Imatinib is safe and effective for long-term CML treatment

This study examined the results of a 10 year imatinib (Gleevec) clinical trial. The study concluded that imatinib is a safe and effective treatment for CML.

Chronic myeloid leukemia (CML) is a disease in which the bone marrow makes too many mature and immature white blood cells. CML is a slowly progressing blood and bone marrow disease. It usually occurs during or after middle age.

The standard first treatment for chronic phase CML (the earliest phase of disease) is a tyrosine kinase inhibitor. This type of treatment blocks a protein involved in cancer growth. The drug imatinib is a tyrosine kinase inhibitor. The safety and effectiveness of imatinib was measured in a clinical trial over a period of almost 11 years.

This study began in 2001 and involved 1,106 patients. Patients were randomly divided into two treatment groups. The first group received imatinib, the other received interferon alfa plus cytarabine (a standard treatment for CML at the time). Imatinib was shown to be a more effective treatment early in the trial. Therefore, most of the interferon alfa plus cyarabine group was switched to imatinib for the remainder of the trial.

In the imatinib group, the overall survival rate (time from treatment until death from any cause) at 10 years was 83.3%. Almost half the patients (48.3%) in the imatinib group completed their full course of treatment. 82.8% had a complete cytogenetic response (no remaining leukemia cells). Serious events related to imatinib were uncommon and most frequently occurred during the first year of treatment.

This study determined that imatinib treatment led to long-term benefits, with a low rate of adverse effects.