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

NCT ID: NCT02845232

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 214 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-05-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Intensive chemotherapy

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).

Transfusion

Intervention Type: OTHER

The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.

Lower-intensity treatments

The second study group comprised 70 patients who were treated on frontline by lower-intensity treatments \[LD-AraC(39 patients), azacitidine (16 patients), decitabine (11 patients),tipifarnib (3 patients), or ATRA (1 patient)\]. Patients received LD-AraC 20 mg once or twice daily (according to physician'schoice) by subcutaneous injection for 10 consecutive days. Azacitidine was given at the dose of 75 mg/m2/day for 7 consecutive days by sc injection. Decitabine was administered by intravenous route once daily at 20 mg/m2 for 5 consecutive days. Tipifarnib was given at 600 mg administered orally twice daily for 21 consecutive days in 4-week cycles. ATRA was given at 45 mg/m2until CR achievement followed by maintenance combining 6-mercaptopurine with methotrexate.

Transfusion

Intervention Type: OTHER

The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.

Best Supportive Care

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

Transfusion

Intervention Type: OTHER

The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.

Interventions

Transfusion

The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier THOMAS, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Locations

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet

Pierre-Bénite, , France

Countries

France

Other Identifiers

69HCL16_0461

Identifier Type: -

Identifier Source: org_study_id