DNA Hypomethylating Agents and Lenalidomide in Elderly Patients With Myeloid Malignancies in the US

This will be the first study to comprehensively analyze data from a large and unselected
older AML population in the US, both treated and untreated. These data will widen
understanding of treatment decisions for the older AML population and shed light on the
impact of HMA in this vulnerable population. The findings from this study will help identify
the role of HMA (with its salient features of better tolerability and lesser toxicity) as a
new treatment paradigm for older AML patients and enable comparison of outcomes with HMA vs
other "conventional" leukemia therapies (intensive chemotherapy, low dose cytarabine or best
supportive care). Additionally, with updated SEER-Medicare file carrying Medicare claims
through 2013, this study will help analyze several long term outcome measures extending up to
eight years for MDS patients treated with lenalidomide. Finally, the effectiveness of HMA in
the SEER-Medicare MDS population will be studied by using SEER-Medicare data. This registry
includes information on Medicare MDS beneficiaries - a population age cohort that has the
highest incidence rates for MDS and a large sample size with absolute MDS cases approaching
40000, making it the largest MDS registry in the world.

The overall sample will include cases of MDS and AML newly diagnosed between 2001 and 2011
with claims from 2000 to 2012. Investigators estimate this will include approximately 50,000
patients.Therefore, the Target Follow Up design looks at patient records over a span of 12
years. Consists of patients with myeloid malignancies diagnosed during 2001-2011 at the age
of 66 years or older and alive in September 2004 (i.e. 3 months after FDA approval of
azacitidine for MDS), with known month of diagnosis, and not identified from death
certificates or autopsy only, who had continuous Medicare Part A and B coverage, and were not
enrolled in a health maintenance organization during the period of interest. The overall
sample will include cases of MDS and AML newly diagnosed between 2001 and 2011 with claims
from 2000 to 2012.

Variables of interest to be collected will include: MDS subtypes, age at diagnosis, sex,
race, comorbidities, median household income at the zip code level, treatments (including
supportive care) from diagnosis to AML progression, transfusion status, NCI comorbidity index
score, response to treatments (using International Working Group criteria), physician
characteristics (speciality data),and hospital characteristics (bed size, teaching status,
case volume).

Inclusion Criteria:

- patients with myeloid malignancies diagnosed during 2001-2011 at the age of 66 years
or older

- alive in September 2004 (i.e. 3 months after FDA approval of azacitidine for MDS)

- known month of diagnosis, and not identified from death certificates or autopsy only

- continuous Medicare Part A and B coverage, and were not enrolled in a health
maintenance organization during the period of interest

Exclusion Criteria:

- Anyone under 66 years