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

NCT02845232 | Completed

• 1 other identifier: 69HCL16_0461
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

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

Keywords

Acute myeloid leukemia; Therapy; Blood transfusion; Cost-effectiveness; Prognosis

Outcome Measures

Primary Outcomes (1)

• Estimation of mean blood product transfusions costs (in euros) per patient according to overall survival

  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.

  From starting treatment to death from any cause (up to 21 months)

Secondary Outcomes (2)

• Complete remission (CR) rate

  Duration of study (Month 21)

• Number of blood product transfusions per patient

  Duration of study (Month 21)

Study Arms (3)

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).

Other: Transfusion

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.

Other: Transfusion

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.

Other: Transfusion

Interventions

Transfusion 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; Intensive chemotherapy; Lower-intensity treatments

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Xavier THOMAS, MD-PhD

  Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 27, 2016
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

FR (1)