6533b86cfe1ef96bd12c8348

RESEARCH PRODUCT

Observational study of chronic myeloid leukemia Italian patients who discontinued tyrosine kinase inhibitors in clinical practice.

Gianantonio RostiCarmen FavaCarlo Gambacorti-passeriniValentina GiaiFabio StagnoPatrizia PregnoBruno MartinoDaniele CattaneoMicaela BergamaschiRoberto LatagliataFrancesco CavazziniMarco CerranoFabrizio PaneFederica SoràSara GalimbertiMonica BocchiaPaola BerchiallaGiorgina SpecchiaPellegrino MustoGiuseppe SaglioMarco SantoroMichele BaccaraniFrancesca LunghiChiara ElenaSabina RussoIrene DogliottiLuciano LevatoMassimo BrecciaMonica CrugnolaDavide RapezziGiovanna Rege-cambrinMichele CedroneIsabella CapodannoFrancesco IulianoMario AnnunziataNicola SgherzaLuigia LucianoMatteo DraganiAntonella GozziniDario FerreroGiovanni CaocciAlessandra IurloFausto CastagnettiElisabetta AbruzzeseGabriele Gugliotta

subject

MaleImatinib mesylate discontinuation; chronic myelogenous leukemia; treatment-free remission; long-term outcomes; molecular response; cml patients; recommendations; management; dasatinib; cessationchemistry.chemical_compound0302 clinical medicineTreatment Free RemissionPregnancyMED/15 - MALATTIE DEL SANGUEInterquartile rangeingleseMedicinedasatinibChronic Myelogenous Leukemiatreatment-free remissionPonatinibmolecular responseHematologyMiddle AgedProtein-Tyrosine Kinasescml patientsDasatinibTreatment OutcomeLeukemia Myeloid Chronic-PhaseDisease ProgressionImatinib MesylateFemaleChronic Myelogenous Leukemia; Discontinuation; Treatment Free Remissionlong-term outcomesmanagementmedicine.drugAdultmedicine.medical_specialtyChronic Myeloid LeukemiaSocio-culturaleDiscontinuationArticletyrosine kinase inhibitors discontinued treatment chronic myeloid leukemia treatment-free remission (TFR)Safety-Based Drug Withdrawals03 medical and health scienceschronic myeloid leukemia tyrosine kinase inhibitors discontinuationMedian follow-upLeukemia Myelogenous Chronic BCR-ABL PositiveInternal medicineImatinib mesylate discontinuationHumansProtein Kinase InhibitorsRetrospective Studiesbusiness.industryImatinibmedicine.diseaseDiscontinuationrespiratory tract diseasesSettore MED/15 - MALATTIE DEL SANGUEcessationNilotinibchemistryrecommendationsbusiness030215 immunologyChronic myelogenous leukemia

description

It is judged safe to discontinue treatment with tyrosine kinase inhibitors (TKI) for chronic myeloid leukemia (CML) in experimental trials on treatment-free remission (TFR). We collected a total of 293 Italian patients with chronic phase CML who discontinued TKI in deep molecular response. Seventy-two percent of patients were on treatment with imatinib, and 28% with second generation TKI at the time of discontinuation. Median duration of treatment with the last TKI was 77 months [Interquartile Range (IQR) 54;111], median duration of deep molecular response was 46 months (IQR 31;74). Duration of treatment with TKI and duration of deep molecular response were shorter with second generation TKI than with imatinib (P<0.001). Eighty-eight percent of patients discontinued as per clinical practice, and reasons for stopping treatment were: toxicity (20%), pregnancy (6%), and shared decision between treating physician and patient (62%). After a median follow up of 34 months (range, 12-161) overall estimated TFR was 62% (95%CI: 56;68). At 12 months, TFR was 68% (95%CI: 62;74) for imatinib, 73% (95%CI: 64;83) for second generation TKI. Overall median time to restart treatment was six 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 second generation TKI is feasible and safe in clinical practice.

10.3324/haematol.2018.205054http://hdl.handle.net/10807/135727