A large group of international researchers conducted efficacy and safety analyses of long-term use of imatinib in the treatment of chronic myeloid leukemia (CML). They randomly assigned patients with newly diagnosed chronic phase CML to receive either imatinib or interferon alfa plus cytarabine. Long-term analyses (10 or more years of follow-up) included overall survival, response to treatment, and serious adverse events.
The median follow-up was 10.9 years. Among the patients in the imatinib group, the estimated overall survival rate at 10 years was 83.3%. Nearly half the patients (48.3%) who had been randomly assigned to imatinib completed study treatment with imatinib, and 82.8% had a complete cytogenetic response.
Researchers concluded that the efficacy of imatinib persisted over time and that long-term administration of imatinib is not associated with unacceptable cumulative or late toxic effects. The study findings were published in The New England Journal of Medicine
and the title of an accompanying editorial was simply "Imatinib Changed Everything." Study findings are available here