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02.03.2018 | original report | Ausgabe 2/2018 Open Access

memo - Magazine of European Medical Oncology 2/2018

APPLY: A prospective observational study of clinical practice patterns of darbepoetin alfa use in patients with chemotherapy-induced anemia in Romania

Zeitschrift:
memo - Magazine of European Medical Oncology > Ausgabe 2/2018
Autoren:
Nicoleta Mariana Berbec, Dana Lucia Stanculeanu, Nicoleta Sorina Badelita, Mariana Vasilica, Dorel Ionel Popovici, Andrei Colita, Cristina Neacsu, Alexandru Iordan
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s12254-018-0390-4) contains supplementary material, which is available to authorized users.

Author contribution statement

According to the definition given by the International Committee of Medical Journal Editors (ICMJE), all authors listed above qualify for authorship based on making one or more of the substantial contributions to the intellectual content of: (i) Conception and design; (ii) Analysis and interpretation of data; (iii) Participation in drafting of the manuscript; (iv) Critical revision of the manuscript for important intellectual content. Nicoleta Mariana Berbec and Dana Lucia Stanculeanu contributed equally to the manuscript.

Summary

Purpose

The primary objective of this study was to evaluate the compliance of Romanian physicians with the national therapeutic protocol and international guidelines on treatment with erythropoiesis-stimulating agents in anemic cancer patients receiving chemotherapy. The secondary objective was to assess the hemoglobin (Hb) level change due to anemia treatment and safety of darbepoetin alfa.

Methods

This was a single-arm, prospective, longitudinal, multicenter, observational study in patients with nonmyeloid malignancies and symptomatic chemotherapy-induced anemia treated concomitantly with darbepoetin alfa. Patients were followed for the duration of chemotherapy, but no shorter than three and no longer than eight cycles, irrespective of their exposure to darbepoetin alfa.

Results

In this study, 497 patients with a mean age of 60.6 years were analyzed. Most patients (80.7%) were initiated on darbepoetin alfa at a Hb of 9–11 g/dL, congruent with recommendations. The median Hb increased by 0.9 g/dL between baseline and week 12. Hb target achievement was higher among patients treated according to guidelines than those initiated at Hb < 9 g/dL. A similar trend was observed for red blood cell transfusion requirements. No new safety signals were reported for darbepoetin alfa.

Conclusions

The majority of patients were treated according to national and international recommendations. Guideline adherence was associated with more frequent achievement of Hb targets and lower red blood cell transfusion requirements compared with patients starting anemia treatment with darbepoetin alfa at lower-than-recommended Hb levels.
Zusatzmaterial
Laboratory assessments at enrolment, an analysis of the influence of different factors on the primary and secondary outcomes, the proportion of patients with Hb level ≤ 10 g/dL at initiation of darbepoetin alfa, the time to achieve the Hb target level, as well as the proportion of patients receiving chemotherapy at full dose on schedule
12254_2018_390_MOESM1_ESM.docx
Literatur
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