Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT02845232
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Blood transfusion requirement represents one of the most significant cost driver associated with acute myeloid leukemia (AML). In addition to an increase prevalence of co morbidities in older patients, AML in older patients is more often associated with adverse features than in younger adults. Physicians might therefore decide to offer palliative or supportive care rather than intensive chemotherapy. An alternative treatment could be low-intensity therapy, such as LD-AraC or hypomethylating agents, which demonstrated better results than only Best Supportive care (BSC). Blood transfusion requirement represents one of the most significant cost driver associated with AML.

The present study assesses the cost-effectiveness of intensive chemotherapy versus Best Supportive Care (BSC) versus alternative therapies (hypomethylating agents, low-dose cytosine arabinoside (LD-AraC), or other investigational drugs) in elderly patients aged 70 years or older regarding blood product transfusions from a French payer perspective. Intensive chemotherapy and BSC were the comparators in this analysis, since they continue to represent the most commonly used treatment for elderly AML according to the defined status of patients considered as 'fit' or 'unfit' for intensive chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Status Verified: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-22
• Last Update Submitted: 2016-07-22
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Age ≥ 70 years old
• AML according to the World Health Organization (WHO) criteria (% of blasts ≥ 20% in bone marrow aspiration).
• All FAB subtypes.
• Any type of AML (de novo or secondary)
• All participants to clinical trials gave their written informed consent

Exclusion Criteria

• Have an Eastern Cooperative Oncology Group (ECOG) score ≥2
• Active uncontrolled infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival	From starting treatment to death from any cause (up to 21 months)	The cost-effectiveness of blood product transfusion was determined among initial treatment subgroups: patients receiving intensive chemotherapy, patients receiving low-intensity treatments, and patients treated only by BSC.

Secondary Outcome Measures

Name	Time	Method
Complete remission (CR) rate	Duration of study (Month 21)	Complete remission (CR) was defined by bone marrow aspiration, which was required to consist of more than 50% normal cellularity with evidence of trilineage maturation and less than 5% bone marrow blasts, no evidence of extramedullary disease, and regeneration of the peripheral neutrophil count to 1.0 × 109/L and the platelet count to 100 × 109/L. The persistence of myelodysplastic features did not exclude the diagnosis of CR.
Number of blood product transfusions per patient	Duration of study (Month 21)	Decisions concerning transfusion indications were based on institutional policy and the clinical judgment of treating physicians. Transfusion practice was consistent during the period of study. Prophylactic transfusions were consistently given at morning platelet counts of \< 20 ×109/L and haemoglobin level \< 80 g/L. Protocol Blood products were leukoreduced through discarding the buffy coat and administered through a standard 140 to 170 µm blood filter but were not irradiated

Trial Locations

Locations (1)

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet; 🇫🇷 Pierre-benite, France