Brief Title
Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly
Official Title
Economic Analysis of Blood Product Transfusions According to the Treatment of Acute Myeloid Leukaemia in the Elderly
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.
Study Type
Observational
Primary Outcome
Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival
Secondary Outcome
Complete remission (CR) rate
Condition
Acute Myeloid Leukemia
Intervention
Transfusion
Study Arms / Comparison Groups
Intensive chemotherapy
Description: First group: 68 patients receiving a combination of intermediate-dose cytarabine and an anthracycline. One patient with acute promyelocytic leukaemia (APL) also received all-trans retinoic acid (ATRA).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
214
Start Date
March 2013
Completion Date
May 2015
Primary Completion Date
December 2014
Eligibility Criteria
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
Gender
All
Ages
70 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Xavier THOMAS, MD-PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02845232
Organization ID
69HCL16_0461
Responsible Party
Sponsor
Study Sponsor
Hospices Civils de Lyon
Study Sponsor
Xavier THOMAS, MD-PhD, Principal Investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Verification Date
July 2016