Newly Diagnosed Myeloid Leukemia Responds to Imatinib
*In a 5-year follow-up of patients with newly diagnosed CML, imatinib was
superior to interferon-{alpha} plus cytarabine. *
The dramatic efficacy of imatinib (Gleevec) in chronic myeloid leukemia
(CML) patients has made it a paradigm for targeted cancer therapies.
Researchers now provide 5-year follow-up data on patients who were treated
in the phase III, industry-sponsored, IRIS study. Eleven hundred six
patients with newly diagnosed CML were randomized to daily oral imatinib or
the combination of interferon-[image: {alpha}] plus cytarabine. The primary
endpoint was event-free survival; secondary endpoints were complete
hematologic, cytogenetic, and molecular responses. Crossover was allowed for
inadequate response to or toxicity of originally assigned therapy; 65% of
patients crossed over to imatinib, whereas only 3% crossed over to
interferon-[image: {alpha}] plus cytarabine. As a result, very few
patients received
long-term interferon, and this report focused on the imatinib-treated
patients.
By 12 months, 96% of imatinib patients achieved complete hematologic responses,
and 69% achieved complete cytogenetic responses; these rates were 98% and
87%, respectively, at 5 years. At 5 years, 89% of patients were alive, and
83% had experienced no disease-related events. The estimated annual rates of
progression to accelerated phase or blast crisis decreased over time: 1.5% in
year 1, 1.8% in year 2, 1.6% in year 3, 0.9% in year 4, and 0.6% in year 5.
All patients who achieved complete cytogenetic responses and molecular
responses (defined as >3 log reduction in BCR-ABL transcripts) survived at 5
years, without progression to accelerated phase or blast crisis. No
difference in survival was noted between patients who were assigned
initially to imatinib and those who crossed over to imatinib. Side effects
of imatinib therapy included edema, muscle cramps or joint pain, diarrhea, and
rash. One patient developed heart failure.
*Comment:* Only 7% of imatinib-treated patients progressed to accelerated
phase or blast crisis. Risk for progression decreased over time and was <1%
in years 4 and 5 of imatinib therapy; overall survival of imatinib-treated
patients was 89%. These impressive results confirm imatinib as standard
therapy for initial treatment of CML patients. As noted by the authors, the
current recommendation is to continue therapy indefinitely, because relapses
occur in some patients when treatment is discontinued. Ongoing questions
relate to administration of higher initial doses of imatinib and integration
of next-generation kinase inhibitors (i.e., dasatinib and nilotinib) into
treatment algorithms. Safety and toxicity of long-term therapy still require
assessment, especially in view of recent reports of cardiomyopathy and
congestive heart failure in a small subset of patients.
*— Michael E. Williams, MD*
Full report coming.
--
Zavie Miller (age 68)
67 Shoreham Avenue
Ottawa, Canada, dxd AUG/99
INF OCT/99 to FEB/00, CHF
No meds FEB/00 to JAN/01
Gleevec since MAR/27/01 (400 mg)
CCR SEP/01. #102 in Zero Club
PCRU 5/02 at RVH (suspect)
2.8 log reduction Sep/05
3.0 log reduction Jan/06
PCRU 11/06 at The Ottawa Hospital
e-mail: [EMAIL PROTECTED]
Tel: 613-726-1117
Fax: 309-296-0807
Cell: 613-202-0204
Yahoo ID: zaviem
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