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QOL in CML Better With Imatinib Than With Interferon

QOL in CML Better With Imatinib Than With Interferon

PHILADELPHIA—Chronic myeloid leukemia (CML) patients treated with imatinib
mesylate (Gleevec) reported better quality of life (QOL) than those on
interferon/cytarabine, and those who switched from interferon/cytarabine to
imatinib reported improved QOL, compared with those who remained on
interferon, Elizabeth A. Hahn reported. This is clinically important because
about 20% of CML patients drop out of interferon treatment within 6 months
due to intolerable adverse effects.

In an oral presentation at the 44th Annual Meeting of the American Society
of Hematology (ASH abstract 346), Ms. Hahn discussed QOL studies in 1,106
patients with chronic phase CML randomized to either imatinib or interferon/cytarabine
in the IRIS (International Randomized IFN vs STI571) trial. The QOL analyses
were done by Ms. Hahn and her colleagues from Evanston Northwestern
Healthcare’s Center on Outcomes, Research and Education, and from Novartis
Pharmaceuticals Corporation.

Ms. Hahn, who is director of biostatistics at the center, said that QOL
was a secondary endpoint in the trial protocol and that 95% of patients
participated in the QOL study. "Quality of life is an important endpoint
because it captures multiple aspects of the patient’s own assessment of the
effect of disease," she said. QOL was assessed using the Functional
Assessment of Cancer Therapy-Biological Response Modifiers (FACT-BRM). The
primary QOL endpoint was the Trial Outcome Index, a measure of physical
well-being, functional well-being, and treatment-specific features.
Social/family and emotional well-being were also evaluated. Ms. Hahn reported
analysis of questionnaires from 530 patients initially randomized to imatinib
and 519 initially randomized to interferon/cytara-bine. Statistical analysis
was based on intention to treat.

Study Results

"We found that the imatinib patients largely preserved their baseline QOL
but that after the first month on interferon/cytarabine, patients had a sharp
drop in the Trial Outcome Index and never did recover to baseline (P <
.001)," Ms. Hahn said (see Figure).

The researchers considered a 5-point difference in the Trial Outcome Index
as being clinically important. "We saw a 17-point difference between patients
treated with imatinib and those treated with interferon/cytarabine,
indicating that the QOL effect is highly clinically important as well as
statistically significant," Ms. Hahn said. Overall, patients on imatinib
reported better daily functioning and well-being, less fatigue, milder
emotional and cognitive problems, and fewer side effects, compared with those
on interferon/cytarabine.

During 18 months of treatment, 261 patients crossed over from interferon/cytarabine
to imatinib. When this subgroup was analyzed, they showed a fast improvement
in the Trial Outcome Index. "The crossover patients immediately experienced
an improvement in all QOL endpoints. Their Trial Outcome Index scores
remained statistically different from patients who had been on imatinib
throughout, but the difference was narrowing and at 18 months, it was less
than the 5-point difference considered clinically meaningful," she said. The
investigators concluded that there are large statistically significant and
clinically important differences in the primary QOL endpoint that favor
imatinib out to 18 months of treatment in chronic phase CML. Social/family
and emotional well-being were also better on imatinib.

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