Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,167
- Locations
- 67
- Primary Endpoint
- Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia
Study Overview
Brief Summary
The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.
Detailed Description
This is a longitudinal, observational, prospective, multicentre, cohort study, conducted on a representative sample of public and/or private hospital-based oncologists and haematologists practicing in Metropolitan France.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients, aged 18 years and older, seen by the oncologist or hematologist for chemotherapy.
- •Patients for whom the oncologist or hematologist has decided the initiation of an epoetin alpha biosimilar treatment (Retacrit®) for anemia.
- •Patients informed about the computer processing of their medical data and their right of access and correction.
Exclusion Criteria
- •Patients with hemoglobin concentrations >11 g/dL.
- •Patients who have been transfused within the previous month.
- •Patients who are hypersensitive to erythropoietin or one of its excipients.
- •Patients participating or having participated in the previous month in a clinical trial in the field of anaemia in oncology.
- •Patients refusing to participate in the observational study.
Outcomes
Primary Outcomes
Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia
Time Frame: Patients are included at the time of the epoetin alpha biosimilar treatment initiation for chemotherapy-induced anemia and followed up to 12 to 16 weeks
The efficiency of epoetin alpha biosimilar will be assessed by the responders'rate according to European Society for Medical Oncology (ESMO) guidelines. This rate will be compared depending on the iron supplementation. The safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation.
Secondary Outcomes
- Experience of patients treated with Retacrit®(At 12 to 16 weeks from baseline or at the end of chemotherapy)
- Procedures for evaluating possible iron deficiency and iron supplementation(At 12 to 16 weeks from baseline or at the end of chemotherapy)
- Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia(Baseline visit)
- Impact of iron supplementation on the doses of Retacrit® used, and on treatment duration(At 12 to 16 weeks from baseline or at the end of chemotherapy)