Amgen Aranesp
Research type
Research Study
Full title
Use of Erythropoiesis Stimulating Agents (ESAs) in Patients Receiving Myelosuppressive Chemotherapy in Europe and the UK
IRAS ID
318390
Contact name
Sylvia Feyler
Contact email
Sponsor organisation
Amgen
Duration of Study in the UK
0 years, 5 months, 12 days
Research summary
Myelosuppressive chemotherapy is a common cause of anaemia in cancer patients. Erythropoiesis stimulating agents (ESAs) are a treatment option used to reverse chemotherapy-induced anaemia (CIA) by stimulating red blood cell production. The major aims of ESA treatment are the reduction of a patient’s anaemia symptoms, particularly fatigue, and an improved quality of life.
Darbepoetin alfa is an ESA prescribed in the EU and UK for treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. Following safety concerns regarding increased death or tumour progression following treatment with ESAs such as darbepoetin alfa, a randomised, double-blind, placebo-controlled phase 3 clinical trial in patients with chemotherapy-induced anaemia receiving multi-cycle chemotherapy for the treatment of advanced stage non-small-cell lung cancer (NSCLC) was conducted to assess these safety concerns. The trial demonstrated no increased risk of death or progression as compared to placebo.
However, real-world use of ESAs may differ from use in clinical trials which means that there might be some risks that were not observable in the trial setting. The European Medical Agency have requested that a real-world safety study be conducted as a post-marketing requirement of darbepoetin alfa. This study aims evaluate ESA use and prescribing practices in European and UK settings. Specifically, this study aims to determine if the pattern of use of darbepoetin alfa and other ESAs is consistent with their European label (the instructions of what the medicine is, who should or should not take it, and how to use it) as well as characterise the use of ESAs in cancer patients undergoing myelosuppressive chemotherapy in Europe and the UK.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/PR/0424
Date of REC Opinion
25 Apr 2023
REC opinion
Favourable Opinion