Observational Study of CML Italian Patients Who Discontinued TKIs

Abstract

Abstract Background: Different studies analysed the outcome of patients (pts) who discontinued tyrosine kinase inhibitors (TKIs) reporting a median treatment-free remission (TFR) rate of 55%. On these bases it is judged safe to discontinue treatment in experimental contexts. Aims: Aim of our study was to evaluate TFR in the setting of Italian pts . Material and Methods: We designed a retrospective observational study of Italian pts with chronic phase CML who discontinued TKI treatment in deep molecular response (DMR). All Hematological Centers who are part of the GIMEMA group were invited to participate to this retrospective study and 32 centers had cases and participated to the study. Results: We collected a total of 293 pts. Median age was 59 years; 59%, 30% and 11% of pts were low, intermediate and high Sokal score respectively. 72% of pts were on treatment with imatinib, 28.% with either nilotinib (n=58), dasatinib (n=23) or bosutinib (n=1) at the time of discontinuation. 55% of pts discontinued in first line, 40% in second line, 5% in third line. Median duration of treatment with the last TKI was 77 months (mos, IQR 54;111) median time to deep molecular response (DMR, i.e. undetectable transcript or MR4/MR4.5/MR5) with the last TKI was 46 mos (IQR 30;73), median duration of DMR was 46 mos (IQR 31;74) before stop. Duration of treatment with TKIs and duration of DMR were shorter with 2nd gen TKIs than with imatinib (p Conclusion: Although our study has the limitation of a retrospective study, our experience within the Italian population confirms that discontinuation of imatinib and 2nd gen TKIs is feasible and safe in the clinical practice. Disclosures Fava: Incyte: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Rege-Carmbrin: BMS: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Incyte: Consultancy, Honoraria. Rosti: Pfizer: Research Funding, Speakers Bureau; Bristol Myers Squibb: Research Funding, Speakers Bureau; Incyte: Research Funding, Speakers Bureau; Novartis: Research Funding, Speakers Bureau. Castagnetti: Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. Gugliotta: Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria. Gambacorti-Passerini: Pfizer: Consultancy, Honoraria, Research Funding; BMS: Consultancy. Abruzzese: Bristol Myers Squibb: Consultancy; Incyte: Consultancy; Novartis: Consultancy; Pfizer: Consultancy; ARIAD: Consultancy. Orlandi: Incyte: Speakers Bureau; Bristol-Myers Squibb: Speakers Bureau; Novartis: Speakers Bureau. Pregno: Incyte: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Crugnola: Celgene: Honoraria; Novartis: Honoraria; BMS: Honoraria. Bocchia: Celgene: Other: Travel grant; Novartis: Other: Travel grant; Roche: Other: Travel grant; Jansen: Other: Travel grant. Galimberti: Bristol-Myers Squibb: Speakers Bureau; Novartis: Speakers Bureau; Incyte: Speakers Bureau; Pfizer: Speakers Bureau. Iurlo: Novartis: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria. Breccia: TEVA: Speakers Bureau. Cavazzini: Novartis: Consultancy; Incyte: Consultancy; Pfizer: Consultancy; Bristol-Meyers Squibb: Consultancy. Giai: Novartis: Consultancy, Honoraria; Incyte: Consultancy, Honoraria. Musto: BMS: Honoraria; Celgene: Honoraria; Novartis: Honoraria; janssen: Honoraria. Specchia: BMS: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Incyte: Consultancy, Honoraria. Pane: Novartis: Honoraria, Speakers Bureau. Baccarani: Incyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; BMS: Consultancy, Honoraria. Saglio: Roche: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Ariad: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Ariad: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; BMS: Consultancy, Honoraria; BMS: Consultancy, Honoraria.