Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.

NCT03350152 | Completed

• 1 other identifier: HCL
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. Although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'Older' patients are generally considered those aged 60 years or older. Intensive chemotherapy delivered to the very elderly with AML (patients \_70 years of age), may not be beneficial to most and could be harmful to some. However, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of AML (de novo or secondary). In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. The efficacy of hypomethylating agents has been studied in older AML patients with conflicting results. Recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches. In this study, the investigators focus on patients with AML (\_20% blasts) aged 70 or older seen in our institution over a 14-year period. The objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect

Conditions

Acute Myeloid Leukemia

Keywords

Chemotherapy, Low-intensity therapy, elderly, prognosis,

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  OS was the main endpoint for this analysis. The event for OS was death, and patients were censored at the date of last contact, if alive.

  Date of last contact if alive, up to 100 months

Study Arms (1)

LAM group

Have a diagnosis of AML according to World Health Organization (WHO) classification Are at least 70 years of age

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Have a diagnosis of AML according to World Health Organization (WHO) classification * Are at least 70 years of age * Gender male and female

You may qualify if:

• Have a diagnosis of AML according to World Health Organization (WHO) classification
• Are at least 70 years of age

You may not qualify if:

• \- Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

CORTIAL

Pierre-Bénite, Rhone, 69310, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 22, 2017
• Study Start: January 1, 2000
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 22, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)