Abstract

It is judged safe to discontinue treatment with tyrosine kinase inhibitors for chronic myeloid leukemia in experimental trials on treatment free remission. We collected a total of 293 Italian patients with chronic phase chronic myeloid leukemia who discontinued tyrosine kinase inhibitors in deep molecular response. 72% of patients were on treatment with imatinib, 28% with second generation tyrosine kinase inhibitors at the time of discontinuation. Median duration of treatment with the last tyrosine kinase inhibitor was 77 months (IQR 54;111), median duration of deep molecular response was 46 months (IQR 31;74). Duration of treatment with tyrosine kinase inhibitors and duration of deep molecular response were shorter with 2nd generation tyrosine kinase inhibitors than with imatinib (p<0.001). 88% of the Italian patients discontinued per clinical practice and reasons for stopping treatment were: toxicity for 20% of patients, pregnancy for 6% patients and shared decision between treating physician and patient for 62% of cases. After a median follow-up of 34 months (Min-Max 12-161) overall estimated treatment free remission was 62% (95% CI 56;68). At 12 months treatment free remission was 68% (95% CI 62;74) for imatinib, 73% (95% CI 64;83) for 2nd generation tyrosine kinase inhibitors. Overall median time to restart treatment was 6 months (IQR 4;11). No progressions occurred. Although our study has the limitation of a retrospective study, our experience within the Italian population confirms that discontinuation of imatinib and 2nd generation tyrosine kinase inhibitors is feasible and safe in the clinical practic

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