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Clinical Trial
. 2009 Dec;94(12):1669-75.
doi: 10.3324/haematol.2009.010629. Epub 2009 Jul 31.

High Rates of Durable Response Are Achieved With Imatinib After Treatment With Interferon Alpha Plus Cytarabine: Results From the International Randomized Study of Interferon and STI571 (IRIS) Trial

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Free PMC article
Clinical Trial

High Rates of Durable Response Are Achieved With Imatinib After Treatment With Interferon Alpha Plus Cytarabine: Results From the International Randomized Study of Interferon and STI571 (IRIS) Trial

François Guilhot et al. Haematologica. .
Free PMC article

Abstract

Background: Imatinib is the standard of care for newly diagnosed chronic-phase chronic myeloid leukemia. The largest randomized clinical trial of imatinib was the multinational IRIS trial in which 1106 patients were randomized to receive either imatinib 400 mg/day or a standard regimen of interferon-alpha plus cytarabine.

Design and methods: Patients were allowed to cross over to the opposite treatment for intolerance, lack of response, disease progression, and, following release of the initial efficacy data, reluctance to remain on therapy with interferon-alpha plus cytarabine. The safety and efficacy of imatinib in patients who crossed over from interferon-alpha plus cytarabine to imatinib is reported here.

Results: Of 553 patients originally assigned to interferon-alpha plus cytarabine, 65% crossed over to imatinib, of whom 67% continue to receive treatment. After a median of 54 months of imatinib treatment on study, 93% achieved complete hematologic remission, 86% achieved major cytogenetic remission, and 81% achieved a complete cytogenetic remission as the best observed response. Estimated rates of freedom from progression to accelerated or blast phase and overall survival were 91% and 89%, respectively, at 48 months after starting imatinib.

Conclusions: This is the largest analysis to date describing the efficacy of imatinib in patients who have received prior therapies for chronic myeloid leukemia and it demonstrates excellent responses to this treatment. (ClinicalTrials.gov identifier: NCT00006343).

Figures

Figure 1.
Figure 1.
Complete cytogenetic responses among patients randomized to IFN-α + Ara-C in the IRIS trial who crossed over to imatinib according to the reason for change. Progression (as reason for crossover) was defined as an increase in white blood cell count, loss of complete hematologic response, or loss of major cytogenetic response (CCyR: complete cytogenetic response).
Figure 2.
Figure 2.
Estimated outcome rates at 48 months following initiation of imatinib in patients who crossed over from IFN-α + Ara-C. Progression (as reason for crossover) was defined as an increase in white blood cell count, loss of complete hematologic response, or loss of major cytogenetic response.
Figure 3.
Figure 3.
Overall survival for all patients in the intent-to-treat population. Data are presented for patients initially randomized to the imatinib (solid line) or IFN-α + Ara-C (dashed line) treatment arms. At 6 years, overall survival rates were 88% for patients randomized to imatinib versus 84% for patients randomized to IFN-α+ Ara-C (p=0.075).

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