IRIS molecular substudy
Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia
Phase 3N = 1,106
- Population
- Newly diagnosed chronic-phase CML; transcript analysis in patients with a complete cytogenetic remission
- Design
- Substudy of the randomized IRIS trial: BCR-ABL transcript levels measured by quantitative real-time PCR in the blood of patients with a complete cytogenetic remission, expressed relative to the median level in 30 patients with untreated chronic-phase CML.
- Arms
- Imatinib (experimental): Imatinib
- IFN-α + cytarabine (control): Interferon alfa plus cytarabine
- People
- Hughes TP, International Randomised Study of Interferon versus STI571 (IRIS) Study Group
Δ MMR+33 pointsΔ MMR+37 points
Show the numbers
| Endpoint | Analysis | Imatinib | IFN-α + cytarabine | Effect |
|---|---|---|---|---|
| MMRPatients who had a complete cytogenetic remissionReduction in BCR-ABL transcript levels of at least 3 log at 12 months, relative to the median level in 30 patients with untreated chronic-phase CML (the paper's own definition, not the later international-scale definition) | primaryHughes 2003 | 57% | 24% | P=0.003 |
| MMRAll treated patients (estimated by the authors from complete cytogenetic remission rates of 68% in the imatinib group and 7% in the interferon plus cytarabine group at 12 months)Reduction in BCR-ABL transcript levels of at least 3 log at 12 months, relative to the median level in 30 patients with untreated chronic-phase CML (the paper's own definition, not the later international-scale definition) | primaryHughes 2003 | 39% | 2% | P<0.001Model-based estimate stated in the abstract, not an observed proportion. |
| Endpoint | Analysis | Imatinib | IFN-α + cytarabine | Effect |
|---|---|---|---|---|
| MMRPatients who had a complete cytogenetic remissionReduction in BCR-ABL transcript levels of at least 3 log at 12 months, relative to the median level in 30 patients with untreated chronic-phase CML (the paper's own definition, not the later international-scale definition) | primaryHughes 2003 | 57% | 24% | P=0.003 |
| MMRAll treated patients (estimated by the authors from complete cytogenetic remission rates of 68% in the imatinib group and 7% in the interferon plus cytarabine group at 12 months)Reduction in BCR-ABL transcript levels of at least 3 log at 12 months, relative to the median level in 30 patients with untreated chronic-phase CML (the paper's own definition, not the later international-scale definition) | primaryHughes 2003 | 39% | 2% | P<0.001Model-based estimate stated in the abstract, not an observed proportion. |