Clinical trial NCT02845232: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
Therapy
Blood transfusion
Cost-effectiveness
Prognosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 214
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups of elderly patients aged 70 years or older, with AML. 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).

The second study group comprised 70 patients who were treated on frontline by lower-intensity treatments \[LD-AraC(39 patients), azacitidine (16 patients), decitabine (11 patients),tipifarnib (3 patients), or ATRA (1 patient)\].

The last study group comprises 76 patients: 31 patients received supportive care, while 36 patients also received hydroxyurea and 9 patients received 6-mercaptopurine.

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.


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

Primary outcomes:
measure: Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival
timeFrame: From starting treatment to death from any cause (up to 21 months)
Secondary outcomes:
measure: Complete remission (CR) rate
timeFrame: Duration of study (Month 21)
measure: Number of blood product transfusions per patient
timeFrame: Duration of study (Month 21)
Other outcomes:
Locations:
city: Pierre-benite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet
Study officials:
affiliation: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
name: Xavier THOMAS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: