IRIS
Trial question
What is the role of imatinib in patients with newly diagnosed chronic-phase CML?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 1106
1106 patients (455 female, 651 male)
Inclusion criteria: patients with newly diagnosed chronic-phase CML
Key exclusion criteria: uncontrolled serious medical conditions, prior chemotherapy or treatment with any investigational agent, hematopoietic-cell transplantation, major surgery within the preceding four weeks, or seropositive for the HIV
Interventions
N=553 imatinib (400 mg PO daily)
N=553 interferon alfa plus low-dose cytarabine (interferon alfa, target dose 5 million U per square meter of body-surface area per day and cytarabine subcutaneous 40 mg of maximal daily dose for 10 days every month)
Primary outcome
Complete cytogenetic response
76.2
14.5
76.2 %
57.2 %
38.1 %
19.1 %
0.0 %
Imatinib
Interferon alfa plus low-dose
cytarabine
Significant
increase ▲
NNT = 1
Significant increase in complete cytogenetic response (76.2% vs. 14.5%; RR 5.26, 95% CI 2.14 to 8.38)
Secondary outcomes
Significant increase in freedom from progression to accelerated-phase or blast-crisis CML (96.7% vs. 91.5%; RR 1.06, 95% CI 0.43 to 1.69)
Significant increase in complete hematologic response (95.3% vs. 55.5%; RR 1.72, 95% CI 0.7 to 2.74)
Safety outcomes
Significant difference in discontinuation of treatment or crossover to the alternative treatment group (14.3% vs. 89.2%).
Conclusion
In patients with newly diagnosed chronic-phase CML, imatinib was superior to interferon alfa plus low-dose cytarabine with respect to complete cytogenetic response.
Reference
O'Brien SG, Guilhot F, Larson RA et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003 Mar 13;348(11):994-1004.
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