Acute Myeloid Leukemia Clinical Trial
Official title:
Effect of Age on Treatment Decision-Making in Elderly Patients With Acute Myeloid Leukemia
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).
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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