Time of Response to TKI Therapies May Influence Patient Outcomes in CML

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Early optimal response to TKIs is associated with reductions in treatment failures, poor outcomes, progression of disease, and death.
Early optimal response to TKIs is associated with reductions in treatment failures, poor outcomes, progression of disease, and death.

Patient quality of life is linked to time of optimal response to treatment with either nilotinib or imatinib in chronic myeloid leukemia, according to the results of a study in BMC Cancer.1

The data supporting this conclusion were drawn from a prospective, longitudinal study of 59 patients with chronic-phase, newly diagnosed chronic myeloid leukemia (CML-CP) who were randomly assigned to receive 1 of 2 tyrosine kinase inhibitors (TKIs): nilotinib 300 mg twice daily (28 patients) or imatinib 400 mg once daily (31 patients). Health-related quality of life (HRQoL) was evaluated at baseline and every 3 months in the first 2 years, and then every 6 months over the subsequent 3 years.

A complete cytogenetic response was defined as 0% Philadelphia chromosome-positive metaphases by standard cytogenetics, and HRQoL was measured using the Medical Outcomes Study, a 36-item health survey.

The researchers determined that early response to treatment (within 12 months) with either TKI was associated with better quality of life scores, but the benefits that were seen varied at different time points. They concluded approximately 75%, 73%, and 48% of patients achieved optimal response by 3, 6, and 12 months, respectively.

Achieving optimal response at 12 months, specifically, “was the sole factor associated with significantly improving physical component summary [scores] over time (P = .0160).” Meanwhile, responses occurring within the first 3 months of treatment did not appear to have an impact on HRQoL scores.

At 5 years, the rates of failure-free survival and progression-free survival were significantly higher in patients who experienced an optimal response at 3, 6, or 12 months compared with the rates in those who did not see an optimal response at any time within the first year of TKI treatment.

There was no difference observed between the HRQoL scores of patients treated with nilotinib or imatinib — but nilotinib appeared to have an advantage in terms of clinical efficacy. “Patients treated with nilotinib had a higher probability of achieving optimal response at 12 months than those treated with imatinib (approximately 68% vs 29%),” the authors noted, and when compared to imatinib, “nilotinib-induced response may directly benefit HRQoL outcomes in patients with CML-CP.”

Overall, the authors concluded that “TKI therapy responses within 1 year can possibly predict both future treatment outcomes and physical and mental well-being of patients with CML-CP.”


  1. Yu L, Wang H, Milijkovic D, Huang X, Jiang Q. Achieving optimal response at 12 months is associated with a better health-related quality of life in patients with chronic myeloid leukemia: a prospective, longitudinal, single center study. BMC Cancer. 2018;18(1):782. doi: 10.1186/s12885-018-4699-5

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