact of darbepoetin alfa on quality of life in daily practice following anemia treatment guideline revisions

Abstract

Objective:

This study aimed to evaluate the impact of darbepoetin alfa (DA) on hemoglobin (Hb) levels and quality of life (QoL) in cancer patients with anemia in current daily practice following several revisions of anemia treatment guidelines.

Methods:

This was a prospective, multi-center, observational study across Germany in non-myeloid cancer outpatients with chemotherapy-induced anemia treated with DA. Age, sex, cancer type, stage, and therapy, performance status, anemia status and treatment, and Hb concentrations were recorded for up to 18 weeks in a web-based registry. Optional QoL assessments were collected at baseline and at the end of DA treatment.

Main results:

Of 984 eligible patients, 978 had complete anemia data, 492 also had complete QoL data. In the 978 patients, mean age was 64 (standard deviation, SD 12) years, 62% of patients were women. Breast (26%) and gastrointestinal (22%) cancer were most prevalent. Therapy was palliative in 44% of patients and initiated with curative intent in 29%. Mean baseline Hb was 9.5 (SD 0.9) g/dL, which increased by an average of 1.2 g/dL. In 67% of patients Hb increased either to 10–12 g/dL or by ≥2 g/dL; no Hb response was seen in 219 patients (22%); increases of 0 to 1, >1 to 2, and >2 g/dl were seen in 216 (22%), 265 (27%), and 278 (28%) patients, respectively. Anemia treatment did not result in any significant differences of performance status. However, QoL improvements were significantly greater in Hb responders, although a linear relationship with Hb increments was lacking. None of 47 fatal cases was considered related to treatment with DA.

Conclusion:

Patients treated with DA in routine clinical practice had increases in Hb and reported improvement in QoL. Due to the uncontrolled design, no conclusions can be made regarding causality to treatment and the clinical relevance of the improvement.

Keywords::

• Cancer-associated anemia
• Observational study
• Treatment practice

Transparency

Declaration of funding

The study was supported by Amgen GmbH, Germany.

Declaration of financial/other relationships

T.S. has disclosed that she/he has been a consultant, study investigator and conference speaker for Amgen. E.H. and A.K. have disclosed that they are employees of Amgen. M.K., O.L. and U.V.-K. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank all participating investigators for contributing data. Medical writing support (funded by Amgen) was provided by Uwe Totzke (TDS SA, Switzerland). Statistical analysis (funded by Amgen) was provided by Axel Hinke and Heidi Eustermann (WiSP GmbH, Germany).

Previous presentation: Preliminary results of the study have been presented as a poster at ESMO 2012, 28 September – 2 October 2012, Vienna, Austria; Steinmetz T. et al. 1567P.