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1706 Choice of Tyrosine Kinase Inhibitor and Early Events during the First Year of Therapy in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia (CML) Patients with Concomitant Diabetes: A “Campus CML” Study

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Clinical Practice (Health Services and Quality), Non-Biological therapies, CML, Chronic Myeloid Malignancies, Diseases, Therapies, Adverse Events, Myeloid Malignancies, Study Population, Human
Saturday, December 10, 2022, 5:30 PM-7:30 PM

Isabella Capodanno, MD1*, Mario Tiribelli, MD2*, Maria Cristina Miggiano, MD3*, Cristina Bucelli, MD4*, Francesco Cavazzini, MD5*, Sabrina Leonetti Crescenzi, MD6*, Sabina Russo, MD7*, Emilia Scalzulli, MD8*, Andrea Bernardelli9*, Luigiana Luciano, MD10, Olga Mulas, MD11*, Giuseppina Loglisci, MD12*, Chiara Elena, MD13*, Umberto Pizzano, MD14*, Immacolata Attolico, MD15*, Gianni Binotto, MD16*, Elena Crisà, MD17*, Paolo Sportoletti, MD18*, Ambra Di Veroli, MD19*, Anna Rita Scortechini, MD20*, Annapaola Leporace, MD21*, Maria Basile, MD22*, Monica Crugnola, MD23*, Fabio Stagno, MD, PhD24, Pamela Murgano, MD25*, Davide Rapezzi, MD26*, Debora Luzi, MD27*, Alessandra Iurlo, MD, PhD28*, Monica Bocchia, MD29*, Carmen Fava, MD, PhD30, Alessandra Malato, MD31*, Sara Galimberti, MD32*, Iolanda Donatella Vincelli, MD33*, Malgorzata Monika Trawinska, MD34*, Michele Pizzuti, MD35*, Giovanni Caocci, MD36, Massimiliano Bonifacio, MD37*, Giuseppe Saglio, MD, PhD38, Giorgina Specchia, MD39, Massimo Breccia, MD40* and Roberto Latagliata, MD19*

1Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, RE, Italy
2Division of Hematology and BMT, Department of Medical Area, University of Udine, Udine, Italy
3Hematology Department, San Bortolo Hospital, Azienda ULSS8 "Berica" di Vicenza, Vicenza, Italy
4Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
5Institute of Hematology, Cona Ferrara, ITA
6Hematology Unit, San Giovanni Hospital, Rome, Italy
7Division of Hematology, Policlinico “G. Martino”, University of Messina, Messina, Italy
8Hematology, Department of Translational and Precision Medicine, Policlinico Umberto I, Sapienza University, Rome, Italy
9Hematology, University of Verona, Verona, Italy
10Hematology Unit, Federico II University of Naples, Napoli, Italy
11Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy
12Hematology Unit, Vito Fazzi Hospital, Lecce, Italy
13Department of Hematology Oncology, Foundation IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy
14Hematology, University of Udine, Udine, Italy
15Hematology and Stem Cell Transplantation Unit, AOUC Policlinico, Bari, Italy
16Department of Medicine, Hematology and Clinical Immunology, Padua School of Medicine, Padua, Italy
17Division of Hematology, Department of Translational Medicine, Università del Piemonte Orientale Amedeo Avogadro, AOU Maggiore della Carità, Novara, Italy
18Section of Hematology, Department of Medicine and Surgery, Center for Hemato-Oncological Research (CREO), University of Perugia, Perugia, Italy
19Hematology, Belcolle Hospital, Viterbo, Italy
20Division of Hematology, Department of Molecular and Clinical Sciences, Polytechnic University of Marche, Ancona, Italy
21Hematology Unit, Azienda Ospedaliero Universitaria Sant' Andrea, Rome, Italy
22Hematology, Giuseppe Moscati Hospital, Taranto, Italy
23Hematology and BMT Center, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
24Chair and Hematology Section, Ferrarotto Hospital, Catania, Italy
25Division of Hematology, S. Elia Hospital, Caltanissetta, Italy
26S.C. Ematologia, ASO S. Croce e Carle, Cuneo, Italy
27Hematology, Azienda Ospedaliera - S. Maria Terni, Terni, ITA
28Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
29Hematology, University of Siena, Azienda Ospedaliera Universitaria Senese, Siena, Italy, Siena, Italy
30Hematology Division, Ospedale Mauriziano, University of Turin, Torino, Italy
31Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy
32Section of Hematology, Department of Clinical and Experimental Medicine, University of Pisa, Azienda ospedaliera Pisana, Pisa, Italy
33UOC Ematologia Grande Ospedale Metropolitano BMM, Reggio Calabria, Italy
34Hematology S. Eugenio Hospital, ASL RM2, Rome, Italy
35Ematologia, Azieda Ospedaliera S. Carlo, Potenza, Italy
36University of Cagliari, Monserrato, CA, Italy
37Department of Medicine, Section of Hematology, University of Verona, Verona, Italy
38Divisione Universitaria di Ematologia e Terapie Cellulari, A.O. Ordine Mauriziano, Turin, Italy
39Hematology Section, Department of Emergency and Transplantation - GIMEMA WP CML, University of Bari Aldo Moro, Bari, Italy
40Division of Hematology, Department of Translational and Precision Medicine, Azienda Policlinico Umberto I, Sapienza University, Rome, Italy

Background Tyrosine kinase inhibitors (TKIs) have dramatically changed the treatment of chronic myeloid leukemia (CML). Most of data on the TKIs safety derive from sponsored controlled trials, where patients with multiple comorbidities had fewer opportunities to be included. Many questions about the management of newly diagnosed CML can only be answered by analysing large cohorts in real world practice.

Methods To evaluate the choice of TKI and the incidence of early events during the 1st year of therapy in newly diagnosed chronic phase CML patients with concomitant diabetes, we retrospectively studied 1732 CP-CML patients diagnosed from 1/2012 to 12/2019 at 33 Italian Hematology Centres and treated with frontline imatinib (IM) or second-generation TKIs (2G). Among these, 197 patients (11.4%) had concomitant diabetes.

Results The main clinical features at diagnosis of the entire cohort and in patients with diabetes are reported in the Table. Compared with non-diabetic patients, subjects with diabetes were older, had higher Sokal and ELTS scores (Sokal intermediate + high 74.5% vs 59.2%, ELTS intermediate + high 62.6% vs 41.1%) and were more likely affected by other comorbidities as arterial hypertension, COPD, ischemic heart disease/cerebrovascular events and previous neoplasms: as a consequence, diabetic patients reported a higher number of concomitant drugs (> 5 in 38.6% vs 10.1%, p<0.001). The number of white blood cells at diagnosis was lower in diabetic patients (44.9x109/l vs 59.3 x109/l, p=0.008)). Significant differences were observed in the choice of frontline TKI: comparing diabetic with non-diabetic patients, IM was prescribed in 72% vs 54%, dasatinib in 23.4% vs 15.3% and nilotinib in 4.6% vs 30.7% of cases (p<0.001). There were 51 early events (25.9%) in the 1st year of treatment leading to permanent frontline TKI discontinuation in the diabetic patients, compared to 285 (18.7%) in non-diabetic patients (p=0.037). One-year cumulative incidence of TKI permanent discontinuation was 25.9% (95%CI 19.8 – 32.0) in diabetic patients compared to 18.5% (95%CI 16.6 – 20.4) in non-diabetic patients (p=0.015).

Conclusions This real-world study on over 1700 CML patients shows that concomitant diabetes is an important factor in newly diagnosed CML patients, affecting both the clinical presentation and the frontline treatment choice: in addition, concomitant diabetes is linked to a high incidence of early events and frontline TKI permanent discontinuation.

Disclosures: Elena: Novartis: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Blueprint: Membership on an entity's Board of Directors or advisory committees. Binotto: Novartis, BMS, Incyte, Pfizer: Honoraria. Crugnola: Amgen: Speakers Bureau; Novartis: Speakers Bureau. Stagno: Celgene, Incyte, Novartis, Pfizer: Honoraria, Speakers Bureau. Iurlo: Novartis, BMS, Celgene, Incyte, Pfizer: Honoraria. Galimberti: Abbvie Incyte, Novartis, Janssen, Astrazeneca, Pfizer: Honoraria. Saglio: Novartis: Speakers Bureau. Breccia: Novartis, Incyte, Pfizer, BMS, Abbvie: Honoraria. Latagliata: Novartis: Honoraria; BMS: Honoraria.

*signifies non-member of ASH