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Gleevec (imatinib) as first line therapy in CML found to be
Responses to imatinib found to be durable at 42 months
December 4-7, 2004. San Diego, California.
The American Society of Hematology is the world's largest professional society concerned with the
management of blood disorders.
Poitiers, Sunday 5th December 2004 -- CHU in Poitiers, France, today
announced results of a study showing that newly diagnosed patients with
a certain form of leukemia who are treated early with imatinib are more
likely to achieve complete cytogenetic responses (the elimination of
leukemic cells, a major goal of therapy) and have improved long-term
New data from the largest study of CML patients (1106 patients
included) ever conducted International Randomized IFN vs. ST1571 (IRIS)
study, were presented today at the annual meeting of the American
Society of Hematology (ASH). In the study, newly diagnosed patients with
chronic-phase Philadelphia chromosome-positive (Ph+) chronic myeloid
leukemia (CML) who achieved cytogenetic responses early had improved
rates of progression-free survival compared to those who did not achieve
early responses. Responses to imatinib were shown to be durable at 42
"The IRIS study continues to show durable responses in patients
treated with imatinib," said Pr Francois Guilhot, Head of Oncology
Hematology and Cell Therapy Department, CHU La Miletrie, Poitiers,
France. "For patients who achieved the highest responses at 12 months,
the probability of remaining free of the leukaemia was very high."
The landmark analysis showed that at 42 months, 84% of patients taking
imatinib remained progression free, and only 6% progressed to the more
advanced disease stages (accelerated phase and blast crisis). Overall
survival (based on CML-related deaths) in patients treated with imatinib
was 97% at 42 months. Patients taking imatinib as first treatment who
achieved a complete cytogenetic response (CcyR) within 12 months of
therapy had a 93% progression free survival rate at 42 months, compared
with 74% in those without CcyR. For patients who had achieved CcyR and a
thousand-fold (3 log) or greater reduction in Bcr/Abl transcript level
(called a molecular response) at 12 months, the probability of remaining
progression free was 98% at 42 months, compared with 90% for patients
with CcyR and less than a thousand-fold reduction and 75% for patients
who had not achieved CcyR.
In CML, a molecular response is the disappearance or reduction in
quantities of Bcr-Abl transcripts, which produce the abnormal protein
responsible for driving the proliferation of white blood cells that
occurs in CML patients. CHR refers to the normalization of blood counts,
lasting for at least four weeks; however, the Ph chromosome positive
(Ph+) cells may still be present. In McyR, less than 35% of cells
containing the Philadelphia chromosome (the genetic abnormality that
characterizes most cases of CML) are detected. In CcyR, Ph+ cells
This study, abstract n?21, was published in Blood, Volume 104, Issue
11, November 16, 2004
About IRIS Study
IRIS: the largest Phase III CML study to date.
From June 2000 to January 2001, 1106 patients were enrolled at 117
centers in 16 countries in the IRIS study (553 randomized to each
treatment arm). This was the largest and most rapidly accrued phase III
CML to date The IRIS study (study 106) protocol allows for a crossover
in the case of lack of response, loss of response, or intolerance of
treatment. After interim analysis of the trial data, the initial study
protocol was amended by the Independent Data Monitoring Board (IDMB) to
enable patients in either arm to cross over if no MCR had occurred after
1 year of treatment, instead of 2 years as initially required, and to
enable patients in the IFN + ara-C arm to cross over to imatinib at any
time, if desired.
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Copyright ? 2004 The Doctors Lounge.
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