Elisabetta Abruzzese1, Alberto Bosi2, Massimo Breccia3, Mariella D'Adda4, Nicola Di Renzo5, Anna Marina Liberati6, Raffaele Porrini7, Ester Maria Orlandi8, Fabrizio Pane9, Ester Pungolino10, Federica Sorà11, Fabio Stagno12, Ginny P. Sen13, Fabiana Gentilini14, Francesco De Solda14 and Carlo Gambacorti-Passerini15.
S. Eugenio Hospital, Roma, Italy.
2 U.O. di Ematologia, Azienda Ospedaliera Universitaria Careggi, Firenze, Italy.
3 Azienda Policlinico Umberto I-Università Sapienza, Roma, Italy.
4 Azienda Ospedaliera Spedali Civili di Brescia, Italy.
5 U.O. di Ematologia e Trapianto di Cellule Staminali P.O "Vito Fazzi" - Lecce.
6 Università degli Studi di Perugia, - A.O. Santa Maria di Terni, Italy.
7 Ospedale Sant'Andrea Roma, Italy.
8 Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
9 University of Naples Federico II, Italy.
10 A.O. Ospedale Niguarda Ca' Granda, Milano, Italy.
11 UOC di Ematologia, Policlinico Universitario 'A. Gemelli', Roma, Italy.
12 Divisione Clinicizzata di Ematologia, AOU Policlinico – V. Emanuele Catania, Italy.
13 ICON Clinical Research, San Diego, California, USA.
14 Bristol-Myers Squibb, Rome, Italy.
15 Azienda Ospedaliera San Gerardo, University of Milano Bicocca, Monza, Italy.
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Background and Objective: While
tyrosine kinase inhibitors (TKIs) have transformed CP-CML management,
limited data exist on their use in clinical practice.
Material and Methods
|Table 1. Patient demographics according to first-line TKI therapy and all patients. †Percentages are calculated using the total number of patients for whom data on ECOG performance status are available as the denominator. ECOG performance status is defined as: 0, fully active; 1, restricted strenuous activity; 2, ambulatory and capable of all self-care, no work; 3, capable of only limited self-care; 4, completely disabled. ‡Sokal score categories; low-risk: Sokal score <0.8; intermediate-risk: Sokal score 0.8–1.2; high-risk: >1.2. ¶Hasford score categories; low-risk: Hasford score ≤780); intermediate-risk: Hasford score >780–≤1480; high-risk: Hasford score >1480.|
|Table 2. The number and percentage of patients followed for a minimum of 12 months tested for CyR (FISH, BM, or both) or MR (including IS and non-IS). Includes assessments performed after index TKI start date, between 30 days and 3, 6 and 12 months, respectively. *The denominator is the total number of patients with a CyR test done with date present. †The proportion of MR tests not on the IS includes ‘no’ and ‘unknown’.|
|Figure 1. The proportion (%) of Italian patients from SIMPLICITY with documented response monitoring. (A) CyR monitoring for the overall population, and for those patients receiving IM and second-generation TKIs, over the years of first-line TKI initiation. Both FISH and BM cytogenetic tests were included as long as a date was documented. Patients had to be followed for ≥12 months. Includes assessments performed after index TKI start date, between 30 days and 12 months later. (B) MR monitoring patterns during the first 12 months of treatment according to the year of first-line TKI initiation – result on IS. Dashed line corresponds to the proportion of patients with CyR or MR monitoring during the first 12 months across the entire study period. N indicates the number of patients per cohort. BM: bone marrow; CyR: cytogenetic response; FISH: fluorescence in situ hybridisation; IM: imatinib; IS: international scale; MR: molecular response TKI: tyrosine kinase inhibitor.|
|Figure 2. Proportion (%) of patients in Italy (left hand panel) and the rest of the European SIMPLICITY population (excluding Italy; right hand panel) who discontinued TKI treatment within the first 12 months of first-line TKI. DAS: dasatinib; IM: imatinib; NIL: nilotinib; TKI: tyrosine kinase inhibitor.|
|Figure 3. TKI switching patterns in SIMPLICITY in Italy (left hand panel) and the rest of the European SIMPLICITY population (excluding Italy; right hand panel) within the first 12 months of first-line TKI. No patients switched from the imatinib retrospective cohort in Italy. IM: imatinib; TKI: tyrosine kinase inhibitor.|
|Table 3. Intolerances leading to discontinuation of first-line TKI within 1 year of initiation among patients who switched to a second-line TKI within 1 year from initiating first-line TKI. The denominator is the number of patients in the column whose primary reason for discontinuation of first-line TKI is intolerance.|