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3617 Choice of Frontline Tyrosine-Kinase Inhibitor in Very Elderly Patients with Chronic Myeloid Leukemia: A “Campus CML” Study

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Elderly, Clinical Research, Real World Evidence, Study Population, Clinical Practice (e.g. Guidelines, Health Outcomes and Services, and Survivorship, Value; etc.)
Monday, December 13, 2021, 6:00 PM-8:00 PM

Roberto Latagliata1*, Isabella Capodanno, MD2*, Maria Cristina Miggiano, MD3*, Cristina Bucelli, MD4*, Francesco Cavazzini, MD5*, Sabrina Leonetti Crescenzi, MD6*, Sabina Russo, MD7*, Gioia Colafigli, MD8*, Mario Annunziata, MD9*, Federica Sora, MD10*, Massimiliano Bonifacio, MD11*, Luigiana Luciano, MD12, Giovanni Caocci, MD13, Giuseppina Loglisci, MD14*, Chiara Elena, MD15*, Rikard Mullai, MD16*, Imma Attolico, MD17*, Gianni Binotto, MD18*, Elena Crisà, MD19*, Alessandra Iurlo, MD, PhD4*, Paolo Sportoletti, MD20*, Ambra Di Veroli, MD1*, Anna Rita Scortechini, MD21*, Annapaola Leporace, MD22*, Alessandro Maggi, MD23*, Monica Crugnola, MD24*, Fabio Stagno, MD, PhD25, Rosaria Sancetta, MD26*, Pamela Murgano, MD27*, Davide Rapezzi, MD28*, Debora Luzi29*, Monica Bocchia30*, Carmen Fava, M.D.31, Alessandra Malato, MD, PhD32*, Jolanda Donatella Vincelli33*, Elisabetta Abruzzese, MD34, Giuseppe Nicola Saglio, MD, PhD35, Giorgina Specchia, MD36, Massimo Breccia, MD37* and Mario Tiribelli, MD38*

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

Introduction Treatment of chronic phase (CP) chronic myeloid leukemia (CML) with tyrosine kinase inhibitors (TKIs) proved to be almost equally effective in young and elderly patients. Three TKIs, imatinib (IM), dasatinib (DAS) and nilotinib (NIL), are approved for frontline therapy in Italy. Choice of frontline TKI is based on a combined evaluation of patient’s characteristics and expectations, with age usually playing a prominent role. However, to date, few data are available on patterns of TKI selection in very elderly patients.

Aim To analyse the use of frontline TKI therapy in a large and unselected cohort of very elderly CP-CML patients

Methods We retrospectively evaluated 332 patients aged ≥75 year diagnosed from 1/2012 to 12/2019 at 36 Hematology Centres participating at the “Campus CML” project.

Results Clinical features at diagnosis for the whole cohort and according to frontline TKI are reported in Table 1. As to frontline TKI, 285 patients (85.8%) received IM and 47 (14.2%) a 2G-TKI (DAS n=28, 59.5%; NIL n=19, 40.5%). Of the 285 IM-treated patients, 192 (67.3%) started with standard dose (400 mg/day) and 93 (32.7%) with a reduced dose (300 mg/day n=64, 22.5%; <300 mg/day n=29, 10.2%). Among the 47 patients starting a 2G-TKIs, 35 (74.4%) received standard dose and 12 (25.6%) a reduced dose (NIL <600 mg/day n=3; DAS 80 mg/day n=4 and 50 mg/day n=5). There were no differences between patients treated with imatinib or 2G-TKI (Table 1); only a previous cerebrovascular event was reported in a significantly higher rate of IM-treated patients. It is however evident that the distinct toxicity profiles of NIL and DAS had an impact on TKI choice as, for example, no patient with diabetes or ischemic heart disease received NIL.

Following widespread introduction of generic IM in Italy in early 2018, patients were divided in 2 groups: among 238 patients diagnosed from 2012 to 2017, 198 (83.1%) received IM and 40 (16.9%) a 2G-TKI, while patients diagnosed in 2018-2019 were treated with IM in 87/94 (92.5%) cases and with a 2G-TKI in 7 (7.5%) cases only (p=0.028).

Conclusions IM remains the frontline drug of choice in very elderly CML patients, and this trend seems to increase after the introduction of the generic formulation. However, 2G-TKI are used in a small but sizeable group of patients, without a clear correlation with baseline CML features, thus probably reflecting a physician’s evaluation of patient’s fitness and/or expectation. Efficacy and safety of initial reduced TKIs doses in the setting of very elderly patients warrant further analyses.

Disclosures: Latagliata: Novartis: Honoraria; BMS Cellgene: Honoraria; Pfizer: Honoraria. Bonifacio: Novartis: Honoraria; Pfizer: Honoraria; Amgen: Honoraria; Bristol Myers Squibb: Honoraria. Elena: CELGENE: Other: funding for meeting participation; PFIZER: Membership on an entity's Board of Directors or advisory committees; NOVARTIS: Membership on an entity's Board of Directors or advisory committees; GILEAD: Membership on an entity's Board of Directors or advisory committees. Iurlo: Novartis: Speakers Bureau; Incyte: Speakers Bureau; Pfizer: Speakers Bureau; Bristol Myers Squibb: Speakers Bureau. Sportoletti: AstraZeneca: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria. Stagno: Pfizer: Consultancy, Honoraria, Other: Support for attending meetings and/or travel; InCyte: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Other: Support for attending meetings and/or travel, Research Funding. Abruzzese: Pfizer: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Incyte: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria. Breccia: Bristol Myers Squibb/Celgene: Honoraria; Incyte: Honoraria; Abbvie: Honoraria; Pfizer: Honoraria; Novartis: Honoraria.

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