a new therapy is preferable to the standard therapy. The
gold standard for these comparisons is the phase III clini-
cal trial. An example of the importance of quality of life in
a phase III study can be seen in the head-to-head compari-
son of a new therapy, imatinib (Gleevec), with the stan-
dard interferon-alpha plus low-dose cytarabine in patients
with newly diagnosed chronic myeloid leukemia.
After 12 months of treatment, the imatinib group had a signifi-
cantly better quality of life than the interferon/cytarabine
group. In particular, the imatinib group had better daily
functioning, less fatigue, fewer cognitive problems, and
better social functioning. In fact, the imatinib group actu-
ally had an increase in emotional well-being as compared
to base-line, as patients felt better able to cope with ill-
ness, and were less worried and sad. In addition, patients
who crossed over to imatinib experienced an improvement
in quality of life, as compared with patients who contin-
ued with the interferon/cytarabine regimen. As a result,
these findings contributed to imatinib becoming the new
standard therapy for newly diagnosed chronic myeloid
leukemia.