Before imatinib, chronic myeloid leukaemia moved on within a few years in most patients to an acute, fatal phase. This study showed that with one tablet a day, more than 8 out of 10 patients were alive after 10 years, and most of them had their disease fully under control. Today, most people with CML who take their medicine regularly can expect to live almost as long as other people of the same age.
Philadelphia chromosome-positive CML in adults
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Chronic phase | |||
| Imatinib | 400 mg once daily | Oral, with food and a large glass of water | Continuous |
| Accelerated or blast phase | |||
| Imatinib | 600 mg once daily | Oral | Continuous |
Other tyrosine kinase inhibitors (dasatinib, nilotinib, bosutinib, ponatinib, asciminib), with their doses and monitoring points, are covered on the leukaemia page.
Philadelphia-positive CML in adults (first line or later)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Chronic phase | |||
| Imatinib | 400 mg once daily | Oral, with food and a large glass of water | Continuous |
| Accelerated or blast phase | |||
| Imatinib | 600 mg once daily | Oral | Continuous |
In the absence of severe adverse reactions, a dose increase from 400 to 600 mg (chronic phase) or from 600 to 800 mg (400 mg twice daily; advanced phase) may be considered. Severe hepatic impairment: 300 mg per day.
On the page “Leukaemia” · Treatment regimens and dosing in CML
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Imatinib 400 mg orally daily.
Interferon alfa 5 million IU/m² subcutaneously daily plus cytarabine 20 mg/m² subcutaneously daily for 10 days each month.
Source of the regimen details: Full text of the paper in PMC (PMC5901965), Methods section
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in chronic phase, diagnosed within 6 months before enrolment and with no prior treatment (except hydroxyurea or anagrelide).
Primary endpoint: progression-free survival (in the initial analyses).
Long-term analyses: overall survival, response to treatment (cytogenetic and molecular) and serious adverse events.
Serious adverse events that investigators considered related to imatinib were uncommon and occurred mostly in the first year of treatment. Long-term imatinib use was not associated with unacceptable cumulative or late toxic effects.
IRIS was the landmark trial that made imatinib the standard first-line treatment for CML and established the "targeted therapy" model in oncology. Imatinib (now available as a generic) remains one of the first-line options in the ELN 2020 recommendations, alongside the second-generation inhibitors (dasatinib, nilotinib, bosutinib). The long-term follow-up of this study showed that a deep, durable molecular response later became the basis of the "treatment-free remission" (TFR) approach.
Because of extensive crossover of patients from the interferon group to imatinib, a long-term comparison of survival between the two groups was not possible and the analyses focused on the imatinib group. Data on non-serious adverse events were not collected after 5.5 years. Only about half of the patients continued imatinib until the end of the study.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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