Effect of Age on Treatment Decision-Making in Elderly Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those
      aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly
      patients, owing to comorbidities, the greater possibility of other hematopoietic disorders,
      and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy,
      administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy for
      this patient population. This approach improved survival compared with supportive care
      (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that
      the results of intensive chemotherapy in elderly patients remain poor. Although complete
      remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term
      survival has been poor. Furthermore, most clinical trials have only enrolled patients with an
      adequate performance status (PS).

      Prognostic models have been developed from clinical trial data to predict the outcomes for
      older patients. However; each model relies on chronologic age. Age is a surrogate measure for
      both changes in tumor biology and patient characteristics. Understanding which patients are
      likely to benefit from intensive therapies versus low-intensity therapies or supportive care
      is critical. The definition of "fit" to undergo intensive induction therapy has not been
      established, and the therapeutic choice is mainly determined by physician and patient
      decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more
      beneficial than best supportive care and hydroxyurea. The recent availability of new drugs
      that could have an improved side effect profile and, in some cases, bioavailability might
      offer future improvement for this patient population. In this setting, the investigators have
      tended to consider, since 2007, patients aged ≥70 years as potential candidates for
      alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they
      presented in good physical condition.

      The investigators goal was to determine whether age ≥ 70 years could represent a useful and
      simple cut off for treatment decision-making in clinical practice and whether low-intensity
      therapy could be an alternative therapeutic approach to intensive chemotherapy even for
      patients aged ≥ 70 years who were theoretically "fit" (WHO /ECOG/ PS of ≤ 2).
    


Intervention name(s): Age of patient
Intervention type(s): Other
Intervention description(s): Historical Comparison Between Patients Aged 60 to 69 and Patients Aged ≥ 70 Years Treated With Intensive Chemotherapy.
Comparison between Intensive Chemotherapy and Low-Intensity Treatments in Patients Aged ≥70 Years.
Improvement of Treatments Over Time
Overall Survival (OS) of patients aged ≥ 70 Years during3 study periods. Period 1, from 1985 to 1999, during which all patients with acute Myeloid Leukemia received an intensive chemotherapy regimen at the University Hospital. Period 2, from 2000 to 2006, during which all patients received an Intensive Chemotherapy regimen, Improved Supportive Care and follow-Up protocol at the University Hospital. Period 3, From 2007 to 2014, during Which patients received Improved Supportive Care and follow-up protocol at the University Hospital and "Personalized" Therapy (Intensive Chemotherapy or Low-Dose Intensity Treatment)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Acute myeloid leukemia (AML)
      
Keywords: Acute myeloid leukemia; Chemotherapy; Low-intensity therapy; Older patients; Prognosis; Supportive care